VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1811017
Sex: F
Age:
State:

Vax Date: 04/17/2021
Onset Date: 04/01/2021
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 Date: 20210417; Test Name: Body temperature; Result Unstructured Data: Test Result:98 to 100 Fahrenheit

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Had a fever in 12 hours; temperature: 98F to 100F; Tiredness; Muscle pain; This is a spontaneous report from a non-contactable consumer. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on 17Apr2021 at 11:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 17Apr2021, the patient had a fever in 12 hours, temperature 98F to 100F, which lasted for 12 hours and was fully recovered after 36 hours. On an unknown date in Apr2021, the patient experienced tiredness and muscle pain. On 17Apr2021, the patient underwent body temperature and the result was 98 to 100 Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was resolved on an unknown date in Apr2021 (also reported duration of 36 hours) and for the events tiredness and muscle pain were resolved on an unknown date in Apr2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1811018
Sex: F
Age:
State: OH

Vax Date: 04/16/2021
Onset Date: 04/17/2021
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: Test Date: 20210417; Test Name: Body temperature; Result Unstructured Data: Test Result:103 degrees.

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Fever 103 degrees; Rigors; Severe body aches/Muscle pain; Severe body aches/Muscle pain; Fatigue; Nausea; Anorexia; Severe Headache; This is a spontaneous report from a contactable consumer, the patient. A 60-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 16Apr2021 at 15:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disease, fibromyalgia, migraines, paroxysmal atrial fibrillation, gastroesophageal reflux disease (GERD), hypercholesterolemia, anemia of chronic disease, cerebrovascular accident (CVA) and brain aneurysm. The patient had no known drug allergy. 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 omeprazole (PRILOSEC), famotidine (PEPCID), aluminium hydroxide, magnesium hydroxide, simeticone (MYLANTA), progesterone (PROMETRIUM) and estradiol (MANUFACTURER UNKNOWN); all for an unknown indication from 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 24Mar2021 at 14:30 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. On 17Apr2021 at 04:00, the patient experienced fever 103 degrees, rigors, chills, severe body aches/muscle pain, fatigue, nausea, anorexia and severe headache. 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 103 degrees, rigors, chills, severe body aches/muscle pain, fatigue, nausea, anorexia and severe headache was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: PRILOSEC [OMEPRAZOLE]; PEPCID [FAMOTIDINE]; MYLANTA [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE;SIMETICONE]; PROMETRIUM [PROGESTERONE]; ESTRADIOL.

Current Illness:

ID: 1811019
Sex: M
Age:
State: VA

Vax Date: 04/16/2021
Onset Date: 04/17/2021
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: Panic attack like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 14:30 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medications. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 17Apr2021 at 03:30, the patient experienced panic attack like symptoms which were really bad that lead to an emergency room visit. The patient contacted his health care provider at the time of writing this and was told this was related to sympathomimetic amines. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Therapeutic measures were taken as a result of panic attack like symptoms which included treatment with unspecified medication to relieve anxiety. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event panic attack like symptoms was not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1811020
Sex: M
Age:
State: VA

Vax Date: 04/18/2021
Onset Date: 04/18/2021
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: Intense hives occurred 5h post injection on scalp, arms, legs, neck, and most severely on the lower abdomen.; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 18Apr2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to deodorant, laundry detergents and had been exposed to PEG in lab environment. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 18Apr2021 at 17:00, 5 hours post injection, the patient experienced intense hives on scalp, arms, legs, neck and most severely on the lower abdomen and there was no injection site reaction nor any other side effects. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were 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 intense hives on scalp, arms, legs, neck, and most severely on the lower abdomen were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811021
Sex: F
Age:
State: NC

Vax Date: 04/16/2021
Onset Date: 04/17/2021
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: My entire body, other than my face, chest and tops of my feet felt like I had a sunburn when touched or clothes rubbed against my skin. There was no rash and my skin looked normal.; Chills; Fever; Nausea; Extreme sinus blockage; Fatigue; 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: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 16:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's thyroiditis, stage 2 kidney disease and high blood pressure. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and dicycloverine (DICYCLOMINE); 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: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 16:15 (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 vaccination. On 17Apr2021 at 12:00, the patient experienced her entire body, other than her face, chest and tops of her feet felt like she had a sunburn when touched or clothes rubbed against her skin. The patient reported that there was no rash and her skin looked normal. The patient also experienced chills, fever, nausea, extreme sinus blockage and fatigue. The events did not result in doctor or other health care 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 felt like she had a sunburn when touched or clothes rubbed against her skin, chills, fever, nausea, extreme sinus blockage and fatigue were resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds: LEVOTHYROXINE; LOSARTAN; DICYCLOMINE

Current Illness:

ID: 1811022
Sex: M
Age:
State: UT

Vax Date: 04/17/2021
Onset Date: 04/19/2021
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: Severe nausea; Vomiting; Diarrhea; Chills; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Apr2021 at 15:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient had known allergy to nuts. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient experienced severe nausea and vomiting and diarrhea starting at 09:00, and on the same day the patient also experienced chills. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe nausea, vomiting, diarrhea and chills was not recovered at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1811023
Sex: M
Age:
State: MD

Vax Date: 03/29/2021
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: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Painful arthritis in left hand; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 29Mar2021 at 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to 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 were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the right arm on 01Mar2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 05Apr2021 at 00:00, the patient experienced painful arthritis in left hand, that he never had before. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 painful arthritis in left hand was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811024
Sex: M
Age:
State: CA

Vax Date: 03/01/2021
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: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: my arm, where the injection was placed had a red circle about the size of a quarter and had a lump; my arm, where the injection was placed had a red circle about the size of a quarter and had a lump; left upper arm where injection was administered started to hurt in the muscle and surrounding areas/the pain is still intense while sleeping; left upper arm where injection was administered started to hurt in the muscle and surrounding areas/the pain is still intense while sleeping; This is a spontaneous report from a contactable consumer. A 74-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 01Mar2021 at 11:30 as Dose 2, Single for covid-19 immunization. Medical history none, patient was in excellent condition. The patient's concomitant medications were not reported. Historical vaccination the patient received first dose of bnt162b2, administered in Arm Left on 08Feb2021 11:30 (at the age of 74-year-old) as dose 1, single for covid-19 immunisation with no adverse reaction. The patient was not received any vaccine in four weeks. The patient had no covid prior to vaccination nor been tested positive post vaccination. The patient had no known allergies.On 01Apr2021, after 4 weeks of 2nd Pfizer Covid 19 shot, the patient stated that his left upper arm where injection was administered started to hurt in the muscle and surrounding areas. Very painful when turning my arm in certain positions. Been like this for at least a month. Last week my arm, where the injection was placed had a red circle about the size of a quarter and had a lump. After 3 days later it was gone however, the pain is still intense while sleeping. Therapy for the events included taking 600 mg of ibproferon so he could sleep and Heat packs on upper left muscle area. On an unknown date, the patient had recovered from the events injection was placed had a red circle about the size of a quarter and had a lump while the outcome of the other events was not recovered. No follow up attempts were possible; Information about lot/batch number cannot be obtained. No further information was expected.

Other Meds:

Current Illness:

ID: 1811025
Sex: F
Age:
State: OH

Vax Date: 04/15/2021
Onset Date: 04/18/2021
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: Menstral cycle started 3days aftervaccine. "Im" have normal cycles and they begin the 1st week of each month. "Iv" never had a cycle mid month.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 15Apr2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021, the patient experienced menstrual cycle started 3 days after vaccine. The patient had normal cycles and they begin the first week of each month and she never had a cycle in mid of the month. It was reported that it was unsure how long it would last as it was lighter than usual but still odd for her body. The patient did not receive any treatment for 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 menstrual cycle started 3 days after vaccine, she had normal cycles and they begin the first week of each month and she never had a cycle mid-month was resolving at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1811026
Sex: F
Age:
State: MI

Vax Date: 04/17/2021
Onset Date: 04/17/2021
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: 20210417; Test Name: Body temperature; Result Unstructured Data: Test Result:102 degrees; Comments: Severe fever 102?

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Severe fever 102; Body so sore couldn't get out of bed.; Going to the restroom was almost impossible; Coldest I've ever been in my life.; Headache for three days straight.; Confusion; Dizziness; Sweat so much at night I had to drink electrolyte water to stay hydrated every half an hour.; Could not sleep what so ever.; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 16:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took paracetamol (TYLENOL) and experienced drug allergy. Prior to 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 norethisterone (MINI PILL) for birth control, from an unknown date and unknown if ongoing. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 13:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 22:00 the patient experienced severe fever 102 (unspecified units) and body so sore that she could not get out of bed. The patient reported that going to the restroom was almost impossible and was the coldest she had ever been in her life. She had a headache for three days straight, confusion and dizziness. The patient sweat so much at night she had to drink electrolyte water to stay hydrated every half an hour and could not sleep what so ever. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of events. On 17Apr2021, the patient underwent body temperature test and the result was 102 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the reported events. The clinical outcome of the events severe fever 102, body so sore could not get out of bed, going to the restroom was almost impossible, feeling cold, headache, confusion, dizziness, sweating, and could not sleep what so ever was recovering at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: MINI PILL

Current Illness:

ID: 1811027
Sex: F
Age:
State: NC

Vax Date: 04/15/2021
Onset Date: 04/15/2021
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: Left armpit swollen and painful; Left armpit swollen and painful; Chest pain; Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 13:15 (at the age of 30-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. The patient previously received cefaclor (CECLOR) and sulfamethoxazole/trimethoprim (SEPTRA) on an unspecified 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: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 12:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021 at 15:00, the patient experienced left armpit swollen and painful, beginning hours after injection and lasted at least 4 days (it was 4 days since injection and both pain and swelling had persisted). On 15Apr2021, 8-9 hours after injection, the patient experienced chest pain and difficulty breathing that lasted for 36 hours. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain and difficulty breathing was recovered on 17Apr2021 after the duration of 36 hours while the events left armpit swollen and painful was not recovered at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1811028
Sex: F
Age:
State:

Vax Date:
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: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Extreme tiredness; Coughing; Headache; Runny nose; Stuffy nose; Short of breath; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. Medical history and Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received ciprofloxacin (CIPRO) and neomycin sulfate; polymyxin b sulfate; gramicidin (NEOSPORIN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced extreme tiredness, coughing, headache, runny nose, stuffy nose, short of breath and also reported that these symptoms where not present 3 days after first Dose. 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 extreme tiredness, coughing, headache, runny nose, stuffy nose, short of breath was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1811029
Sex: F
Age:
State:

Vax Date: 04/16/2021
Onset Date: 04/18/2021
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: Upper right back pain; Like upper flank pain; Chills; Takes my breath away; This is a spontaneous report from a non-contactable nurse, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 16Apr2021 at 19:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. 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 ascorbic acid (VITAMIN C), vitamin b complex (B COMPLEX), magnesium (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and multi (MANUFACTURER UNKNOWN); all for unknown indications from an unknown date and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 18Apr2021 at 19:00, 48 hours after vaccination, the patient experienced upper right back pain and it went bad overnight, worsening through day 3 post-vaccination. Like upper flank pain which takes the breath away and chills but no fever. It was reported that the patient might go to emergency room. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events upper right back pain, upper flank pain which takes the breath away and chills was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds: VITAMIN C [ASCORBIC ACID]; VITAMIN B COMPLEX; MAGNESIUM; CALCIUM.

Current Illness:

ID: 1811030
Sex: M
Age:
State: TX

Vax Date: 04/18/2021
Onset Date: 04/19/2021
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: Test Date: 20210419; Test Name: Body temperature; Result Unstructured Data: Test Result:102; Comments: at 05:00

Allergies:

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

Symptoms: Leg cramps; Shacking; Fever 102; Sever vomiting; Feeling very very fatigue; Swollen at the injection site; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 18Apr2021 at 15:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure and high cholesterol; but all had been under control for 5 years. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took levofloxacin (LEVAQUIN) and experienced drug allergy to LEVAQUIN antibiotic. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 05:00, the patient experienced leg cramps, shaking, fever 102 (units unspecified), severe vomiting, felt very very fatigue, swollen at the injection site. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events leg cramps, shaking, fever 102 (units unspecified), severe vomiting, felt very very fatigue, swollen at the injection site was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811031
Sex: M
Age:
State: CT

Vax Date: 04/17/2021
Onset Date: 04/18/2021
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: Test Date: 20210418; Test Name: Body temperature; Result Unstructured Data: Test Result:99.5; Comments: Fever

Allergies:

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

Symptoms: Very Sore upper left arm,; Body aches; Slight fever - 99.5; General feeling of unwellness; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male 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 17Apr2021 at 15:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high blood pressure (HBP), and ulcerative colitis (UC). The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER3783) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 20:00 the patient experienced very sore upper left arm, body aches, slight fever 99.5 and general feeling of unwell. On same day the patient underwent body temperature test and the result was 99.5 (unspecified unit). The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were 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 sore upper left arm, body aches, slight fever 99.5 and general feeling of unwell were recovered on 19Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811032
Sex: F
Age:
State: TN

Vax Date: 04/09/2021
Onset Date: 04/10/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Headache; Fatigue; Aching joints and bones; Aching joints and bones; Body temperature fluctuations; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 12:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously 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 12Mar2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021 at 14:00, the patient experienced headache, fatigue, aching joints and bones and body temperature fluctuations. 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 headache, fatigue, aching joints and bones and body temperature fluctuations was recovered on an unknown date in Apr2021.No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1811033
Sex: F
Age:
State: AR

Vax Date: 03/31/2021
Onset Date: 04/08/2021
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: Rash on the right side of my body; It was itchy then started burning.; Rash on the right side of my body, that started 1 wk after vaccination. It was itchy.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 31Mar2021 at 08:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (pcos). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 04:00, the patient experienced a rash on the right side of her body, that started 1 week after vaccination. It was itchy then started burning. It looked like her skin was burned. Since the vaccination, the patient had not been tested for COVID-19. 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. The clinical outcome of the event rash on the right side of patient's body, itchy and skin was burned was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811034
Sex: F
Age:
State: WV

Vax Date: 04/17/2021
Onset Date: 04/18/2021
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: The second day i had injection site swelling the size of my cupped hand; Redness; Pain; Nauseous the entire night after my injection; The next morning every joint was in severe pain; The next morning every muscle was in severe pain; She couldn't fully close her fist due to swelling and all she wanted to do was sleep.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER879) via an unspecified route of administration on 17Apr2021 at 12:45 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19 from Jan2021, pneumonia and known allergies to possible penicillin. Prior to 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 trazodone (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. On 17Apr2021, on the first day, the patient was ok. On 18Apr2021, the second day after vaccination, she had injection site swelling the size of her cupped hand. She also had redness and pain. She was nauseous the entire night after her injection. The next morning every joint and most on her muscles were in severe pain. She couldn't fully close her fist due to swelling and all she wanted to do was sleep. She called in sick the third day. She felt it would be dangerous to drive to work. The fourth day, she was much better. She had severe COVID-19 in January2021. She had pneumonia and was in hospital for a week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were 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 injection site swelling, redness, pain, nauseous, every joint and most on her muscles were in severe pain and couldn't fully close her fist due to swelling and all she wanted to do was sleep was recovering at the time of report. No follow-up attempts are needed. No further information is expected.

Other Meds: TRAZODONE

Current Illness:

ID: 1811035
Sex: M
Age:
State: WI

Vax Date: 04/17/2021
Onset Date: 04/19/2021
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: Hurts to breathe; Tired; Headache; Joint aches; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on 17Apr2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and environmental allergy since unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included salbutamol (ALBUTEROL) and loratadine (CLARITIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient experienced tiredness, headache, joint aches and it hurt to breathe. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tired, headache, joint aches and hurts to breathe were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: ALBUTEROL [SALBUTAMOL]; CLARITIN [GLICLAZIDE]

Current Illness:

ID: 1811036
Sex: F
Age:
State: ME

Vax Date: 04/08/2021
Onset Date: 04/14/2021
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 Date: 20210413; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Pending; Comments: Nasal swab

Allergies:

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

Symptoms: Retinol migraine six days post vaccination followed by several days of extreme fatigue; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 11:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took rheum palmatum (RHUBARB) and doxycycline (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced retinol migraine six days post vaccination followed by several days of extreme fatigue. The event resulted in emergency room/department or urgent care. On 13Apr2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was pending. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event retinol migraine six days post vaccination followed by several days of extreme fatigue was resolved with sequelae On an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811037
Sex: F
Age:
State: FL

Vax Date: 04/19/2021
Onset Date: 04/19/2021
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:

Allergies:

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

Symptoms: Itchiness all over; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 19Apr2021 at 15:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's, hypothyroidism, polycystic ovarian syndrome (PCOS), vitamin b12 deficiency and vitamin d deficiency. The patient had no known allergies to medications, food, or other products. Concomitant medications included paracetamol (TYLENOL), ibuprofen (MANUFACTURER UNKNOWN), levothyroxine sodium (UNITHROID), vitamin d nos (VIT D) and cyanocobalamin (B-12); all for an unknown indication from an unknown date and unknown if ongoing. 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 19Apr2021 at 15:45, the patient experienced itchiness all over and sore arm. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchiness all over and sore arm were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: TYLENOL; IBUPROFEN; UNITHROID; VIT D [VITAMIN D NOS]; B-12.

Current Illness:

ID: 1811038
Sex: F
Age:
State: CA

Vax Date: 01/11/2021
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: Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Unevaluable event

Symptoms: Experienced tingling in my body; Extreme dizziness; And falling; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on [05Oct2021], this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received bnt162b2 (Pfizer-BioNTech), second single dose intramuscularly on 11Jan2021 (Batch/Lot Number: EL3249) for covid-19 immunisation at age of 48-year-old. Medical history and concomitant medications were none. The patient previously received first single dose of bnt162b2 on 19Dec2020 intramuscularly on right deltoid for COVID-19 immunisation (Batch/Lot Number: EJ1685). The patient experienced tingling in body followed by extreme dizziness and falling and events all being transferred to the emergency room. The patient underwent lab test included electrocardiogram with unknown results. Outcome of the events was unknown.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events ( Paresthesia, Dizziness, Fall) and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1811039
Sex: M
Age:
State: MA

Vax Date: 04/14/2021
Onset Date: 04/19/2021
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: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 27, via an unspecified route of administration, in the left arm, on Apr 14, 2021, at 19:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On Apr 19, 2021, at 19:30, patient had a severe migraine with aura. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures taken as a result of the event and included treatment with ibuprofen 800mg. Since the vaccination, patient has not tested for COVID-19. The outcome of severe migraine with aura resolved with sequelae on an unknown date in Apr 2021. No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1811040
Sex: F
Age:
State: VA

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: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210401; Test Name: Body temperature; Result Unstructured Data: Test Result:102; Comments: Fever

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Muscle pain (not simply aches); Joint pain (not simply aches); 102 Fever; Extreme shaking chills; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 09:15(at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to two antibiotics and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), ergocalciferol (VIT D), biotin (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and krill (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Apr2021, the patient experienced muscle and joint pain (not simply aches), 102 fever, extreme shaking chills (fever not present at that time) and extreme fatigue. On the same day, the patient underwent body temperature test and the result was 102 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not tested for COVID-19. The clinical outcome of the events muscle and joint pain, 102 fever, extreme shaking chills and extreme fatigue was resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds: SIMVASTATIN; VIT D [ERGOCALCIFEROL]; BIOTIN; ACETYLSALICYLIC ACID

Current Illness:

ID: 1811041
Sex: F
Age:
State: MI

Vax Date: 04/13/2021
Onset Date: 04/16/2021
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: Swollen lips that have dried and cracked; Swollen lips that have dried and cracked; Swollen lips that have dried and cracked; become uncomfortable apparent skip rash/reaction around mouth, temple, back of knees and groin; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 13Apr2021 at 16:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included 1.5 functioning kidneys, double ureters on both and known allergy to penicillin, other antibiotics, red dye 40, gluten, bananas and other food sensitives. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021, the patient experienced swollen lips that have dried and cracked and become uncomfortable apparent skip rash/reaction around mouth, temple, back of knees and groin. The event 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 swollen lips that have dried and cracked and become uncomfortable apparent skip rash/reaction around mouth, temple, back of knees and groin was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811042
Sex: F
Age:
State: IA

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: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Started period 4/20/21. It is extremely heavy; Started period 4/20/21. It is extremely heavy and completely abnormal for me.; Felt like heavy menstrual cramps continually from 4/10/21 to 4/20/21; My face went numb 20 minutes after the shot.; Had arm pain for a day; Extreme fatigue; The inside of the mouth is swollen; There is a bumpy texture on the inside of the lip.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 09:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to 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 patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. On 09Apr2021 at 09:50 (also reported as 09:45) 20 minutes after the shot the patient's face went numb. The patient had arm pain for a day. The patient experienced extreme fatigue, the inside of the mouth was swollen and there was a bumpy texture on the inside of the lip. On 10Apr2021, the patient experienced what felt like heavy menstrual cramps continually from 10Apr2021 to 20Apr2021. On 20Apr2021, the patient had period. It was extremely heavy and completely abnormal for the patient. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain for a day was recovered on 10Apr2021 and felt like heavy menstrual cramps continually was recovered on 20Apr2021. The clinical outcome of the events face went numb 20 minutes after the shot, extreme fatigue, inside of the mouth was swollen, bumpy texture on the inside of the lip, started period, it was extremely heavy and completely abnormal was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811043
Sex: F
Age:
State: IL

Vax Date: 04/19/2021
Onset Date: 04/19/2021
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: Chest pain; tightening across chest; Significant body aches and pain throughout the night; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 12:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included birth control. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medication for birth control from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Apr2021 at 20:45, the patient experienced chest pain and tightening across chest, this was what came at onset of symptoms about 8 hours post vaccine. On 19Apr2021, the patient experienced significant body aches and pain throughout that night. 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 chest pain, tightening across chest, body aches and pain throughout the night was resolving at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1811044
Sex: F
Age:
State: KS

Vax Date: 04/19/2021
Onset Date: 04/19/2021
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: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone propionate (FLONASE), ethinylestradiol, levonorgestrel (JOLESSA), nadolol (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and sertraline (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 29Mar2021 at 09:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 20:00, the patient experienced fever, headache, aches and nausea. No therapeutic measures were taken as results of the events. The events 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 events fever, headache, aches, nausea was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds: FLONASE [FLUTICASONE PROPIONATE]; JOLESSA; NADOLOL; SERTRALINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE.]

Current Illness:

ID: 1811045
Sex: F
Age:
State: FL

Vax Date: 04/02/2021
Onset Date: 04/06/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: Itching all over; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic rhinitis, hypothyroidism, osteopenia and had known allergy to penicillins. The patient received codeine (MANUFACTURER UNKNOWN) on an unknown date, for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 06Apr2021, the patient experienced itching all over. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken and included diphenhydramine hydrochloride (BENADRYL) and alprazolam (XANAX). The clinical outcome of the event itching all over was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811046
Sex: F
Age:
State: IA

Vax Date: 04/10/2021
Onset Date: 04/11/2021
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:

Allergies:

Symptom List: Nausea

Symptoms: Injection arm unable to lift,, basically immobile; Numbness in mouth; Severe chills; Fever 2+ days,; Severe headache; Severe body ache; Lymph nodes in injection arm and neck swollen; Lymph nodes in injection arm and neck painful; Face twitch and painful days 3- 5; Face twitch and painful days 3- 5; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 10Apr2021 at 10:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had relevant medical history (unspecified) and allergies to medications, food, or other products (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. 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 left arm on 20Mar2021 at 11:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 11Apr2021 at 02:45, the patient experienced severe chills, fever for 2 plus days, severe headache, severe body ache all lasting for 4 days. Lymph nodes in injected arm and neck was swollen and painful. The patient had face twitch and painful for 3-5 days. On 17Apr2021 day 7, the patient experienced numbness in mouth. On 20Apr2021 day 10, on the day of reporting the patient was unable to lift injected arm and was basically immobile. 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 severe chills, fever, severe headache, severe body ache, lymph nodes in injected arm and neck swollen and painful, face twitch and painful was recovered with sequelae on an unknown date in Apr2021. The clinical outcome of the event numbness in mouth was unknown; while that of the event injected arm unable to lift and was basically immobile was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811047
Sex: F
Age:
State: MA

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:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: "i" was having mass body inflammation; causing subluxation of several of "my" joints/subluxation of shoulder; at the site bruising (bruise is still healing now), and pretty bad; Brain fog; "I" deal with chronic pain and my usual treatment couldn't touch how painful it was; A quarter-sized raised lump at the site; Shoulder where the vaccine was given was very swollen; Extreme exhaustion; Extreme pain in "my" joints, especially on the right side; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151) via an unspecified route of administration in the right arm on 09Apr2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included mast cell activation syndrome (MCAS) and joint hypermobility syndrome. 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 were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 19Mar2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 09Apr2021, when the patient received the vaccine, it felt like the needle actually moved something aside in her shoulder. Later that evening (on 09Apr2021), the patient was having mass body inflammation causing subluxation of several of her joints, extreme exhaustion and extreme pain in joints, especially on the right side. The patient stated, she dealt with chronic pain and her usual treatment could not touch how painful it was. As per the patient, the shoulder where the vaccine was given was very swollen, including a quarter-sized raised lump at the site plus bruising (bruise was still healing), and pretty bad subluxation of her shoulder. The worst of the pain and swelling resolved in 1-2 days, but the fatigue and brain fog persisted for 5 days. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chronic pain and shoulder where the vaccine was given was very swollen was resolved on an unknown date in Apr2021, after the duration of in 1-2 days. The clinical outcome of the events fatigue and brain fog was resolved on an unknown date in Apr2021, persisted for approximately 5 days. The clinical outcome of the events mass body inflammation, subluxation of several of joints/subluxation of shoulder, a quarter-sized raised lump, extreme exhaustion, extreme pain in joints, especially on the right side was resolved on an unknown date in Apr2021. The clinical outcome of the event bruising was resolving (also reported as still healing). No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811048
Sex: F
Age:
State: IL

Vax Date: 04/09/2021
Onset Date: 04/13/2021
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: Rash on face neck upper chest; Slight headache; Red itchy watery eyes; Red itchy watery eyes; Red itchy watery eyes; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 01:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tofacitinib citrate (XELJANZ) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 10:00, the patient experienced rash on face, neck, upper chest, slight headache and red itchy watery eyes. 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 rash on face, neck, upper chest, slight headache and red itchy watery eyes were resolving at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: XELJANZ

Current Illness:

ID: 1811049
Sex: F
Age:
State: CA

Vax Date: 04/15/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: Initial 12-24 hours: sore arm, tingling in arm; Initial 12-24 hours: sore arm, tingling in arm; Chills; Fatigue; Sore throat; Tight chest; Cough; Persistent headache; Joint pain; Foggy brain; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to 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 patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. On an unknown date in Apr2021, within initial 12-24 hours the patient experienced sore arm and tingling in arm. 3-5 days after vaccination the patient experienced chills, fatigue, sore throat, tight chest, cough, persistent headache, joint pain, foggy brain and dizziness. 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 sore arm, tingling in arm, chills, fatigue, sore throat, tight chest, cough, persistent headache, joint pain, foggy brain and dizziness was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811050
Sex: F
Age:
State: NV

Vax Date: 04/03/2021
Onset Date: 04/06/2021
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: Tremor

Symptoms: Severe congestion; swelling in feet arms legs and hands; headache; Extreme fatigue; Short of breath; Body soreness; Irritability; Soft stools; Loss of taste; Loss of smell; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (COMIRNATY; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 at 15:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included congestive heart failure, hypertension, hypothyroidism, narcolepsy, musculoskeletal disorder, arthritis and sciatica. 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 metoprolol succinate (METOPROLOL), hydralazine hydrochloride (HYDRALAZINE), losartan (MANUFACTURER UNKNOWN) and levothyroxine sodium (LEVOTHYROXIN); all from an unknown date for unknown indication and unknown if ongoing. The patient previously received morphine sulfate (MORPHINE), codeine (MANUFACTURER UNKNOWN) and metronidazole (FLAGYL) and experienced drug allergy. On 06Apr2021, the patient experienced severe congestion, swelling in feet arms legs and hands, headache, extreme fatigue, short of breath, body soreness, and irritability, and soft stools, loss of taste and smell. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events congestion, swelling in feet arms legs and hands, headache, extreme fatigue, short of breath, body soreness, irritability, soft stools, loss of taste and smell was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: METOPROLOL; HYDRALAZINE; LOSARTAN; LEVOTHYROXIN

Current Illness:

ID: 1811051
Sex: F
Age:
State: WA

Vax Date: 04/06/2021
Onset Date: 04/06/2021
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: "I" started feeling a little more tired than usual; Slightly sore at the vaccine site; "My" right hand started to feel extremely tingly/ Every time "I" moved it or touched anything it felt like that area was full of needles; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 06Apr2021 at 08:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and known allergies to hops (beer). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included vitamin d nos (VITAMIN D); for an unknown indication from an unknown date and unknown if ongoing. On 06Apr2021 at 10:00, a little over an hour after her vaccination, the patient started feeling a little more tired than usual and slightly sore at the vaccine site. After a while she took a nap, sleeping on the side where she got the vaccine. When she woke up (which was sometime between 3-4 hours after the vaccine) her right hand started to feel extremely tingly. Every time she moved it or touched anything it felt like that area was full of needles. After about 10-15 mins though this went away. A couple hours later, the patient no longer felt tired, and though her arm was a little sore over the next day or so, it was nothing significant. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling a little more tired than usual, right hand started to feel extremely tingly, every time she moved it or touched anything it felt like that area was full of needles was resolved on 06Apr2021, while that of slightly sore at the vaccine site was resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds: VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1811052
Sex: M
Age:
State: FL

Vax Date: 04/12/2021
Onset Date: 04/01/2021
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: Severe flu symptoms; rash that spreading on both arms.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications were not reported. It was unknown that 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. On 14Apr2021 at 02:00, 36 hours after vaccination, the patient experienced severe flu symptoms including fever, sore throat, cough, extreme congestion. On an unknown date in Apr2021, 1 week after vaccination the patient experienced rash that spreading on both arms. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash that spreading on both arms and severe flu symptoms was not resolved at the time of report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1811053
Sex: F
Age:
State: MO

Vax Date: 04/12/2021
Onset Date: 04/19/2021
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: Test Date: 20210419; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:93-95; Comments: My oxygen was 93-95, which is low for me usually 97-99.; Test Date: 20210419; Test Name: Body temperature; Result Unstructured Data: Test Result:99.7 Units:[degF]

Allergies:

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

Symptoms: Around 4 was still feeling fatigue so took a nap 1.5 hour. Developed a fever (99.7F) around 6:30.; Yesterday around 1 pm I started feeling fatigued; Chilled, but no fever; My oxygen was 93-95, which is low for me usually 97-99.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 12Apr2021 at 13:30(at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic back pain, fibromyalgia, osteoarthritis, osteopenia, myofascial syndrome, high blood pressure, basal cell carcinoma, spinal stenosis and known allergies to ACE inhibitors. The patient previously took tramadol hydrochloride (ULTRAM) and prednisone (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to 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 cyclobenzaprine (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); both for an unknown indication from unknown date and unknown if ongoing. On 19Apr2021 at 13:00, the patient experienced started feeling fatigued and chilled, but no fever around 13:00 and she went for a 2-minute walk around 14:30. Around 16:00, the patient still felt fatigue so took a nap 1.5 hour. She developed a fever (99.7F) around at 18:30. She took 2 Tylenol. The patient oxygen was 93-95, which was low for her usually 97-99. Fever and oxygen returned to normal by 22:00. The patient went to bed as normal and woke up fine the next morning. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of fever, chills and included treatment with two paracetamol (TYNELOL) . On 19Apr2021, the patient had body temperature test and the result was 99.7 degrees Fahrenheit. On 19Apr2021, the patient underwent Oxygen saturation test and the result was 93-95 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 99.7 Fahrenheit and oxygen was 93-95, which was low for her usually 97-99 was recovered on 19Apr2021 at 22:00 whereas the events feeling fatigued and chilled on an unknown date at Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds: CYCLOBENZAPRINE; AMLODIPINE

Current Illness:

ID: 1811054
Sex: F
Age:
State: TN

Vax Date: 04/11/2021
Onset Date: 04/12/2021
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 Date: 20210412; Test Name: Pulse rate; Result Unstructured Data: Test Result:Elevated; Comments: Elevated heart rate (blood pressure and pulse), Time: 15:00; Test Date: 20210412; Test Name: Blood pressure; Result Unstructured Data: Test Result:Elevated; Comments: Elevated heart rate (blood pressure and pulse) Time; 15:00; Test Date: 20210418; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Elevated heart rate (blood pressure and pulse); Elevated heart rate (blood pressure and pulse); Severe headache; Leg pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 11Apr2021 at 09:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid issues - only left lobe and known allergy to Sulfa. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included ergocalciferol (VITAMIN D2) 50,000 IU and doxycycline (MANUFACTURER UNKNOWN); both 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. On 12Apr2021 at 15:00, the patient experienced elevated heart rate (blood pressure and pulse), severe headache and leg pain. On the same day, the patient underwent blood pressure and the result was found to be elevated and also the patient underwent pulse rate and the result was found to be elevated. On 18Apr2021, the patient underwent nasal swab and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events elevated heart rate (blood pressure and pulse), severe headache and leg pain was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: VITAMIN D2; DOXYCYCLINE

Current Illness:

ID: 1811055
Sex: F
Age:
State: WY

Vax Date: 02/21/2021
Onset Date: 02/21/2021
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:

Allergies:

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

Symptoms: Extreme exhaustion since the second dose vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 21Feb2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 22Jan2021 at 15:00 (at the age of 57-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 21Feb2021, since the second dose vaccine, the patient experienced extreme exhaustion. The patient did not know if this was related to the second dose of the vaccine but reported that it had occurred since that time. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme exhaustion was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811056
Sex: M
Age:
State: MI

Vax Date: 04/17/2021
Onset Date: 04/18/2021
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: Swollen injection site; Sore injection site; Swollen lymph nodes in left armpit and left neck/clavicle; Cold sweats; Headache; Fever; chills; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0164) via an unspecified route of administration in the left arm on 17Apr2021 at 14:00 as a single dose for COVID-19 immunisation. Medical history included allergy to wasp/hornet stings and anomalous pulmonary veins. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin D nos (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN) ) from an unknown date for an unknown indication and unknown if ongoing. The patient received other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the right arm on 27Mar2021 as a single dose for COVID-19 immunisation. On 18Apr2021 at 09:00, the patient experienced fever, chills, cold sweats, headache, sore injection site, swollen injection site, swollen lymph nodes in left armpit and left neck/clavicle. 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 fever, chills, cold sweats, headache, sore injection site, swollen injection site, swollen lymph nodes in left armpit and left neck/clavicle was resolving at the time of this report. No follow-up attempts are possible. No further information is expected

Other Meds: VITAMIN D NOS; ZINC.

Current Illness:

ID: 1811057
Sex: F
Age:
State: NY

Vax Date: 04/13/2021
Onset Date: 04/15/2021
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: Pain in extremity

Symptoms: Nausea; Vomiting; Congestion; Low energy; Headache; Cough; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient 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 13Apr2021 at 15:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid condition and iron deficiency anemia. 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 vaccination. The patient did not receive any other medications within two weeks of vaccination. On 15Apr2021 at 12:00, the patient experienced nausea, vomiting, congestion, low energy, headache and cough. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were 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 nausea, vomiting, congestion, low energy, headache and cough were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811058
Sex: F
Age:
State: MA

Vax Date: 04/15/2021
Onset Date: 04/16/2021
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:

Allergies:

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

Symptoms: Severely swollen lymph nodes, particularly clavicle lymph node on left side is swollen over collar bone; nausea; light headed; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 at 09:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included pernicious anemia, mal rotation and asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/levonorgestrel (SEASONIQUE), omeprazole (MANUFACTURER UNKNOWN), cyanocobalamin (B-12) and vitamins nos (DAILY VITAMINS); all for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation and received metoclopramide (REGLAN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021, the patient experienced severely swollen lymph nodes, particularly clavicle lymph node on left side is swollen over collar bone, nausea and light headed. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severely swollen lymph nodes, particularly clavicle lymph node on left side is swollen over collar bone, nausea and light headed was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: SEASONIQUE; OMEPRAZOLE; B-12; DAILY VITAMINS

Current Illness:

ID: 1811059
Sex: F
Age:
State: NJ

Vax Date: 01/01/2021
Onset Date: 02/18/2021
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: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Hives; Aprrox 1-2 weeks after 2nd vaccination hives broke out.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EI3302) via an unspecified route of administration on the right arm on an unspecified date in Jan2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder and autoimmune hives. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have known allergies. Concomitant medications included thyroid medications (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Feb2021, the patient experienced hives. It was reported that the patient had chronic urticaria but not had hives for 6 years. Approximately 1-2 weeks after second vaccination hives broke out. She still had hives in April. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included numerous treatments. The clinical outcome of the event hives was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1811060
Sex: M
Age:
State: OH

Vax Date: 04/14/2021
Onset Date: 04/17/2021
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: Cold sore; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 14Apr2021 at 14:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, hypertension and hyperlipidemia. The patient did not have any allergies to food, medications, or other products. 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 allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and golimumab (SIMPONI); all medications for an unknown indication from an unknown date and unknown if ongoing. On 17Apr2021 at 09:00, the patient experienced cold sore. The event did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with ABREVA. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event cold sore was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: ALLOPURINOL; ATORVASTATIN; LISINOPRIL; SIMPONI

Current Illness:

ID: 1811061
Sex: M
Age:
State: MA

Vax Date: 04/13/2021
Onset Date: 04/13/2021
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: Allergic reaction to the sun; Red rash on exposed skin that was itchy; Red rash on exposed skin that was itchy; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, allergy to cats and overweight. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included phentermine (MANUFACTURER UNKNOWN), topiramate (MANUFACTURER UNKNOWN) and montelukast sodium (SINGULAIR); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 09:30 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. On 13Apr2021 at 14:00, few hours after receiving the second dose, the patient had an allergic reaction to the sun within two minutes of exposure and also had red rash on exposed skin that was itchy. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were 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 allergic reaction to the sun, red rash on exposed skin that was itchy was not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: PHENTERMINE; TOPIRAMATE; SINGULAIR

Current Illness:

ID: 1811062
Sex: F
Age:
State: PA

Vax Date: 03/09/2021
Onset Date: 03/16/2021
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: Test Date: 20210316; Test Name: Weight; Result Unstructured Data: Test Result:Lost 7 pounds in 72 hours

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: An 18 hour bout of fever; cyclical vomiting; Lost 7 pounds in 72 hours. This is a spontaneous report from a contactable consumer (patient) reported for herself. A 49-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Ep7533, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 09Mar2021 at 14:00 pm (age at vaccination was 49 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The facility where the most recent COVID-19 vaccine was administered was Health Clinic/ Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 16Mar2021 at 20:00 pm, the patient experienced an 18 hour bout of fever, cyclical vomiting and the patient lost 7 pounds in 72 hours. The patient received treatment with Phenegren. The patient recovered with lasting effects. The outcome of the events was resolved with sequel on an unspecified date in 2021. No follow-up attempts are required. No further information is expected.

Other Meds:

Current Illness:

ID: 1811063
Sex: F
Age:
State: CT

Vax Date: 04/11/2021
Onset Date: 04/12/2021
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:

Allergies:

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

Symptoms: Break out on the skin/ spread as a rash under the ribcage and back; Break out on the skin that looked like poison ivy; Itchy; In some spots oozing.; Bad headache; Chills; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Mar2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 00:00, the patient experienced break out on the skin that looked like poison ivy but spread as a rash under the ribcage and back, itchy and in some spots oozing, bad headache, chills and heart palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were 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 breaks out on the skin that looked like poison ivy but spread as a rash under the ribcage and back, itchy and in some spots oozing, bad headache, chills and heart palpitations was resolving at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1811064
Sex: F
Age:
State: CA

Vax Date: 04/19/2021
Onset Date: 04/19/2021
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: Pain started to radiate up my arm, from the injection site, up to my neck and collar bone; Pain in neck/ The lump was painful to the touch.; Firm lump the size of a marble on neck; Area is also red and swollen; Area is also red and swollen; Sweat profusely; Pain has begun to radiate up the left side of head; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0161) via an unspecified route of administration in the arm left on 19Apr2021 at 11:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication, from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Apr2021, the patient experienced pain started to radiate up her arm, from the injection site, up to her neck and collar bone, pain in neck, and upon inspection found a firm lump the size of a marble on neck. The area was also red and swollen. The lump was painful to the touch. She began to sweat profusely the at the time the pain started and the pain had begun to radiate up the left side of her head. The events 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. Therapeutic measures were not taken for the reported events. The clinical outcome of the events pain started to radiate up her arm, from the injection site, up to her neck and collar bone, pain in neck, firm lump the size of a marble on neck, area was red and swollen, sweat profusely and pain begun to radiate up the left side of her head was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: IBUPROFEN

Current Illness:

ID: 1811065
Sex: F
Age:
State: VA

Vax Date: 02/26/2021
Onset Date: 02/26/2021
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:

Allergies:

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

Symptoms: Severe tinnitus, affecting hearing and sleep.; Affecting hearing and sleep.; Affecting hearing and sleep.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Feb2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 26Feb2021, the patient experienced severe tinnitus, affecting hearing and sleep. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event severe tinnitus, affecting hearing and sleep was not recovered at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1811066
Sex: F
Age:
State: NY

Vax Date: 04/16/2021
Onset Date: 04/20/2021
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: "My" neck began to itch, "I" rubbed it with "my" hands for a few minutes and then it started to tingle; "I" went to look in the mirror and noticed that "my" neck and "my" face, were red.; "I" then began to feel a warm sensation on "my" arms and legs/ The warm, rushing sensation in "my" extremities lasted for about 5 minutes.; upon looking at them, "I" noticed red rashes around "my" elbows and knees/Around 2 hours later, the rashes were completely gone.; "My" neck began to itch, "I" rubbed it with "my" hands for a few minutes and then it started to tingle; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 16Apr2021 at 09:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The medical history included fibromyalgia, anxiety, panic disorder, depression, kidney stones, allergy to nickel which caused dermatitis and allergy to contrast dye which caused anaphylaxis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included escitalopram (MANUFACTURER UNKNOWN), vitamin b complex (VITAMIN B), ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D) and probiotic (unspecified); all for unknown indications from unknown dates and unknown if ongoing. On 20Apr2021, around 11:10, the patient's neck began to itch, she rubbed it with her hands for a few minutes and at 11:15, it started to tingle, she went to look in the mirror and noticed that her neck and her face were red. The patient then began to feel a warm sensation on her arms and legs and upon looked at them, she noticed red rashes around her elbows and knees. The warm, rushing sensation in her extremities lasted for about 5 minutes. The rashes were began to subside at that point. Around 2 hours later, the rashes were completely gone. 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 neck began to itch, then it started to tingle, neck and face were red was unknown, while the clinical outcome of the event felt a warm sensation on arms and legs was resolved on 20Apr2021 at 11:20 and red rashes around elbows and knees was resolved on 20Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds: ESCITALOPRAM; VITAMIN B [VITAMIN B COMPLEX]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am