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: 1812225
Sex: M
Age:
State:

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

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result: 101; Comments: fever of 101.

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Having a fever of 101 towards the end of second day; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date at the age of 26-years-old and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01May2021 at 15:15 at the age of 26-years-old as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. On an unknown date, towards the end of second day the patient had fever of 101. On an unknown date, the patient underwent body temperature test and the result was 101 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was unknown at the time of this report. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812226
Sex: F
Age:
State:

Vax Date: 04/30/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Chills; Low fever; Joint pains; Muscle aches; Mild nausea; Fatigue; Injection site pain; headaches; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 30Apr2021 at 16:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications included colecalciferol (VITAMIN D3) and multi vitamin GUMMY; both for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 05:00, the patient experienced chills, low fever, joint pains, muscle aches, headaches, mild nausea, fatigue and injection site pain. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, low fever, joint pains, muscle aches, headaches, mild nausea, fatigue and injection site pain were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds: VITAMIN D3

Current Illness:

ID: 1812227
Sex: M
Age:
State: CA

Vax Date: 05/04/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
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: lost his sense of taste; My right ear is hurting and partially blocked; My right ear is hurting and partially blocked/right ear hurts; couldn't sleep; sore arm; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173; Expiration Date: 31Aug2021), via an unspecified route of administration, on 04May2021 15:00 at the age of 55-year-old, in Arm Left, as dose 1, single for COVID-19 immunization. Medical history included ongoing High Blood Pressure Diagnosed 9 years ago, ongoing Right sided weakness started 9 years ago, aortic dissection from an unknown date and unknown if ongoing started 9 years ago, ongoing Uses cane or walker to walk started 9 years age. Concomitant medication included LOSARTAN taken for hypertension, start and stop date were not reported and patient reported that had been taking this for 9 years and ongoing, ATORVASTATIN taken for an unspecified indication, start and stop date were not reported, ASPIRIN taken for anticoagulant therapy, start and stop date were not reported patient reported that had been taking this for about 7 years also ongoing. Patient known allergies reported as no. Patient did not received any other vaccine within 4 weeks prior to covid vaccine. Patient had not been diagnosed with covid-19 prior and post vaccination. Patient reported that after vaccination on Tuesday night, 04May2021, the right ear was hurting like crazy. Patient couldn't sleep from the pain and almost called 9-1-1. Patient stated that on a scale of 1-10 the pain was an 8 or 9. Patient did not know what to do about this. Patient reported that the pain level fluctuates. The ear pain between a 5 up to a 9 on a pain scale of 1-10. The pain fluctuated but it is constant all day. Patient was clarified his ear started hurting about 17:00. When probed for the outcome of his right ear hurting, patient was explained the pain is going on and off, on and off. On a scale of 1 to 10 with 10 being highest, the pain is about a 9 and goes from 7 to 5 and then goes back to 7 and then back to 8 or 9, just like that the whole day. Patient noticed that lost his sense of taste today, 07May2021 at 12:00 noon. Patient said he's not sure how his smell goes. When probed for details he said his sense of smell is fine. Patient stated that he almost called 911 but he was worried about his family so he didn't call and he endured the pain. Treatment was not received as a result of AE. Patient was not hospitalized, not went to emergency room, no physician visit. The clinical outcome of the event sore arm was recovered in May2021, and all events were not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: LOSARTAN; ATORVASTATIN; ASPIRIN

Current Illness: Blood pressure high (9 years ago); Walking aid user (He says now he walks with a walker); Weakness left or right side (9 years ago)

ID: 1812228
Sex: F
Age:
State: VA

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 10/23/2021
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: headache; nausea; really tired; had fever for a little bit; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 20-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route at left arm on 09Apr2021 at 10:00 am (lot number: EN6202) (age at vaccination 20-year-old) as dose 2, single for COVID-19 immunisation. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route at left arm on 22Mar2021 at 09:00 am (lot number: EN6208) as dose 1, single for COVID-19 immunisation which was a defective dose. she did not get symptoms after the 1st dose of the vaccine. The patient medical history was reported as none and concomitant medication was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect and additional Vaccines Administered on Same Date of the Pfizer Suspect: None. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had testing for COVID19 regularly and has not had covid19 and every test she has taken is negative for covid19. The patient had a headache, nausea, and was really tired and had fever for a little bit; states the symptoms started the night of 09Apr2021. The adverse events did not required to visit ER or MD office. She has not required treatment for the reported events. 24 hours later after the symptoms started and resolved the night of 10Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812229
Sex: F
Age:
State: NY

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 10/23/2021
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: Body aches; Migrating joint pain; Significant swelling of the lymph nodes in left arm pit; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 28Apr2021 at 08:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included an unspecified birth control pill on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 07Apr2021 at 08:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 18:00, the patient experienced body aches, migrating joint pain and significant swelling of the lymph nodes in left arm pit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, migrating joint pain and significant swelling of the lymph nodes in left arm pit were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812230
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
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: Extreme fatigue; Nausea; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 08:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 at 20:00, the patient experienced extreme fatigue, nausea and vomiting. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, nausea and vomiting was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812231
Sex: F
Age:
State: IN

Vax Date: 04/29/2021
Onset Date: 04/30/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Extreme diarrhea on second day, eating nothing and still having liquid feces; Extreme diarrhea on second day, eating nothing and still having liquid feces; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Apr2021 at 22:00, on second day of vaccination, the patient experienced extreme diarrhea, the patient was eating nothing and was still having liquid feces. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event's extreme diarrhea on second day, eating nothing and still having liquid feces was not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812232
Sex: F
Age:
State: AR

Vax Date: 04/27/2021
Onset Date: 04/28/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Severe headache for three days.; Fatigue for three days; Muscle pain for three days; Very sore arm at place of injection and through the shoulder; Very sore arm at place of injection and through the shoulder; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 27Apr2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included brewers' cancer 2018 for which patient completed treatment in 2019. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tamoxifen (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received tramadol (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 24Mar2021 at 10:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Apr2021 at 00:00, the patient experienced severe headache for three days, fatigue for three days, muscle pain for three days and very sore arm at place of injection and through the shoulder. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with OTC medication, rest and lidocaine patches (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fatigue and muscle pain were resolved on 01May2021; while that of the very sore arm at place of injection and through the shoulder were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: TAMOXIFEN

Current Illness:

ID: 1812233
Sex: F
Age:
State: PA

Vax Date: 04/30/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
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: Intense chills; Body aches; Muscle soreness; Stiffness; Weakness; Joint pain in lower body; Severe vertigo; Dizziness; Loss of appetite; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 30Apr2021 at 17:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The medical history included obesity, anemia, childhood thyroid disorder, severe childhood bronchitis and recent abortion. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The concomitant medications included sertraline hydrochloride (ZOLOFT) and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER0734) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 03:00, the patient experienced intense chills, body aches, muscle soreness, stiffness, weakness, joint pain in lower body, severe vertigo, dizziness and loss of appetite. It was also reported that survey was taken 24 hours after the second shot. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense chills, body aches, muscle soreness, stiffness, weakness, joint pain in lower body, severe vertigo, dizziness and loss of appetite were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds: ZOLOFT; ADDERALL

Current Illness:

ID: 1812234
Sex: F
Age:
State: NJ

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210429; Test Name: Body temperature; Result Unstructured Data: Test Result: 103.6 (Unspecified units); Comments: Fever.

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Normal chills and chills where my body was uncontrollably shaking; Stomach pain; Body aches; Sore arm; Fever highest 103.6; Diarrhea; Normal chills and chills where my body was uncontrollably shaking; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 29Apr2021 at 07:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and allergy to sulfa medications. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included allium sativum (garlic) (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and colecalciferol (VITAMIN D3); all on an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 08:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 18:00, the patient experienced chills both what patient said were normal chills and chills where her body was uncontrollably shaking, fever highest 103.6, stomach pain, diarrhea, body aches, and sore arm. On 29Apr2021, the patient underwent body temperature and the result was 103.6 (unknown units). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events normal chills and chills where body was uncontrollably shaking, fever highest 103.6, stomach pain, diarrhea, body aches, and sore arm was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: Garlic [Allium Sativum]; Fish Oil; Aspirin [Acetylsalicylic Acid]; Vitamin D3; Zinc

Current Illness:

ID: 1812235
Sex: F
Age:
State: CO

Vax Date: 04/30/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
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: Vomiting; Fever; Pain in joints; Severe headache; Lymph node swelling; Pain in body; Severe pain in legs; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 30Apr2021 at 12:45 at the age of 26-years-old as a single dose for COVID-19 immunisation. Medical history included asthma and known allergies to peanuts, legumes, seasonal, animal, and various foods. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included VITAMINS, OMEPRAZOLE, CETRIZINE, AND KRI, all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 09Apr2021 at 10:15 at the age of 26-years-old as a single dose for COVID-19 immunisation. On 01May2021 at 01:00, after second shot, the patient experienced vomiting, fever, pain in joints, severe headache, lymph node swelling, pain in body, severe pain in legs, and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events experienced vomiting, fever, pain in joints, severe headache, lymph node swelling, pain in body, severe pain in legs and pain at injection site was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: OMEPRAZOLE; CETIRIZINE HYDROCHLORIDE; KRI

Current Illness:

ID: 1812236
Sex: F
Age:
State: GA

Vax Date: 03/12/2021
Onset Date: 03/15/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Hand X-Ray; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: Rheumatoid factor; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Pain in left hip/butt/Mild to moderate joint pain on one side of hip.; Knuckle pain in right hand; Palm turning red and emanating heat; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 12Mar2021 at 10:30(at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD) and anxiety. The patient had known allergy to sulfa drugs and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), multivitamins (MANUFACTURER UNKNOWN) and omeprazole (PRILOSEC) all from an unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 20Feb2021 at 12:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 15Mar2021, 3 days after the second dose, the patient experienced pain in left hip/butt/mild to moderate joint pain on one side of hip. It was reported that, the joint pain seems worse when the patient first got up and seems to improve slightly when she get moving. On an unknown date in 2021, about 3 weeks after the second dose, the patient experienced knuckle pain in right hand that seemed to flare for 1-2 weeks and finally with palm turning red and emanating heat. It hurt to grip the steering wheel of car. The patient went to primary care and got tested for rheumatoid factor and lupus, had hand x-rayed and everything came back completely normal. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events knuckle pain in right hand and palm turning red and emanating heat were recovered with sequelae on an unknown date in 2021. The clinical outcome of the event pain in left hip/butt/mild to moderate joint pain on one side of hip was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: SERTRALINE; PRILOSEC [OMEPRAZOLE]

Current Illness:

ID: 1812237
Sex: F
Age:
State: MN

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
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: Diarrhea; back aches; lower body aches; left hip aches; Muscle aches in lower back and left hip; This is a spontaneous report from a regulatory authority. A contactable 82-year-old Female consumer (patient) reported that. An 82-years-old female patient received (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: ER8737; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 01Apr2021 (age at vaccine 82-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included glucose tolerance impaired from an unknown date and unknown if ongoing diagnosed 16-18 years ago with prediabetes and started Metformin about 8 years ago, hip arthroplasty from 15Oct2004 to an unknown date The left hip was 15Oct2004, hip arthroplasty from 26Jul2012 to an unknown date The right hip was 26Jul2012, spinal operation from 2002 to an unknown date, blood pressure abnormal, gastrooesophageal reflux disease, had reflux longer because she was quite young when she had that, around 70, surgery and colonoscopy all from an unknown date and unknown if ongoing. patient previously received historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6207 Expiration Date: Jul2021), via intramuscular route of administration, administered Both were in the left arm, upper arm on 11Mar2021 as dose 1, single for COVID-19 immunization, shingles shot VARICELLA ZOSTER VACCINE second shingle shots, immunisation Her arm, upper, swelled up 2 inches wide and 4 inches long, shingles shot VARICELLA ZOSTER VACCINE immunisation her arm had a fever, It was before 2018 because that was before she started keeping a journal. Concomitant medications included metformin (METFORMIN) taken for glucose tolerance impaired, hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for blood pressure abnormal, amlodipine besilate (NORVASC) taken for blood pressure abnormal, pantoprazole (PANTOPRAZOLE) taken for gastrooesophageal reflux disease, all from on start and stop date were not reported; simvastatin (ZOCOR) taken for an unspecified indication, start and stop date were not reported. it was reported asks where call handler is located, because she was in the Philippines and she enjoys knowing where people are located that she speaks with. She states that she has to find her cell phone which has a locator thing and her car keys on there. That was the first thing she had. She clarifies that her vaccine was 01Apr2021 and on 02Apr2021 she had diarrhea all day and then it went away and the next day she was okay. She clarifies that she does not have vision issues, but the stuff is really fine print, really really really small print on the bottle but at least she found it and can read it. She states that she heard that the Pfizer BioNTech Vaccines are all proven now. She just heard that the vaccine is approved. She asks if call handler has heard that. She adds she is going to get a magnifying glass so she can read with certainty. She also states because she is old and asks if that is a motivation. She has three daughters that are 60, 59, and 48 that have not gotten the vaccine and she does not know why. One was at 10 am, and she knew she could not leave until 10:38 am with the first one. The second one, she does not remember. The second one was in the morning, on April Fools Day. AEs following prior vaccinations: Yes, she received the second shingles shot and she cannot remember when it was but she had a reaction to the second shingle shots. Her arm, upper, swelled up two inches wide and four inches long. It had a fever in it. she clarifies that she did not have an increased body temperature, but that her arm had a fever. She did not get the Moderna because she heard it had a reaction like this, like the fever her arm had. She does not know NDC, EXP, LOT, or manufacturer for the shingles vaccine. She was trying to figure out when she got her shingles shot. She thought she could find it but she cannot. it was before 2018 because that was before she started keeping a journal. She adds that is everything, she just has to and wants to report it. she adds it will go away before she dies. she adds that it is just a good day, every day is a good day. She figures if she can get up and walk around it is a good day. Description of complaint: While reporting that Advil cause constipation, she states the writing on the bottle is tiny. Advil: liquid gel. 200 mg. She thought Advil was Ibuprofen but it says it is an NSAID which is different and is like Aleve. she adds, anyhow, it is helping. she adds she does not have any NDC, UPC, LOT, expiration, or additional details because they were on the box and she threw away the box. There are a lot of directions on it. she adds that the box states it is distributed by Pfizer and that she does see that the LOT is R85563 and expiration Jan2023. She stated, she did call in on 05May and reported side effects from the Pfizer Vaccine. And so, you should have a record for me for calling in. It was the 05May and she definitely know now that it was a side effect she was having pain in my left hip and my back because on the 17May I woke up in the morning and my pain was gone. So, I know it definitely was. She thought maybe it was just some other problem. But I thought. she called in anyhow on the 5th. she had my vaccine on the first and then on the second she had diarrhea all day and then she started developing the pain in my back and my hip. Then she waited she saw my Doctor and he told me to take Tylenol not Tylenol he told me to take Advil (treatment) and finally she called on the 05May to report it and now she was calling to report it and then she was calling to tell whoever can put this in my record that she woke up on the 17th, two weeks later and she had no pain. So, she do definitely know that it was from the vaccine. The patient experienced muscle aches in lower back and left hip, back aches, lower body aches and left hip aches all from on Apr2021, diarrhea on 02Apr2021. The clinical outcome of the events muscle aches in lower back and left hip, back aches, lower body aches and left hip aches was recovered on2021, diarrhea recovered on 02Apr2021 and lower body aches was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: METFORMIN; HYDROCHLOROTHIAZIDE; NORVASC; PANTOPRAZOLE; ZOCOR

Current Illness:

ID: 1812238
Sex: F
Age:
State: FL

Vax Date: 03/02/2021
Onset Date: 03/11/2021
Rec V Date: 10/23/2021
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: An itchy rash on stomach, back and upper legs; stomach, back and upper legs blistering; This is a spontaneous report from a contactable consumer or other non HCP reporting for herself (patient). A 69-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 12:45 PM (at the age of 69-years-old) as dose 2, single for covid-19 immunization. The patient medical history included penicillin allergy. Concomitant medication(s) included salbutamol (ALBUTEROL HFA), losartan, atorvastatin and latanoprost all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269, expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 08Feb2021 (at the age of 69-years-old) as dose 1, single for covid-19 immunization. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and patient had not been tested for COVID-19 since the vaccination. On 11Mar2021, the patient experienced an itchy rash on stomach, back and upper legs. sometimes blistering. Patient stated that about a week after got my second covid shot she broke in a rash. She had rash all over her stomach and her back and upper legs. It was very itchy and she went to 5 doctors including a dermatologist and nobody knew about it. Patient stated she had steroid, steroid cream and nothing was helping. Therapeutic measures were taken as a result of event and patient used Prednisone steroid cream. The outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: Albuterol HFA; Losartan; Atorvastatin; Latanoprost

Current Illness:

ID: 1812239
Sex: F
Age:
State: LA

Vax Date: 05/05/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
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: fever; shivers - hot and cold and has thrown-up; thrown up last night and this morning; This is a spontaneous report received from a contactable consumer (patient, self reported). A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 05May2021, as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. On an unspecified date in May2021, the patient had high fever, shivering hot and cold, thrown up last night and this morning and mentioned she is in the military and was told by her instructor to call Pfizer. The patient wanted to know on what she should do about the side effects if she would be good to carry on and response included. Response: Spoke from attached documents and as per the Pfizer-BioNTech COVID-19 EUA PI (6 Overall Safety Summary and 6.1 Clinical Trials Experience) LAB-1457-7.0, Revised: 06 April 2021. Gave disclaimer that Pfizer was unable to make any treatment recommendations for individual patients and referred to HCP for further guidance. There were medical questions addressed by this program forwarded/referred to medical information. Outcome of the events were unknown. No follow up attempts are needed. Information on lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812240
Sex: F
Age:
State: NY

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: Calcium; Result Unstructured Data: Test Result: Elevated.

Allergies:

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

Symptoms: Allergic reaction; Severe pain in her bone, hip and pelvic area.; Severe pain in her bone, hip and pelvic area.; Felt tired, extremely exhausted for 10 days; Elevation in her calcium levels; I had pain on my thighs (when I woke up), getting this burning pain in my finger tips; Finger burning and finger tips they don't list things like nerve pain.; Nerve pain; Joint and muscle pain; Joint and muscle pain; I was in a lot of pain; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8729, Expiration date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 13Apr2021 (age at vaccination was 66 years) as dose 1, single for COVID-19 immunization. The patient's medical history included parathyroid disorder and hypertension. Concomitant medication included aliskiren fumarate (TEKTURNA) taken for an unspecified indication. On an unspecified date the patient experienced allergic reaction, severe pain in her bone, hip and pelvic area, felt tired, extremely exhausted for 10 days, elevation in her calcium levels, i had pain on my thighs (when i woke up), getting this burning pain in my finger tips, finger burning and finger tips they don't list things like nerve pain, nerve pain, joint and muscle pain and I was in a lot of pain. The next day, she said she felt a severe pain in her bone hip and pelvic area. Even after 3 or 4 days she said that the pain in those areas became severe. She said she felt tired and this feeling subsided after a week but the pain in her bone hip and pelvic area still lingered. She also said a couple of days ago, she was diagnosed with parathyroid and has noticed an elevation in her calcium levels. With this, consumer wanted to know if the vaccine causes a spike in calcium levels. She also wanted to know what she should do about this. She wanted to know if other people have reported these symptoms. Patient reported some side effects about four days after she took the vaccine. After she took that vaccine, had developed really bad pains the next morning, with the first dose. It felt like in her pelvic bones were in excruciating pain and in her thigh bones in both legs. It subsided a little but is still there. Is lingering to the point where it is very uncomfortable. They say to reach out to the primary care physician and she has all ready done that several times. She asked her to do an antibody test to see where the numbers are. She is frightened to take the second dose. It's been over three weeks now and is not gone. The next morning after vaccination the patient woke up not even 24 hours, she woke up in the morning and was lying in bed, felt severe pain in her pelvic area. She had pain on her thighs (when I woke up) felt like in the bones the pain. It was so painful she wanted to go to the ER and she pushed through it. It lasted for 3-4 days then at that point she went to her PCP ruled out blood work. She was extremely exhausted for 10 days, she had a phone conversation with PCP who said they were not sure you could be having the side effects. Some days aren't as bad as others, last night was bad, pain in the bones in the thigh and pelvic area. Couple of days joint pain and index finger burning sensation and then yesterday left finger burning and finger tips they don't list things like nerve pain. Joint and muscle pain but this feels like joint, muscle, nerve pain. She reported some people who have Covid they have nerve problems. She said the vaccine can cause neurological issues. She saw the neurologist and questioned that today and he said people are coming in with nerve damage. No one SHE knew experienced what she's been experiencing. She asked what if she have more side effects, like what is 2nd one going to do. She asked What happens if she don't get the 2nd dose. She have electrical pain; I read some people are getting side effects from the vaccine up to 2 months after the vaccine. The patient reported probably about 6 days after vaccination, she had lot of pain. She was worried about her events as it was not going away. Reporter seriousness for Severe pain in my pelvic bone and my thigh bones; Pelvic pain and the bone pain still hurts and it hurts sometimes like at night, it is a little bit more than the day was reported as unspecified. The patient underwent lab tests and procedures which included blood calcium which showed elevated on an unspecified date. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: Tekturna

Current Illness:

ID: 1812241
Sex: F
Age:
State: CA

Vax Date: 04/16/2021
Onset Date:
Rec V Date: 10/23/2021
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: Callers have cough; Flu; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported that: A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported, expiration date was not reported) via an unspecified route of administration on 16Apr2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient went to 16Apr2021 to take first shot and have appointment for 08May2021 for this Friday, but patient can't go (for the second dose), had flu and cough little bit. Patient don't have right to go there. Patient would like to know if she could go next Monday. The clinical outcome of the event was unknown. .No follow-up attempts were needed, information about lot/batch number could not be obtained.

Other Meds:

Current Illness:

ID: 1812242
Sex: M
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Cough; Pain; This is a spontaneous report from a contactable consumer (patient's sister). A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, after second dose the patient experienced cough and some pain. It was unknown if the patient received any treatment for the event. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812244
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 10/23/2021
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: Headache; This is a spontaneous report from a Pfizer-sponsored program via Regulatory Authority. A contactable consumer reporting for a 57-year-old female patient who received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR TAB 11MG), via an unspecified route of administration from 02Feb2021 (Batch/Lot number was not reported) to 02Feb2021, at 11mg (tablets) for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient also received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA 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 immunisation. On an unspecified date, the patient experienced headache. Stated she had a mild headache lasting about 1 hour after COVID vaccine. Patient was off the medication two times due to recommendation from MDO while receiving first and second dose of vaccine. Patient was off medication one week after first dose and 4 days after second dose. Outcome of the event was unknown. The action taken in response to the event for tofacitinib citrate was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: Xeljanz XR

Current Illness:

ID: 1812245
Sex: F
Age:
State: NY

Vax Date: 04/17/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: blood sugar level; Result Unstructured Data: Test Result: irregular blood sugar level.

Allergies:

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

Symptoms: I have been having issues with irregular Blood Sugar levels after Corona vaccination/ever since I had the vaccine, I've been having some pretty crazy blood sugar number; This is a spontaneous report from a contactable consumer (Patient). A 48-years-old female patient (Unknown if pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 17Apr2021 (at the age of 48-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Diabetes, Neurosarcoidosis, Pachymeningitis, autoimmune disease (Patient take treatment and go for infusion (Pixiz infudion) once a month. Patient taking a medication called Mycophenolate, but patient was told when get the vaccine to take myself off it for period of time because it suppresses patient immune system because patient had an unknown autoimmune disease so taking that for the autoimmune disease. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced I have been having issues with irregular blood sugar levels after corona vaccination/ever since i had the vaccine, i've been having some pretty crazy blood sugar number. The patient underwent lab tests and procedures which included investigation irregular blood sugar level. Therapeutic measures were taken for irregular blood sugar levels with Metformin, Glipizide, and Insulin. Endocrinologist told me to take more insulin and use more until get steady normal blood sugar levels so as far as treatment that is the best that she recommends at this time Patient wanted to know if vaccine blocking the efficacy of Diabetes treatment. It was reported that patient was supposed to get the second dose this Saturday coming up. The outcome of event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812246
Sex: F
Age:
State: NY

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 10/23/2021
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: 20210504; Test Name: Body temperature; Result Unstructured Data: Test Result:100.2-100.6F

Allergies:

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

Symptoms: Fever 100.2-100.6F; Severe headache; Body aches; This is a spontaneous report from a contactable consumer (Pfizer employee), the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the left arm on 04May2021 at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ethinylestradiol/norgestimate (SPRINTEC) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3248) via intramuscular route of administration in the left arm on 13Apr2021 at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 20:00, the night of the injection, the patient experienced fever of 100.2-100.6 Fahrenheit lasting until noon the next day. The patient also experienced severe headache and body aches for 24 hours following injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 100.2-100.6F, severe headache and body aches was recovered on 05May2021. No follow-up attempts are needed. No further information is expected.

Other Meds: SPRINTEC

Current Illness:

ID: 1812247
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: She is scared to get her second dose tomorrow; got a few hives on my body; This is a spontaneous report from a contactable consumer. This 33-year-old female consumer (patient) reported for herself that a 33-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number were not reported), via an unspecified route of administration on 16Apr2021 at the age of 33-years-old as DOSE 1, SINGLE for covid-19 immunization. The patient medical history included asthmatic and allergies (Patient used Zyrtec) from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date in Ap2021, the patient experienced got a few hives on my body, She was scared to get her second dose tomorrow. It was reported that patient had already received her first dose of the vaccine. Patient set to have her second shot tomorrow. The first shot patient broke out and got a few hives on her body. Patient was told by the doctor to take Benadryl before going. Patient read that shouldn't take any antihistamines. Patient did not know what really should. Patient asthmatic too. Patient just want to make sure it won't interact. Patient wanted to take precautions. Usually, she uses Zyrtec because she suffers from allergies but they thought she was just nervous. She thought it was weird that she broke out into certain spots. Patient stated that if she has to take something she will go purchase it. If she has to take something, then she will. Patient was worried about getting the second vaccine. Patient thought that somebody else has probably reported this same thing because she has other friends who say that they had small allergic reaction. 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: 1812248
Sex: F
Age:
State: PA

Vax Date: 04/15/2021
Onset Date: 05/06/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210506; Test Name: Body temperature; Result Unstructured Data: Test Result:101.6 Fahrenheit

Allergies:

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

Symptoms: Cold like symptoms; However patient has a fever ranging 101.6 F/ we took my daughters temp. today and it is 101.6F; This is a spontaneous report from a contactable consumer. This consumer (patients father) parent reported for a 16-year-old female patient (reporters daughter). A 16-years-old female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 15Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patients father would like to know what the acceptable range of temperature is to get the second dose of the vaccine which was scheduled on 06May2021. The patient experienced cold like symptoms in the last few days on an unspecified date, however patient has a fever ranging 101.6 f/ we took my daughters temp. today and it is 101.6F on 06May2021. The patient underwent lab tests and procedures which included body temperature: 101.6 Fahrenheit on 06May2021.The outcome of event was unknown. No follow-up attempts are needed. information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1812249
Sex: F
Age:
State: FL

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

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

Lab Data: Test Name: creatinine; Result Unstructured Data: Test Result:Increased; Test Name: chest x ray; Result Unstructured Data: Test Result:Unknown; Test Name: lymphocytes; Result Unstructured Data: Test Result:Unknown; Test Name: red cell distribution; Result Unstructured Data: Test Result:Unknown; Test Name: COVID test; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: swelling of the lower lip all puffed up; Pain; chills; low grade temp; muscle pain; joint pains; tiredness; The only thing that was little bit up was creatinine; She is not getting relaxed; Aches all over her body, she had body aches all over; She is not well at all; She has been very, very sick; This is a spontaneous report from a contactable consumer (patient's husband) via Medical Information Team. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation : Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, on 16Apr2021 (at the age of 73 year old) as DOSE 2, SINGLE for Covid-19 immunization. Patient medical history include hypertension and cholesterol. Concomitant medication include clonidine (CLONIDINE) 0.1mg, labetalol (LABETALOL) 100 mg, spironolactone (SPIRONOLACTONE) 25 mg for Blood pressure, rosuvastatin (ROSUVASTATIN) 10mg for Cholesterol , acetyl salicyclic acid (ECOTRIN) 325mg for Blood thinning, benazepril (BENAZEPRIL) 10mg and nifedipine (NIFEDIPINE). Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, on 25Mar2021 (at the age of 73 year old) as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced swelling of the lower lip all puffed up, pain, chills, low grade temp, muscle pain, joint pains, tiredness, the only thing that was little bit up was creatinine, she is not getting relaxed, aches all over her body, she had body aches all over, she is not well at all, she has been very, very sick on an unspecified date. She began to have side effects on the 19th of 2021 and was subsequently seen in the Emergency room and her Primary care doctor. she took the second dose, tomorrow make it three weeks since she took it but she has been very sick for the past she has fever, aches all over her body and she is laid up with it and yesterday her lips became swollen and all puffed up she had body aches all over and it's not going away, they went to the emergency room last week memorial. Her current symptoms include Pain, chills, low grade temp, muscle pain, joint pains, tiredness, and swelling of the lower lip. Laboratory tests carried out includes red cell distribution, lymphocytes, the only thing that was little bit up was creatinine, she was at 1.37 with the creatinine, it was 90 something (Further not clarified hence not captured) test and she was negative for that, they did a chest x ray, blood work and urine, they did everything, and they send it to her primary care physician on Monday and he ordered some more test. Everything was negative. But she has to go back and see him again on Monday coming again, but she was not getting relaxed, she's still puffed up and this happened for two weeks. she was not well at all. Treatment received for the events includes Tylenol. she has been taking for 3 weeks and antibiotics. Tomorrow makes it three weeks since she had this adverse condition. The patient underwent lab tests and procedures which included blood creatinine: Increased, chest x-ray: unknown, lymphocyte count: unknown, red cell distribution width normal: unknown, sars-cov-2 test was negative on an unknown date. The outcome for all events was unknown. No follow up attempts are needed, No further information is expected.

Other Meds: CLONIDINE; LABETALOL; SPIRONOLACTONE; BENAZEPRIL; ROSUVASTATIN; ECOTRIN; NIFEDIPINE.

Current Illness:

ID: 1812250
Sex: F
Age:
State: VA

Vax Date: 04/10/2021
Onset Date: 04/30/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Mouth sores corner of lip to inside cheek area; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 10Apr2021 at 13:30 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, eczema, allergy to multiple antibiotic, allergy to nuts, latex immediate and delayed IgE 86 and Cyanoacrylate(Mecrylate)Epoxy allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included multivitamin, levothyroxine sodium (SYNTHYROID) (reported as Synthyroid.75) and hydroxyzine hydrochloride (HYDROXIZINE); all from unknown date for unknown indication and unknown if ongoing. The patient previously took cyclobenzaprine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 14:00 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 18:00, the patient experienced mouth sores at the corner of lip to inside cheek area. It was unknown whether therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mouth sores at the corner of lip to inside cheek area was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: SYNTHYROID; HYDROXIZINE

Current Illness:

ID: 1812251
Sex: M
Age:
State: NY

Vax Date: 04/30/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
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: bad chills; low blood sugar; intense pain on both sides of his temples, temples felt squeezed in a vice and left temple pain; severe headache; Fever; This is a spontaneous report from a contactable consumer (patient himself). A 68-years-old male patient received BNT162bB2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWD170; Expiry Date: 31Aug2021), via an unspecified route of administration in Arm Left on 30Apr2021 as dose 2, single (at the age of 68-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162bB2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWD150; Expiry Date: 31Jul2021), via an unspecified route of administration in Arm Left on 09Apr2021 as dose 1, single for COVID-19 immunisation. On 01May2021, the patient experienced severe headache, fever and intense pain on both sides of his temples, temples felt squeezed in a vice and left temple pain. On 05May2021, the patient experienced bad chills and low blood sugar. He felt an intense pain on both sides of his temples which eventually sub-sided. 5 days later, he said the pain came back, but it was not as severe, and was only on one side. He said that he was worried because headaches are the start of a brain clot. With this, he wants to know if it is normal for a headache to reoccur after 5 days. It was reported that his temples felt squeezed in a vice lasted 2 days. It was reported that he expected that last night, which was almost a week later, he experienced such bad chills. He put on 2 sweaters, used a comforter, and heat. He stated it was very unusual. He caulked it up to be low blood sugar. Reporter stated he was watching his diet those days. On that morning he woke up with the pain again in his left temple. It was the pain he had the day after the vaccine. The same as the first time, but not as severe, only on one side. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812252
Sex: F
Age:
State: NC

Vax Date: 04/20/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
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: Tongue got tingly; Mouth is like if she's eating a sour gummy bear, it was very watery; Very tired; Not feeling well; Body was shaking when she was awake; Weird pain on her right side on her rib; pain shoulder; Pain under my breast; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that, A 38-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0162) (at the age of 38 years old), dose 1 via an unspecified route of administration on 20Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced, she did not remember when she had her first shot. She received the first shot on 20Apr2021. When she had her first shot, her tongue got tingly, like a tingly sensation, and her mouth was like she was eating a sour gummy bear, it was very watery. She further described as it would come and go for the first day she took the vaccine, she thought the second one too. She was very tired, not feeling well, her body was shaking when she was awake. She also had this weird pain on her right side on her rib. She did not know what it was, it was still not going away. It was not like she broke something, but she had herself doing exercise or something, it was kind of there, the pain. She had never had the pain before, she did not know if it was due to vaccine. She had pain under her breast and shoulder and a few days after she received the shot, she had sour taste in her mouth, the latter has resolved in 2021. The outcome of all the events was unknown, and the outcome of the event mouth is like if she's eating a sour gummy bear, it was very watery was recovered on an unspecified date in 2021 and Weird pain on her right side on her rib was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812253
Sex: M
Age:
State: IA

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: a bad cold; cough; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer sponsored program. A male patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was scheduled this afternoon for his 2nd dose but had a bad cold and cough. The reporter wants to know if it was ok to receive the 2nd dose. 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: 1812254
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Asthmatic reaction; This is a spontaneous report received from a contactable Pharmacist. A patient of an unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the Pfizer COVID vaccine approximately 3 months ago and they came down with an asthmatic reaction and based off of that they have not been able to get the second dose until this time. Basically, what the pharmacist was trying to ask was if the patient could get the second dose of the Pfizer COVID vaccine or do they need to get another COVID vaccine from another manufacturer. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1812255
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Feeling unwell; Muscle pain; Joint pain; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient) via a program and the Regulatory Authority. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration, administered on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced muscle pain, feeling unwell, joint pain, nausea, and headache. Patient reported that she was afraid to take the second dose of the vaccine since she had these terrible side effects. 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: 1812256
Sex: F
Age:
State:

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
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: experiencing diarrhea; experiencing chills; experiencing tiredness; experiencing muscle pain; experiencing joint pain; experiencing nausea; Not feeling well at all; This is a spontaneous report received from a Program. A contactable consumer (patient) reported for herself. A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FW0161, Expiry date: unknown) on 14Apr2021 via an unspecified route of administration as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient received her first dose last 14Apr2021. The second dose was scheduled tomorrow 05May2021. The second week after getting the first dose, she was experiencing diarrhea, chills, tiredness, muscle pain, joint pain, and nausea. She was still experiencing this until now and not sure if she can take the second dose tomorrow on 05May2021. She was notified as well that there was no available second dose from the facility where she gets the first dose. Patient reported that the first week after the vaccine she felt fine, but that the last 2 weeks she has not been feeling well at all. Patient reported that she was supposed to go back tomorrow, 05May2021, to have the second dose of the Covid-19 vaccine. Patient stated that she thinks that with every vaccine, when patient don't feel well, she don't go, and get vaccinated. Patient inquired if that was true because she doesn't think that she should get the second dose of the Covid-19 vaccine if she isn't feeling well. Patient was recommended that to reach out her primary care physician for further guidance. Patient reported that she tried to reschedule the appointment for her second dose of the Covid-19 vaccine that was scheduled for tomorrow, 05May2021. Patient reported that when she tried to reschedule the appointment, the website said that there was not going to be any more vaccines in her area. Patient inquired if she was supposed to have the second dose of the Covid-19 vaccine within 6 weeks of the first dose. Patient declined to complete safety report, stating that she was not feeling well on unspecified date in Apr2021 and didn't feel up to it. She had side effect from the vaccination, and she called her doctor. He said that she felt fine the first week, so this was not side effects. He said if she doesnt feel well she should not get the second dose because she was supposed to go tomorrow. If patient didn't had the side effects immediately does that mean that it's not side effects from the vaccine. She got side effects from the flu vaccine. Patient was having chills, nausea, diarrhea, muscle aches, and pains. Outcome of event Not feeling well at all was unknown and all other events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812257
Sex: M
Age:
State: PA

Vax Date: 05/04/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
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: He experienced shortness of breath; bit of dizziness; sore arm right after the shot; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0175) via an unspecified route of administration, administered in Arm Left on 04May2021 (Age at Vaccination 44-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Blood pressure high from an unknown date and unknown if ongoing. Concomitant medications were not reported. In May2021 He experienced shortness of breath, a bit of dizziness, and sore arm right after the shot and within 15 minutes it has gone away. It was reported that I have a consumer on the other line, he got the first dose of the Pfizer BioNTech Covid-19 vaccine, and I actually addressed his concern. I have already answered his concern about the side effect that he experienced. Now this was just to report the symptom that he had been when he got the first dose when he had the first dose it was 04May2021 and the second dose was scheduled on 25May2021. He experienced shortness of breath right after getting the first dose, but it was just for about 15 minutes and then right after that it started and he experienced a sort of dizziness, those were the only recorded symptoms that he had. When paraphrased the concern, consumer stated, right after in 5 minutes within a few minutes after the shot. When probed for event outcome, consumer stated Yes, it only lasted in 5 or 10 minutes. Patient did not receive any treatment. The outcome of the events was recovered on May2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812258
Sex: F
Age:
State: MI

Vax Date: 02/24/2021
Onset Date: 04/05/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: She had labs drawn today primarily for arthritis; Result Unstructured Data: Test Result:Unknown Result

Allergies:

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

Symptoms: unable to get out of bed; difficulty walking and has been having to use a walker; edema in legs; sever leg pain (muscle and joint pain)/had joint and muscle pain that affected her whole leg from her hip to her toes; sever leg pain (muscle and joint pain)/severe pain in her legs; sever leg pain (muscle and joint pain)/had joint and muscle pain that affected her whole leg from her hip to her toes; leg swelling/edema in her legs/calf and upper leg are still swollen; This is a spontaneous report received from a contactable consumer (Patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration, administered in right arm on 24Feb2021 (at the age of 78 years old) as a single dose for COVID-19 immunization. The patient's medical history included Diabetes and high blood pressure from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration, administered in right arm on 04Feb2021 (at the age of 78 years old) as a single dose for COVID-19 immunization. The patient had not visited emergency room or physician office due to the event. On 05Apr2021 the patient experienced sever leg pain, Muscle pain, leg swelling, edema in legs while on an unspecified date the patient was unable to get out of bed. On 12Apr2021 the patient experienced difficulty walking and has been having to use a walker. The reporter reported that the patient received both doses at (Redacted). The patient was not provided with any paperwork or information on who to call to report side effects when patient received her vaccine. Patient's husband received the vaccine at the medical center. The patient called the number that was listed on the papers. The reporter reported that patient's left ankle is back to normal in regards to the swelling. Patient's calf and upper leg are still swollen. The patient underwent lab tests and procedures which included Arthritis on an unspecified date. The outcome of the events of Joint pain, Leg pain, Muscle pain, Swelling of legs was recovering while for Movements abnormal was unknown and for Walking difficulty and edema in legs was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812259
Sex: F
Age:
State: TN

Vax Date: 03/26/2021
Onset Date: 03/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: COVID-19; Test Result: Positive ; Comments: Caller states she had Covid and she had it bad. Caller states it took her about three months,

Allergies:

Symptom List: Tremor

Symptoms: Swelling on the face; Rashes, fine bumps on her face, neck, and arms; Itching on her right arm; Her arm was hurting form the vaccine; an allergic reaction; This is spontaneous report from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: ER8733, Expiry date: not reported) (age at the time of vaccination was 38 years), administered in Arm Left on 26Mar2021 at 10:15 as dose 1, single for COVID-19 immunization. The patient's medical history included anemic since Jan2021, Covid-19, allergies to penicillin. The patient's concomitant medication included Iron for anemic since Jan2021. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. The patient reported that the patient had some allergic reactions after the first dose of the vaccine. On 26Mar2021, the patient had little bit of swelling on the face and rashes, fine bumps on her face, neck and arms, itching on her right arm. The patient was recommended by the facility when she went for her second dose last 16Apr2021 schedule for an allergy testing first. The patient should continue to get her second dose or not. The outcome of the event an allergic reactions was unknown and other events was recovered on 27Mar2021. No follow-up attempts were needed. No further information was expected

Other Meds: IRON

Current Illness: Anemic

ID: 1812260
Sex: F
Age:
State: TX

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 10/23/2021
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: rashes- one on her neck, right groin, and thigh.; Low grade fever; Rash was reported as worsened; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 26-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533, Expiration date: unknown) via an unspecified route of administration on 01May2021 (at the age of 26 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration, administered in arm right on 02APR2021 (at the age of 26 years old) as dose 1, single for covid-19 immunization and experienced arm soreness and fatigue. On 01May2021 patient experienced fatigue and on 02May2021 rashes- one on her neck, right groin, and thigh; low grade fever and rashes in a few areas of her body, that seem to be progressed. The caller also had a low-grade fever, fatigue but it was fine. Today the caller woke up with 4 different rashes and still had a fever. The caller read that if you're allergic you may have a rash on the arm where she had the shot. The caller wants to know have her symptoms been reported and if everything was okay. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812261
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: Mouth irritation; blood blister on the inside of my mouth; This is a spontaneous report from a contactable Consumer. This 65-year-old female Consumer (patient) reported for self via medical information team. A 65-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EN6199, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 03Mar2021 (65-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) 100 mg once a day taken for an unspecified indication, and atorvastatin (ATORVASTATIN) 40 mg once a day taken for an unspecified indication. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Batch/lot number: EN6201, Expiry date: unknown) via an unspecified route of administration, on 10Feb2021 (age at vaccination: 65-years-old) as dose 1, single for COVID-19 immunization. It was reported that on an unspecified date in Mar2021, three weeks after the second dose patient developed a blood blister inside her mouth and mouth irritation. that she had the first dose of the Pfizer covid 19 vaccine on 10Feb2021 and the second dose on 3Mar2021. Reporter reported that three weeks after the second dose she developed a blood blister inside her mouth. reporter asked if other people have reported this and how long is it likely to last. she is going to her dentist. Reporter stated she saw a study on line that is looking at 1580 HCP who experienced mouth ulcers and blisters but she did not know which vaccine. weeks of the second vaccine, I started experiencing some mouth irritations, primarily the one I that am really the most concerned about is like a blood blister on the inside of my mouth and again it was like the 3rd week of Mar or so and it still has not gone away. I have an appointment with my dentist tomorrow, but I thought I should talk to you first and see if there are other people reporting this and you know what you think about it what I should tell the dentist potentially what I felt." Patient stated she was going to her dentist and no treatment has been taken for the events. The patient said she will go to the dentist tomorrow, if I could find out if there is any probable correlation between the vaccine you know blisters in my mouth." The patient not received any treatment for events. The outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: LEVOTHYROXINE; ATORVASTATIN

Current Illness:

ID: 1812262
Sex: F
Age:
State: CA

Vax Date: 04/13/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
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: nausea/nauseous feeling after she eats; oily taste; lost her appetite; fever; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0153, Expiration date: unknown) via an unspecified route of administration, administered in left arm (left shoulder) on 13Apr2021 (age at vaccination was 63 years) as dose 2, single for COVID-19 immunization. The patient's medical history included ongoing multiple sclerosis since 1995. She was now in a wheelchair and walker. She shrunk. Shrinking was prior to getting the vaccine. That was her MS fault. The patient did not have any family medical history relevant to AE. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6207, Expiration date: unknown) via an unspecified route of administration, administered in left arm (left shoulder) on 20Mar2021 (age at vaccination was 63 years) as dose 1, single for COVID-19 immunization and didn't have a reaction. She never got the flu and never worried about it and she hasn't received a flu vaccine. No additional vaccines were administered on same date of the Pfizer suspect. The vaccine was not administered at Military Facility. The patient got both doses of the Pfizer COVID vaccine and since then for the past 2 or 3 weeks on an unspecified date in Apr2021, she had nausea/nauseous feeling after she eats, oily taste in the mouth, didn't have appetite/lost her appetite and fever. She had no site pain. The only thing that had been going on for 2 weeks was she had lost her appetite and had nauseous feeling after she eats. She drinks a lot of water. and had her food brought in from the retirement community she lives in. She noticed the nausea was not going away. The nausea had just come on and she didn't feel like eating. She used to enjoy bananas as a snack and now that turns her off. She still liked blueberries. She eats blueberries and they were fine. The meals were heavy on her stomach. Cashews keep her bowels regular instead of taking drugs. She had to force herself to eat cashews now. It was not the same. It had been going on a while. Her final shot was on 13Apr2021. Two weeks later she was felt fully vaccinated, so by 27Apr2021. She was disable and there was only so far she could go. She has not had vomiting or diarrhea. She just had no appetite. She noticed when she was in bed and lays flat she didn't have any problem. It was mostly during the day when she eats. She didn't go out of her way to get the little extras. She knew she had lost weight, but hasn't been weighed recently. She had MS and was a little concerned. She spoke to the regulatory authoritywho told her the studies. She was afraid the MS would affect her. She was expecting a fever and that didn't happen, but now she had fever. If she had to have another one in a year she will get it. She wondered if this had been reported and how long it would last. She received the response stating that there were reports of nausea but not for oily taste in the mouth and lost of appetite. She was recommended to check this with her physician. She was curious if that was a side effect and would it go away. As of right now she had breakfast that morning and she felt something in her stomach like the nauseous feeling. She had a taste in her mouth. It felt like her mouth was oily. She brushes her teeth. She usually drinks water, but occasionally drinks coffee. She was trying to flush her system with the water, but she didn't want to flush the vaccine out of her. The adverse events did not require a visit to Emergency Room or Physician Office. No relevant tests were done. There was a product complaint. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Multiple sclerosis (She shrunk. Shrinking was prior to getting the vaccine. That was her MS fault.)

ID: 1812263
Sex: M
Age:
State: NY

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
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: all and of his muscles and joints are hurting; all and of his muscles and joints are hurting; light headed; headaches; it also caused insomnia, he is not able to sleep; emotional problems; ligament and joint, pain in pelvis, knees, all over; ligament and joint, pain in pelvis, knees, all over; Cant move; joint problems; muscle problems; ligament problems; cant concentrate; feels very tired; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 14Apr2021 (at the age of 71-year-old) as single dose for COVID-19 immunization. Medical history included a back problem and was diagnosed with prostate cancer about 3 years ago, almost 4 years ago. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in right arm on 17Mar2021 (at the age of 71-year-old) as single dose for covid-19 immunization. The patient received the Pfizer covid vaccine and was complaining of side effects for the last month as follows: Cant move, joint problems, muscle problems, ligament problems, pain and pelvis knees all over lightheaded, cant concentrate. The patient was wondering if these side effects- he had a big problem: he can't move, has joint problems, emotional problems, muscle problems, ligament and joint, pain in pelvis, knees, all over, and it's been going on since his second dose, on the 14Apr2021. Added he also felt very tired, lightheaded, can't concentrate. He was having a real bad side effect, having a problem. The patient can't move and all and of his muscles and joints were hurting, like unbelievably. It even hurts to put the patient's legs on the bed. Everything hurts. He wanted to know if there was anything he could do to ease the pain and would this be permanent. That was bad, he could not move. He was light headed and had headaches. The patient had his second dose over a month ago, enquired how long these symptoms would last. Events were steady for a couple of weeks. The muscle pain had eased up a little bit but was still very bad, its not good. All of these events started at the same time after the second dose but the patient was unsure of the exact date. States it also caused insomnia, he was not able to sleep. Muscle pain improved a little bit. He wanted to know if these would go away or these are permanent side effects. The patient was informed that beyond what is described in the Prescribing Information, Pfizer does not have information on how long what you are experiencing may last. There may be many factors to consider including your medical history and medical condition. The patient was advised to consult with doctor/healthcare provider about what he have experienced/are experiencing. Doctor/healthcare provider is in the best position to advise about the appropriate action to take as the doctor/healthcare provider is most familiar with his medical condition, clinical history, how his treatment has been conducted and any relevant information to his specific case.The outcome of events all and of his muscles and joints are hurting, light headed, headaches, insomnia was not recovered; other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812264
Sex: M
Age:
State: SC

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

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

Lab Data: Test Date: 202103; Test Name: Skin Biopsy; Result Unstructured Data: Test Result:Allergic reaction; Comments: Allergic reaction to something different in body

Allergies:

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

Symptoms: He said the rash then spread up his legs to his upper body, and develop a rash all over the body that has continued; This is a spontaneous report from a contactable consumer or non-health care professional (patient). A 78-year-old contactable male patient receive bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no: not reported/ Lot number: EN6204) via unspecified route of administration in arm left on 10Mar2021 15:30 as dose 2, single for covid-19 immunization. Medical history included ongoing Hypertension from an unknown date, he has probably had it for 20 years, Ongoing High cholesterol from an unspecified date, He had it for about 20 years and ongoing Prednisone induced diabetes. It came as a result of an operation he had maybe 10, 11 years ago. He had an eye operation and there was an infection of the nerve between his brain and eye. He was on prednisone for a half a year for that. It was not an eye operation it was his temporal artery. Temporal artery operation from an unknown date to unknown if ongoing, He had it 10 or 11 years ago. Concomitant medications included ongoing Metoprolol (METOPROLOL )from an unknown date which he has been on it for years, ongoing Glipizide (GLIPIZIDE )from an unknown date which he has been on it for probably a year or longer, ongoing Pioglitazone (PIOGLITAZONE ) from an unknown date which he has been on it for a couple years, ongoing Lisinopril (LISINOPRIL) from an unknown date which he has been on it for a couple years, Ongoing Amlodipine(AMLODIPINE BESILATE) from an unknown date which it is a substitute for Norvasc and he has been on it for 2, 3, 4 years, ongoing Low dose Aspirin (ACETYLSALICYLIC ACID)from an unknown start date which he has been on it for 2, 3, 4 years and ongoing Atorvastatin (ATORVASTATIN CALCIUM) from an unknown start date which he has been on it for 2, 3, 4 years and taken for an indication for hypertension. No family medical history relevant to AE. No Prior Vaccinations taken within 4 weeks and no AE following prior vaccinations. No additional vaccines administered on same date of the Pfizer suspect. Historical vaccine include patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no: not reported/ Lot number: EN6204) via unspecified route of administration in arm right on 17Feb2021 as dose 1, single for covid-19 immunization. It was reported that patient completed the doses of the PFIZER-BIONTECH COVID-19 VACCINE and got his second shot of the Covid-19 Vaccine almost 2 months ago now. Within a week of the second vaccination, on an unknown date in Mar2021, he began with rash start on his lower legs and then spread up his legs to his upper body and develop a rash all over the body that has continued. He consulted his dermatologist and suggested that he got it from the vaccine. Initially he was diagnosed to have toe-nail fungus and later on his dermatologist told him that it was a reaction from the vaccine. He used OTC ointment Cortisone 10 (max strength and not to use more than 3 or 4 times daily) for skin allergies, seems to have made the scabbing go away, but left a discoloured rash. AE(s) required a visit to Physician Office and no visit to Emergency Room. Seriousness of the case received as No. Investigation Assessment reported as Yes. On an unknown date in Mar2021 (the second or third week in March), dermatologist who did a biopsy and results came back that he was having an allergic reaction to something different in his body. The only thing that was different was the vaccine. He said he had been to a dermatologist who mis diagnosed rash and he was now looking for a new dermatologist with something to work with. Therapeutic measures taken as he was prescribed with prednisone which has a very little effect, did not seem to solve the problem. He was wondering if Pfizer has run across this type of experience before, especially because it has been for so long. Outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: METOPROLOL; GLIPIZIDE; PIOGLITAZONE; LISINOPRIL; AMLODIPINE BESILATE; ASPIRIN (E.C.); ATORVASTATIN CALCIUM

Current Illness: Diabetes; High cholesterol (He's had it for about 20 years.); Hypertension (He has probably had it for 20 years.)

ID: 1812265
Sex: M
Age:
State: IL

Vax Date: 04/24/2021
Onset Date: 04/25/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: the spots are dry; started to develop into what looked like a rash but the spots are more isolated; pinkish color spots on my stomach/Second dose: pinkish spots on his stomach/spots are on his stomach and around his waist line; felt terrible; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0172; expiration date: Aug2021) via an unspecified route of administration, administered in Arm Left on 24Apr2021 at the age of 31-year-old as DOSE 2, SINGLE for covid-19 immunisation. Medical history included leukemia (from ages 3 years to 5 years). The patient's concomitant medications were not reported. Previously too first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0150) at Left Arm on 03Apr2021 (Early in the day) as dose, 1 single for covid-19 immunisation and reported felt gross, felt groggy on 03Apr2021. On 29Apr2021, after 5 days of vaccination, the patient experienced pinkish color spots on my stomach/second dose and around his waistline, started to develop into what looked like a rash, but the spots are more isolated, on 25Apr2021 felt terrible, the spots are dry on an unspecified date. It was reported that when he received the second Covid-19 vaccine he felt fine the day of. The next day he felt terrible. He received his second dose on 24Apr2021. Then on 29Apr2021, he started noticing pinkish spots on his stomach. It started to develop into what looked like a rash but the spots are more isolated. The spots are on his stomach and around his waistline. The spots haven't gone away and there are quite a few. The spots are not itching. He would say the spots are staying about the same. Some more have developed but mostly staying the same. It looks like the spots are dry but that could be from him being active and moving around or maybe is skin a little dry. Did not any AE require a visit to emergency room, physician office. No prior vaccinations (within 4 weeks). The outcome of event was felt terrible was unknown and rest all was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812266
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: They woke up with chills and body aches; She has a small amount of rash; They woke up with chills and body aches; This is a spontaneous report received from a contactable consumer (Patient). A female patient of unspecified 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 an unspecified date 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, formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. The patient stated that she and her husband have received both Pfizer covid 19 vaccine doses. The patient stated that they didn't experience any adverse reaction after first dose. The patient's concomitant medications were not reported. The patient received second vaccine dose around 10 days ago (unspecified date) and had chills and body aches. The patient had a small amount of rash started the next day or the other day (unspecified date) and it was lingering. Outcome of event rash was not recovered and for other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021524234 Same reporter/report type/product/event and different patients

Other Meds:

Current Illness:

ID: 1812267
Sex: M
Age:
State: SC

Vax Date: 04/20/2021
Onset Date: 05/04/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210504; Test Name: Fever; Result Unstructured Data: Test Result:High; Comments: worst high fever

Allergies:

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

Symptoms: the worst high fever; congestion; craziness in stomach; This is a spontaneous report from a contactable consumer or other non-healthcare professional (the patient). A male patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: not reported, expiry date: not reported ) via an unspecified route of administration on 20Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 04May2021, the patient experienced worst high fever, congestion, craziness in stomach and he was scheduled to get the second dose 10May2021. He wants to know if he can still get the second dose and what lymphadenopathy is. The patient underwent lab tests which included high body temperature on 04May2021.The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812268
Sex: F
Age:
State: MI

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 10/23/2021
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: My throat felt like it was swelling up; The next day I had a temperature; body aches; nauseaus; fatigue; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in Dec2020, single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient experienced my throat felt like it was swelling up, the next day had a temperature, body aches, nauseaus and fatigue. She said that she had the first covid vaccine in December and had a reaction. She said that her throat felt like it was swelling up. No other reaction initially. The next day she had a temperature, body aches, nauseau, and fatigue. She was told because of her reaction. She asked that whether she should not get the second dose. She knew it was little late now but this virus was not going away. She was looking for input into how she should move forward. She asked that she could get another dose in the future. She was worried about the fall and the ever changing virus. Outcome of the events were unknown No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812269
Sex: M
Age:
State: MA

Vax Date: 04/29/2021
Onset Date: 05/03/2021
Rec V Date: 10/23/2021
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: headaches; heaviness of the chest; stiffed neck; body aches; This is a spontaneous report from a contactable Nurse. This nurse (patient wife) reported for a patient (reporter husband) that: A 67-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0165) via an unspecified route of administration on 29Apr2021 (At the age of 67 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included myocardial infarction from an unknown date and unknown if ongoing 5 years ago. Patient had previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ERW729) via an unspecified route of administration on 08Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient had experienced headaches. On 03May2021, the patient experienced heaviness of the chest, stiffed neck and body aches. He was rushed to ER for consultation She wants to know if there are reported cases such as stiffed neck and heaviness of the chest. Caller reported that the patient did go to the emergency room because he had a previous heart attack 5 years ago and the patient didn't want to take a chance. Caller reported that the emergency room staff performed complete testing and the patient's heart was ok. Caller reported that the patient has been in touch with his cardiologist and the cardiologist informed the patient that his heart was fine. At the time of reporting, the outcome of the events stiff neck, headache and body aches was not recovered and the event heaviness of the chest was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812270
Sex: F
Age:
State: ID

Vax Date: 04/09/2021
Onset Date: 04/11/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: runny nose; headache; Soreness: She couldn't lift her arm; stomach ache; nauseated; Big rash on the whole muscle; This is a spontaneous report from a contactable consumer (herself). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was ER8729), dose 2 via an unspecified route of administration, administered on left arm on 09Apr2021 14:00, at the age of 73 years as DOSE 2, SINGLE for covid-19 immunisation. Medical history included, pneumonia from an unknown date and unknown if ongoing. for pneumonia or the flu shot she received No additional administered Vaccines. she stopped getting the flu vaccine. She had the pneumonia shot given one time in one arm then the flu shot in the other arm all at the same time and she ended up in the ER. The patient does not have NDC, LOT, EXP for pneumonia or the flu shot she received. She declined to give further details regarding the event stating it was 15 years ago. No known allergies, family medical history and concomitant medications were reported. Previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was EN6199), dose 1 via an unspecified route of administration, administered on left arm on 17Mar2021 at an age of 73 years as DOSE 1, SINGLE for covid-19 immunisation. The patient did not received any prior vaccinations within 4 weeks. The patient experienced that she received the 2nd dose 3 weeks ago and yesterday on 05May2021 she started to get a stomach ache like she was going to vomit. She's nauseated and she also mentioned that she has had a runny nose on an unspecified date. Stomach ache started on 05May2021. She is miserable at night and is still miserable. She is very uncomfortable. No vomiting, very nauseating, its a continual ache. Runny nose started a week out from getting the vaccine. Its still ongoing, still dripping. It has improved, not nearly as bad. On an unspecified date headache its been off and on since she got the shot. On 11Apr2021 big rash on the whole muscle where she got the vaccine she has a big mobus rash. Attempted to clarify what caller meant by mobus. Caller stated a pretty big rash on the whole muscle. Attempted to clarify when the rash first began. Caller stated it was the second day after the vaccine. The vaccine was on 09APR2021. It went away in the first couple of days. Soreness: She couldn't lift her arm on an unspecified date. It went away. It was reported the first one was easy and the second one gave her trouble she wondered if she had the flu but its not flu season. She does not know why she has a horrible stomach ache because she is never sick. Treatment received She had some ginger ale called ginger beer non alcoholic ginger. It helped with her stomach ache she had a couple of bottles. One yesterday and today and it hasn't helped much. If she vomits maybe she will feel better. And runny nose treated with just blowing nose. Headache, Big rash on the whole muscle, Soreness with no treatment. The clinical outcome of the events stomach ache and nauseated was unknown, runny nose outcome was recovering, headache outcome was unknown, big rash on the whole muscle outcome was recovered on 13Apr2021, soreness: she couldn't lift her arm outcome was recovered. Information on Lot/Batch number was available. No further information is expected.

Other Meds:

Current Illness:

ID: 1812271
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Allergic reaction, the symptoms have been debilitating; This is a spontaneous report from a regulatory authority. A contactable consumer (reporter daughter) reported for an unspecified age female patient received bnt162b2, (Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration on unknown date or covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications was not reported. On an unknown date,patient experienced allergic reaction and on four weeks there was no improvement. Reporter stated that we were on four weeks and she not improved. The symptoms have been debilitating. if there was any information could you guide us with, so far all of what the doctors have been prescribed has not helped her improve. The outcome of event was not recovered. No follow-up attempts was needed

Other Meds:

Current Illness:

ID: 1812272
Sex: F
Age:
State: MI

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

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

Lab Data: Test Date: 202104; Test Name: bilirubin test; Result Unstructured Data: Test Result:elevated; Comments: Her bilirubin was off, she believes slightly elevated 1.4 or 1.6; Test Date: 202104; Test Name: blood glucose test; Result Unstructured Data: Test Result:HIgh; Comments: she found out her fasting blood sugars were 120 or 130.; Test Date: 202104; Test Name: A1C; Result Unstructured Data: Test Result:Normal; Comments: A1C was high end of normal; Test Date: 202104; Test Name: Hemoglobin; Result Unstructured Data: Test Result:Normal; Test Name: rapid test; Test Result: Negative ; Test Name: Regular test; Test Result: Negative

Allergies:

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

Symptoms: slept the whole next day after the vaccine; Her fasting blood sugars were high; Her bilirubin was off, she believes slightly elevated 1.4 or 1.6.; cold like symptoms; cough; headache; stuffiness and running nose; really, really tired; stuffiness and running nose; not feeling like herself; sinus drainage; This is a spontaneous report from a contactable other health care professional (patient herself). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration in arm left on 16Apr2021 as dose 1 single (at the age of 47-year-old) for COVID-19 immunisation. The patient's medical history included Wolfe Parkinson white syndrome, adds this was a problem with electrical current in heart. She has had this a good ten or fifteen years, anxiety, this was occasional, off and on 15 or 20 years, diabetes mellitus, her mom and brother were diabetic from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Ativan, when she flies. On 17Apr2021, slept the whole next day after the vaccine. On an unspecified date in Apr2021, the patient experienced her fasting blood sugars were high, her bilirubin was off and she believed slightly elevated 1.4 or 1.6. On an unspecified date 2021, the patient experienced cold like symptoms, cough, headache, stuffiness and running nose, was really, really tired, not feeling like herself and sinus drainage. It was reported that the cough and the headache began and then more stuffiness and drainage and stuff came a few days later. The cough was better and not as much as in the beginning. The stuffiness, running nose and good old fashion cold symptoms were lingering a little bit. It was reported that she could have slept the whole next day after the vaccine and she was really tired. It had gotten better. She states that since getting the vaccine she has not felt quite normal. It has not stopped her from doing anything, but she just has not felt like herself. That started right after and it was going on. It was reported that she went to the primary care physician visit because she did not feel like herself and for other events. The patient underwent lab tests and procedures on an unspecified date in Apr2021 which included blood bilirubin increased: elevated, her bilirubin was off, she believes slightly elevated 1.4 or 1.6, blood glucose: high, she found out her fasting blood sugars were 120 or 130, A1C, glycosylated haemoglobin: normal, A1C was high end of normal, haemoglobin: normal and on an unknown date rapid and regular SARS-COV-2 test: negative. Therapeutic measures were taken as a result of headache included Motrin, 600 mg, each pill was 200 mg. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1812273
Sex: F
Age:
State: NY

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 10/23/2021
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: Headache; face started to flush and was warm; red rash in the shape of a square or triangle on the right arm; red rash that was itching on her arm.; ringing in her ears; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that, A 72-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0167; Expiration Date: 31Aug2021) (at the age of 72 years old), dose 2 via an unspecified route of administration, administered in arm left on 06May2021 11:00 as dose 2, single for covid-19 immunisation. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: ER8731), dose 1 via an unspecified route of administration on 15Apr2021 as dose 1, single for covid-19 immunisation. She thought that she had gained weight called as COVID fat. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included amlodipine (Amlodipine) taken for blood pressure abnormal from an unspecified start date and ongoing. Patient received her second dose of vaccine on 06May 2021 and reported that on 06May2021 a few moments ago her face started to flush and was warm, had a ringing in her ears, and had a red rash in the shape of a square or triangle on the right arm (she received the vaccine in the left arm) appeared. She stated that she was starting to experience a headache on an unspecified date and also stated she was getting another rash on the back of her right arm. She was concerned she may be having a bad reaction to the vaccine and stated she was in no mood to pass away. No additional vaccines administered on same date of vaccine. There was no prior vaccination within four weeks. The outcome for the events of face started to flush and was warm, red rash that was itching on her arm and ringing in her ears was recovered on 06May2021. The outcome for the event of red rash in the shape of a square or triangle on the right arm was not recovered. The outcome for the event of headache was unknown. Follow-up attempts completed. No further information expected.

Other Meds: AMLODIPINE

Current Illness:

ID: 1812274
Sex: F
Age:
State: OH

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 10/23/2021
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: 2019; Test Name: Thyroid checked where they inject; Result Unstructured Data: Test Result:No result

Allergies:

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

Symptoms: Sore arm; felt puffy in the back of her throat; felt like pressure down on that Thyroid area; felt a little swollen; pinched my throat and went down to my thyroid, and lasted for 4 hours; tight around neck; harder to swallow; This spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program Support. A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0158, Expiration date: 31Jul2021) on 06May2021 at 08:00, via an unspecified route of administration, in right arm as DOSE 1, single for covid-19 immunization (age at the time of vaccination: 60-year-old). Patient medical history included: Thyroid issue that gets checked every 2 year and a Fib ongoing for which she takes medication. Patient does not have any problems. She had a nodule, and it was checked every few years to make sure everything was good. Patient did not receive any vaccine on the same day when BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06May2021, after taking the first shot, at 11:00 the patient felt puffy in the back of her throat. She added by 11:00, she felt like pressure down on that Thyroid area. It felt a little swollen and pinched her throat, went down to her thyroid and lasted for 4 hours. She felt this kind like it was tight around neck, harder to swallow, a little full kind of pressure there, it moved from top of throat, moving down and was right there when her Thyroid was tested, and they injected something. Patient stated it felt like the same type of thing after she received the first dose Pfizer Covid Vaccine. It was not like she could not swallow. She has no problem breathing and she could eat. By 12:00 this was all gone. She also had sore arm for which she took Tylenol at 11:30. The outcome of the events (felt puffy in the back of her throat, felt like pressure down on that Thyroid area, felt a little swollen, pinched my throat and went down to my thyroid, and lasted for 4 hours, tight around neck, and harder to swallow was resolved on 06May2021 at 12:00. The outcome of the event sore arm was unknown. The patient wanted to know if the side effect will be worse after second vaccine. She has not received second dose of Pfizer Covid-19 Vaccine and feels like she is not protected. She would like to know if she can safely complete the series, as she doesn't feel protected. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: AFib.

ID: 1812275
Sex: M
Age:
State: NJ

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: There is also a very small raised blemish near the site of the injection; soreness in my left shoulder muscle; soreness in my left shoulder muscle; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date: not reported), via an unspecified route of administration on left arm on 04Mar2021 as dose 1, single for Covid 19 immunization. Medical history and concomitant medications were not reported. After first shot of covid vaccine, the patient was noticed with soreness in his left shoulder muscle. The area of soreness from the first shot was still there. It was mild and more noticeable when he extends his arm to its limits. There was also a very small, raised blemish near the site of the injection. The patient received both covid shots. The patient received second shot on 25Mar2021. There was no soreness from the second shot. Outcome of events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am