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: 1645749
Sex: F
Age:
State: CA

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

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

Lab Data: Test Date: 202107; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:UNKNOWN; Comments: Since the vaccination, has the patient been tested for COVID-19?:Yes; Test Date: 20210225; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Serve headache; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Jul2021 at 10:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient did not have any known allergies to medication, food or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Feb2021, the patient underwent nasal swab (COVID-19 virus test) and the result was negative. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Jul2021 at 18:00 the patient experienced severe headache and vomiting. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Jul2021, patient underwent COVID-19 virus test and the result was unknown. The clinical outcome of the events severe headache and vomiting was not recovered at the time of this report. The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645750
Sex: F
Age:
State: CO

Vax Date: 02/24/2021
Onset Date: 03/01/2021
Rec V Date: 08/28/2021
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: 202103; Test Name: body weight; Result Unstructured Data: Test Result:lost 20 pounds

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: tiredness; patient was so tired; Muscle pain; swelling throat and lymph nodes.; Diarrhea/ having diarrhea for three years but it was now worse; Joint pain; she can't do any of the domestic housekeeping chores she usually did; swelling throat and lymph nodes; has lost 20 pounds since getting the shot; Patient can't do anything, can't even walk; These side effects all were started three weeks after the vaccination (Mar2021); they have been lingering a long time and getting worse; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6200) via an unspecified route of administration, in the left arm, on 24Feb2021 (at the age of 77-year-old) (in the morning), as single dose, for COVID-19 immunization. The patient's medical history diarrhea, crohn's disease, kidney cancer with removal of her kidney two years ago and colonoscopy. Patient's concomitant medications were not reported. The Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9299, expiry date: Unknown) via an unspecified route of administration, in the left arm, on 03Feb2021 (in the morning), as single dose, for COVID-19 immunization. Patient had the vaccination in Feb2021 (both doses). Patient had a lot joint pain, muscle pain, some trouble swallowing. Patient had some dental work done and they thought maybe that was it because her jaw has been sore but the dentist said no, her jaw checked out good, adds this dentist was like oral facial pain. Patient was still experiencing tiredness; patient was so tired she can't do any of the domestic housekeeping chores she usually did, swelling in her throat and lymph nodes. These side effects all were started three weeks after the vaccination (Mar2021); they have been lingering a long time and getting worse. Patient can't do anything, can't even walk, can't do nothing. Patient has also been having diarrhea. Patient has been having diarrhea for three years but it was now worse. Mentioned patient has lost 20 pounds since getting the shot. Mentioned that the doctor who did the colonoscopy, was treating her for diarrhea with a prescription of Kreon and Citron, but she still has diarrhea, but not like she had it before. Patient is having blood work tomorrow (unspecified date) because her doctor thinks this might be serious. No Emergency Room visit. Patient visited physician office, gone to the regular doctor for diarrhea. They have been treating her for diarrhea before the vaccine but now it was worse. The patient underwent lab tests and procedure which included the body weight and result was lost 20 pounds on an unknown date in Mar2021. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645751
Sex: F
Age:
State: NM

Vax Date: 04/14/2021
Onset Date: 07/25/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Hot, sore, turgid area (about 6 cu inches) at site of shot extending seemingly to the bone; Painful when using arm to pull up out of a chair; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (well controlled) and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN) for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jul2021 at 18:00 the patient experienced hot, sore, turgid area (about 6 cu inches) at site of shot extending seemingly to the bone and was painful when she used the arm to pull herself up out of a chair. Patient thought it was cellulitis. On 27Jul2021 patient saw the doctor and the doctor confirmed that it was not cellulitis. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with amoxicillin (MANUFACTURER UNKNOWN) 1000 mg thrice daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hot, sore, turgid area (about 6 cu inches) at site of shot extending seemingly to the bone and painful when she used the arm to pull herself up out of a chair were not recovered at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds: LISINOPRIL; BABY ASPIRIN.

Current Illness:

ID: 1645752
Sex: F
Age:
State: WA

Vax Date: 07/22/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Weight; Result Unstructured Data: Test Result:around 180 lbs

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: It was a pretty strong spasm and was completely uncontrollable/it was my right arm that started doing spasms; Muscles in my arm started twitching; episodes of muscle twitches; It was feeling like fire inside my arm; My fingers started tingling; Contraction of the muscle; This is a spontaneous report from a contactable consumer reported for herself. A 50-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 22Jul2021 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 22Jul2021, the patient experienced muscles in her arm started twitching almost immediately, well not quite immediately, while later it started having these episodes of muscle twitches and during the evening last night, the muscles were spasming and then it was spasming and it was feeling like fire inside her arm and that lasted till about 12 o'clock then the spasming stopped and it was a pretty strong spasm and was completely uncontrollable and then it stopped, then her fingers started tingling and then didn't had any spasms for a little while and now it's just back to being little twitches again. The muscle spasming, it is not a spasm that causes pain. It's a contraction of the muscle. Consumer stated, "I would also like to know if the 2nd shot is advisable." Due date of 2nd shot: Consumer stated, "I am not sure the exact date but its 15Aug I think." The patient did not receive any treatment and just tried to apply pressure or massage it out and just try to do physically something to help it. The patient underwent lab tests and procedures which included weight: around 180 lbs. Outcome of the event muscle spasm was recovered; while others events was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1645753
Sex: F
Age:
State: DE

Vax Date: 07/22/2021
Onset Date: 07/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Repetitive pulsing sound in left ear; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jul2021 at 13:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to bananas, watermelon, cantaloupe, honeydew (fruit allergy). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Jul2021 at 20:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jul2021 at 07:00, the patient experienced repetitive pulsing sound in left ear. Therapeutic measures were not taken for the events. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event repetitive pulsing sound in left ear was not resolved at the time of report. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645754
Sex: M
Age:
State:

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

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

Lab Data: Test Date: 20210726; Test Name: tested positive for Covid-19; Test Result: Positive; Comments: tested positive for Covid-19 yesterday.

Allergies:

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

Symptoms: Her father got both doses of the vaccine back in January; tested positivefor Covid-19 yesterday; This is a spontaneous report from a contactable consumer patient via sponsored program. A 90-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported), as a single, second dose via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported) as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient experienced both doses of the vaccine back in January, tested positive for covid-19 yesterday. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 26Jul2021 tested positive for Covid-19 yesterday. The outcome of the event was reported as unknown. The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645756
Sex: F
Age:
State: OH

Vax Date: 07/23/2021
Onset Date: 07/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Body that itches really bad; Breaking out in a rash on her arms; This is a spontaneous report from a contactable consumer (patient) via the Regulatory Authority. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FA6780; expiration date: 01Sep2021), via an unspecified route of administration, administered in the left arm on 23Jul2021 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. Medical history included lupus and thyroid disorder. Concomitant medications included gabapentin, prednisone taken for lupus, and SYNTHROID taken for thyroid disorder. The patient reported that she received her first dose of BNT162B2 vaccine on 23Jul2021. The following day on 24Jul2021, the patient experienced a breaking out in a rash on her arms and body that itches really bad. The patient was taking Benadryl at night, so that she doesn't wake up itching. The patient was also using poison ivy medicine to try and relieve the rash and itching because she doesn't know what else to do. The patient wanted to know how long does the side effects last and if she should get the second dose scheduled for 23Aug2021. The patient was also wanted to know if she does get the second dose, will the side effects be even worse. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: GABAPENTIN; PREDNISONE; SYNTHROID

Current Illness:

ID: 1645757
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Feeling unwell; Feels like tremors inside, like shaking; if she moves around too much she feels it more; When she moves around she feels more like chills and tremors kind of like anxiety; When she moves around she feels more like chills and tremors kind of like anxiety; This is a spontaneous report from a contactable consumer. This consumer (husband) reported for a female patient (wife). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 23Jul2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, the patient felt like tremors inside, like shaking; if she moves around too much, she feels it more. When she moves around, she feels more like chills and tremors kind of like anxiety. Reporter stated that She did the 2nd dose of Pfizer vaccine (Unspecified Vaccine) on Friday and within a last couple of days, she's feeling unwell more than the first couple of days in particularly (incomplete sentence). I will explain it exactly, she felt like tremors inside, like shaking, if she moves around too much, she feels it more, if she rest, she feels better and then if again when she moves around she feels more like chills and tremors kind of like anxiety, so we wanted to make sure that it's not one of the serious side effects that we need to pursue somebody. I did have a way to check her vitals here, I had the thermometer, I had an oximeter and I have a blood pressure gauge so I can do that right now and let you know how it reads. Reporter also stated that this stuff was not going to help right now, I need to know if I need to take my wife to the emergency room or not and asked was there something you can help him. Outcome of the events was unknown. Information about Lot/Batch number is requested.

Other Meds:

Current Illness:

ID: 1645758
Sex: M
Age:
State: NJ

Vax Date: 07/24/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:99.7; Comments: his temp goes to 100.9

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: his temperature fluctuates; feels like he has a cold; body aches; he is weak all through the day; lost all his appetite; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number FA6280), dose 1 via an unspecified route of administration on 24Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced his temperature fluctuates, feels like he has a cold, body aches, he is weak all through the day, lost all his appetite. The patient underwent lab tests and procedures which included body temperature: 99.7 his temp goes to 100.9. He said that his temperature fluctuates and this morning his temperature was 100.9. He said that he is driving to work and right now has a temperature of 99.7. He feels like he has a cold, he has body aches, he is weak all through the day, and said that when he goes home his temp goes to 100.9. He also stated that he lost all his appetite and has no appetite. He said that maybe the air conditioner has something to do with it. There is bad handwriting on his vaccination card and he had trouble reading the Lot number. The caller said that he is kind of wondering if these are usual side effects, he said that from people that he works with, he said that they usually say that their symptoms are gone after 2 days and he still has symptoms, and it has been 4 days now. No further details provided. Caller did not have time to complete a safety report at this time as he was at work. The outcome for all events was unknown. Follow-Up (13Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645759
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 05/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: hla-b27; Result Unstructured Data: Test Result:Positive; Comments: I do test positive for hla-b27; Test Date: 202101; Test Name: COVID-19; Result Unstructured Data: Test Result:Covid; Comments: Covid early in Jan2021

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: The vaccine activated an autoimmune condition. spondyloarthritis The second shot made it so much worse. I did not realize what was happening. Though pulled back, cracked rib, etc. got worse and wor; Though pulled back; The vaccine activated an autoimmune condition. spondyloarthritis The second shot made it so much worse. I did not realize what was happening. Though pulled back, cracked rib, etc. got worse and wor; The vaccine activated an autoimmune condition. spondyloarthritis The second shot made it so much worse. I did not realize what was happening. Though pulled back, cracked rib, etc. got worse and wor; Night stiffness; Pain in feet; Pain in feet, back and in soft tissues around bone joints; Pain in feet, back and in soft tissues around bone joints; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on an unspecified date in 2021 (Batch/Lot Number: ER8735) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included HBP (high blood pressure), high cholesterol but under control with meds and COVID-19 in Jan2021. Concomitant medications included atorvastatin and lisinopril. Historical vaccine included BNT162B2 (Lot number: Ek8737), dose 1 on an unspecified route in the arm left on 05Apr2021 at 02:00 PM (at the age of 52-years-old) for COVID-19 immunization in which the vaccine activated an autoimmune condition spondyloarthritis. The patient had no relevant past drug history. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient diagnosed with COVID-19 prior to vaccination. It was reported that the vaccine (1st shot) activated an autoimmune condition - spondyloarthritis. The second shot made so much worse. He did not realize what was happening. Though pulled back, cracked rib, etc. got worse and worse. Night stiffness. He was almost crippled, he had pain in feet, back and in soft tissues around bone joints. Finally, he got into a doctor and got on ENBREL and CELEBREX. Which made him feel 99% back to normal. The patient mentioned that the shot crippled him and activated an autoimmune. He was tested positive for hla-b27, as he found out. And he also had covid early in Jan2021. So he had antibodies most likely already. He added that no one believed the shot caused it; but there was no doubt it did based on timeline and symptoms. The patient had not been tested for COVID-19 since the vaccination. The events' onset date was on 09May2021 with unknown outcome. No hospitalization/prolonged. Therapeutic measures were taken as a result of the events. The events resulted to doctor or other healthcare professional office/clinic visit Follow-up attempts are completed. No further information is expected.

Other Meds: ATORVASTATIN; LISINOPRIL

Current Illness:

ID: 1645760
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: My cycle has become irregular; This is a spontaneous report from a contactable consumer (patient). A female patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: Unknown, expiry date: unknown), via an unknown route of administration on an unknown date as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced 'my cycle has become irregular'. It happened right after taking the 2nd vaccine. When paraphrased, consumer stated, "Irregular, it is no longer the same. It is irregular." The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645761
Sex: M
Age:
State: AR

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: I am experiencing brain fog and muscle cramps on a regular basis.; I am experiencing brain fog and muscle cramps on a regular basis.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, cardiac arrhythmia (reported as quadrant of heart with different rhythm than others), crohn's (reported as chrohn's). The patient had no known allergies to medications, food, or other products. The patient had received other medications (unspecified) within two weeks of vaccination. 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. From 07Apr2021, the patient has been experiencing brain fog and muscle cramps on a regular basis. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events experiencing brain fog and muscle cramps on a regular basis was not resolved at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645762
Sex: F
Age:
State: LA

Vax Date: 07/24/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202102; Test Name: covid-19; Result Unstructured Data: Test Result:Positive; Comments: have the Covid 19 virus in Feb2021

Allergies:

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

Symptoms: woke up a lot and she was moving around all night; feels like the wheels in her head are constantly spinning, mind doesn't stop; runny nose; trouble sleeping/got out of bed at 2:30AM in the morning and she was wide awake at 4:00AM and not feeling tired, she was wide open; mood swings up and down, mad, sad, happy; headache; crying; mood swings up and down, mad, sad, happy; moodiness; Wheels in her head are turning; This is a spontaneous report from a contactable consumer (patient herself). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 24Jul2021 at 10:00 as (at the age of 51-Years-old) dose 1, single for COVID-19 immunisation. Vaccine was not administered at military facility. Medical history included COVID-19 from Feb2021 to an unknown date have the COVID-19 virus in Feb2021. The patient previously received flu vaccine 6 years ago with achy arm. Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken for gastric disorder from an unspecified start date and ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect was not available. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). The patient experienced mood swings up and down, mad, sad, happy, feels like the wheels in her head are constantly spinning, headache, crying, moodiness and wheels in her head are turning on Jul2021, trouble sleeping on 24Jul2021, runny nose on 25Jul2021, woke up a lot and she was moving around all night and mind doesn't stop on 27Jul2021. AEs were not resulted in visit of emergency room or physician office. Patient even bought a pack of cigarettes because she has to always be doing something. She can't keep going like this. She knows it's a problem that she has to deal with. She's on her fifth day after the COVID-19 vaccine. People that she has spoken with say the second COVID-19 vaccine is stronger and has more effects. If this is the case, and her body is reacting to the vaccine like this, she won't be able to get the second dose. She is asking if her symptoms have been reported. When probing height and weight she states she wondered why no one asked her about her height and weight when she was getting her COVD-19 vaccine. She did call her primary care doctor this morning but he wasn't much help with this. She woke up this morning and thought these symptoms have got to go away. She also wants to be able to go on vacations and the COVID-19 vaccine is being required. She had coworkers who had the COVID-19 vaccine so she went ahead and decided to get it. She reports she doesn't get a flu shot anymore. She provides the following information historically. Years ago both her shoulders were frozen. It's the way she is built and her sister has the same problem. She had one shoulder freeze and the next year, her other shoulder froze up. She had a surgery and the doctor cranked her shoulders around to break up the deposits that were in her shoulders. She received a flu vaccine that year and her arm was so achy and kind of stiff. She was worried about it. She remembers asking if she can receive the flu shot in a different part of her body but she was told she can't. She doesn't get the flu shot anymore. This occurred about 6 years ago. She does not have any product information for that flu vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test with result positive on Feb2021 have the COVID-19 virus in Feb2021. The outcome of the event runny nose was resolved on 25Jul2021, headache was unknown and the outcome of the remaining events were reported as not recovered.

Other Meds: OMEPRAZOLE

Current Illness:

ID: 1645763
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: Left ear felt blocked, tinnitus was acting up; Tingling in her earlobe; Swollen eardrum on the left side; Second shot, which was supposed to be on 02Jul2021, but she is holding off/she skipped the 2nd dose for fear it would cause hearing loss; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left (left upper arm) on 28May2021 14:22 (at the age of 40-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included temporomandibular joint syndrome (TMJ) from 2020, the patient had it over a year now. The patient's concomitant medications were not reported and no other products reported. The patient had no history of previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). The patient had all prior vaccines and can't remember any adverse reactions. The patient had first shot was on 28May2021, and she came home, took a shower, within a couple of hours her left ear felt blocked and her tinnitus was acting up. She felt like something was poking in her ear, on the left side, she was unsure if it was related, but then she had the tingling sensation/felt tingling in her ear lobes later that night, and that started for the next couple weeks, and she still had it until 02Jul2021, but she did not do that shot yet, as she was nervous why that would happen, and she did research, and she thought some people reported tinnitus, hearing loss, and she still had tingling, which was now gone. The tingling stopped, so that's good. But she would like to get the second dose to be fully vaccinated, but she was unsure if something worse may happen. But because of the ear tingling she skipped the 2nd dose for fear it would cause hearing loss. Caller reports that she can't remember the exact date that the tingling to her ear lobes stopped but reports that it eventually went away. She went to Doctor Sunday, she can't remember when, but it was recent, as she had a swollen eardrum on the left side, she was unsure if it's related to the vaccine, but the tingling did stop, but she has TMJ, and she had the swollen eardrum, she was unsure if its vaccine related, or both, but it's gone now and it's not swollen, and she wondered if the tingling of the earlobe could be worse with the second shot or affect the hearing. She called the pharmacy, they said they had no side effects like that, and caller researched and it said some people had side effects with ears, and at the ENT visit yesterday she thinks, it was someday this week, she was so tired, she cannot confirm if it's related to the vaccine, it was a follow up from urgent care, where she was diagnosed with a swollen ear drum in the left ear, and they said everything was fine, that it could be related to TMJ or could or could not be related to the vaccine, but the doctor's opinion was it would be ok to get the vaccine because her ears looked fine. She was wondering if there are any reports of Tinnitus or ear tingling from the vaccine and if so, did those people lose their hearing. She was asking, if the second dose was administered later than the recommended time interval does that change the efficacy, it's been more than 6 weeks since her first dose. Alternative dosing regimens of Pfizer-BioNTech COVID-19 Vaccine have not been evaluated. The decision to implement alternative dosing regimens resides with health authorities; however, we at Pfizer believe that it was critical for health authorities to conduct surveillance on implemented alternative dosing schedules to ensure that vaccines provide the maximum possible protection. The adverse events not required visit to emergency room. No relevant test done. The outcome of the events Tingling in her earlobe and Swollen eardrum on the left side was recovered on an unspecified date in 2021 and 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: 1645764
Sex: F
Age:
State: NJ

Vax Date: 01/11/2021
Onset Date: 02/08/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210208; Test Name: Blood pressure; Result Unstructured Data: Test Result:Issues mmHg; Test Date: 20210208; Test Name: Heart rate; Result Unstructured Data: Test Result:Increased

Allergies:

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

Symptoms: Bilateral SN hearing loss; Ear fullness; Tinnitus; Dysautonomia; Vestibular neuritis; Heart rate increased; Blood pressure issues; Vision changes; Rash; Hyperthyroidism; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), intramuscular in left arm, on 11Jan2021 at 01:15 PM (13:15) (at the age of 48 years), as dose 2, single, for COVID-19 immunization. The patient's medical history included asthma, seasonal allergies, and allergies to sulfa drugs. The patient's concomitant medications included cetirizine hydrochloride (ZYRTEC), Montelukast sodium (SINGULAIR), and fluticasone propionate/ salmeterol xinafoate (ADVAIR). The patient previously received the first dose of BNT162B2 (Lot Number: EJ1685) on 21Dec2020 at 01:15 PM at the age of 48 years (intramuscular in left arm) for COVID-19 immunization and experienced no reaction on exposure to previous vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Feb2021, the patient experienced bilateral SN hearing loss, ear fullness, tinnitus, dysautonomia, vestibular neuritis, heart rate increased, blood pressure issues, vision changes, rash, and hyperthyroidism. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Treatment was received for the adverse events including steroids, oral and intratympanic medications, and beta blockers. The events were considered serious as disabling or incapacitating. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.; Sender's Comments: Based on plausible temporality the causal role of the BNT162B2 vaccine cannot be excluded for the reported events. 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: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SINGULAIR; ADVAIR

Current Illness:

ID: 1645765
Sex: F
Age:
State:

Vax Date: 07/26/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pain the arm; feeling a little tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that, A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration on 26Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain the arm and feeling a little tired. It was reported that, caller got her 1st dose and had severe reactions to it like cramping, pain in the arm and she was tired. She mentioned even a possible blood clot. She stated she got the 2nd dose yesterday but has had only pain the arm and feeling a little tired. Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645766
Sex: F
Age:
State: MO

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

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

Lab Data:

Allergies:

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

Symptoms: Seizures; This is a spontaneous report from a contactable consumer (Patient) or other non-health care professional. This is a report received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history included immunodeficiency, I'm immunocompromised, gastrointestinal disorder from an unknown date and unknown if ongoing. Recently she had undergone several surgeries, radiology, and chemotherapy for a problem in my lower intestine. The patient concomitant medications were not reported. The patient previously took dilantin [phenytoin sodium] for seizure, levetiracetam for seizure. On an unspecified date patient had previous episodes of seizures. She would want to know if the Pfizer-BioNTech COVID-19 Vaccine would "trigger" seizures. Outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645767
Sex: M
Age:
State: PA

Vax Date: 05/14/2021
Onset Date: 07/23/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: sick with Covid 4 days ago; sick with Covid 4 days ago; This is a spontaneous report from a contactable consumer (Patient's mother). A 12-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0181; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Arm Left on 06Jun2021 as dose 2, single for COVID-19 immunisation. Patient had earlier received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0176; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Arm Left on 14May2021 as dose 1, single for COVID-19 immunisation. Related lot numbers: fill lot EP8727, and formulated drug product lot EP8608. Medical history included mild asthma from 2019 and ongoing, diagnosed 2 years ago. The patient's concomitant medications were not reported. Prior vaccination within 4 weeks none. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Family Medical History Relevant to AE(s) were none. Predisposing factors were unknown. The patient experienced sick with covid 4 days ago on 23Jul2021, this should be looked into to see if the dosages he received had an issue in production. It was reported that Patient received two doses of the Covid Vaccine and was fully vaccinated and ended up sick with Covid 4 days ago. Reporter want to report this as this should be looked into to see if the dosages he received had an issue in production or others who received doses from the same batch are positive for Covid. reporter would like to speak with someone about this since your clinical findings for his age group indicate 100% protection. Caller was not sure if there was an issue during the manufacturing process for that batch of vaccines. Caller verified the information provided by the transferring agent and states the patient was diagnosed with covid on Sunday 25Jul2021 and his symptoms of covid started late Friday or early morning Saturday. Relevant Tests were none. Primary infection site was reported as unknown. Adverse events did not require a visit to emergency room nor Physician Office. Stated that the patient had no treatment for the reported event. Patient received no treatment for reporting events. Upon follow-up received on 29Jul2021 from a Product Quality Complaint Group. This report included Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot EW0176 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0176, fill lot EP8727, and the bulk formulated drug product lot EP8608. A complaint sample was not returned. No re. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EW0181 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 EW0181, fill lot EP8732, and bulk formulation lot EP8613. A complaint sample was not returned. No related quality issues were identified during the investing. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EW0176 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0176, fill lot v EP8727, and the formulated drug product lot EP8608. 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. Reporter seriousness for was fully vaccinated and ended up sick with covid four days ago was unspecified. The outcome of events was Unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Asthma (mild asthma diagnosed 2 years ago)

ID: 1645768
Sex: F
Age:
State: TN

Vax Date: 05/21/2021
Onset Date: 05/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Soreness at injection site; This is a spontaneous report from a contactable nurse (patient). This nurse reported in response to HCP letter sent via follow-up letter which included that a 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), via intramuscular, administered in deltoid right on 21May2021 at 15:00 (vaccinated at the age of 55 years) as DOSE 1, SINGLE for covid-19 immunisation. Vaccination facility type was other and not administered at military facility. Medical history, prior vaccinations and concomitant drugs were none. Family medical history includes Heart disease and diabetes mellitus (DM). The patient experienced soreness at injection site on 21May2021. First vaccine adverse reaction except arm soreness at injection site. Relevant tests were none. Outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645769
Sex: U
Age:
State: CA

Vax Date: 06/09/2021
Onset Date: 06/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: fever; body ache; headache; tired; no appetite; This is a spontaneous report received from a contactable consumer (patient). An unspecified gender 73-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 09Jun2021 09:00 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19May2021 09:00 for COVID-19 immunization. On 10Jun2021 patient was experienced with fever, body ache, headache, tired and no appetite. Outcome of events was recovered on 12Jun2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645770
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: Little by little I started getting ill feelings; Still ill feeling; Down feeling/I am unwell; Little by little I started getting ill feelings; Still ill feeling; Down feeling; Tiredness; Sore throat once in a while; Nausea; Woke up and my right ear I could hear my heartbeat I mean really, really loud that it kind of woke me up; Loud enough; Had one more time the same heartbeat; Woke up and my right ear I could hear my heartbeat I mean really, really loud that it kind of woke me up; Loud enough; Had one more time the same heartbeat; Chills; Eye was kind of swollen, something in the right eye I had, all red, the white was red for somehow the middle thing pop; Eye was kind of swollen, something in the right eye I had, all red, the white was red for somehow the middle thing pop; Eye was kind of swollen, something in the right eye I had, all red, the white was red for somehow the middle thing pop; Some were just annoying; Not really bad off, it is just annoying, the way I feel just not myself like I like to do things when I can't; Some were just annoying; Not really bad off, it is just annoying, the way I feel just not myself like I like to do things when I can't; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included blood pressure high, Kidney disease and thyroid. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) at 100-25 mg taken for blood pressure measurement, start and stop date were not reported. It was reported that little by little patient started getting ill feelings; Still ill feeling; down feeling. Patient Some were just annoying; Not really bad off, it is just annoying, the way patient feel just not myself like I like to do things when I cannot and then, now patient was just, patient was down feeling, sore throat once in a while and so patient cannot take the second one. patient just want everybody to know patient was not refusing because patient feeling unwell and then patient cannot take the second one and then patient can start all over again. Patient had her first vaccine COVID 19 on June 28th at a pharmacy. Patient had no swelling, absolutely nothing, patient was very happy about it and then little by little patient started getting ill feelings, some were listed, and some were just annoying, and it does not stop, like patient was supposed to take the second one on the 20th and patient could not. Patient called the Pharmacy and explained them what happened, and she said that we will suggest that you already have taken the first you can do it later but patient still ill feeling. Patient had tiredness and patient have chills, sore throat, nausea and feeling unwell and the worst one, one night patient do not remember it probably around the 16th, woke up and my right ear I could hear my heartbeat I mean really, really loud that it kind of woke me up and I mean it is loud enough so, patient did not know what to do, it was in the middle of the night and it finally stopped. And then, when patient got up my eye was kind of swollen and there was something in the right eye patient had, all red, the white was red for somehow the middle thing pop, I guess. So that is the worst one and then patient had one more time the same heartbeat. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100962774 same product and event, different patients

Other Meds: LOSARTAN HCTZ

Current Illness:

ID: 1645771
Sex: F
Age:
State: GA

Vax Date: 03/19/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: swelling; lumps and bumps on her lips; lumps and bumps and grainy feeling in her lips is ongoing; toothache; cystic pimple at the injection site around her mouth; This is a spontaneous report from a contactable consumer, the patient. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) dose 2 via an unspecified route of administration on 19Mar2021 as dose 2, single (at 56-years-old) for covid-19 immunisation. Medical history included allergy to sulfa. Concomitant medication included hyaluronic acid (RESTYLANE) taken for an unspecified indication from 07Jul2021 to an unspecified stop date; hyaluronic acid, lidocaine (RESTYLANE L) taken for an unspecified indication from 07Jul2021 to an unspecified stop date; hyaluronic acid (JUVEDERM VOLUMA) taken for an unspecified indication from 07Jul2021 to an unspecified stop date. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration on 19Feb2021 as dose 1, single (at 56-years-old) for covid-19 immunisation. Patient was injected with 1 syringe of Restylane Kysse in the lips and 1 syringe of Restylane Lyft in the cheeks, and 2 syringes of Voluma, injected around the mouth area, on 07Jul2021.Patient had immediately experienced swelling in the areas, the same date of injection, 07Jul2021. Patient swelling was subsided after a couple of days (exact date unknown) and in Jul2021, patient started to feel lumps and bum on her lips when she applied lipstick (exact date unknown). she palpated the area and could feel the lumps and bumps and it also felt grainy. Patient also reported that, within a couple days of the injection, she developed a cystic pimple at the injection site around her mouth (exact date unknown), on her nasolabial fold and it subsided after a few days (exact date unknown). Patient reported that, in Jul 2021, last week sometime (exact date unknown) she developed a toothache. The lumps and bumps and grainy feeling in her lips is ongoing, as well as the toothache. she notified the injecting HCP who told her to wait a full 2 weeks before coming back in to the office. she only took vitamins and supplements (unspecified) daily. Patient had not received fillers in the past. She denied any other vaccinations in the past 6-12 months, also denied that any illness leading up to injection date. she had a dental cleaning on 09Jun2021. Patient had not received treatment. The outcome of the event swelling and mouth cyst was recovered and for rest all it was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up

Other Meds: RESTYLANE; RESTYLANE L; JUVEDERM VOLUMA

Current Illness:

ID: 1645772
Sex: F
Age:
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 44-year) on 26Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 26Jul2021 the patient experienced diarrhea, soreness of arms, swelling of underarm (arm where she got injected) that has a knot and feels warm, swollen lymph nodes. It was reported that the patient reported diarrhea, soreness of the arm, swelling under the arm that was injected after receiving her first dose of the Pfizer COVID-19 vaccine. The caller clarified that there was a knot under the arm that feels warm and said that it was a swollen lymph node. The caller also reported that her son also experienced swollen lymph nodes after he received the vaccine same day as her and the patient asked if swollen lymph node was one of the side effects of Pfizer COVID-19 vaccine. The clinical outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645773
Sex: U
Age:
State:

Vax Date: 07/26/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Feverish feeling; Rash on my face, chest; Severe swollen on my Lymph node underneath my armpit on my arms on the vaccine site; Severe swollen on my Lymph node underneath my armpit on my arms on the vaccine site; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration on 26Jul2021 (Lot Number: FA7484) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (LOT number: EW0196) on 21Jun2021 and patient was fine with the first dose. It was reported that patient was just had a question for his/her second dose. Patient was fine with the first dose but for a second dose which he/she received yesterday (before reporting date). On Jul2021 patient experienced the Feverish feeling, patient woke up and patient got rash on his/her face, chest and patient got severe swollen on Lymph node underneath his/her armpit on arms on the vaccine site. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1645774
Sex: M
Age:
State:

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

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

Lab Data: Test Date: 2021; Test Name: antibody test; Result Unstructured Data: Test Result:no antibodies

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, unknown lot number), dose 2 via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection) on an unknown date as single dose for covid-19 immunisation. Patient received the two doses of the Pfizer?s COVID-19 vaccine, he was not sure but believes that it could have been two months ago on an unknown date in 2021. He was an immunocompromised patient and presented no antibodies after receiving the second dose of the Pfizer's COVID-19 vaccine. When he received the second dose of the vaccine he had mild flu like symptoms. He also wanted to know if a low level of antibodies could indicate that he requires a third "booster" dose. He was advised to get revaccinated by his physician. Patient underwent lab test which included antibody test on an unknown date in 2021 and which showed no antibodies. The outcome of the events was unknown. The lot number for the vaccine bnt162b2 was not provided and has been requested.

Other Meds:

Current Illness:

ID: 1645775
Sex: M
Age:
State: SC

Vax Date: 07/21/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: dementia has gotten worse since he received the vaccine; violently explosive /he is having tantrums and rages; cognitive ability has decreased; violently explosive /he is having tantrums and rages; paranoid; This is a spontaneous report from a contactable consumer (patient's wife). A 68-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 21Jul2021 at 16:00 (Batch/Lot Number: FA6780) (at the age of 68-year-old) as dose 1, single for COVID-19 immunization. There were no additional vaccines administered on the same date of the Pfizer vaccine. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Medical history included ongoing dementia with lewy bodies (diagnosed several years ago), liver transplant from 2009 (had the transplant due to Hepatitis C), ongoing diabetes (diagnosed prior to 2009), ongoing kidney disease (diagnosed sometimes after 2009), ongoing high blood pressure, ongoing depression (suffered from depression most of his life, hepatitis C, liver cirrhosis, trouble walking, muscle mass loss, and lost weight. The patient has trouble walking and muscle mass loss due to the dementia. The patient has lost weight due to diabetes, dementia and kidney disease and being a liver transplant patient. The patient had no family medical history relevant to the adverse events. Concomitant medications included tacrolimus (PROGRAF) taken for liver transplant from 2009 and ongoing; insulin glargine (LANTUS) taken for diabetes from an unspecified start date and ongoing (since before 2009); lisinopril taken for an unspecified indication from an unspecified start date and ongoing; carvedilol (COREG) taken for blood pressure high from an unspecified start date and ongoing; colchicine (COLCRYS) taken for gout from an unspecified start date and ongoing; allopurinol taken for gout from an unspecified start date and ongoing; celecoxib (CELEXA) taken for depression from an unspecified start date and ongoing; quetiapine fumarate (SEROQUEL IR) as antipsychotic from an unspecified start date and ongoing; mycophenolate mofetil (CELLCEPT) taken for liver transplant from 2009 and ongoing; donepezil hydrochloride (ARICEPT; reported as "Aracept") taken for lewy body dementia from an unspecified start date and ongoing (several years). On 21Jul2021, the patient experienced dementia has gotten worse since he received the vaccine, violently, and cognitive ability has decreased. On Jul2021, the patient experienced tantrums and ranges and paranoid. The reporter stated that her husband received the first dose of the Pfizer BioNTech Covid-19 Vaccine on 21Jul2021. She stated that almost immediately afterward he became "violently explosive" and has not improved since. The patient has a history of Lewy Body Dementia, diabetes, hepatitis C, kidney disease, liver cirrhosis, and he has had a liver transplant. The reporter stated that her husband's dementia has gotten worse since he received the vaccine, and he does not realize it. The reporter stated that he was having tantrums and rages, and that he has been paranoid after watching the news that if he and his wife are not fully vaccinated, they will get Covid-19 and die. The patient's wife asked, considering his health history and his reaction after the first dose, if he should get the second dose of the Pfizer BioNTech Covid-19 Vaccine. She stated that she will speak with her husband's transplant physician. The reporter stated she was not sure if the vaccine was even safe for him with his kidney issues due some of the inactive ingredients like sodium and potassium. She reported that her husband received on 21Jul2021 his first dose of the Pfizer Covid-19 vaccine. The patient has had a liver transplant, was diabetic, has severe kidney disease and Lewy Body Dementia, and immediately after the vaccine the patient has become very violent and has not changed since then. The patient got his vaccine at (withheld). The reporter stated the pharmacist lied to them. She asked him if the Covid 19 vaccine was approved by the FDA and he said yes but she was reading it was only approved for the emergency authorization use. She was afraid for him to have the second dose of the vaccine. She reported that the patient has lost weight due to diabetes, dementia and kidney disease and being a liver transplant patient. He has gotten more and more violent, dementia has worsened, he wants to just argue. She reported that he also has gout, states he has trouble walking and muscle mass loss due to the dementia, becomes violently explosive if he is out in public around a lot of people. The events did not require a visit to emergency room and physician office. There were no relevant tests. The outcome of the events was not recovered.

Other Meds: PROGRAF; LANTUS; LISINOPRIL; COREG; COLCRYS; ALLOPURINOL; CELEXA [CELECOXIB]; SEROQUEL IR; CELLCEPT [MYCOPHENOLATE MOFETIL]; ARICEPT

Current Illness: Blood pressure high (Verbatim: high blood pressure); Dementia with Lewy bodies (Verbatim: lewy body dementia diagnosed several years ago); Depression (Verbatim: Depression suffered from depression most of his life); Diabetes (Verbatim: Diabetes diagnosed prior to 2009); Kidney disorder (Verbatim: kidney disease diagnosed sometimes after 2009)

ID: 1645776
Sex: F
Age:
State: NY

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
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: 202105; Test Name: heart rate; Result Unstructured Data: Test Result:Increased

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: lung issues; heart issues; random heart rate spike; This is a spontaneous report from a non-contactable consumer. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration in left arm on an unspecified date in May2021 as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. It was unknown if the patient received any concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. The patient experienced lung issues, heart issues and random heart rate spike on an unspecified date in May2021. It was reported that the patient feels iffy about the vaccine. Patient was hospitalized 2 times due to reaction to vaccine. She also stated the vaccine gave her heart and lung issues but they're finally going down some but still having random heart rate spike. Since the vaccination, patient has not been tested for COVID-19 and it was unknown if any treatment was received for the event. Outcome of events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1645777
Sex: F
Age:
State: OH

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: The area where received the 2nd vaccination had no feeling; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the right arm on 27Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 30Mar2021 at 08:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021, the area where the patient received the second vaccination had no feeling. She could not feel her skin to the touch but she had muscular feeling. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event. The patient contacted her physician who advised her to contact Pfizer as reported. The clinical outcome of the event the area where received the second vaccination had no feeling was not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1645778
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: ill feelings; Still ill feeling; Down feeling; Tiredness; Sore throat once in a while; Nausea; I am unwell; Woke up and my right ear I could hear my heartbeat; I could hear my heartbeat I mean really, really loud that it kind of woke me up;; Chills; Eye was kind of swollen; in the right eye I had, all red, the white was red; in the right eye I had, all red, the white was red for somehow the middle thing pop; Some were just annoying; Not really bad off, it is just annoying, the way I feel just not myself; Some were just annoying; Not really bad off, it is just annoying, the way I feel just not myself; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is a 2nd of 2 reports. This consumer reported for a female patient that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EWO80), dose 1 via an unspecified route of administration on 28Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ill feelings; still ill feeling, down feeling, tiredness, sore throat once in a while, nausea, unwell, woke up and right ear could hear, could hear heartbeat i mean really, really loud that it kind of woke me up, chills, eye was kind of swollen, in the right eye i had, all red, the white was red, in the right eye i had, all red, the white was red for somehow the middle thing pop, some were just annoying; not really bad off, it is just annoying, the way i feel just not myself (irritability, and feeling abnormal) on an unspecified date. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100962492 same product and event, different patients

Other Meds:

Current Illness:

ID: 1645779
Sex: F
Age:
State: NY

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

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

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:Fine; Comments: everything was fine

Allergies:

Symptom List: Nausea

Symptoms: rainbow vision going across her eye; looked one way and saw like rainbow, kind of halos/I had rainbow vision, floating in front of my eyes; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection,Batch/Lot Number: EW0217; Expiration Date: 30Sep2021), via intramuscular, administered in left arm on 27Jul2021 14:00 (at age of 51-year-old) as dose 1, 0.3 ml single for covid-19 immunization. Medical history included respiratory illnesses in the past, pneumonia and bronchitis, this was a couple of years ago, and recovered completely. The patient previously had an allergic to Erythromycin, allergic reaction as a baby and never took it again.Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. No AE(s) following prior vaccinations.Other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none.The patient's concomitant medications were not reported she took vitamins, but no medicine. On 28Jul2021, 11:15 next day after receiving the vaccine the patient experienced rainbow vision going across her eye; looked one way and saw-like rainbow, kind of halos/patient had rainbow vision, floating in front of her eyes, but it was impeding her vision. The patient confirmed this rainbow vision was not ongoing and persisting at this time.She was driving home today and all of a sudden, her vision got a little weird.It just happened that one time. The caller wants to know if that is a side effect. The patient did not visit emergency room or physician's office. The patient underwent lab tests and procedures which included blood test: everything was fine on an unspecified date. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645780
Sex: F
Age:
State: KY

Vax Date: 07/12/2021
Onset Date: 07/14/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210714; Test Name: blood sugars; Result Unstructured Data: Test Result:Increased

Allergies:

Symptom List: Injection site pain

Symptoms: RA flare; mental fogginess; extreme fatigue; increased blood sugars; joint pains; increased depression; generalized weakness; the worst migraine in over 25 years; This is a spontaneous report from a contactable other health professional (patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Jul2021 10:30 (Lot Number: EW0179; at the age of 49-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis (RA), hypothyroidism, allergies, and migraine. Concomitant medications were not specified. The patient previously took etanercept (ENBREL) and ibuprofen (MOTRIN) for migraine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 14Jul2021, the patient experienced RA flare, extreme fatigue, increased blood sugars, joint pains, increased depression, mental fogginess, generalized weakness, and the worst migraine in over 25 years. It was reported that patient have not had a migraine in 20 years that was untreatable with Motrin (for clarification) and thought this was after not having Enbrel for weeks prior to COVID vaccination. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the information currently available, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional 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 RAs, Ethics Committees, and investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1645781
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: Metallic taste immediately following injection that lasted about 24 hours; Headache and nausea with vertigo; Headache and nausea with vertigo; Headache and nausea with vertigo; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 27Jul2021 at 15:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic Epstein-Barr virus infection, osteonecrosis, hyperacusis, supraventricular tachycardia and allergy to latex, contrast dye, PCN, Sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 25Jun2021 at 17:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation and took cefalexin (KEFLEX) on an unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jul2021 at 15:30, immediately following injection, the patient experienced metallic taste lasted about 24 hours, headache and nausea with vertigo. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events metallic taste immediately following injection was resolved on 28Jul2021 and of the headache and nausea with vertigo was not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1645782
Sex: F
Age:
State: FL

Vax Date: 04/14/2021
Onset Date: 07/26/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Double ear infection/ ear infection; She couldn't hear out of her left ear and it was hurting.; left ear was hurting; sore for one day; got sleepy around 7:00PM; swollen lymph node in her right armpit; She did start to feel sick; Her throat was bothering her; her ear started bothering her; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route on 26Mar2021 (at the age of 53-years) as dose 1, single in the right arm and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8737), via an unspecified route on 14Apr2021 (at the age of 53-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included Fibromyalgia, her right ovary taken out and appendix taken out, cyst taken out on 1983, C-section with her son, Incarcerated umbilical hernia, double hernia surgery on 2012, incarcerated strangulating hernia on 2015, had cellulitis in her knee she fell and hurt it, she was too heavy, perimenopause. The patient concomitant medications were not reported. The patient previously took flu vaccine on unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unspecified date of 2021, the patient experienced throat was bothering her, she did start to feel sick, her ear started bothering her, Double ear infection/ ear infection, couldn't hear out of her left ear, left ear was hurting, sore for one day, got sleepy around 7:00PM, swollen lymph node in her right armpit and she wondered if she had the Covid 19 virus. She went to the hospital and she didn't have the flu and she didn't have Covid 19. She reports the man in the room next to her did have the Covid 19 virus and he was acting up. It was a man in his 60's. She came home and nursed herself and got better then on Thursday her ear started bothering her. She went to her doctor and was diagnosed with a double ear infection on 26Jul2021. Patient was calling for information regarding a booster vaccine but then mentioned timing between the first and second doses. She and her family members have been fully vaccinated. All received their Covid 19 vaccines 14 days apart. Reporter stated that when probing weight she reports she is too heavy even thought she doesn't look it. When she tells people how much she weighs they are surprised. When probing for medical history she reports she's had surgeries since she was 16 years old. She's had her right ovary taken out, her appendix taken out, a cyst taken out in 1983. Then she had a C-section with her son and then an incarcerated umbilical hernia. Then in 2012 she had a scheduled double hernia surgery. In 2015 she had another incarcerated strangulating hernia and that almost took her out and 2 years ago she messed her knee up and got cellulitis. She fell and hurt it. She went to the doctor for her ear on Monday, 26Jul2021. She had gone to the emergency room before that for a virus. She forgot to ask her doctor if she had a middle or outer ear infection. With the Covid 19 vaccine she reports she was sore for one day and she and her brother both got sleepy around 7:00PM when they got their vaccines. She also got a swollen lymph node in her right armpit. It went away after a couple of days. The outcome for the events sore for one day was resolved on Jul2021, swollen lymph node in her right armpit was resolved on 2021 and other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100963485 same reporter/product/event, different patient;US-PFIZER INC-202100963484 same reporter/product/event, different patient;US-PFIZER INC-202100963483 same reporter/product/event, different patient

Other Meds:

Current Illness:

ID: 1645784
Sex: F
Age:
State: MD

Vax Date: 04/09/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: echocardiogram; Result Unstructured Data: Test Result:ruled out, no fluid on her heart; Test Date: 202106; Test Name: Vascular test; Result Unstructured Data: Test Result:left arm, no blood clots; Test Date: 20210723; Test Name: Vascular test; Result Unstructured Data: Test Result:both arms, no blood clots

Allergies:

Symptom List: Tremor

Symptoms: She had a swelling in the injection site on both doses and both sites.; arm started swelling, puffing up/she still has puffiness in the right arm; couldn't lift that arm; This is a spontaneous report from a contactable consumer(patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry Date: unknown, NDC number: 59267-1000-1), via an unspecified route of administration, administered in Right arm on 09Apr2021 at 09:45 in the morning (at the age of 62-years-old) as dose 1, 0.3 ml single for covid-19 immunization. Patient medical history (including any illness at time of vaccination) was acid reflux from an unknown date, allergies from an unknown date. She had to stay a little while because she has allergies to everything. There were no concomitant medications. Investigation Assessment was Yes. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine were none. Prior Vaccinations (within 4 weeks) If applicable, list of any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were none. AE(s) following prior vaccinations were none. family medical history relevant to AE(s) were not provided. It was reported that she had her 1st dose of the vaccine on her right arm last 08Apr2021 and got her 2nd dose on her left arm last 30Apr2021. She had a swelling in the injection site on both doses and both sites. It was reported that ever since she received the Pfizer shot at (withheld) in Apr, the first shot was at the beginning of Apr, her first shot was put in her right arm, her arm started swelling, puffing up on 09Apr2021. She had to stay a little while because she has allergies to everything. It started puffing up and the nurse was massaging it. She could not lift that arm on an unspecified date in Apr2021, she had to take two Tylenol and ice it. she still has puffiness in the right arm on 09Apr2021. She has seen vascular medicine twice to rule out, and there no blood clots, right side and left side, she had an echogram of her heart, and they ruled out no fluid on her heart. Patient Details: Ethnicity: That is probably why she is having an adverse reaction; she is mixed but states she is (Withheld). Reporter asked why her mother, who is 86 years old got it and nobody else got. She told her doctor that she was going to call the CDC and she said she should. They have done every test she can think of and she has seen a rheumatologist, and they said its not in her joints and everybody thinks its a side effect from the vaccine, but she has not ever had swelling in her arms before, and all of a sudden one is bigger than the other. She's on the fourth floor. She was looking through all the papers, and her girlfriend was saying she signed something and she could not remember so she just found all these papers, the VAX sheet for caregivers, emergency release of Pfizer BioNTech Covid 19 to prevent, she just found that sheet and thats where she got the number, through (specialty facility). She did talk to her doctor prior to taking it. She has allergic reactions she thinks it was anesthesia, just had in October and she had that with shellfish, the contrast, so she has allergic reactions and they told her what this was made up of and gave her the ingredients and at one time they thought she had celiac, but thats not it, her stomach where she can't eat everything, She can't lay flat, she has to be raised up, head has to be elevated, acid reflux, so she talked to the gastroenterologist, she was calling all doctors before she got the shot and they said its okay for her to get the shot because it's made up of stuff like jello. Pfizer BioNTech Covid 19 vaccine: Indication: Well, supposedly to protect her from the COVID 19, it says that Pfizer is supposed to be 96-97%, isn't that what Pfizer was supposed to be? That is what Covid is supposed to be, but 97% protective of getting the virus and it says that having this vaccination will prevent her, now she has heard some people have died even after getting the vaccination, buy they claim it is supposed to help her if she did contract it and she wouldn't be that severely impacted. She also took it because of her age, she rather be safe than sorry, that was the main reason, to be safe than sorry because of her age, shes 62, she got the vaccination. Her primary doctor said that her antibodies, when they injected it within her, her antibodies know something foreign was injected in her and she guesses its fighting and thats why its swelling. Time of Onset of AE(s) was not provided. AE(s) required a visit to Physician Office but did not require Emergency Room, she was going to since nobody could figure out where its coming from but thank god she did not. The patient underwent lab tests and procedures which included echocardiogram: ruled out, no fluid on her heart on an unspecified date in Jul2021, Vascular (vascular test): The first one was in Jun2021 at a lab, community radiology, that was the first one on unspecified date in Jun2021, they did the left arm and said no blood clot, then 23Jul2021 she had another done at vascular medicine and they looked at both arms to do a comparison and there was no blood clot. Reporter seriousness for arm started swelling, puffing up and couldn't lift that arm was unspecified. The outcome of event, arm started swelling, puffing up/she still has puffiness in the right arm was not recovered and for 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: 1645785
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Right side of face by jaw line startedfeeling numb; Lip swelling; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 28Jul2021 at 10:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications were not reported. 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 28Jul2021 at 11:30, the patient experienced numbness on the right side of face by the jaw line and then bottom lip had started swelling. It happened an hour before the time of this report and the patient stated she would report if it started to swell more. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. It was unknown if any therapeutic measures were taken as a result of the events. The clinical outcome of the events numbness on right side of face by jaw line and lip swelling were not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1645786
Sex: M
Age:
State: NC

Vax Date: 03/26/2021
Onset Date: 04/02/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Swollen lymph nodes on left side of neck and under left arm. Under left arm is still swollen as of 28Jul2021; This is a spontaneous report from a contactable consumer (patient). This consumer reported different events for different vaccine doses for the same patient. This is one of the two reports. A 25-year-old male patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 26Mar2021 (Batch/Lot Number: EP7534) single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Apr2021, the patient experienced swollen lymph nodes on the left side of neck and under the left arm. The patient received the second dose of BNT162B2 on 05Jul2021 (Lot number: EN6206). Lymph node under the left arm was still swollen as of 28Jul2021. The patient did not receive treatment for the event but required a doctor or other healthcare professional office/clinic visit. The patient did not have COVID prior to the vaccination and was not COVID tested post vaccination. Outcome of the event was not recovered. The event was reported as serious disabling, incapacitating. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645787
Sex: F
Age:
State: SC

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

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

Lab Data: Test Name: CT; Result Unstructured Data: Test Result:Unknown results; Test Name: ultrasound; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: Bones were aching; Muscle twitching; Had no mental clarity; Shaking; Chills; She hasn't had good sleep; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 18Jun2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included chronic Lyme disease. She has chronic Lyme disease (Intent: History) from many years. The patient's concomitant medications were not reported. The patient reported that she had her first and only COVID vaccine on 18Jun2021 and she was slowly approaching the 42nd day, she thinks it will be this Friday and she was wondering about this because she hasn't had her 2nd dose for a variety of reasons. The first reason being that she had a really bad reaction to the first dose, the kind they talk about the 2nd dose producing, only worse. She has also had health conditions and has had to take tests for them in the meantime. Before she gets her 2nd dose, she wanted to know if there was any literature on if one had the bad reaction with the first shot if the second will make less of a reason, like was it backwards from what has happened to most. The patient reported that if that happens then it sounds about right because she has adverse reactions to most things. The patient reported that she received her first dose of the Pfizer-BioNTech COVID-19 Vaccine on 18Jun2021 and she has still not received her second dose because with her first dose she had a lot of symptoms - her bones were aching, she had muscle twitching, she currently (voice not clear), she had no mental clarity, shaking and chills and (voice not clear) she hasn't had good sleep, all on an unspecified date. She also mentioned that she has chronic Lyme disease (Intent: History) from many years and she was not sure if she should get her second dose so. She wanted to know if she was able to get her second dose. The patient reported that she knew there will be side effect but hers were pretty bad and it lasted for a long time like probably two or three weeks and she still has some of them so, she has to technically take the second dose and she has to take it before Friday if she was going to take it because then her 42 days will be up. The patient clarified that she knew that she could take her shot, in fact her medical doctor told her she should. Meanwhile before she started her first shot, the reason she had waited so long was because she had gone to several test including CT, ultrasound and all (clarification unknown). She didn't want to be sick and she had to go into these tests, and she did not have these test as the result of the shot. They were already scheduled so, what she wanted to find out that the the second shot generally supposed to be worse of the first shot so she wanted to know if it's there in history like the first shot made me that bad if the second shot if she got it, it may be better or just the same (as reported). The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1645788
Sex: F
Age:
State: MD

Vax Date: 05/04/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: mucous; Cough; she didn't feel bad or have an shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 72-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 11:00 (Batch/Lot Number: EW0175; Expiration Date: Aug2021) as DOSE 2, SINGLE for covid-19 immunisation. Patient Age at Time of Vaccination was 72 years. Medical history mentions that she had a fainting spell a couple of years ago, before she got the shot she saw a cardiologist for a check up; and he listened to her lungs; she had no heart problems and she has high cholesterol. Family Medical History Relevant to AE stated that one sister and she got the Moderna and had no reaction at all. There were no concomitant medications. Caller stated she was not on any other prescription medications. Previously patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 Time: 12:00 Noon (Batch/Lot Number: EW0161; Expiration Date: Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date three weeks after second dose in Jun2021, the patient experienced mucous and cough. It was stated that she had made an appointment for a pulmonologist, she didn't feel bad or have a shortness of breath.Patient on the line calling regarding side effects after the second dose of the vaccine, the Pfizer COVID 19 vaccine. She had a lot of mucus and coughing for a few weeks. Wanted to know if there were reports about this side effect. She consulted a pulmonologist who required her to use an inhaler which will be for a lifetime. Caller confirmed information provided by transfer agent but states she ended up not using the inhaler. It was probably about three weeks after the vaccine that she realized she had mucous, it built up gradually. She went to a pulmonologist in the middle of Jun2021. Adds she had gotten the second shot in May2021. Then she made the appointment in Jun2021 and was seen about three days later. Reported for about two or three weeks it was not just a cough but spitting up mucus too. Stated the doctor wanted her to use the inhaler but when she read about it she decided not to start it. By the middle of Jun2021 she was already getting over it and after another week or two weeks she was fine. Added it was noticeable at three weeks; then for two weeks bad it was bad; and then it went away; it was about a month total. Added she did research online about this. She just wants to make sure she will be okay not using the inhaler. Added a few weeks ago she reported her event to VAERS. Patient was not in emergency room. The outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645789
Sex: F
Age:
State: WI

Vax Date: 07/20/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Body is weak/ feeling weak in her body; dizziness/ keeps being dizzy; Left arm joint pain (injection arm).; Left jaw bone pain; Two fingers in right hand asleep; Feels like she has a cold, nose feels wet; Not walking fast, doesn't want to fall. State that this is weird because she feels like her body is weak.; Left arm joint pain (injection arm); This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0196, Expiration date: was not reported) via an unspecified route of administration (age at vaccination 62-year) in Right Arm on 20Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took septra and experienced drug hypersensitivity (Caller mentions she is allergic to Septra, like Bactrim). Patient previously received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0181, Expiration date: was not reported) via an unspecified route of administration (age at vaccination 62-year) in Left Arm on 29Jun2021 as dose 1, single for COVID-19 immunization and experienced her left-hand fingers went to sleep for about 7-8 hours. Prior Vaccinations (within 4 weeks) / list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as None. On 20Jul2021 the patient experienced dizziness/ keeps being dizzy; in Jul2021 the patient experienced left arm joint pain, body is weak/ feeling weak in her body, left jaw bone pain, two fingers in right hand asleep, feels like she has a cold, nose feels wet, Caller mentions that she is not walking fast, doesn't want to fall. state that this is weird because she feels like her body is weak, left arm joint pain. AE does not require to visit Emergency Room/Physician Office. Caller states that she has a question; Says that she had the vaccine on 20Jul2021 and keeps being dizzy, today she woke up and her body is weak, asks if this is normal after the vaccine, what she can do possibly about it. She states she is trying to call her primary care but is having difficulty getting through; States that her husband has called health insurance company for her also. Caller denies any medications, medical conditions, labs, testing or treatments relevant to report. The seriousness of the events was reported as non-serious. The clinical outcome of dizziness/ keeps being dizzy was recovering, while the outcome of all other events was unknown. Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1645790
Sex: F
Age:
State:

Vax Date: 07/22/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report. A contactable female consumer (patient) reported for herself of an unspecified age received bnt162b2 (PFIZER COVID 19 VACCINE, Solution for injection, Lot Number: not reported), dose 1 via unspecified route on 22Jul2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient that had the on 22Jul2021 who experienced sore arm in 2021 and wanted to know if it was safe to go to a funeral after receiving the first dose. The outcome of event was unknown. The 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: 1645791
Sex: F
Age:
State: NC

Vax Date: 04/27/2021
Onset Date: 05/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Humming in ears; This is a spontaneous report from a contactable nurse. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an intramuscular route of administration on 27Apr2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia, hypocalcemia, vitamin d deficiency, penicillin allergy, peanut allergy, shellfish allergy, reaction to sulfites and food allergy (chocolate and eggplant allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ubidecarenone (COENZYME Q10), vitamin b12 nos (VITAMIN B12), methylsulfonylmethane (MSM), fish oil/vitamin e nos (OMEGA 3), probiotics nos (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and vitamin k nos (VITAMIN K) all from an unknown date and unknown if ongoing for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151), via an intramuscular route of administration on 06Apr2021, as a single dose for COVID-19 immunisation. The patient previously took sulfur (MANUFACTURER UNKNOWN), estrogen nos (MANUFACTURER UNKNOWN) and progesterone(MANUFACTURER UNKNOWN) and experienced allergy with all. On 11May2021, the patient experienced humming in ears. Therapeutic measures as a result of the event included treatment with flonase nasal spray and ASA 81mg. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event humming in ears was not resolved at the time of this report.

Other Meds: COENZYME Q10 [UBIDECARENONE]; VITAMIN B12 [VITAMIN B12 NOS]; MSM [METHYLSULFONYLMETHANE]; OMEGA 3 [FISH OIL;VITAMIN E NOS]; PROBIOTICS NOS; VITAMIN D [VITAMIN D NOS]; VITAMIN K [VITAMIN K NOS.]

Current Illness:

ID: 1645792
Sex: M
Age:
State: NC

Vax Date: 07/26/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: son experienced swollen lymph nodes. Got the vaccine same day as her; This is a spontaneous report from a contactable consumer (parent). This consumer reported for a male patient that, a male patient of 44 years old received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported, Expiry date: Unknown), dose 1 via an unspecified route of administration on 26Jul2021 as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen lymph nodes. got the vaccine same day as her on Jul2021. The patient got her first dose of the Pfizer covid 19 vaccine last 26Jul2021, experienced diarrhea, soreness of arms, swelling of underarm (arm where she got injected) that has a knot and feels warm. Reported also that her son experienced swollen lymph nodes. Got the vaccine same day as her Asking if swollen lymph node was one of the side effects of our vaccine. Asked what they can do to ease the pain and swelling. Outcome of the event was unknown. Information about lot/ Batch number has been requested.

Other Meds:

Current Illness:

ID: 1645793
Sex: M
Age:
State: IN

Vax Date: 07/24/2021
Onset Date: 07/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Broke out in Hives two days later on face, hands and arms; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 24Jul2021 at 12:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Jul2021, two days after the vaccine, the patient broke out in hives on face, hands and arms. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event hives on face, hands and arms was recovering at the time of this report.

Other Meds:

Current Illness:

ID: 1645794
Sex: F
Age:
State: RI

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

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

Lab Data:

Allergies:

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

Symptoms: anaphylactic shock; severe itching; tingling in my extremities; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jul2021 07:45 (at the age of 80years) as dose 1, single for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included known allergies: fish, seafood; No chronic health conditions. There were no concomitant medications. The patient previously took Medrol, Cephalosporins, Naprosin, Celebrex, and class c cortisones (neomycin sulfate) and experienced allergy. The patient did not have Covid-19 prior to vaccination. On 14Jul2021 20:00, the patient experienced eight episodes of severe itching and tingling in her extremities over 6 days. Upon each onset she took 50 mg of Benadryl. Within a half hour she was better, but she was afraid as she gets anaphylactic shock. The patient was not tested for Covid-19 post vaccination. The outcome of events as recovering.

Other Meds:

Current Illness:

ID: 1645795
Sex: M
Age:
State: NY

Vax Date: 06/10/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
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: Headache; Numbness in the face; Migraine after he had 1st Pfizer dose/migraine was returning; Migraine after he had 1st Pfizer dose/migraine was returning; This is a spontaneous report from a contactable nurse (patient's parent). A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0177), via an unspecified route of administration on 10Jun2021 (at the age of 19 years old) as dose 1, single for COVID-19 immunization. Medical history included migraine (but he was fine for like the last 2 years), diabetes, and food and drug allergy (not further specified). Concomitant medications were not reported. The reporter stated that the patient got his migraine on an unspecified date in Jun2021 after he had 1st COVID vaccine on 10Jun2021, the next day, 11Jun2021, he started having headache and continued on to the point that they ended up scheduling the Doctor's appointment. He was having anywhere from 2-7 migraines a day and they had the Doctor appointment and the Doctor started treatment on him. His migraine was so bad that he had numbness in his face and required an emergency room (ER) visit for that. The reporter thought that the Pfizer vaccine may have somehow contributed to the side-effects his migraine was returning. It was reported that the headache became different instead, he used to have migraine like once in a while, they go away and they were treatable, now they are coming in clusters and Tylenol, Ibuprofen even the prescribed medication the Doctor had given him which was Topamac was not helping and reached to severe enough level that he was actually having numbness in his face. The reporter said that after getting that Pfizer vaccine, the patient started getting severe migraines every day. They were bringing him to a point of tears. Nothing he had experienced before was like this. The outcome of the event "migraine was returning" was not recovered, and for other events was unknown.

Other Meds:

Current Illness:

ID: 1645796
Sex: F
Age:
State: CA

Vax Date: 07/25/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: Body temperature; Result Unstructured Data: Test Result:low grade fever; Test Date: 202010; Test Name: SARS-CoV-2 test; Test Result: Positive

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Headache; low grade fever; chills; body aches; joint pain; It feels like she had Covid all over again; This is a spontaneous report received from a contactable (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 25Jul2021 as dose 1, single for covid-19 immunisation. The patients medical history included patient had Covid in October and was sick for a long time, but then got well. The patient's concomitant medications were not reported. The patient got her fist dose of the Pfizer BioNTech Covid-19 vaccine on Sunday, 25Jul2021 and on Jul2021, the patient experienced it feels like she had Covid all over again. Her symptoms included low grade fever, chills, body aches, joint pain, and headache. Patient was asking if it was normal to have it (side effects) this long and was it something she should be concerned with,How long will that last? Seriousness reported as no. The patient underwent lab tests and procedures which included positive sars-cov-2 test on Oct 2020. The outcome of all events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1645797
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: the caller noticed her thumb and pinky fingers felt tingly and numb; she felt tingling in her fingers/it is still in her thumb and is still tingling; ear infection; super sick; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 56-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration in arm on an unspecified date in May2021 (at the age of 56-years-old) as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. No reactions were reported with the first dose. Patient had the second covid shot she has a question about a experience she had been having. It was reported that on an unspecified date in May2021 after administration of second dose on the way home from receiving the vaccine in her arm, her upper arm, the patient noticed her thumb and pinky fingers felt tingly/tingling and numb, so she just shook it out. That night she reported she felt like she slept on that arm and thought it fell asleep. She would like to know if it was possible they hit a nerve and would like information on the tingling. She further stated that she was super sick with an ear infection and forgot about the numbness/tingling. She said that she was very skinny. She said that she had been dealing with medical issues currently, and put the tingling on the back burner, but realized this week it was still in her thumb and was still tingling. She said that she had a lot of flu shots in the past but has never had the tingling. Now 3 months later she was recovering at home and noticed that her thumb was still numb and tingling sometimes but not in pain. She was very petite and wondered if the vaccination provider administered the vaccine in a nerve to cause this side effect. It was very concerning. The outcome of the events was recovering. The lot number for the vaccine, [Pfizer/BioNTech Covid-19 Vaccine], was not provided and will be requested during follow up. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1645798
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: hives all over body; This is a spontaneous report from a contactable Other Health Professional. A 4-decade old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient complained of hives all over body after 3 days later on an unspecified date. Rash disappeared a few days later. The clinical outcome of the event was recovered on an unknown date. Information about Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1645800
Sex: M
Age:
State: LA

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

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

Lab Data:

Allergies:

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

Symptoms: He experienced right leg rash; Mild headache; Body aches; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unspecified date in 2021 as dose 1 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. Patient mentioned that he had taken the shot 3 weeks ago and he was about to get his second dose but he experienced right leg rash and mild headache and body aches in 2021. The outcome of events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1645801
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 04/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: CAT scan; Result Unstructured Data: Test Result:Cervical Dystonia

Allergies:

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

Symptoms: torticollis/ cervical dystonia; tremors; muscles spasms; stiff neck; This is a spontaneous report from a contactable consumer(patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot Number: ER2613) (at age 42-years-old) as dose 2, single for covid-19 immunisation. The first dose was received on 04Mar2021 09:00(lot number: EN6205) (at age 42-years-old) on the left arm. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium taken for an unspecified indication, start and stop date were not reported. Patient started having neck issues, tremors and muscles spasms about 2-3 weeks after the second dose. She was experiencing stiff neck, and torticollis and as progressed it got worse she ended up in the ER and a CAT scan. She was referred to a neurologist that diagnosed with cervical dystonia for which patient had been under care. Patient did not had any previous medical issues prior to the Covid-19 Vaccine. Events started on 13Apr2021 13:00 and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Botex injection medication and physical therapy was given as treatment for the events. Outcome of the event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: LEVOTHYROXINE SODIUM

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am