VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1793329
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: she got rashes all over her body; This is a spontaneous report from a contactable consumer (patient) received from Pfizer-sponsored program with Regulatory Authority Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Apr2021 as dose 2, single for Covid-19 immunisation. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single on 05Apr2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that after the second dose she got rashes all over her body on an unspecified date. The outcome of the event unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793330
Sex: F
Age:
State: PA

Vax Date: 04/16/2021
Onset Date: 04/18/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:racing; Comments: It was accompanied by racing heart rate; Test Date: 20210423; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: I had a huge mood drop; racing heart rate; nausea; hand tremors; teeth chattering; overwhelming sadness; what I would call depression mixed with anxiety; what I would call depression mixed with anxiety; crying uncontrollably; This is a spontaneous report from a contactable consumer or other non-HCP. A 49-years-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was ER8734) via an unspecified route of administration on 16Apr2021 at 14:00, administered in left arm (age at the time of vaccination was 49-years-old) as DOSE 2, SINGLE dose for COVID-19 immunization. The relevant medical history included disoriented, dizzy, felt drunk, paranoid thoughts, chills, nausea, forgetfulness, slightly depressed mood and Fatigue from 23Mar2021, Soy Allergy, Gluten Dairy (food) allergy and OA HTN PMDD, from an unspecified date. The patient's concomitant medications included Vitamin C (ASCORBIC ACID), Wellbutrin (BUPROPION HYDROCHLORIDE), Zoloft (SERTRALINE HYDROCHLORIDE), Zyrtec (CETIRIZINE HYDROCHLORIDE), Vitamin D (NOS), LISINOPRIL from an unspecified date and for an unspecified indication. The patient had COVID prior to vaccination and was tested for COVID post the vaccination. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was Zn6208) via an unspecified route of administration on 23Mar2021, as DOSE 1, SINGLE dose for COVID-19 immunization. On 18Apr2021, the patient experienced I had a huge mood drop, racing heart rate, nausea, hand tremors, teeth chattering, overwhelming sadness, what I would call depression mixed with anxiety. After the first dose, the patient was shopping later in the day and became disoriented, dizzy. She felt drunk. It lasted for several hours. She was also having paranoid thoughts. She had to ask husband to pick her up because she did not think could drive. After that, she had the effects that most people report (chills, nausea, forgetfulness, slightly depressed mood, fatigue, etc). After the second dose, she was fine initially and then 2 days later (Sunday night), she had a huge mood drop. It was very significant. It was accompanied by racing heart rate, nausea, hand tremors, teeth chattering, and overwhelming sadness and what I would call depression mixed with anxiety. That was not a normal occurrence for me even though I use medication for Mood disorder. She called her psych and she suggested the use of Ativan to counteract the effects the patient was feeling. Since that time, She had about 5 of these episodes which vary in length from 20 minutes to more than a day. This was not my norm. crying uncontrollably. The patient underwent lab tests and medical procedures which included Nasal Swab SARS-CoV-2 antibody test on 23Apr2021, which showed result Negative and another lab test and medical procedure of Heart rate on an unspecified date, which showed result It was accompanied by racing heart rate. The clinical outcome of all the events was Not recovered. No follow-up attempts are possible: No further information is excepted.

Other Meds: VIT C; WELLBUTRIN; ZOLOFT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VIT D [VITAMIN D NOS]; LISINOPRIL

Current Illness:

ID: 1793331
Sex: F
Age:
State:

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: had nausea and feels like vomiting; stated that her nose is running; has allergies; legs are all shaky; weak; gets cold chills down her legs to feet; aches in everything; cannot seem to do anything; she feels faint and has absolutely no stamina; extremely fatigued; can hardly stay awake; first couple of days had a splitting headache; aches in her muscles, joints and everything; aches in her muscles, joints and everything; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on 20Apr2021 as Dose 2, single for COVID-19 immunization. Medical history and family history was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date for Covid-19 immunization. The patient's concomitant medications were not reported. After taking second dose of vaccine on 20Apr2021, the patient had splitting headache and aches in her muscles, joints and everything for first couple of days. The patient stated that kind of pain has gone away but had slight headache up until today (At the time of reporting). The patient was extremely fatigued and can hardly stay awake. The patient reported that a lot of her symptoms are kind of common and she cannot differentiate. She had nausea and feels like vomiting. Her nose was running, and she does not know if it was her allergies. The patient was weak, and her legs were really shaky. Therefore, the patient was bothered. She felt fainted and has absolutely no stamina. The patient stated that, when she does one thing, a little physical exertion and she was done, and she could not seem to get her stamina back like she could not seem to do anything. The patient was still having side effects. The outcome of adverse events (spitting headache, aches in her muscles, joints and everything) was recovering and outcome of other events was not recovered at the time of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1793332
Sex: F
Age:
State: FL

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Throat swelled up; Mild food allergic reaction.; This is a spontaneous report from a contactable consumer(patient). A 26-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0153), via an unspecified route of administration, administered in Arm Left on 06Apr2021 11:45 as DOSE 1, SINGLE for COVID-19 immunization (26 year when vaccinated). Medical history included food allergy (Had an allergic reaction after eating watermelon last year but otherwise nothing else that I'm aware of). Concomitant medication included fexofenadine (FEXOFENADINE). The patient was not having covid prior vaccination and has not been covid tested post vaccination. 06-APR-2021 13:00 patient reported that Throat swelled up, but not enough to go to the hospital or ER. Felt similar to having a mild food allergic reaction. No treatment was received for the adverse event. The outcome of the events was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.

Other Meds: FEXOFENADINE.

Current Illness:

ID: 1793333
Sex: F
Age:
State: NJ

Vax Date: 04/24/2021
Onset Date: 04/25/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Stomach ache; nausea; diarrhea; zero energy; no concentration; heat flashes; exasperated; arthritis joint pain; Sore throat; runny nose; slight cough; allergic reaction to pineapple which i never had; metallic taste alot of acid; gastric gas; lack of appetite; dizzy; This is a spontaneous report received from a contactable other hcp. A 63-years-old non pregnancy female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: Ew0164) via an unspecified route of administration in Arm Left on 24Apr2021 08:00 (age at vaccination 63years old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 2 weeks prior to the COVID vaccine. Medical history included colon cancer from an unknown date and unknown if ongoing, arthritis assist from an unknown date and unknown if ongoing, colitis ulcerative from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: Ew0164) via an unspecified route of administration in Arm Left on 03Apr2021 (age at vaccination 63years old) as single dose for covid-19 immunisation and experienced dizziness. Since the vaccination, the patient had not been tested positive for COVID-19. On 25Apr2021 at 15:30 the patient experienced stomach-ache, nausea, diarrhoea, zero energy, no concentration, heat flashes, exasperated, arthritis joint pain, sore throat, runny nose, slight cough, allergic reaction to pineapple which i never had, metallic taste a lot of acid, gastric gas, lack of appetite, dizzy. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793334
Sex: F
Age:
State: FL

Vax Date: 04/25/2021
Onset Date: 04/25/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bone pain; Dots, pinkish on top of the skin/ Dots on her leg and skin; Painful upon injection/ arm pain; Nausea; Dizzy; was throwing up and she threw up 3 times; Feel cold; Chills; Have a low grade fever; Joint pain; Headache; Her eyes were hurting; Numbness in her hands and toes; This is a spontaneous report from a contactable consumer. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: ER8735), via an unspecified route of administration, in arm on 25Apr2021, as DOSE 2, SINGLE for covid-19 immunization (age at vaccination: 36-years-old). The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: ER8737), via an unspecified route of administration, in left arm on 4Apr2021, as DOSE 1, SINGLE for covid-19 immunization. When the patient got the shot, after 2 hours of receiving the vaccine, she had a little bit of arm pain which was normal and resolved on 6Apr2021. The clinical course was as follows: On 25Apr2021, the patient received the second dose and mentioned that it was painful upon injection, but she didn't felt pain the first 2-3 hours. 3 hours later she had nausea and was dizzy. 4 hours later, was throwing up and she threw up 3 times, and her arm started to feel pain. About 7-8 hours later she started to feel cold, like chills, and started to have a low-grade fever, arm pain, joint pain, headache, her eyes were hurting, she got mostly all of the side effects. The highest fever was almost 102. She had numbness in her hands and toes, too.On 26Apr2021, everything was same, but her highest fever was 102.8 and she had nausea but wasn't throwing up. On 27Apr2021, patient continued to have a low-grade fever of 101 and sometimes 103 and after that she was okay. The caller had a headache and numbness, but no more arm pain, only bone pain but lighter than the other two days. On 28Apr2021, in the morning when she woke up, she was fine but still had numbness in her hands. She saw dots, pinkish on top of the skin. Around 6:00 PM, she started to see the same "dots" on her legs and her skin- it felt like blood was there. On 29Apr2021, patient went to the emergency room at 12:00AM, the doctor in the emergency room checked her blood. The patient mentioned that it looked like pieced by pieces, like it was blood. Patient saw that on her lips too. Patient's blood results were fine. The patient still can see that on her skin but it's a little bit lighter now. The numbness in her fingers and toes is still there. She was never admitted into the hospital. The patient was at hospital last night but added that everything was okay. The outcome of the event Painful upon injection and arm pain was recovered two days after the vaccination on 27-APR-2021. The outcome of the event was throwing up and she threw up 3 times was recovered one days after the vaccination on 26-APR-2021. The outcome of the events Nausea, Dizzy, Feel cold, Chills, Have a low grade fever, Joint pain, headache, her eyes were hurting, numbness in her hands and toes, Dots, pinkish on top of the skin/ Dots on her leg and skin and bone pain was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793336
Sex: F
Age:
State: FL

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

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

Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:fine; Test Date: 20210425; Test Name: fever; Result Unstructured Data: Test Result:102; Test Date: 20210426; Test Name: fever; Result Unstructured Data: Test Result:102.8; Test Date: 20210427; Test Name: fever; Result Unstructured Data: Test Result:101; Test Date: 20210427; Test Name: fever; Result Unstructured Data: Test Result:103

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: painful upon injection; arm pain; Nausea; dizzy; felt Cold; chills; Fever; Headache; eyes were hurting; joint pain; numbness in her hands and toes; dots, pinkish on top of the skin; throwing up; she had a little bit of arm pain; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient (age at vaccination: 36 years) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8737 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 04Apr2021, as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8735 and expiry date was not reported), via an unspecified route of administration, on 25Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was calling about the Pfizer covid vaccine. The caller was reporting on side effects stating she was at the hospital last night, but everything was okay. On 04Apr2021, the patient had a little bit of arm pain. On 25Apr2021, the patient got her second dose, and it was still painful upon injection, but she didn't feel pain the first 2-3 hours. 3 hours after receiving the second dose, the patient had nausea and was dizzy. 4 hours after the second dose on 25Apr2021 the caller was throwing up, she threw up 3 times, and her arm started to feel pain. About 7-8 hours after the second dose, the patient started to feel cold, like chills, and started to have a low grade fever, arm pain, joint pain, headache, her eyes were hurting, she got mostly all of the side effects. The highest fever was almost 102. The patient had numbness in her hands and toes, too. On 26Apr2021, it was exactly the same thing. The patient had nausea but not throwing up and 102.8 was her highest fever on 26Apr2021. On 27Apr2021, the patient still had a low grade fever of 101 and sometimes 103 and after that she was okay. The patient had a head-ache and numbness, but no more arm pain, only bone pain but lighter than the other two days. When the caller woke up on 28Apr2021, in the morning she was fine but still had numbness in her hands. The patient started to see dots, pinkish on top of the skin, she thought it was a side effect so she wasn't paying attention to it. The patient was wearing a long skirt. Around 6:00pm, she started to see the same "dots" on her legs and her skin- it felt like blood was there. The patient went to the emergency room at 12:00am. The doctor in the emergency room checked the patient's blood. She described that her skin looked like "pieced by pieces, like it was blood". The emergency room doctor thought it could be the patient's platelets or red blood cell count. Then the patient saw this on her lips too. The patient's blood results were fine. The patient still sees this today on her skin but its a little bit lighter now. The numbness in her fingers and toes was still there. The patient was never admitted into the hospital. The patient asked was it rare to have that side effect of the skin. The patient thought it was a rash but the doctors told her that it was an inflammatory response. Outcome of the event she had a little bit of arm pain was recovered on 06Apr2021 and for all other events was unknown. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1793337
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/15/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 04/15/2021; Test Name: Body temperature; Result Unstructured Data: Test Result: 100?F; Comments: 100?F.

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: This is a spontaneous report from a noncontactable consumer (patient). A 23-year-old female patient received BNBNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# and expiration date: not reported), at the age of 23, via an unspecified route of administration, in left arm, on an unspecified date, single dose, for COVID-19 immunization. Medical history included major depressive disorder. The patient was not pregnant at the time of vaccination. The patient's concomitant medications not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient experienced 100?F and had repeated extreme vomiting on Apr 15, 2021. The patient did not receive treatment for the events. The outcome of the events: recovering. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1793338
Sex: F
Age:
State: FL

Vax Date: 04/07/2021
Onset Date: 04/18/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Headache; neck pain; pain in eyers ears, arms, in the back of the legs, calves,feet and the whole body; feel sick; fever; This is a spontaneous report from a contactable consumer (Patient). A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/lot number: E100151) dose 1, Via an unspecified route of administration, administered in right arm on 07Apr2021 at 12:30 AM as a single dose (at the age of 38 year) for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ascorbic acid, ferrous fumarate (VITRON C). Past drug included Sulfa Bactrim and Metoclopramide. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks of vaccination include Centrun Woman, Vitron C. Prior to vaccination, the patient was not diagnosed with COVID-19. On 18Apr2021 at 23:30, the patient experienced headache, neck pain, pain in eyers ears, arms, in the back of the legs, calves, feet and the whole body, feel sick, fever. Since the vaccination, the patient had not been tested for COVID-19. Patient felt sick and fever on the same date. The patient reported that she had reactions to the vaccine during the night. Outcome of events were not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: VITRON C

Current Illness:

ID: 1793339
Sex: F
Age:
State: FL

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Right after second dose, very tired; Headache, neck pain /A month later, I still have neck pain and headaches Especially during my period; Headache, neck pain /A month later, I still have neck pain and headaches Especially during my period; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Apr2021 16:30 (at the age of 44-year-old) (Lot Number: ER8735) as dose 2, single for COVID-19 immunization. The patient medical history was none. The patient was not pregnant at the time of vaccination. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Mar2021 16:30 (at the age of 44-year-old) (Lot Number: EP6955) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient reported that right after second dose, patient was very tired, had headache, neck pain. A month later, she still had neck pain and headaches especially during her period. The patient reported that she never had never suffered from headaches prior to taking the vaccine. The patient did not receive treatment for the events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1793340
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: Her face and throatwere a little puffy; Her face and throatwere a little puffy/throat is swollen; Her throat was swollen and irritated; Inside of the mouth she has a rash that looks like thrush but is very painful; Inside of the mouth she has a rash that looks like thrush but is very painful; Her face and hand were very hot; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother) from a Pfizer Sponsored Program. A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 17-years-old). The patient medical history and concomitant medications were not reported. The mother of the patient stated that on 16Apr2021 her daughter (the patient) received the first dose of vaccine and afterward her face and hand were very hot and usually she was cold. The next day on 17Apr2021 her face and throat were a little puffy, inside of the mouth she has a rash that looks like thrush but was very painful. Her throat was swollen and irritated. Her doctor prescribed medication prednisone 10mg for one week and she was feeling much better now. Her doctor recommended not taking the second dose, it could be worse than the first. Her doctor suggested calling Pfizer. The patient was recovering from the events at the time of report. No follow up attempts are needed. Information on lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793341
Sex: F
Age:
State: AL

Vax Date: 04/12/2021
Onset Date: 04/12/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Fever; achy chills; shaky and achy all over; shaky and achy all over; Tiredness; pain/ache in the injection site; This is a spontaneous report from a contactable consumer. This 73 year-old female consumer (patent) reported herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150, Expiry Date, NDC number : not reported), via an unspecified route of administration on 12Apr2021 (at the age of 73 years) as dose 2, single for covid-19 immunisation. Medical history included Fibrous tissue in her bone marrow from an unknown date and unknown if ongoing. The caller's red count got low and she had to get blood transfusions about once a month. Concomitant medication(s) included epoetin alfa epbx (RETACRIT [EPOETIN ALFA EPBX]) taken to helps build red blood cells, start and stop date were not reported. She received previously first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 22Mar2021 at 13:00 (at the age of 73 years) as dose 1, single for covid-19 immunisation and by that night her arm was a little sore and it was gone by the next day (sore arm). Investigation assessment was not done. The caller thought it said BPT534, she was unsure. The patient took Pfizer Covid vaccine to try to avoid the Covid. Second dose of the vaccine was administered on 12Apr2021 and side effects were observed starting 22Apr2021. Caller had a sore arm which started on 12Apr2021 (the same day) as when she received the vaccine, but it was not as bad as the first vaccine. Caller also mentioned some pain/ache in the injection site. Referred to HCP for further clinical recommendations. On 22Apr2021 at 15:00 (10 days after the second dose), the caller started having chills and fever. The caller was shaky and achy on 22Apr2021 at 15:00 and that happened over night but then it quit. The caller did not feel well and she feels tired and that began 22Apr2021. The caller has felt really tired since then. The caller had a fever of 103.4 on 23Apr2021 and 24Apr2021. The caller started taking Tylenol to get the fever down but the fever stayed up all night. Unknown lot, NDC, and expiration date for the Tylenol. Caller would like to know if achy chills, fever and tiredness appearing 10 days later after getting the PFIZER-BIONTECH COVID-19 VACCINE was normal and has been reported. The caller takes prescribed medications but declines to provide information on the medications. Reporter asked if there were any reports of this happening days later. Most people said that it usually happens a couple of days after receiving the vaccine. Until 23Apr2021, chills went away. Fever was improved at the time of report. Event tiredness was ongoing but improving. The outcome of event fever recovered on an unspecified date in 2021, shaky and achy all over recovered on 22Apr2021 and chills was recovered on 23Apr2021. The outcome of event tiredness was recovering while the outcome of other events was unknown. Information on Lot/Batch number was available. No further information is expected.

Other Meds: RETACRIT [EPOETIN ALFA EPBX]

Current Illness:

ID: 1793342
Sex: F
Age:
State:

Vax Date: 04/27/2021
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pain started 24 hours in to the vaccine/quite a bit of pain; Her epidural site area was tender about 24 hours after her second dose; her muscles are so tight in her thighs/if she walks quite a bit it has been going down to her butt, thighs, and calves and they are very tight; Muscle pain in her thighs, whole buttocks was in pain and spine area was in pain in the lower back.; Muscle pain in her thighs, whole buttocks was in pain and spine area was in pain in the lower back.; Muscle pain in her thighs, whole buttocks was in pain and spine area was in pain in the lower back.; Feeling fatigued; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 15:30 (at the age of 34-year-old) (Lot Number: EW0165) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Apr2021 15:30 (at the age of 34-year-old) (Lot Number: EW0150) as dose 1, single for COVID-19 immunization. On 28Apr2021, patient experienced feeling fatigued after the vaccine and the pain started 24 hours in to the vaccine. The patient reported it seemed to have triggered an area where she had an epidural on 30May2019 when she had her son. The patient stated that the epidural area was very tender, had muscle pain in her thighs, whole buttocks was in pain and spine area was in pain in the lower back. The patient said it felt better with rest, and she would say it has gotten better since originally it was more spread out before, literally from her hips out, but now it was concentrated where she got the epidural. The patient said she had just finished her period cycle also, so she doesn't know if that was related. She said it was very tender, which she has never felt this before, and her muscles were so tight in her thighs, it was like the blood was not circulating or something, her butt was very tender and very sore. She said that the bottom half of her was not doing amazing. The patient received paracetamol (Tylenol) heating pad and even used a massager. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793343
Sex: F
Age:
State: IN

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Reported pain in every joint in her body currently/every single joint in her body hurts; This is a spontaneous report from a contactable consumer reported for herself. This report is not related to a study or programme. A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 29Apr2021 (at the age of 26-years-old) as DOSE 1, SINGLE for SARS-COV-2 immunization/ COVID-19 immunisation. The patient took COVID vaccine as she was planning to travel. The patient medical history and concomitant medications included none. The patient experienced reported pain in every joint in her body currently/every single joint in her body hurts on 29Apr2021 in the middle of the night. Patient got her first COVID vaccine the day before this report and overnight every single joint in her body started to hurt. She expected to have pain, but she didn't expect it to be this bad. The event every single joint in her body hurts was reported as worsened. Patient wanted to know if she could take pain killers and would this interact with the vaccine. Referred to HCP. Investigation assessment included none. Patient declined to provide details on height, weight, and primary hcp. Clinical outcome of event was ongoing and not recovered at the time of this report. No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1793344
Sex: F
Age:
State: CA

Vax Date: 04/27/2021
Onset Date: 04/28/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: today she experienced a rash; Injection site pain and redness; Injection site pain and redness; Severe Fatigue; severe headache; muscle pain; chills; joint pain; feeling extremely unwell; couldn't get out of bed for 24 hours; bedridden; swollen lymph nodes/swollen and painful lymph node under her left arm; swollen lymph nodes/swollen and painful lymph node under her left arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot Number EW0162) via an unspecified route of administration on 27Apr2021 as dose 2, single (age at vaccination: 56 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot Number EW0158) via an unspecified route of administration on 06Apr2021 as dose 1, single for COVID-19 immunisation. On 28Apr2021, the patient experienced, injection site pain and redness, severe fatigue, severe headache, muscle pain, chills, joint pain, feeling extremely unwell, could not get out of bed for 24 hours; bedridden, swollen lymph nodes/swollen and painful lymph node under her left arm. On 30Apr2021, today she experienced a rash. She does not know if she had a fever or not because she does not own a thermometer. and she was feeling extremely unwell. It was stated that she recovered and most resolved by 29Apr201 at 17:00, so it lasted from Wednesday morning until 41 hours later. She still had a swollen and painful lymph node under her left arm, but it has improved. She has a rash that started today. Stated the rash is something she has had before when she has been sick with a cold, so she does not know, it may be an immune response. Treatment received was none, just stayed in bed for a day and a half and was surprised she had a reaction and she did not expect to be bedridden for a day. Caller stated she did some research and the more robust response a person has, the stronger their immune system is. I had a pretty robust reaction to the vaccine and wonder if that was a sign of having a greater immunity than someone who did not had a reaction. The clinical outcome of the event swollen lymph nodes/swollen and painful lymph node under her left arm was resolving, the event today she experienced a rash was not resolved and rest of the events on 29Apr2021 17:00 was resolved. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793345
Sex: F
Age:
State: CA

Vax Date: 04/17/2021
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rash; Spots on arms and legs; Itching rash; Spots on arms and legs; Weakness; Muscle weakness/left side of body, left leg was weak on the left side, at the toes, the upper leg; Not feeling well; I threw up/ vomiting; discomfort when I eat something in my stomach; Nausea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 81-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 17Apr2021 (Batch/Lot Number: EW0169) as dose 1, single for COVID-19 immunization (at the age of 81-years-old). Medical history included osteoporosis from an unknown date and unknown if ongoing. The concomitant medications were not reported. It was reported that the patient received first dose of vaccine and patient experienced rash, spots on arms and legs, itching rash, weakness, muscle weakness/left side of body, left leg was weak on the left side, at the toes, the upper leg, not feeling well, I threw up/ vomiting, discomfort when I eat something in my stomach, nausea on Apr2021. "The patient wanted to know about the rash because she got lots of spots on her arms and her legs and she don't know if they come from the COVID19 shot. They look like circles but she don't know if they just, that they always there, but taken the COVID19 shot, it broaden our it. Just seems like Pfizer broad them to head. You know like broaden upward so she have rash to her. It look like a rash. All she has been itching today. She did not have feel the itching yesterday like this and she was so used to go out to. She just assume somebody's sting bite from the grass. She was not sure when she read this as soon as possible, did a check it and read it. That's one of thing she was calling about and the other was the weakness, the muscle weakness, not for they gave her shot but the let you know it's like and she was not feeling well. She wanted to know about the side effect as she have took the vaccine the first dose on 17Apr2021 and she had not feeling well since then but don't know if what is in this that was causing the problems, because she have a left side of her body, her left leg was weak on the left side, at the toes, the upper leg and it seems like the stomach, her stomach she threw up the first 3 days couple of days later she threw up but that's left she don't have that vomiting what she do have was discomfort a gist discomfort when she eat something in her stomach and she don't know if that's on the same basis of nausea or not but anyway there was discomfort there and she was wondering which one of the items in this vaccine is causing that. So, if it's in the vaccine then I'll know that it's bad and how long does this symptom last after we take the vaccine because she was scheduled to go and get the other one on Sunday and she don't know whether she should because she still have these side effects and if this was true side effect that was what she wanna know". The patient not recovered from the events. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1793346
Sex: F
Age:
State: IL

Vax Date: 04/29/2021
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Nausea; fever; diarrhea; body aches location; sore legs, but this kept getting worse; sore legs, but this kept getting worse; chills; cold; Right arm injection site soreness; Really sick; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0150) via intramuscular route of administration, administered in Arm Right on 29Apr2021 12:45 (at the age of 58 years old) as dose 2, single for COVID-19 immunisation. Medical history included multiple sclerosis from 08Jan2021 to an unknown date (Multiple sclerosis diagnosed 08 Jan 2021. She had prior to getting vaccine), allergies to wheat from an unknown date and unknown if ongoing (Diagnosed allergies to wheat diagnosed 6 years ago), shoulder surgery from an unknown date and unknown if ongoing (Prednisone shot as far back as 15 years ago with shoulder surgery), seasonal allergy from an unknown date and unknown if ongoing (All seasonal allergies diagnosed 2 years ago), mild aortic atherosclerosis from Jan2021 to an unknown date, respiratory illness from an unknown date and unknown if ongoing, genetic /chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, compromised immune status. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)) taken for cardiac prevention from Jan2021 to an unspecified stop date. The patient previously took steroids and experienced drug allergy, tetracycline [tetracycline hydrochloride] and experienced drug allergy, sulfa drugs and experienced drug allergy. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0179) via intramuscular route of administration, administered in Arm Left on 08Apr2021 13:00 (at the age of 58 years old) as dose 1, single for COVID-19 immunisation and experienced vaccination site pain. The patient experienced chills, cold on 30Apr2021 02:30, fever on 30Apr2021 08:30, diarrhea on 30Apr2021 07:00, body aches location on 30Apr2021 02:30, sore legs, but this kept getting worse on 30Apr2021 02:30, nausea on 30Apr2021 09:30, right arm injection site soreness on 29Apr2021 13:00, really sick on Apr2021. Reported as, she received second dose 29Apr2021. Really sick, cold, chills, fever, diarrhea, body aches location. She has sore legs, but this kept getting worse. Cold chills so badly, diarrhea, several Right arm soreness was worse with second dose and she can hardly lift her arm. Cold chills are worse even after warm bath. Right arm injection site soreness after second dose 13:00. It was harder going in. The first one she did not feel at all. Just the jab part of the second one. She called hospital hotline to see what she needed to do. She wanted to know if this could be COVID and does she need to be tested. They told her if she still has symptoms on Sunday, she should get checked. Outcome of the event fever, sore legs, but this kept getting worse, really sick were unknown and not recovered for rest of events. No follow-up attempts are needed. No further information is expected.

Other Meds: ASPIRIN (E.C.)

Current Illness:

ID: 1793347
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: pain under arm and armpit, almost like gland or lymph node; pain under arm and armpit, almost like gland or lymph node; headache; fever; fatigue; has pain where vaccine given in arm; nausea/it was like a queasy feeling; still not feeling like great; sweating; it was hard around the area where the vaccine was given too; This is a spontaneous report from a contactable Consumer or other non-HCP ((patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER8736 and Lot Expire Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 26Apr2021 at 17:00 (at the age of 49-year-old), as DOSE 1, SINGLE for covid-19 immunisation. There were no additional vaccines administered on Same Date of the Pfizer Suspect. The patient medical history was not reported. Patient Medical History (including any illness at time of vaccination) was none. The patient had no family Medical History Relevant to AE(s). The patient concomitant medications were not reported. No prior vaccinations (within 4 weeks). On 26Apr2021, after the vaccination, the patient experienced nausea/it was like a queasy feeling and pain where vaccine given in arm, on 27Apr2021, she experienced headache, fever and fatigue and on 28Apr2021, she experienced pain under arm and armpit, almost like gland or lymph node. On an unspecified date in Apr2021, the patient experienced sweating and not feeling like great. The clinical details of the events as follows: Patient is a 49-year-old female who received her first dose of the Pfizer BioNTech COVID-19 vaccine on Monday, 26Apr2021 and experienced the following symptoms after: headache, nausea, fever, fatigue, pain in the arm where the vaccine was given, pain under the arm and armpit almost like a gland or lymph node, and sweating. Patient would like to know if these side effects are normal. She was concerned about how long they would last. Patient stated that she has heard that these side effects typically occur with the second dose of the vaccine, so she is wondering if she gets her second dose, would her reaction be worse. Basically, has had a lot of side effects all week. She was wondering, it is now Friday and still not feeling like great. She was wondering if this is a normal reaction to the Pfizer Covid Vaccine. Headache: patient stated this began on 27Apr2021. The headache had gone away and now it seems to have kind of came back. Nausea: This began later on the evening patient received the vaccine on 26Apr2021. She stated it was like a queasy feeling and stated this was not ongoing, it went away on Wednesday, 28Apr2021. She stated she did have a little nausea on Tuesday 27Apr2021 also and stated the nausea was gone completely. Fever: This began on Tuesday afternoon 27Apr2021, she stated her last fever was on Wednesday night, 28Apr2021. She did not have fever anymore, it was gone. Fatigue: she stated she also has fatigue. The fatigue began Tuesday, 27Apr2021 and was persisting. Has pain where vaccine given in arm: This began a few hours after she received first dose Pfizer Covid Vaccine. This was ongoing and has improved. She stated it was hard around the area where the vaccine was given too on an unknown date in Apr2021. Pain under arm and armpit, almost like gland or lymph node: This began on Wednesday, 28Apr2021 and was ongoing slightly and stated it has improved. The AE(s) did not require a visit to Emergency room and physician office. Relevant tests were none. There was no Investigation Assessment provided. The patient outcome of the events fever and nausea/it was like a queasy feeling was Resolved on 28Apr2021. The events fatigue, pain where vaccine given in arm and pain under arm and armpit, almost like gland or lymph node was not resolved and the outcome of the other events headache, not feeling like great and sweating and hard around the area where the vaccine was given too was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793348
Sex: F
Age:
State: VA

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
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: felt cold; chest pain; her arm hurt so bad on the left hand side; she had sharp pains in her head; she doesn't sleep at night because she aches so bad; Blade in the back hurt; she doesn't sleep at night because she aches so bad; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown) via Intramuscularly in arm right on an unknown date in Apr2021 at 6: 30 (at the age of 74-years-old) as dose 2, single for COVID-19 immunization in pharmacy/drug store. The patient's medical history included Don't use left arm, this is related to the polio that she had when she was 6 years old, polio, right leg gives out, sinus problems, allergies since an unknown date and ongoing and handicapped. Concomitant medications were not reported. The patient took unspecified muscle relaxer and unspecified nerve tablet since an unknown date and ongoing. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration (injection) on right arm on an unknown date (Batch/Lot number unknown) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did noy have any adverse events. On an unknown date in Apr2021, the patient felt cold, experienced chest pain, her arm hurt so bad on the left hand side, she had sharp pains in her head, she doesn't sleep at night because she aches so bad. Blade in the back hurt. Consumer stated that after receiving the second dose Pfizer Covid-19 vaccine she was on the couch all day, she felt cold and could not get warm and that resolved on the next day's evening. She also has experienced chest pain and arm pain ever since. She is not getting any sleep at night and wanted to know if this will continue. She reported that the day after she received the second dose of the Covid-19 vaccine, she was on the couch all day until 5:00 PM, So cold that she had to wear a blanket and jacket. She reported that she had mostly all of the symptoms that were in the vaccine information book. She reported that the day after she received the Covid-19 vaccine, she started getting chest pain, her arm hurt so bad on the left hand side, and she had sharp pains in her head. She reported that she called the pharmacist told her that her side effects should have never lasted this long. She stated that now she was calling Pfizer to have Pfizer tell her what to do. She reported that she doesn't sleep at night because she aches so bad. She wasn't planning on taking the Covid-19 vaccine, but her doctor informed her that it would be a good idea for her to get the Covid-19 vaccine. She stated that she doesn't know if it would have been a good idea or not. She reported that she was handicapped. She doesn't know if being handicapped had something to do with her side effects but it shouldn't have. She reported that she could not remember the date for when she received her second dose of the Covid-19 vaccine. She reported that she took an 800 mg so her arm was not hurting at time of call on 30Apr2021. She reported that her arm was hurting before she left the house. She reported that she only had sharp pains in her head for a minute or two. She reported that the trouble sleeping did not occur the first day that she had the Covid-19 vaccine, trouble sleeping began right after that because when her chest and arm started hurting there was no way for her to sleep. She has to have vaccines in her right arm because she doesn't use her left arm. She reported that she has sinus problems and allergies, and they keep her on a lot of stuff like that. Consumer reported that she usually just takes a muscle relaxer and some kind of pain pill. The adverse event did not result in Emergency Room or Doctor or other healthcare professional office/clinic visit. The outcome of events felt cold and headache was recovered, chest pain, pain in extremity, she doesn't sleep at night because she aches so bad, Blade in the back hurt was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Allergy; Handicap; Left arm paresis; Leg discomfort; Sinus disorder

ID: 1793349
Sex: F
Age:
State: IL

Vax Date: 04/27/2021
Onset Date: 04/28/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Lymphnodes swollen under right arm; throat swollen; trouble breathing especially at night; This is a spontaneous report received from a contactable consumer (Patient). A 51-year-old non-pregnant female patient received bnt162b2 (BNT162B2; Solution for injection; Lot number: Unknown), via an unspecified route of administration, administered in right arm as dose number unknown, single on 27Apr2021 at 09:00 (at the age of 51-year-old) for covid-19 immunisation at doctor's office/urgent care. Patient had no known allergies and had been diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been tested for Covid 19 since the vaccination. The patient's concomitant medications were not reported. On 28Apr2021 at 21:00, the patient experienced lymph nodes swollen under right arm, throat swollen and trouble breathing especially at night. No treatment was received as result of adverse events. Device Date was 01May2021. At the time of this report, the outcome of events was not recovered. No follow up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793350
Sex: M
Age:
State: CA

Vax Date: 02/21/2021
Onset Date: 02/24/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210310; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: shortness of breath; extreme weakness; fatigue; unable to climb down stairs; slight iron deficiency; This is a spontaneous report from a contactable consumer (Patient). A 75-year-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in the left arm on 21Feb2021 at 13:30 (age at the time of vaccination was 75-year-old) as dose 2, single for COVID-19 immunisation. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in the left arm on 31Jan2021 at 10:30 (age at the time of vaccination was 75-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included high cholesterol, hypertension, bipolar and hay fever, all from an unknown date and unknown if ongoing. Patient was allergic to Sulfa and Vicodid. Prior to vaccination patient was not identified for Covid-19. Concomitant medication included simvastatin (SIMVASTATIN), tamsulosin (TAMSULOSIN), lamotrigine (LAMICTAL) and montelukast (MONTELUKAST) all taken for an unspecified indication, start and stop date were not reported. No other medications in four weeks. On 24Feb2021, the patient experienced shortness of breath, for almost SEVEN weeks (starting first week) (quick, forceful, repeated, EXHALATIONS, interspersed with short, normal inhalations), extreme weakness, fatigue, unable to climb downstairs and slight iron deficiency. AE required Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The patient did not receive any treatment for events. Since the vaccination patient has tested for covid-19. On 10Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) result was negative. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: SIMVASTATIN; TAMSULOSIN; LAMICTAL; MONTELUKAST

Current Illness:

ID: 1793351
Sex: M
Age:
State: CA

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210428; Test Name: Temp 102.5; Result Unstructured Data: Test Result:temp 102.5; Comments: temp 102.5.

Allergies:

Symptom List: Unevaluable event

Symptoms: muscle pain; Today, very short of breath; temp 102.5; uncontrollable chills; no appetite; no thirst; blistering; headache; weird bone; This is a spontaneous report from a contactable consumer reported for male (patient himself). A 53-years-old male patient received (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: ER8729), via an unspecified route, administered in Left Arm on 28Apr2021 at 04:45 PM (53-years-old at vaccination) as Dose 2, Single for Covid-19 immunization. Facility of the most recent COVID-19 vaccine was administered was reported as Other. The patient's medical history included asthma, hypertension, high T3 (triiodothyronine). The patient's concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and nebivolol hydrochloride (BYSTOLIC) within 2 weeks of vaccination. The patient past medications included terramycin, tetracycline and penicillin and the patient was allergic to all past drugs. 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. The patient previously took historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: EW0176), via an unspecified route, administered in Left Arm on 06Apr2021 at 03 :45 PM (53-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. The patient had experienced BRVO (Branch Retinal Vein Occlusion) in the right eye approximately 1 week after first dose of injection. The patient received Shot in eyeball for 1st, nothing yet for the 2nd. On 28Apr2021 at 08:00 AM, the patient experienced muscle pain, very short of breath, temp 102.5, uncontrollable chills, no appetite, no thirst, blistering, headache, weird bone. Since the vaccination the patient had not been tested for COVID-19. These events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment medication for resulted events. Device date was reported as 28Apr2021. The clinical outcome of the events was unknown. No follow-up attempts are needed. No further information was expected.

Other Meds: SYNTHROID; CYTOMEL; BYSTOLIC

Current Illness:

ID: 1793352
Sex: U
Age:
State: GA

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

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

Lab Data:

Allergies:

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

Symptoms: Sore arm; Chills; Fever; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration in arm on an unspecified date as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient experienced sore arm, chills, fever, nausea. The outcome of all events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793353
Sex: U
Age:
State:

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 10/16/2021
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: I had an allergic reaction; My tongue starts very heavy; Roof of my mouth and I guess back of my mouth close to my throat were itchy; progressed to feeling like I have sand under my tongue; My throat was extremely dry; I had difficulty in swallowing the water; My voice was very raspy; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot Number: ER 3734, Expiry Date and NDC number were unknown), as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Apr2021, the patient reported that had couple of different side effect within 8 minutes of taking the shot had an allergic reaction, tongue starts very heavy, roof of mouth and guess back of mouth close to throat were itchy, progressed to feeling like having sand under tongue, throat was extremely dry, had difficulty in swallowing the water and voice was very raspy. The patient stated that they gave Benadryl, 2 doses. LOT#: consumer stated, ER is that 3734, its 3 or 8, can't read it, let me see if can get something like a power glass if can make it little, larger, if can be more sure, it looks like it could be Pfizer ER looks like it might be could be a 3 could be a 8 can't really tell 734. The patient reported that, has a couple of quick question about Pfizer Vaccine, had the first vaccination, and had an allergic reaction. So, the CDC is saying that they don't recommend a second dose if you had reaction to first dose and want to know whether there is any allergist that could test me to see what it was that was allergic to shot. do you have list of those? So, patient was referred, called the number and they referred patient to you regarding a negative response that had to the first Pfizer Vaccine, and have seen on the CDC website that if you have negative or allergic reaction to the first vaccine then the second vaccine should not be taken. The patient actually has two questions. Does Pfizer have a list of providers or allergic that could test to see what people are allergic to in their shot? So, you have any information so that patient could contact or get an appointment to the allergist in my state? The next question is if patient not able to take the second dose, would be able to check the MODERNA dose because it is also an MRNA shot. The outcome of the events was unknown. Product details (LOT, Expiration Date, NDC and UPC) and Pharmacy details could not be probed as consumer hung up the call abruptly. Hence further probing could not be done. Consent to follow up with the patient which stated, so that why they need my email address so that can follow up with me, that makes sense. ok that's fine, well they can follow up with me by phone. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793354
Sex: F
Age:
State: SC

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210403; Test Name: fever; Result Unstructured Data: Test Result:low grade; Comments: low grade

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Headache; Nausea; Light headedness; Fatigue; Metal taste; Swelling and numbness whole arm/hand; Swelling and numbness whole arm/hand; Pain x4 days; Lung inhale feels abnormal; Face hot/flushed; Low grade fever; Deep pain in armpit, elbow, hand and breast area; Deep pain in armpit, elbow, hand and breast area; Deep pain in armpit, elbow, hand and breast area; Deep pain in armpit, elbow, hand and breast area; This is a spontaneous report from a contactable consumer (patient). A 49-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9266) dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 15:00 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) (at the age of 49-years-old) as DOSE 2, SINGLE for covid-19 immunization at pharmacy or drug store. The patient was not pregnant at time of vaccination. Patient medical history included chronic bronchitis (not currently active though) from an unknown date and unknown if ongoing. Patient concomitant medication(s) included rosuvastatin (ROSUVASTATIN) 10 mg, ergocalciferol (VIT D), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), Multivit and ubidecarenone (COQ 10), all were taken for an unspecified indication, start and stop date were not reported for any. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 16:30, the patient experienced headache, nausea, light headedness, fatigue, metal taste, swelling and numbness in whole arm/hand, pain x4 days, lung inhale feels abnormal, face hot/flushed, had low grade fever and had deep pain in armpit, elbow, hand and breast area. On 03Apr2021, the patient underwent lab tests and procedures which included body temperature which was found to be low grade. The patient did not received any treatment for the events. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: ROSUVASTATIN; VIT D; VITAMIN B12 [CYANOCOBALAMIN]; COQ 10

Current Illness:

ID: 1793355
Sex: F
Age:
State: MD

Vax Date: 04/10/2021
Onset Date: 04/22/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Joint pain two weeks after second dose; This is a spontaneous report from a contactable consumer (Patient reported for herself). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EW0151), via unspecified route of administration, in right arm on 10Apr2021 13:00 as a dose 2, single for COVID-19 immunization. The patient medical history included lichen planus. The concomitant medication of the patient was not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER2613), via unspecified route of administration, in left arm on 20Mar2021 01:00 PM as a dose 1, single for COVID-19 immunization. Patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not received any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed and since the vaccination, the patient was not tested for COVID-19. On 22Apr2021 13:00 the patient experienced joint pain two weeks after second dose. Outcome of the reported event was recovered on an unspecified date of 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793356
Sex: F
Age:
State: NY

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Headache, vomiting, dry heaves, chills, fever, achey bones that kept patient bedridden for 48 hours. Unable to keep liquids or food in stomach for 24 hours. Excruciating headache from cervical spine t; Headache, vomiting, dry heaves, chills, fever, achey bones that kept patient bedridden for 48 hours. Unable to keep liquids or food in stomach for 24 hours. Excruciating headache from cervical spine t; Headache, vomiting, dry heaves, chills, fever, achey bones that kept patient bedridden for 48 hours. Unable to keep liquids or food in stomach for 24 hours. Excruciating headache from cervical spine t; Headache, vomiting, dry heaves, chills, fever, achey bones that kept patient bedridden for 48 hours. Unable to keep liquids or food in stomach for 24 hours. Excruciating headache from cervical spine t; Headache, vomiting, dry heaves, chills, fever, achey bones that kept patient bedridden for 48 hours. Unable to keep liquids or food in stomach for 24 hours. Excruciating headache from cervical spine t; Headache, vomiting, dry heaves, chills, fever, achey bones that kept patient bedridden for 48 hours. Unable to keep liquids or food in stomach for 24 hours. Excruciating headache from cervical spine t; Headache, vomiting, dry heaves, chills, fever, achey bones that kept patient bedridden for 48 hours. Unable to keep liquids or food in stomach for 24 hours. Excruciating headache from cervical spine t; This is a spontaneous report from a non-contactable consumer or other non health care professional. This consumer (patient) reported that a 62-years-old non-pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0161), via an unspecified route of administration, administered in Arm Right on 22Apr2021 at 11:00(at the age of 62-years) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The historical vaccines include bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP 7533), via an unspecified route of administration, administered in Arm Right on 01Apr2021 at 01:00 PM as dose 1, single for COVID-19 immunisation. On 22Apr2021 23:30, the patient experienced headache, vomiting, dry heaves, chills, fever, achey bones that kept patient bedridden for 48 hours. The patient was unable to keep liquids or food in stomach for 24 hours. Excruciating headache from cervical spine to head. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since vaccination. The clinical outcome of event was recovered on an unspecified date in 2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793357
Sex: F
Age:
State: NV

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:99.6 degrees

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: I had normal symptoms (sore arm) up until 9am the next day. I ended up having a fever that got progressively worse throughout the day. My body got super heavy feeling and I had a hard time standing up; I had normal symptoms (sore arm) up until 9am the next day. I ended up having a fever that got progressively worse throughout the day. My body got super heavy feeling and I had a hard time standing up; anytime I moved my head I became disoriented; I went in and out of having body shakes; feeling freezing cold to feeling super hot.; I had a pounding headache during this whole day; whole day and my body just ached in all my joints; I was unable to sleep for about 24 hours; she had a hard time standing upright; her body got super heavy feeling; had to stand very still to get my vision to focus; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration, administered in left arm on 21Apr2021 15:30 (at the age of 35-years-old) as dose 2, single for covid 19 immunization and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration, administered in left arm on 31Mar2021 15:15 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient's medical history was not reported. Patient had relevant past drug history. Patient was not pregnant at the time of vaccination.The patient concomitant medications included calcium, menaquinone 7 (K2), isosorbide mononitrate (FLO) and ascorbic acid (VITAMIN C) and Herb blend taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Apr2021, at 09:00AM, patient had normal symptoms (sore arm) up until 9am the next day and she ended up having a fever that got progressively worse throughout the day and her body got super heavy feeling and she had a hard time standing upright, anytime she moved her head and she became disoriented and had to stand very still to get my vision to focus. She went in and out of having body shakes and feeling freezing cold to feeling super-hot. She had a pounding headache during this whole day and her body just ached in all her joints. It hurt to just sit still and she was unable to sleep for about 24 hours. She felt the fever break around 10pm that night. She felt good enough to make something to eat and feed my dogs. She slept a good 10hours and woke up the next day feeling fine. Her normal body temp averages in the 96.5 area, usually between 94 and 97 degrees. She had her temp taken 2 hours before her fever broke (when she was feeling her worst). Patient not diagnosed with COVID-19 prior to vaccination and not tested for covid 19 after vaccination. Patient underwent lab test included body temperature results her temperature read at 99.6 degrees on unknown date. No treatment received for the events. The outcome of the events was recovered on unspecified date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: CALCIUM; K2; FLO; VITAMIN-C.

Current Illness:

ID: 1793358
Sex: F
Age:
State: WA

Vax Date: 04/23/2021
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: The next day, had chills and fever, muscle and joint pain. Next day, I woke up and felt pain on left side of my neck and could not turn my head towards; The next day, had chills and fever, muscle and joint pain.; The next day, had chills and fever, muscle and joint pain.; The next day, had chills and fever, muscle and joint pain.; 2 hrs after 2nd dose, I was dizzy and nauseous.; 2 hrs after 2nd dose, I was dizzy and nauseous.; Noticeable swelling in the area between left neck and shoulder towards left half of nape/ swelling on back of nape feels like a pinched nerve; felt pain on left side of my neck; Two lymph nodes swollen and painful to touch; could not turn my head towards the left; feels like a pinched nerve giving me headache; This is a spontaneous report from a contactable consumer (patient). A 53 years old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route, administrated in left arm on 23Apr2021 at 15:15 (at age of 53-years-old) as Dose 2, Single for Covid-19 immunization in Pharmacy or Drug Store. The patient was non-pregnant at time of vaccination. The patient's medical history included ongoing migraine, kidney stones, known allergies to Avocado, Almonds and Walnuts. The patient's concomitant medication(s) included propranolol; omeprazole; erenumab aooe (AIMOVIG); frovatriptan within 2 weeks of vaccination. The patient's past drug included clindamycin and experienced drug allergy. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EN6207, Expiration Date: Not reported), via an unspecified route of administration in left arm on 02Apr2021 at 15:45 (at age of 53-years-old) as Dose 1, Single for Covid-19 immunization. On 23Apr2021 at 17:30 (approximately 2 hrs after second dose of vaccination), the patient was dizzy and nauseous. On 24Apr2021 (the next day), the patient had experienced had chills and fever, muscle and joint pain. (Next day on unspecified date in Apr2021), she woke up and felt pain on left side of her neck and could not turn her head towards the left. On an unspecified date in Apr2021, the patient experienced noticeable swelling in the area between left neck and shoulder towards left half of nape, two lymph nodes swollen and painful to touch, swelling on back of nape feels like a pinched nerve giving her headache. Since the vaccination, the patient was not tested for COVID-19. No treatment received for resulted events. Device date was reported as 26Ap2021. The outcome of the events was not recovered. No Follow-up attempts are needed. No further information was expected.

Other Meds: PROPRANOLOL; OMEPRAZOLE; AIMOVIG; FROVATRIPTAN

Current Illness: Allergy (Verbatim: allergies); Allergy to nuts (Known allergies to Avacado, Almonds and Walnuts); Migraine

ID: 1793359
Sex: F
Age:
State: TN

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: I still have dizziness; I still have dizziness and fuzziness; vertigo; Extremely itchy; swollen injection site; Pain in arm; This is a spontaneous report from a contactable consumer or other non hcp (patient) reported for herself that. A 36-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0162; Expiration Date: 31Jul2021 and NDC number: 59267-1000-02) via an unspecified route of administration, administered in Arm Left on 17Apr2021 11:00 (age at vaccination 36-years-old) as dose 1, 0.3ml single for covid-19 immunisation. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included covid-19 from Dec2020 to an unknown date. Patient had been diagnosed with COVID-19 prior to vaccination. The patient had not received any other vaccine within 4 weeks. The patient's concomitant medications were not reported. On 17Apr2021 (same day of vaccination), the patient experienced swollen injection site and pain in arm. On 18Apr2021, the patient experienced extremely itchy. On an unspecified date, the patient experienced dizziness and fuzziness. On 25Apr2021, the patient experienced vertigo, Extreme vertigo starting day 7. Further explained that pain in arm started after half the day passed following vaccine and lasted and was bad for 4 days. Her armed swelled up gulf ball size, at injection, red, from shoulder down to hand was really itchy for a good 7 days after the injection, arm was really sore and couldn't itch. The redness and swelling itching were 24 hours after vaccine and stayed for 7 or 8 days. Never experienced vertigo before. Vertigo hit 8 days after the injection. She realizes it could be unrelated, but just seems strange it would come up. The patient reported that 8 days after vaccine woke up in middle of night with horrible vertigo, bed was spinning like teacup ride at Disneyland and vertigo persisted really bad for 3 days, it's been getting better as the week goes on. The patient stated that spent most of the week in bed, felt like going to fall, had to treat it like a migraine, had light sensitivity and all the things that go with that dizziness, fuzzy, lied in bed with eyes covered and in the dark, was the only way for sense of relief. Saw her doctor. She believes it could be a reaction to vaccine, never had vertigo before, never experienced in her life. Never had a super strong reaction to a vaccine, other than pain at injection site, never had redness and gulf ball size. She was wondering if the vertigo was something people were reporting. The patient visited to doctor or other healthcare professional office/clinic visit. The patient had not been tested since the vaccination. So, therefore she was just now getting her first dose. She stated that her arm did swell up and had redness at the injection site. She states that it got really itchy, and her arm stayed itchy for a week. She stated that she did see her doctor and they prescribed her METHAZOLE or METHAZINE. She was not sure of the name, but it was a drug that supposed to help with dizziness. She stated that she took it for a couple days, but it did more harm than good. She stated that it made her feel loopy and wasn't helpful. She stated she was supposed to get her second dose this Saturday 08May2021 and she was a little concerned from her reaction to the first vaccine, she stated that there was a slight chance that it could be non-vaccine related, but she never had vertigo before and she just wanted to know what Pfizer would recommend, and has Pfizer had other people calling with these symptoms. The outcome of the events I still have dizziness and fuzziness and pain in arm was unknown. The outcome of the events swollen injection site, extremely itchy and vertigo was not recovered. Information on Lot/Batch number was available. No further information is expected.

Other Meds:

Current Illness:

ID: 1793360
Sex: F
Age:
State: AZ

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Midline facial tingling/number starting 30 min after administration. Tingling extends to tongue.; Midline facial tingling/number starting 30 min after administration. Tingling extends to tongue.; On exam pt is neuro intact but has mild right sided facial swelling; This is a spontaneous report received from a contactable physician. The physician reported for a female patient. A 43-year-old female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EW0172) intramuscularly, in left arm on 01May2021 at 20:00 as dose 2, single (at the age of 43-years-old) for COVID-19 immunization. The patient medical history included hypercholesterolemia, Covid-19. The concomitant medication of the patient included phentermine (PHENTERMINE). The patient previously received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via intramuscularly, in left arm on 10Apr2021 as a dose 1, single for COVID-19 immunization. On an unspecified date prior to vaccination, the patient was diagnosed with COVID-19. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. On 01May2021 at 20:30 the patient experienced midline facial tingling/number starting 30 minutes after administration. Tingling extends to tongue. On examination patient was neuro intact but had mild right sided facial swelling. Patient had emergency room visit for the reported events. Patient received the treatment of prednisone 60 mg, diphenhydramine 25 mg and famotidine 40 mg for the reported events. Outcome of all the reported events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: PHENTERMINE

Current Illness:

ID: 1793361
Sex: F
Age:
State: GA

Vax Date: 04/06/2021
Onset Date: 04/07/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Experienced heavy pain in opposite arm of injection; Hot flashes; Chills; Joint pain; Rash; Night sweats; This is a spontaneous report from a contactable consumer. A 32years female (nonpregnant) patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: ER8737) was administered on 06Apr2021 at 12:00pm (age at vaccination was 32) as dose 1, single for covid 19 immunization. The patient medical history and concurrent conditions was Depression, migraine. Patient did not take any other vaccine in four weeks. No covid prior vaccination and did not tested covid post vaccination. On 07Apr2021 11:00 patient Experienced heavy pain in opposite arm of injection, hot flashes, chills, joint pain, rash and night sweats. All occurred 1-11 days after injection. The patient didn't received any treatment. The outcome of all events was Recovered on an unknown date on 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793362
Sex: F
Age:
State: CA

Vax Date: 04/03/2021
Onset Date: 04/08/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I know of a few others who have experinced shingles or female issues directly after the pfizer vaccine.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EW0150, Expiry date: not reported) via intramuscularly, administered in left arm 03Apr2021 11:00 (at the age of 61-year-old) as dose 1, single for COVID-19 immunization. Second dose BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EW0181, Expiry date: not reported) via intramuscularly, administered in left arm 09Jul2021 13:00(at the age of 61-year-old) as dose 2, single for COVID-19 immunization. Medical history included thyroid disorder from 1995 and ongoing. The patient's concomitant medications were not reported. Historical vaccine included: The patient had received the first shingles vaccine in 2018 (Shingrix) and did not get the 2nd shot. List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine (s) was none. On 08Apr2021 (5 days after the vaccine), the patient experienced shingles (Persistent/Significant disability/ Incapacity). AE resulted in emergency room visit. It has been over 3 weeks and I still have pain, numbness, rash is pretty much gone. patient was still taking pain medication. The pain has changed over the 3 weeks and this past week it was centralized to my lower back and lover pelvic area, as in it felt like my ovaries or other parts down there were cramping and being stomped on. (no, I no longer have a monthly cycle). I know of a few others who have experienced shingles or female issues directly after the Pfizer vaccine. Just reporting this to you as it has been 23 days of living hell and I would have held off of the vaccine if I had known this was a possible side effect until more long term information had been gathered. I am in the minority I am sure, but I know in my case this was directly related to the vaccine. Please be aware this is a thing. The patient received Zovirax: 800mg and Hydrocodone: 5-325 mg treatment for the event. Outcome of the event was recovered with sequelae in Jul2021. Follow up attempts completed. No further information is expected.

Other Meds:

Current Illness: Thyroid disorder (Verbatim: Thyroid)

ID: 1793363
Sex: F
Age:
State: FL

Vax Date: 04/30/2021
Onset Date: 05/02/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Extreme hip/joint pain in left leg (glute Med area extremely sensitive to touch) Extreme Pain experienced with sitting on the left hip/side and also when attempting to stand.; Walking around slowly seemed to warm up the muscle with less discomfort; Any rotation at the hip brought on sharp pain as well though (around that glute med,TFL area, around hip); Pain also radiated down to toes; some neck pain; Extreme hip/joint pain in left leg (glute Med area extremely sensitive to touch) Extreme Pain experienced with sitting on the left hip/side and also when attempting to stand.; injection site pain; This is a spontaneous report from a contactable consumer (patient herself). A 44-years-old non-pregnant female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: EW0153, expiration date: not reported), intramuscular, administered in Arm Right on 30Apr2021 12:30 (age at vaccination 44-year-old) as dose 2, single for covid-19 immunization at Pharmacy or Drug Store. Medical history included Iliosoas (hip) injury from 2013 to an unknown date, Exercise induced bronco-spasms from an unknown date and unknown if ongoing, Pre-Diabetic from an unknown date and unknown if ongoing. Patient previously took Pfizer COVID-19 vaccine on 09Apr2021 12:15 PM (lot number: EW0170) administered via Intramuscular route in Right arm (age at vaccination 44-year-old) as dose 1 single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive within 2 weeks of vaccination. Since the vaccination the patient had been tested for covid-19. Prior to vaccination the patient was not diagnosed with Covid-19. The patients concomitant medications were not reported. On 02May2021 at 12:30, the patient experienced extreme hip/joint pain in left leg (glute med area extremely sensitive to touch) extreme pain experienced with sitting on the left hip/side and also when attempting to stand, walking around slowly seemed to warm up the muscle with less discomfort, any rotation at the hip brought on sharp pain as well though (around that glute med, tfl area, around hip), pain also radiated down to toes, injection site pain, some neck pain. Patient was self-treated with ice packs, compression, elevation & Biofreeze (topical menthol pain reliever) PRN as a therapeutic measure for all the events. The clinical outcome of the events was reported as recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793364
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Severe allergic reaction and it looks like my left arm got bad rash and it's bloody; Severe allergic reaction and it looks like my left arm got bad rash and it's bloody; I got blotches on my left arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration in 2021 (Batch/Lot Number: EL9266, Expiry Date, NDC number and UPC number were unknown) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient historical vaccine includes received first dose of BNT162B2 via an unspecified route of administration in 2021 (Batch/Lot Number: 0151 Expiry Date unknown) as dose 1, single for covid-19 immunisation. The patient's concomitant medications were not reported. In 2021 the patient experienced severe allergic reaction and it looks like my left arm got bad rash and it's bloody, I got blotches on my left arm. The patient reported that I don't understand, I am lost. The patient reported that I had the second shot done on Thursday the Covid shot (Pfizer, Covid-19 Vaccine) and I am looking at the severe allergic reaction. I don't know it looks like in my left arm I got a bad rash. It's bloody and today and I noticed is last night, today is Saturday and yesterday I noticed I got blotches on my left arm and I do not know if that is a reaction from the shot. Does it usually happen right away? The patient did not want to answer any of that. The patient stated, I have got Pfizer B100151. Is that it? There is another my second dose EL9266. I do not know I do not see the dose on there. I think that is the LOT, I do not know. It says 0151 for the first shot. Then on the second one it is EL9266, alright. For Expiry date the patient stated that I do not see what you are asking me here. The outcome of the event was unknown. As consumer was not willing to proceed the call. Product details (LOT, Expiration date, NDC and UPC), Pharmacy details and treatment could not be probed over the call. Limited information was available over the call. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793365
Sex: M
Age:
State: NC

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

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

Lab Data: Test Name: liver function test; Result Unstructured Data: Test Result: Really elevated (more recently); Test Date: 2019; Test Name: liver function test; Result Unstructured Data: Test Result: Elevated (prior to the FIRDAPSE study); Test Date: 2019; Test Name: liver function test; Result Unstructured Data: Test Result: Elevated 2 times normal; Test Date: 202007; Test Name: liver function test; Result Unstructured Data: Test Result: Back to normal.

Allergies:

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

Symptoms: Liver function tests elevated; really elevated liver enzymes; elevated two times normal; Symptoms of a cold (got sick); Had a fever for a couple of days; Felt like getting over a bug; This is a spontaneous report received from a contactable consumer (patient) via a company representative. A 47-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot no and Expiration date were not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included Lambert-Eaton myas-thenic syndrome (LEMS), unspecified auto-immune disorders, asthma, abnormal cholesterol, and anxiety. Concomitant medications included firdapse (AMIFAMPRIDINE PHOSPHATE, strength: 10 mg, formulation: Tablet) from 29Jan2019 to Jun2019 at 10 mg 6 to 7 times per day (reported as 70 mg per day) orally for Lambert-Eaton myasthenic syndrome (LEMS), an unspecified cholesterol medication "statin," Klonopin (clonazepam), and omeprazole. On an unknown date in 2019 (reported as "about a month ago" relative to 12Jul2019), after starting the product, the patient's liver function tests were elevated (results not reported). Subsequently, his FIRDAPSE dosage was decreased to 10 mg daily. As of 12Jun2019, treatment with FIRDAPSE was ongoing and the status of the patient's elevated liver function tests was unknown. On 17Jul2019, it was learned that the patient's medical history included elevated liver enzymes which "he had to get down so that he could start in a FIRDAPSE study," and enrollment in a FIRDAPSE study (unknown duration and time period of enrollment). The patient was taking a 70 mg prescribed dose and he normally took 4-5 tablets per day. However, if he was going to be more active, he would take a 70 mg daily dose. On an unspecified date in 2019 (reported as "more recently" relative to 1Jul2019), that patient had some "really elevated" liver enzymes in his blood work. On an unspecified date (reported as 3 weeks ago relative to 17Jul2019), the patient's doctor had reduced the patient to taking one tablet of FIRDAPSE per day until they were able to get his liver enzymes back to "normal." As of 17Jul2019, the patient continued to take FIRDAPSE at 1 tablet a day until he can find the dosage that doid not cause elevated liver enzymes. The status of the elevated liver enzymes was not reported. On 26Sep2019, it was learned that on an unspecified date, the patient's liver enzymes were elevated to "two times normal" (previously reported as really elevated). As of 26Sep2019, the patient continued on his reduced dose of FRIDAPSE 10 MG once daily. The status of the elevated liver enzymes was not reported. On 10Dec2019, it was learned on an unspecified date in 2019, the patient's dose was decreased to FIRDAPSE 10 mg at 20 mg twice a week (on 2 separate days throughout the week). He couldn't take any more than 2 FIRDAPSE pills per week or his liver enzymes would go up. The patient's doctor was aware. As of 10Dec2019, the patient continued treatment with the product and the status of the elevated liver enzymes was not reported. The patient felt that "nothing had changed". On an unspecified date "for a time" prior to Jul2020, the patient stopped taking FIRDAPSE all together until his liver function labs came back to "normal." On an unspecified date, to make sure his muscles would not "lose function," he was put back on FIRDAPSE "like once or twice a week" as previously reported. On an un-specified date "last month" (relative to 10Aug2020), the liver functions got back to "normal" and his FIRDAPSE dose was restarted at 10 mg by mouth, 1-2 times a day. As of 10Aug2020, treatment with the product was ongoing at a dose of 10 mg, twice a day (lot number: 3185425, expiration date: Feb2022) and the status of elevated liver enzymes was improved. Liver labs would be checked in a few months (also reported as "by Oct2020"). On an unspecified date, the patient received the Pfizer COVID Vaccine and got sick afterwards, described as symptoms of a cold, "just like getting over a bug". On unspecified dates, he experienced fever for a couple of days and elevated liver enzymes. It was not known if this was the first or second dose of the vaccine. The reporter also stated elevated liver enzymes had been a problem off and on since the patient started FIRDAPSE (not further clarified but previously reported). As of 19Apr2021, the patient's treatment with FIRDAPSE continued. The outcome of the events his symptoms of a cold, feeling like he was getting over a bug, fever, and elevated liver enzymes was resolved on an unspecified date. No follow up attempts are needed, information about lot/batch number cannot be obtained.

Other Meds: Firdapse; Klonopin; Omeprazole

Current Illness:

ID: 1793366
Sex: F
Age:
State: LA

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

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

Lab Data:

Allergies:

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

Symptoms: I currently have severe rash over legs, arms and upper chest.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE UNMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced that currently having severe rash over legs, arms and upper chest. The patient reported that I received Pfizer Covid vaccines. I currently have severe rash over legs, arms and upper chest. Could this possibly be from vaccines and what is best course of treatment. I can send pictures if necessary. Only looking for advice. Seeking nothing else. The outcome of the events unknown. Follow up (02May2021): This is a follow up spontaneous report from a Pfizer sponsored program Follow up(05May2021): case number has been provided. No new information. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793367
Sex: M
Age:
State: NY

Vax Date: 04/03/2021
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Arm soreness/Tingling sensation also felt in fingers, as well as the sharper soreness; Soreness around site of injection; Tingling sensation also felt in fingers; Soreness also encompassed shoulder and left section of my chest; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received first dose of 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 on 03Apr2021 14:00, (at the age of 26-year-old), as 1st dose, single for COVID-19 immunization. Medical history included electrocardiogram qt prolonged, covid-19, food allergy (Some fruits (mainly skins on apples, kiwis, carrots, celery, etc.) But nothing severe). Concomitant medications included Nadolol (20mg, 3x daily). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have covid prior vaccination and no covid tested post vaccination. On Apr2021, the patient experienced arm soreness/tingling sensation also felt in fingers, as well as the sharper soreness, soreness around site of injection, tingling sensation also felt in fingers, soreness also encompassed shoulder and left section of my chest. This lasted 7 days after the first dose, then it was gone. The outcome of the events pain in extremity, vaccination site pain and paresthesia was recovered on an unspecified date in Apr2021 (7 days after vaccination). And outcome of event arthralgia was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: NADOLOL

Current Illness:

ID: 1793368
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: skin is itchy everyday; sleep is disturbed 1-2 days; skin is cracked and dry 1-2 days of the week.; skin is cracked and dry 1-2 days of the week.; flare up; This is a spontaneous report from a contactable other hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2,Solution for injection,Batch/Lot number was not reported, Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1,SINGLE,and bnt162b2 (BNT162B2,Solution for injection, Batch/Lot number was not reported, Expiry date was not reported dose 2 via an unspecified route of administration on an unspecified date DOSE 2,SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced skin is itchy, sleep is disturbed, skin is cracked and dry 1-2 days of the week (skin dry),skin is cracked and dry 1-2 days of the week, flare up.The clinical outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793369
Sex: F
Age:
State: CA

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

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

Lab Data: Test Date: 20210104; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Positive

Allergies:

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

Symptoms: Fever; chills; body aches (severe); fatigue; This is a spontaneous report from a contactable nurse (patient). A 38-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL3246, Expiry date: not reported) via an intramuscular route of administration in arm left on 15Jan2021 (age at vaccination 38-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypertension during pregnancy only 2011 and 2012 and non-smoker from an unknown date and unknown if ongoing. Concomitant medications included multi vitamin d3, zinc, bupropion and fluoxetine taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EK5730, Expiry date: Mar2021), dose 1 via an intramuscular route of administration, administered in arm left on 26Dec2020 as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that the patient had no pre-existing diseases worsened during the SARS-CoV2 infection. The patient had no display clinical signs at rest indicative of severe systemic illness. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. There were not any of the events above considered serious due to being life-threatening or due to persistent or significant disability/incapacity or any other reason. On an unspecified date, the patient experienced fever, chills, body aches (severe) and fatigue. The events did not require hospitalization. Adverse events did not require to visit intensive care unit/ emergency room/ physician office. The event required the initiation of new medication or other treatment or procedure included OTC supplements, ASA 50mg, vit c, vitd3, zinc, famotidine, melatonin, vit b complex, elderberry, multi vitamin and quercetin. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Jan2021 (Nasal swab NAA/PCR). The clinical outcome of the events was unknown. No follow-up attempts are needed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018130 same patient/drug, different dose

Other Meds: VITAMIN D3; ZINC; BUPROPION; FLUOXETINE.

Current Illness:

ID: 1793370
Sex: F
Age:
State: TX

Vax Date: 04/21/2021
Onset Date: 04/26/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 202102; Test Name: had COVID in early Feb; Test Result: Positive

Allergies:

Symptom List: Pain in extremity

Symptoms: Very sore arm for 4 days after vaccine (expected); On day 5, woke up with extreme fatigue; muscle soreness; Headache; Dizziness; Brain fog; Nausea; Feeling feverish; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER8731, expiration date was not reported), via an unspecified route of administration, administered in right arm on 21Apr2021 16:15 (at the age of 25-years-old) as dose 1, single for covid-19 immunization at hospital. The patient medical history included hashimoto's thyroiditis, ADHD, Strattera (allergies to Strattera), covid-19 (I had COVID in early Feb and this feels similar, but not as intense) , allergy. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), metformin, levothyroxine sodium (SYNTHROID), clarithromycin (CLARITAB), azelastine, all taken for unknown indications from an unknown date. List of any other medications the patient received within 2 weeks of vaccination included adderall, metformin, synthroid, azelastine, Clarit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 26Apr2021 at 07:00am the patient experienced very sore arm for 4 days after vaccine (expected). On day 5, woke up with extreme fatigue, muscle soreness, headache, dizziness, brain fog, nausea, and feeling feverish. Still ongoing as of today, but the headache, dizziness, and nausea are gone. I had COVID in early Feb and this feels similar, but not as intense. The patient underwent lab tests and procedures which included had COVID in early Feb (sars-cov-2 test): positive on Feb2021. The adverse events did not result in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect. The reporter assessed the seriousness as non-serious. No treatment was received for the adverse events. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: ADDERALL; METFORMIN; SYNTHROID; CLARITAB; AZELASTINE

Current Illness:

ID: 1793371
Sex: M
Age:
State: GA

Vax Date: 04/20/2021
Onset Date: 04/21/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I began having lots of diarrhea; then it persisted all week; I do have a very runny nose; which was running earlier a little bit; now it's running quite a lot; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in Arm Left on 20Apr2021 (at the age of 83-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood pressure (Verbatim: Blood pressure). Concomitant medication included metoprolol 200 mg Orally, once a day, Tablet taken for blood pressure, start and stop date were not reported. The patient reported that the next day of vaccination on 21Apr2021, he began having lots of diarrhea and then it persisted all week and he had not got any medical help for this. Patient also stated that he had a very runny nose, which was running earlier a little bit but then it was running quite a lot. The patient did not receive treatment for adverse events. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: METOPROLOL

Current Illness:

ID: 1793372
Sex: F
Age:
State: NY

Vax Date: 04/27/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rash on my whole upper torso/ rash from groin to up under her arms and entire upper torso; Sick; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 71-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731) single dose via an unspecified route of administration on 27Apr2021 for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included Escitalopram (LEXAPRO), captopril, hydrochlorothiazide (Hydrochlorothiazide), Losartan (LOSARTAN), Metoprolol (METOPROLOL) and Vitamins: (Consumer stated, Vitamins and something like that). Historical vaccine included first dose (Lot number: ER8730). The patient reported she had her second COVID shot on Tuesday morning on 27Apr2021 and she had many symptoms and sick and also she had rash from groin to up under her arms and entire upper torso. She did not have any rash on the injection site. There were no unaddressed medical questions referred or forwarded to Medical Information. The outcome for the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: LEXAPRO; LOSARTAN; HYDROCHLOROTHIAZIDE + CAPTOPRIL; METOPROLOL

Current Illness:

ID: 1793373
Sex: U
Age:
State: TN

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

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

Lab Data:

Allergies:

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

Symptoms: Encounters an allergen, in my case mold, the vaccine appears to attack the allergen.; Hay fever,; But within 2 days I developed a fever; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported) for Covid-19 Immunization. The patient's concomitant medications were not reported. On an unspecified date the patient were encounters an allergen, in this patient case mold, the vaccine appears to attack the allergen, hay fever, but within 2 days patient developed a fever. Patient recently received your vaccination shots. Patient had found an interesting reaction that occurs. When a vaccinated person encounters an allergen, in patient case mold, the vaccine appears to attack the allergen. patient encountered mold days after patient 2nd shot. patient reaction started as hay fever, which is normal, but within 2 days patient developed a fever. It's as if the vaccine was trying to rid patient of the allergen by attacking it. Patient a friend who has had the same reaction but with cotton wood trees pollen. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793374
Sex: M
Age:
State: WV

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

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

Lab Data: Test Date: 202104; Test Name: Weight; Result Unstructured Data: Test Result:lost 6 lbs

Allergies:

Symptom List: Vomiting

Symptoms: Really sick; Vomiting; Chills with no fever; lost appetite; Weight loss, lost 6 pounds; no taste; This is a spontaneous report from a contactable consumer (parent, mother). A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date (age at vaccination was 62 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hernia repair from 2020 to an unknown date, covid-19 (he had Covid in Nov 2020 he lost 6 pounds) from Nov2020 to an unknown date, weight loss (he had Covid in Nov 2020 he lost 6 pounds) from Nov2020 to an unknown date. Family medical history was reported none. Prior vaccination within 4 weeks was reported as none. Additional vaccines administered on same date of the pfizer suspect was reported as none. Concomitant medications were not reported. Report stated that the patient received the first dose of the Covid-19 vaccine a week and a half ago (exact dates not clarified). On an unspecified date in Apr2021, within a couple days the patient was really sick. It was reported that the patient only vomited once and it was a small amount. He had chills the next day that lasted only for a day. He had lost his appetite a couple of days later. He had lost 6 pounds and the weight loss was due to having no appetite. He also had no taste. The events did not result in visit to ER or physician office. No investigation assessment was reported. The patient underwent laboratory tests that included: weight: lost 6 pounds on an unspecified date in Apr2021. Outcome of all the events was recovered on an unspecified date in 2021 while outcome of event weight loss, sick was unknown. No follow-up attempts are possible. Information about lot/ batch no cannot be requested.

Other Meds:

Current Illness:

ID: 1793375
Sex: M
Age:
State: CT

Vax Date: 04/18/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: he had lost his taste and smell,; he had lost his taste and smell,; had cold sweats; pain in back and legs so bad could not walk.; pain in back and legs so bad could not walk.; pain in back and legs so bad could not walk.; This is a spontaneous report received from a contactable consumer (Patient) from Pfizer. A 48-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 18Apr2021 as dose 2, single for COVID-19 immunization. No Medical history reported. He has went to an urgent care and to his doctor and they were unable to find anything that could be wrong and the Covid shot is the only thing different from his regular routine. The patient's concomitant medications were not reported. The patient reported that he had lost his taste and smell, had cold sweats, pain in back and legs so bad could not walk, he went back to work the next week but still has no energy, is still in pain and having cold sweats. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1793376
Sex: F
Age:
State: PA

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Itching on head, arms, legs, ankle and foot; Fatigue, described as feeling tired with a heavy feeling; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 27Apr2021 12:15 (at the age of 63-year-old) as single dose for COVID-19 immunization. Medical history included Autoimmune hemolytic anemia from 2003 and ongoing; Mild Thalassemia from 2003 and ongoing; Lupus from around 2006 and ongoing; Dermatomyositis from around 2007 and ongoing. She has had autoimmune issues for years. Concomitant medications included 15 different medications. She had taken the same medication for years. The patient had no history of 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). The patient did not receive any additional vaccines on same date of the Pfizer Suspect. The patient had no prior Vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. The patient previously received some different medications and had body rashes in the past (many years ago). This included a body rash with Hydroxychoroquine (does not have the NDC, Lot or expiration date); unsure if she got a rash or sores in her mouth with Hydroxychoroquine (PLAQUENIL, does not have the NDC, Lot or expiration date); a rash with Latex (No identifying information provided); had a hot feeling and her skin turned red with Cat Scan dye (does not know the name of the dye or have an NDC, Lot, or expiration date); unsure if caused a rash or sores in her mouth with Azathioprine (does not have an NDC, Lot or expiration date), it happened back in 2004. The patient experienced fatigue, described as feeling tired with a heavy feeling since 27Apr2021 13.00 and itching on head, arms, legs, ankle and foot since 27Apr2021 13.30. On Tuesday (27Apr2021), she went to pharmacy and got her first vaccine at 12:15 pm. All of her doctors recommended her to get the vaccine because she was immunocompromised. She waited at the vaccine site, for 30 minutes, reclarified, because she was high risk and has many autoimmune issues. She felt fatigued and tired, which she thinks is normal. At 2 pm she started to itch, reclarified as on her head, her side, down her leg to her foot, and it was constant, until about 10 pm that night. She had no rash. The itch was gone the next day. The patient reported that, got first shot of the Pfizer on Tuesday but of course, she got the normal fatigue and tiredness afterwards which was fine now. She got it at 12:15 in the afternoon and then at about 1:30 in the afternoon, she started to get itchy like from head to toe and it was like in different spots that had reached her head, reached arm and all over in different spots and it lasted for about 10 hours. She didn't have a rash, she didn't have any hives and she didn't have anything like that. So, she was just like is this, she didn't know if this was a side effect. She had been reading and trying to figure it out but everything kind of leads to a rash and she didn't have one. Patient asked that when she gets the second vaccine, the itch would happen again, or she would have a worse reaction. Patient had spoken to her primary doctor and her rheumatologist, and they both encouraged her to get the second vaccine. Patient states they recommend that she stay at the vaccine site longer for about like one and a half hour later and put the distance, to be monitored. for about like one and a half hour later and put the distance Patient spoke to her Pharmacist and Pharmacist stated the itching was a red flag and recommended that if her doctor wanted her to get the second vaccine, maybe the doctor can order an EpiPen, in case she has a worse reaction. Patient even asked her hematologist if she should get the second vaccine and he agreed that she should. All of her physicians want her to get the second vaccine, and if she has a bad reaction, it can be dealt with at the time. Patient states she has had autoimmune issues for years, and she was cautious. Patient asked if she goes for the second vaccine, she would have a worse reaction. Reclarified, the Patient states her main concern is getting the second vaccine. Patient states she was afraid of getting a bad reaction, versus actually getting the Covid virus. Patient states she has some protection from the virus after getting the first vaccine. Patient was notified that Medical Information and/or Pfizer was unable to provide medical advice but may have resources to help answer some questions. Patient was encouraged, due to her history, to have another conversation with her healthcare provide regarding her concern. AE(s) did not require a visit to Emergency Room or Physician Office. The patient had no relevant tests. Outcome of the event Itching was recovered on 27Apr2021; Fatigue was recovered on 30Apr2021. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Autoimmune hemolytic anemia; Dermatomyositis (From around 2007); Lupus syndrome (Verbatim: Lupus From around 2006); Thalassemia (Verbatim: Mild Thalassemia From: caller states around 2003)

ID: 1793377
Sex: M
Age:
State: FL

Vax Date: 04/29/2021
Onset Date: 04/30/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Searing Pain in his right arm; Searing pain all throughout his body; Migraine Headache; head feels like he just came back from a night of partying; couldn't open his eyes, it was really bright; tried to get up and he fell on the floor because his balance was off and he had to wait 4-5 hours until he could get up; going into a room and fell into the door; Chest tightness; he wasn't able to talk before because his chest was tight; bouncing of his legs like restless leg syndrome; Temperature; really thirsty; This is a spontaneous report from a contactable consumer (patient). A 49-Year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0158 and expiry date was not reported), via an unspecified route of administration, on 29Apr2021 at 13:00 (age at vaccination: 49 years), as dose 2, a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have family medical history relevant to adverse events. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0151 and expiry date was not reported), via an unspecified route of administration, on 09Apr2021 (age at vaccination: 49 years), as a single dose for COVID-19 immunization. Vaccine was not administered at Military Facility. The patient stated that he thought he had a reaction to the Pfizer Covid vaccine last night. The patient stated his second shot was taken at 13:00 yesterday, 29Apr2021 and at about 03:15 this morning, he had searing pain in his right arm and all throughout his body on 30Apr2021. He was getting migraine headaches and he couldn't open his eyes, it was really bright. He tried to get up and he fell on the floor because his balance was off and he had to wait 4-5 hours until he could get up. He was able to talk now, he wasn't able to talk before because his chest was tight. He also had bouncing of his legs like restless leg syndrome, but that subsided. The patient stated his head feels like he just came back from a night of partying. He clarified that he could get around and didn't look like someone that is 2.5 years old and unbalanced. He clarified the pain in the arm was now only when he touches it. He was going into a room and fell into the door and felt it. The pain was more from the chest down now and improved. He had a temperature, but his blood pressure was okay. He was really thirsty, anything with the vaccine that has to do with that. The patient stated that he called the pharmacy because he had a script ready, and he wanted to know what prescription it was. The pharmacist asked him what was going on with him and said he needs to report his reaction to get the information in the database of people who feel good and bad. The events did not require a visit to emergency room and physician office. The patient did not received any treatment for the events. Outcome of the event searing pain all throughout his body and really thirsty was not recovered, bouncing of his legs like restless leg syndrome was recovered on 30Apr2021, temperature was unknown, and for all other events, it was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1793378
Sex: M
Age:
State: PA

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

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

Lab Data: Test Date: 202105; Test Name: Body temperature; Result Unstructured Data: Test Result:100; Test Name: white cell blood count; Result Unstructured Data: Test Result:no result

Allergies:

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

Symptoms: freezing; still weak; tired; Fever; tried to get my bed but I couldn't my heart was beating kept beating would not stop, beat; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0161; Expiration Date: not reported) via an unspecified route of administration, administered in upper left arm on 01May2021 (age at vaccination 66-year-old) as dose 2, single for COVID-19 immunization. Medical history included diabetic. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in upper left arm, on 03Apr2021 as dose 1, single for COVID-19 immunization. Concomitant medications included lisinopril and tamsulosin. The patient reported that on an unspecified date in May2021 at 10 PM at night he started freezing so he got upstairs and got a couple of blankets and a pocket warmer, real weak, then he tried to get his bed, but he could not, his heart was beating kept beating would not stop, beat. Another side effect, he woke up his fever was with 100. The patient was still weak. Patient asked could he get over now, too tired. He was tired to go anywhere, somewhere. Patient underwent lab tests which included body temperature: 100 on an unspecified date in May2021 and white blood cell count: no result with unspecified date. The patient took two Tylenol as a result of fever and tried to treat lower his fever. Outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: LISINOPRIL; TAMSULOSIN

Current Illness:

ID: 1793379
Sex: M
Age:
State: OR

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: The worst part was that my groin swelled up to about the size of a Cantaloupe. (This also happened to another vet who had his second shot around the same time as I did, within a few days); Rash on arms, hands, legs, feet, and a little bit on chest; fisrt dose on 20Jan2021/second dose on 06Feb2021; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 06Feb2021 15:00 (at the age of 61-year-old) (Lot Number: EL9261) as single dose for COVID-19 immunisation. Relevant medical history included diabetes, hypertension, obesity and known allergies to lithium. Concomitant medications were not reported (the patient was receiving 17 unspecified concomitant medications). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 20Jan2021 (at the age of 61-year-old) (Lot Number: EL3249) for COVID-19 immunisation (inappropriate schedule of vaccine administered). On 07Feb2021, the patient experienced rash on arms, hands, legs, feet, and a little bit on chest. The worst part was that his groin swelled up to about the size of a Cantaloupe. The patient was catheterized in the hospital and over a period of about two weeks he lost about 60-70 pounds in water weight. The patient was hospitalized for 14 days. The adverse events resulted also in Emergency room/department or urgent care. Treatment received for the adverse events included catheterization and furosemide. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am