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: 1812174
Sex: M
Age:
State: GA

Vax Date: 04/14/2021
Onset Date: 04/14/2021
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:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Pressure in eyes; Pressure in head; Severe chills; Headache; Dizziness; Blurred vision; Feeling very cold; Weakness; Could not sleep all night; This is a spontaneous report from a contactable consumer, the patient. A 55-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 14Apr2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. 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 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 23Mar2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 17:00, the patient experienced pressure in eyes and head, severe chills, headache, dizziness, blurred vision, feeling very cold, weakness and could not sleep all night. 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 pressure in eyes and head, severe chills, headache, dizziness, blurred vision, feeling very cold, weakness and could not sleep all night was resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812175
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Severe back pain; Stiff back muscles; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 25Apr2021 at 09:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination which included measles vaccine; mumps vaccine; rubella vaccine (MMR) and tetanus vaccine toxoid; diphtheria vaccine toxoid; pertussis vaccine acellular (Tdap); both on 04Apr2021. Concomitant medications taken within two weeks of vaccination was not reported. On 25Apr2021 at 23:00, the patient experienced severe back pain and stiff back muscles. 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 the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe back pain and stiff back muscles was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812176
Sex: F
Age:
State: PA

Vax Date: 04/22/2021
Onset Date: 04/22/2021
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: Chest pain after shot starting next morning and lasting 2 days.(tightness of chest); tightness of chest; Fatigue; arm soreness; heaviness immediately after shot; feeling like the patient was on fire which lasted 3 days; Itching in eyes; pain in eyes immediately after injection and lasted few days; Fever; pain in whole body aching and feeling like I was on fire which lasted 3 days; severe headache which lasted 4 days; Lightheadedness continually; Severe nausea which started within 10 hours and lasted one and a half days; Could not sleep at all first night after shot; This is a spontaneous report from a contactable consumer, the patient. A 63-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 22Apr2021 at 15:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune thyroiditis, allergies and hypersensitivities to many foods, allergy to medication, preservatives, additives, environmental and chemical. 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 vitamin d3 (MANUFACTURER UNKNOWN) 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: UNKNOWN) via an unspecified route of administration in the left arm on 04Apr2021 at 15:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 15:00, the patient experienced severe headache which lasted 4 days, severe nausea which started within 10 hours and lasted one and a half days, Itching and pain in eyes immediately after injection and lasted few days, fever and pain in whole body aching and feeling like the patient was on fire which lasted 3 days, could not sleep at all first night after shot, light headedness continually, tightness of chest, fatigue, arm soreness and heaviness immediately after shot. On 23Apr2021, the patient experienced chest pain after shot starting next morning and lasting 2 days, The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe headache was recovered on 26Apr2021. The clinical outcome of the events fever, chest pain after shot starting next morning and lasting 2 days and pain in whole body aching and feeling like the patient was on fire which lasted 3 days was recovered on 25Apr2021. The clinical outcome of the events severe nausea which started within 10 hours and lasted one and a half days, Itching and pain in eyes immediately after injection and lasted few days, could not sleep at all first night after shot, light headedness continually, tightness of chest, fatigue, arm soreness and heaviness immediately after shot was resolved 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: VITAMIN D3

Current Illness:

ID: 1812177
Sex: F
Age:
State: RI

Vax Date: 04/22/2021
Onset Date: 04/24/2021
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: Period came two days after the shot, which was earlier than expected; Usually the flow is light at the first half day. But this time, it is very heavy at the very beginning. This is a spontaneous report from a non-contactable consumer, the patient. A 35-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 22Apr2021 at 09:30 (at the age of 35-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 take any concomitant medication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 24Apr2021 at 23:00, two days after the shot, the patient experienced her period, which was earlier than expected and there was no cramp feeling at all this time. The patient used to experience some sort of cramp feeling before and during the first half day and her body tells that period was coming. But this time, it came very silently and had no feelings at all and usually, the flow was light at the first half day, but this time, it was very heavy at the very beginning. 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 period came two days after the shot, which was earlier than expected and usually, the flow was light at the first half day, but this time, it was very heavy at the very beginning was resolved on an unknown date in Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812179
Sex: F
Age:
State: IL

Vax Date: 04/26/2021
Onset Date: 04/29/2021
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: 3 days after second shot "I" have hives all over "my" face.; Slight swelling; This is a spontaneous report from a contactable consumer, the patient. A 61-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 right arm on 26Apr2021 at 12:00(at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient's known allergies were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. The concomitant medications included aciclovir (ACYCLOVIR) 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: EP7534) via an unspecified route of administration in the right arm on 20Mar2021 at 13:00(at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 29Apr2021, 3 days after the second shot, the patient had hives all over her face and slight swelling. The adverse 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 the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives all over the face and slight swelling were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: ACYCLOVIR [ACICLOVIR]

Current Illness:

ID: 1812180
Sex: F
Age:
State: OH

Vax Date: 04/05/2021
Onset Date: 04/06/2021
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: Started menstruating the day after first shot which was 1.5 weeks early.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 11:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 06Apr2021 at 12:00, the patient experienced menstruating the day after the first shot which was 1.5 weeks early. 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 event early menstruation was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812181
Sex: M
Age:
State: FL

Vax Date: 04/02/2021
Onset Date: 04/07/2021
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: Mouth ulcers in various locations along the gum line.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 10:00, the patient experienced mouth ulcers in various locations along the gum line. 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 for the reported events. The clinical outcome of the event mouth ulcers in various locations along the gum line was not resolved at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Apr2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812182
Sex: F
Age:
State:

Vax Date: 02/18/2021
Onset Date: 02/19/2021
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: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: I haven't have a menstrual cycle since receiving the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 29-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 18Feb2021 at 18:45 (at the age of 29-years-old), as a single dose for COVID-19 immunisation.The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Feb2021 at 00:00, the patient did not have a menstrual cycle since receiving the vaccine and pregnancy had been ruled out. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event did not have a menstrual cycle since receiving the vaccine was unknown at the time of this report. The 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 18Mar2021 at 20:30 (at the age of 29-year-old) as a single dose for COVID-19 immunisation.. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812183
Sex: M
Age:
State: KS

Vax Date: 04/06/2021
Onset Date: 04/07/2021
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: Test Date: 20210407; Test Name: Body temperature; Result Unstructured Data: Test Result:100; Comments: Low Temperature (100)

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Headache; Low temperature (100); Myalgia; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 at 11:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included prostate cancer and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other medication within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 09:00, the patient experienced headache, myalgia and had low temperature (100). On that day, the patient underwent body temperature test and the result was 100 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. 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 headache, myalgia and low temperature (100) was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812184
Sex: F
Age:
State: NC

Vax Date: 04/27/2021
Onset Date: 05/01/2021
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:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: swollen, red, and painful toes; swollen, red, and painful toes; swollen, red, and painful toes; having a hard time sleeping; ankle swelling; the toe next to her big toe, on both feet is beet red and swollen was reported as worsened/ankle swelling, and redness on the outside of both feet was reported as worsened; This is a spontaneous case received from a contactable consumer (patient). A 79-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8736), via an unspecified route administered in right arm on 27Apr2021 (age at vaccination 79-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included ongoing COPD (Chronic obstructive pulmonary disease) from 2006, ongoing atrial fibrillation from 2006 and pollen allergy. Concomitant medications included guaifenesin (MUCINEX). The patient reported that the toe right next to her big toe, on the right foot, is beet red and swollen and painful, on May2021 her ankles are also swollen, and she had redness on the outside of her foot on both feet, they have worsened because it started on her right foot, now it was both feet and now the sides of her feet in the morning are red as well, and she was having a hard time sleeping because of the pain from her feet. The outcome of the event ankle swelling and he toe next to her big toe, on both feet is beet red and swollen was reported as worsened/ankle swelling, and redness on the outside of both feet was reported as worsened was not recovered, and outcome of other events was unknown. No follow-up attempts are needed. No further information was expected.

Other Meds: MUCINEX

Current Illness: Atrial fibrillation; COPD

ID: 1812185
Sex: M
Age:
State: KY

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: left arm around my elbow is painful and sore and painful to move; second dose of the vaccine is bothering his joint and muscle; second dose of the vaccine is bothering his joint and muscle; This is a spontaneous report from a contactable consumer. This 68-year-old male consumer (patient) reported for himself. A 68-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: ER8732, expiry date: 31Jul2021) via unknown route in left arm on 31Mar2021 at 03:30PM as single dose (at the age of 68 years old) for COVID-19 immunisation. The patient medical history included Blood Pressure High from an unknown date in May2021. The concomitant medications were not reported. It was reported that he was diagnosed with high blood pressure several years ago and was taking medication for that regularly. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: unknown, expiry date: 31Jul2021) via unknown route in right arm on 10Mar2021 as single dose (at the age of 68 years old) for COVID-19 immunisation and never bothered his right arm. After the one week ago, his left arm where he had the injection at and his elbow are painful and sore, and painful to move and his second dose of the vaccine was bothering his joint and muscle, which started about a week ago. He said when it started he was not sure if it was something he did that day, but he hadn't done anything strenuous. Patient received treatment with Ibuprofen (LOT number: P121258, EXP: Aug2023) 200mg via orally in the morning two days ago, then used Aspirin 81 mg (LOT number: P113296, EXP: Dec2020) took four of them, at different times, starting probably Tuesday 04May2021, he was not sure if they helped or not, because his arm still hurt. He says he didn't take them today. He also reported the bottle had 300 small, coated tablets, and it was sealed and intact when he got it. It was reported that his arm pain is maybe a little better on its own, after he uses it a while it seems to be a little less painful. At the time of this report the outcome of the events were recovering. Follow up attempts were completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1812186
Sex: F
Age:
State: NV

Vax Date: 05/03/2021
Onset Date: 05/04/2021
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: fever; headache; my hands and the soles of my feet hurt; I have a ball under my armpit; pains in her joints; cold; She has a pimple below her armpit and it is swollen now; I felt bone pain; She spent the whole day in bed. She was unable to stand up/It feels like a car slammed into her; I have muscle pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8736; Expiration Date: 03Mar2022), dose 2 via an unspecified route of administration on 03May2021 (at age of 50-year-old) as dose 2, single for covid-19 immunisation. Medical history included renal pain (left kidney pain). Concomitant medication included ciprofloxacin hydrochloride, tinidazole (ciprofloxacin + tinidazole) taken for renal pain, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced i felt bone pain, i have muscle pain, she spent the whole day in bed. she was unable to stand up/it feels like a car slammed into her on 04May2021; fever, headache, my hands and the soles of my feet hurt, i have a ball under my armpit, pains in her joints, cold, she has a pimple below her armpit and it is swollen now on 05May2021. The outcome of events was not recovered. Follow up(05May2021): New information received from a contactable consumer included: vaccine details (Lot number: First vaccine: EP7533, second: ER8736; expiration date for second vaccine 03mar2022), medical history (left kidney pain), concomitant medication (ciprofloxacin), new events (pains in her joints, cold, She spent the whole day in bed. She was unable to stand up/It feels like a car slammed into her, She has a pimple below her armpit and it is swollen now) Follow up attempts are completed. No further information is expected.

Other Meds: CIPROFLOXACIN + TINIDAZOLE

Current Illness:

ID: 1812187
Sex: M
Age:
State: MI

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

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

Lab Data: Test Name: chest x-ray; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: got bronchitis really bad; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported, expiry date: not reported), via an unspecified route of administration, administered in the right arm on 03Mar2021 at 19:10 as dose 1, single for COVID-19 immunisation. The patient's medical history included ongoing cardiac pacemaker insertion, ongoing hypertension, ongoing diabetes mellitus, influenza type A. The patient concomitant medications included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. On an unspecified date on Mar2021, the patient experienced got bronchitis really bad. The event had resulted into a physician office visit. The patient underwent lab tests and procedures which included chest x-ray: unknown result on an unspecified date. The patient received first COVID-19 vaccine and he developed bronchitis afterward. His second dose was due on 24Mar2021. His doctor advised him to wait on getting his second dose. His question was what the recommendations on are receiving his second COVID-19 vaccine. The patient was given the CDC recommendations by. The patient confirmed the details provided by the transfer agent. The patient received his first COVID-19 vaccine on 03Mar2021 and he was supposed to go in for his second dose on 24Mar2021 or 26Mar2021 or something like that. He missed his second COVID-19 vaccine. The week before his second dose was scheduled, he got bronchitis really bad, and his doctor advised him not to get the second COVID-19 vaccine until he was better from the bronchitis. He fought the bronchitis for 3 to 4 weeks. Clarified the date the patient was supposed to receive the second COVID-19 vaccine was 24Mar2021. He did go to the doctor, but he doesn't remember when. He reports he fought the bronchitis right up until the 18Apr2021 or 20Apr2021. At that time, he had recovered from the bronchitis. He adds the following in a historical context. He reports in 2019 he was coming back from and had to stop in. He was hospitalized there with Influenza Type A for 5 days. The Influenza Type A really hurt him, he thought he was going to die. When probing medical history and concomitant medications, he reported, he has a pacemaker, high blood pressure and he is a diabetic. He takes Metformin. He was unsure of the dose of the Metformin. He reports he takes 7 pills. He does not think his pills are relevant to the report. He reports the first time he went to his doctor he was prescribed a steroid and it didn't do anything. The patient does not know the name of the steroid. Product information, NDC/Lot/Expiry, including medication name not known by the patient. Then he went back to the doctor a second time and he was given an inhaler and that didn't work. The patient does not know name of the inhaler, he states it was a common name. The third time around the doctor gave him some pills that he was supposed to take one every day and a stronger steroid and that knocked the bronchitis out of him. His biggest concern was he did not know if he would have to start over with the Pfizer COVID-19 vaccine or not. The patient would like to add that his wife said a lady that lives 6 miles from the patient received the Moderna vaccine and that lady died with a blood clot in her brain. He doesn't know her name. He knows people that have said the Johnson and Johnson vaccine had the blood clots and that scared people all the way around. He declines to file a safety report. Outcome of the event was recovered on 20Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Other Meds: METFORMIN

Current Illness: Blood pressure high; Diabetic; Pacemaker insertion (cardiac)

ID: 1812188
Sex: F
Age:
State: NY

Vax Date: 03/19/2021
Onset Date: 03/01/2021
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: 202012; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: joint pain and body aches; joint pain and body aches; she had body and joint pain and exhaustion after the first dose; her left arm hurt; exhausted; sick; This is a spontaneous report from a contactable consumer (patient). This is one of two reports. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206) via an unspecified route of administration, administered in left arm on 19Mar2021 09:48 (at the age of 57-year-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing Interstim Implant for Bladder from 2016, ongoing Inverted T waves all her life, clarifying she had issues since college, ongoing hypoglycaemia since high school, ongoing gluten intolerance (she stated in her 40s, she was told she had gluten intolerance, and another autoimmune issue referred to as leaky gut. She said she wasn't formally tested for leaky gut, but her leaky gut diagnosis was done by elimination), ongoing asthma diagnosed with moderate asthma as a child and Lobular Carcinoma-Right Breast from Dec2020 to an unknown date, she had a lumpectomy on her right breast in Dec2020. She said at that time, she was diagnosed with a lobular carcinoma that was not cancerous, but considered a high risk lesion, and was removed. The patient's concomitant medications were not reported. No any additional vaccine administered on same date of the Pfizer vaccine. No prior vaccination within four weeks. On an unspecified date in Mar2021, patient got sick. She said she had joint pain and body aches, and her arm, and all that stuff. She clarified the day she got her first COVID-19 Vaccine shot (on 19Mar2021), her (left) arm hurt, and she was exhausted. She said she went to bed at 7:00PM that night (19Mar2021), and the next morning (20Mar2021), she woke up with the joint pain and body aches, condition aggravated. She said the (left) arm pain, joint pain, and body aches hurt less the second day, and eventually went away. Patient stated she didn't go to her doctor because she kept thinking her joint pain would be gone soon, and it hasn't and took ginger (clarified as Nature's Way Brand Ginger Root 1.1g capsule), and turmeric (clarified as Solgar Curcumin) for her joint pain. Outcome of the event joint pain was not recovered and rest all events was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Asthma (Verbatim: Asthma); Gluten intolerance (Verbatim: Gluten intolerance); Hypoglycemia (Verbatim: Hypoglycemia); Inverted T waves (Verbatim: Inverted T waves); Surgery (Verbatim: Interstim Implant for Bladder)

ID: 1812189
Sex: M
Age:
State: IN

Vax Date: 05/03/2021
Onset Date: 05/03/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pain in his body/body aches; little bit of headache; tired; Fever; was not feeling well; coughing; sneezing; This is a spontaneous report from a contactable consumer (patient's mother) via medical information team. A 33-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0173, expiry date: unknown), via an unspecified route of administration, administered in left arm on 03May2021 at 10:30 (at the age of 33 years) as dose 1, single for covid-19 immunization in hospital. The patient medical history included ongoing deafness from an unknown date. Reporter confirmed her son was deaf and he could not explain his symptoms before treatment with the Pfizer COVID 19 vaccine when he was younger, he had an issue with his airways and one of the infections affected his hearing when he was may be 3 or 4. Concomitant medications included daytime Cold medicine (unspecified name) (lot number: 9LT3314 and expiry date: May2021) taken for an unspecified indication, on an unspecified date at 08.00 and stop date were not reported, so now she was giving ibuprofen. The patient did not receive any prior vaccine within 4 weeks. On 03May2021, the patient experienced fever and did not feel good. On 04May2021, the patient experienced pain in his body, little bit of headache and tired. On an unspecified date in 2021, the patient experienced coughing and sneezing. The reporter reported that her son got the Pfizer Covid 19 vaccine on Monday, since yesterday he had a fever and did not feel good. He took cough medication because he did not feel well. The reporter asked if it was normal that he still had a fever and how long would be it lasted. The patient ran a fever maybe 11 or 12 at night the first day, and he still has a fever today and has pain in his body and a little bit of a headache. Caller clarified the product her son took was Daytime Cold and Flu Multi Symptom. The patient was no not doing worse. He also had a temperature now but not worse. The body aches started on 04May2021 and he was tired and it was same as yesterday. He just woke up, and he could not explain it was very well. States might be the headache was also because of the fever, but it was a little better than yesterday. The patient took a pill for the coughing and sneezing, and she told him not to because Tylenol or Ibuprofen was only recommended. Events did not resulted in visit to emergency room or physician office. Patient was planning to get the second dose on 24May2021. Therapeutic measures were taken as a result of fever, pain in his body, little bit of headache, coughing, and sneezing. The outcome of events fever, pain in his body/body aches and tired were not recovered. The outcome event little bit of headache was recovering. The outcome of events sneezing, was not feeling well and coughing were unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Deaf (issue with his airways and one of the infections affected his hearing when he was may be 3 or 4)

ID: 1812190
Sex: F
Age:
State: FL

Vax Date: 01/26/2021
Onset Date: 01/26/2021
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: Test Date: 202102; Test Name: Blood work; Result Unstructured Data: Test Result:PERFECT

Allergies:

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

Symptoms: Headache; The underarm lymph thing lasted about 2 months, maybe a little bit longer of under arm pain.; About 2 weeks later caller started itching from the same area, the waist up, arms, feet, back, stomach and head; This morphed into an underarm lymph thing; body started to burn; not feeling well; Right arm elbow started bothering/sore arm; fatigue; low grade fever; chills; This is a spontaneous report from a contactable consumer (Patient). A 65-years-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL9262), via an unspecified route of administration, administered in Arm Right on 26Jan2021 11:00 (at the age of 65 years old) as, Single dose for covid-19 immunisation. The patient medical history and concomitant medications were not re-ported. Historical vaccine patient previously received (bnt162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EH9899) for covid-19 immunisation, prior vaccinations In 2013 caller took the live shingles vaccine, the one that was only one dose and broke out in shingles. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Jan2021, the patient experienced fatigue, low grade fever, right arm elbow started bothering/sore arm, chills. not feel-ing well on 04Feb2021. this morphed into an underarm lymph thing on 27Mar2021, body started to burn on 17Mar2021, about 2 weeks later caller started itching from the same area, the waist up, arms, feet, back, stomach and head on 31Mar2021. On an unspecified date headache, the under-arm lymph thing lasted about 2 months, maybe a little bit longer of under arm pain. Patients first reaction immediately after the second dose Pfizer Covid Vaccine was fever, chills and sore arm. Caller states the second dose was given on either 26Jan2021 or 25Jan2021 and patient had the re-action start 12 hours later and lasted for 12 hours then stopped. Caller clarifies it began the same day as the second dose Pfizer Covid Vaccine. She recovered with lasting effects. Not feeling well and headache began on 04Feb2021 or 05Feb2021 because recalls and calling her doctor to go back in on 08Feb2021. He headache went away. Not feeling well lasted from 05Feb2021 until a week ago. Caller did not remember when her headache went away. The headache happened off and on and she did not have the headache anymore, caller did have it, too many other serious symptoms, headache was least of caller's problems. she recovered completely from headache. Caller would say this began 27Jan2021 and is insignificant now, she was not 100% but it is insignificant. Stated that it has improved. morphed into under arm lymph thing: This began the day the elbow started, clarifies it was a week after, probably the first week of March. This went away pretty much, in significant now. stated recovered completely. this went away a week ago, hopes she recovered completely, doesn't know. Caller states its been a week and she can speak in full sentences now. About two weeks after the burning started, started to itch: states if you take 17Mar2021 and add 14 days to that, about 2 weeks ago. She was getting calendar to look. the burning started before the itching. States this began maybe 31Mar2021 and it seems to be gone, one can only hope. She thinks so, hopes completely gone, but would say recovered completely unless caller has to call Pfizer back. she went to the doctor who did blood work, then the Rheumatologist, immunologist, allergist, cardiologist and oncologist. Everything on blood work was perfect, was fine. And also went to the gastroenterologist because caller was still fatigued and it was interfering with the caller's daily life. spent two and a half months in pajamas in bed. The patient underwent lab tests and procedures which included blood test result was perfect on Feb2021. The outcome of fatigue, low grade fever, right arm elbow started bothering/sore arm, chills was recovered with sequelae, not feeling well with outcome of not recovered, this morphed into an underarm lymph thing, body started to burn, about 2 weeks later caller started itching from the same area, the waist up, arms, feet, back, stomach and head, headache was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812191
Sex: M
Age:
State: NV

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

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

Lab Data:

Allergies:

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

Symptoms: Coughing; feel congested; got sick with flu; fever; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable male consumer (Patient) of an unspecified age reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced coughing and feel congested, got sick with flu, fever. Patient and his wife will be having their second dose. They got sick with flu, fever and congestion on Tuesday of last week. Patient wanted to know if it was okay to take the vaccine on Wednesday. Clinical outcome of the events was reported as unknown for all the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1812192
Sex: F
Age:
State: NY

Vax Date: 04/19/2021
Onset Date: 04/20/2021
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: vomiting; diarrhea; chills; body aches; unable to eat; feel sick; not feeling well; She was so cold and turned heat up; Wobbly and legs weak; Back, hip and breast hurt; Back, hip and breast hurt; hoarseness and congestion; Feels like ice water running through shoulder and arms; having loose bowels; pains in stomach; fever; Nauseated; This is a spontaneous report from a contactable consumer. This consumer a 89-year-old female patient reported for herself that: A 89 years old female (turning 90 in July), received the first dose of BNT162B2 (Pfizer BioNTech Covid 19 vaccine, formulation: solution for injection, Batch/Lot number: EW0150, Expiry Date of Pfizer COVID vaccine: 01Jul2021) via intramuscular route of administration in right arm on 19 Apr 2021 dose 1, single (age at vaccination 89 years old) for covid-19 immunization. Patient's medical history including but not limited to these conditions diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Allergies to artificial sweeteners, thyroid, breast cancer, macular degeneration,operation. The patient's concomitant medication included levothyroxine for her thyroid, bevacizumab (AVASTIN [BEVACIZUMAB]) taken for macular degeneration, and had two bouts of cancer and patient refused estrogen blockers, chemo and radiation. The patient had not adverse event prior vaccinations. The patient had not received any vaccinations within 4 weeks. On 21Apr2021 patient experienced loose bowels, feels like ice water running through shoulder and arms, fever, stomach pains, affected voice and has hoarseness and congestion and On 23Apr2021 Back, hip and breast hurt. Patient experienced chills, Wobbly and legs weak, diarrhoea, vomiting, not feeling, unable to eat, body aches, She was so cold and turned heat up on unknown date, Nausea on 20Apr2021. Today is the first day that she's had an appetite. She had been having loose bowels, nausea and diarrhoea for 14 days. Patient was allergic to sucrose and all articficial sweeteners. Patient had a bad effect and was still having it. First shot was about 19 Apr 2021. She did not realize there was an artificial sweetener in it. She was allergic to them. She had a lot of loose bowels and stomach pains from that. She was very allergic to artificial sweeteners. She had a bad autoimmune response. Patient stated affected her voice and she had congestion. Sometimes her voice cuts out. On Tuesday after getting it, patient was not feeling well, but she had a previously scheduled doctor visit and she decided to keep her appointment. On the next day, Wednesday, she felt there was ice water running through shoulder and arms. Patient also had a fever. Patient was so cold and turned heat up and was scared her cat would suffocate. Patient felt wobbly and nauseated. Patient still had Nausea and diarrhoea. Patient had stomach pains. Patient had not been able to eat much. Patient did not have a fever when she went to doctor on 20 Apr 2021. It started 21 Apr 2021 and broke about 3 days later in the middle of the night. Starting yesterday, patient had been able to eat without having stomach pains and feeling nauseous. Patient feels stronger. Patient had weakness in legs and was wobbly. Patient had been walking to make it stronger. It had improved. Patient feels stronger every day. Her back hurt, hip hurt and every place she had an operation on in the past hurt. She gets a shot in eye for macular degeneration. The doctor came out and checked and said nothing in the vaccine that would conflict with that condition. She had a list that she gave to him. It is used for cancer but they use it in your eye for macular degeneration. She said it was Avastin. It is a different name too, but there is another big name that she cannot remember. She has not had a shot recently and she cancelled her appointment because of the vaccine. It has been 2 months since last shot. She did not want to have too much stuff in her system and does not take drugs or over the counter things. The outcome of weakness in legs and was wobbly recovered while other were unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: LEVOTHYROXINE SODIUM; AVASTIN [BEVACIZUMAB]

Current Illness:

ID: 1812193
Sex: F
Age:
State: SD

Vax Date: 04/19/2021
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: Test Date: 20210419; Test Name: Body temperature; Result Unstructured Data: Test Result:101; Comments: 101 fever

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Severe headache; 101 Fever; Chills; Sweats; Vomiting; Joint aches; Fatigue; Brain fog; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 19Apr2021 at 08:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos thyroidism and metabolic syndrome. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN) and progesterone (MANUFACTURER UNKNOWN), all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 08:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation and received codeine (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. On 19Apr2021 at 20:00, the patient experienced severe headache, 101 fever, chills, sweats, vomiting, joint aches, fatigue, brain fog and confusion. On the same day, the patient underwent body temperature test and the result was 101 (units unspecified). 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 severe headache, 101 fever, chills, sweats, vomiting, joint aches, fatigue, brain fog and confusion was resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: METFORMIN; LEVOTHYROXINE; LIOTHYRONINE; PROGESTERONE.

Current Illness:

ID: 1812194
Sex: F
Age:
State: CA

Vax Date: 04/29/2021
Onset Date: 04/30/2021
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:

Allergies:

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

Symptoms: huge red area around the place the shot was given/She has a red mark around the area she got the shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-year-old female patient received first dose bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8732, Expiration date: Unknown) via an unspecified route of administration, administered in arm left on 29Apr2021 at 08:55 (age at vaccination 23 years) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 was administered was reported as clinic. Vaccination administered at military facility was reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect or patient age at first and subsequent immunizations if dates of birth or immunizations are not available was reported as none. Additional vaccines administered on same date of the pfizer suspect was reported as none. The patient 's medical history and concomitant medications were not reported. Prior vaccinations within 4 weeks was reported as no. Adverse events following prior vaccinations was none. Patient's medical history including any illness at time of vaccination was none. Family medical history relevant to adverse events was none. On 30Apr2021, patient experienced huge red area around the place the shot was given/She has a red mark around the area she got the shot. Caller would like to know whether she should be concerned about her side effect or if she should see a doctor. She was asking the risks of the Pfizer-BioNTech Covid-19 Vaccine and what should she do about side effects. She reported on the Covid 19 vaccine and who explained she just got the 1st dose recently and experienced a huge red area around the place the shot was given. It was given on 29Apr2021 hasn't gotten better and she was calling to see if she should go to urgent care for this. She explained the red area was noticed the next day and it was about the same since it was noticed, not better or worse. Seriousness of the event was non serious. Investigation Assessment was reported as no. Relevant tests was reported as no. Adverse events did not result in Emergency room or physician office visit. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812195
Sex: F
Age:
State: CA

Vax Date: 05/03/2021
Onset Date: 05/05/2021
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: uncomfortable; my eye was hard to open; my eye is completely blood shot, watery and just doesn't feel right.; my eye is completely blood shot, watery and just doesn't feel right.; my eye is completely blood shot, watery and just doesn't feel right.; Her right eye looks a little glossy and red; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0167 and expiration date was not reported), via an unspecified route of administration in left arm on 03May2021 at 13:00 (Age at vaccination was 49 years) as dose 2, single for covid-19 immunisation. Medical history included ongoing blood cholesterol is high from unspecified date to ongoing. The patient did not have adverse events prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol, start and stop date were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0164), via an unspecified route of administration, administered in left arm, on 13Apr2021 at 13:00 (Age at vaccination was 49 years) as dose 1, single for COVID-19 immunization. On 05May2021 around 02:30 AM the patient woke up in the middle of the night and eye was hard to open/ couldn't open right eye/eye may be hard to open because eyes were shut has she was asleep, eye completely blood shot, watery/right eye was watery and just doesn't feel right. Patient right eye looks little glossy and red. It was uncomfortable. Patient asked if this is side effect of vaccine. The patient did not perform any relevant test. Patient didn't visit emergency room and physician office. The clinical outcome of eye disorder and malaise was unknown while other was not recovered. Response: Spoke from EUA Fact Sheet for Healthcare Providers: LAB-1457-7.0 Revised: 06Apr2021: 6.2 Post Authorization Experience. Spoke from attached VR Consumer Document: A review of the Prescribing Information for Pfizer BioNTech covid 19 Vaccine did not find information regarding blood shot eye that is hard to open and watery. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer BioNTech Covid 19 Vaccine). Because your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider is in the best position to advise you about the appropriate action to take. No follow-up attempts are needed. No further information is expected.

Other Meds: LIPITOR [ATORVASTATIN]

Current Illness: Cholesterol high

ID: 1812196
Sex: U
Age:
State: MD

Vax Date: 02/27/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: My face is flushed/ I look red; My face is flushed, reddish colored and feel warm; my arms are kind of flushed looking; blotchy; my face feel very warm; My face is flushed, reddish colored and feel warm; my arms are kind of flushed looking; blotchy; my face feel very warm; I look red; I notice some redness on my arms; It's very uncomfortable; my face was getting flush; This is a spontaneous report from a contactable consumer (patient). A 58-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 27Feb2021 (at the age of 58 years old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included ongoing type 1 diabetes, ongoing heart disease and bypass surgery. Concomitant medication(s) included insulin (mealtime insulin shot) 3 times a day and dose varies from 5 units to 8 units (since 7 years), metoprolol tablet once a day, ongoing and atorvastatin calcium tablet at a dose of 80 mg, once a day orally, all three taken for an unspecified indication; acetylsalicylic acid (ASPIRIN) 81 mg, once a day, orally taken for cardiac disorder, start and stop dates were not reported. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient stated, they received both the Pfizer Vaccine shot. Got the 2nd one on 27Feb2021. Havent had any problems, about 2 weeks ago, its been a while (on an unspecified date in Apr2021) patient started feeling like at the end of the day the face would look flushed, red and feel warm but it would fade away as the night passes and now over last 2 days it came back and its kind of same repeating, their face feels very warm, they look red and notice some redness on the arms too now. Patient gets it once in a while now, had it for about two days straight and it seems to be more intense, the face looks like they actually out in the sun and the arms are starting kind of like reddish. Patient does not know if that is normal or if that happens or could be possible because of the vaccination. Patient states dont know if this is related, they are just trying to figure out before going to the hospital. Thought that was kind of a long time to get a reaction. Patient's face is flushed, reddish colored and feel warm. They also have some, it looks like their arms are kind of flushed looking too like red, and its kind of blotchy (unspecified date in Apr2021). When the concern was paraphrased, patient stated it got much worse. Got the vaccine in left arm both times. No treatment in response to event. Patient stated, no, they thought of trying to find if this was something possibly related to this or not and to see if they can go to doctor because its very uncomfortable right now (unspecified date in Apr2021). Its been so long since patient got the shot so its the last one thing they thought was, it take this long, and the reaction but they thought they should find out. No therapeutic measures were taken for any of the events. The clinical outcome of all the events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: INSULIN; METOPROLOL; ASPIRIN; ATORVASTATIN CALCIUM

Current Illness: Heart disease, unspecified (Verbatim: Heart disease); Type 1 diabetes mellitus (Verbatim: Type 1 diabetes)

ID: 1812197
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: Achy; Unable to stand up; Nausea; Can't hold food down; Cold; Throwing up/Vomiting; Headache; Muscle pain; Joint pain; Slight fever; Chills; Unable to sleep; Very weak; Feeling unwell; This is a spontaneous report from a contactable consumer. This consumer reported for a 69-year-old female patient. A 69-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch number: Not reported/Lot Number: EW0170, expiration date: Unknown), via an unspecified route of administration, administered in left arm on 01May2021 (Age at the vaccination 69 years), as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8737), via an unspecified route of administration, administered in left arm on 10Apr2021 (age at the vaccination 69 years), as DOSE 1, SINGLE for COVID-19 immunization and she had no side effects. On 02May2021 the patient experienced headache, muscle pain, joint pain, throwing up/vomiting, cold. On an unspecified date in May2021, the patient experienced chills, slight fever, feeling unwell, achy, unable to stand up, unable to sleep, very weak. On 04May2021 the patient experienced nausea, can't hold food down. The reporter was calling on behalf of his mother and stated that his mother had her second dose of the COVID vaccine on 01May2021. That same day, she had no symptoms. The day after she started coming down with a cold. Until now she had been getting worse. Yesterday she started vomiting. She can't hold food down. She had a headache, muscle pain, joint pain, and nausea. She was feeling unwell. She was vomiting. It was reported that the vomiting started yesterday noting that she cannot hold down any food or liquids. It was reported that she was very weak adding that right now she did not have a fever. Reporter started that 45 minute to one hour ago she vomited when she tried to have a piece of bread and some water. She was able to walk by herself today and not as achy today. Reporter stated his concern was being able to sleep and hold food down without vomiting. Reporter stated that his friends experienced the same thing, and it only lasted a day or two. She needed guidance on what to do next. She did not have a prescribing doctor. She got the vaccine at the local pharmacy. She got her first vaccine on 10Apr2021. She had no side effects after the first one. First lot: ER8737. She got both shots in her left arm. The outcome of the events headache, muscle pain, joint pain, nausea, throwing up/vomiting, cold, can't hold food down was not resolved. The outcome of the events chills, slight fever, feeling unwell, achy, unable to stand up, unable to sleep and very weak was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812198
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: rash after each dose of the vaccine; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, NDC number/ Expiry Date: Not Provided), via an unspecified route of administration on an unspecified date as DOSE1, SINGLE for covid-19 immunization. The patient medical history included shingles (Shingles at a younger age) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient developed rash a day after each dose of the vaccine. It was reported that, the patient stated she developed rash a day after each doses of the Pfizer-BioNTech COVID-19 vaccine. She mentioned the day before getting the first vaccine, a medication she took and to which she had not reacted in the past was increased. She said 2 weeks after vaccination the rash was persisting, thus her doctor recommended her to stop the medication that was increased to see what would happen following the second dose of the vaccine. She specified the rash persisted and worsened after the second dose. She said it was been 4 weeks and the rash not going away. She described it as a crazy itchy rash travelling on her body, that was all over the place. She said it felt like a deep sort of pain and compared it to her previous experience of Shingles. She added she has a history of Shingles at a younger age. She specified both a cardiologist and dermatologist were consulted for her symptom. She specified she may start a medication for Shingles today depending on her HCP's guidance. The outcome for the event was unknown.

Other Meds:

Current Illness:

ID: 1812199
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: redness on the injection site/ Redness and swelling is going down her arm; arm was a little sore; arm was swollen/ Redness and swelling is going down her arm; fever; This is a spontaneous report from a Pfizer Sponsored Program. A 79-year-old contactable female consumer(patient) reported for herself that: A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737, expiry date: 31Jul2021), via an unspecified route of administration, administered in arm left on 30Apr2021 11:00 (at the age of 79-years) as dose 2, single for covid-19 immunization. The patient relevant medical history includes thyroid removed (Removed 13 years ago due to cancer). Family Medical History her son was diabetic Relevant includes: Caller mentions that her was son was allergic to Cipro and Levaquin but the patient did not know if that was the same medical background. He passed away last year right at the beginning of COVID. Caller adds her son was diabetic. The patient concomitant medications include levoxyl (Start: 2008 Stop: Ongoing). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (at the age of 79-years), dose 1, on an unspecified date for covid-19 immunization. The patient received 2nd vaccine last Friday, 30Apr2021 at 11.00 am and on 01May2021 had redness on the injection site and was now starting to run a fever, arm was a little sore, arm was swollen/ Redness and swelling is going down her arm. today the patient had noticed the redness had travelled down her arm and was just wondering if that was something that was normal ? The patient was given paperwork on the vaccine that said the patient had different things that was possible. With the first shot, the patient did not had any anything/ any problems at all, but the second shot was a little bit different. The patient confirms her arm was not as sore today but the redness was continuing to go down her arm. She clarifies further the swelling was basically Saturday, which the nurse had said there was a possibility the patient would had swelling and soreness. So, her arm was swollen and sore on Saturday and then Saturday night, it started with the redness, and then yesterday the redness started going down her arm and it was not swollen or sore in the muscle now, but the patient was just concerned with the redness. Does the redness go away or if it was something the patient needed to follow-up on. The redness was a little bit more than what it was since it first began since it was further down her arm. As far as the soreness goes, her arm was not that sore, but the swelling and redness was going down her arm. Patient was kind of coerced into doing it by 2 friends who was both fighting cancer. The caller drives these friends to their appointment for chemo, and the nurses there thought it was a good idea the patient did get the vaccine, so the patient did not transfer anything to their cancer patients. The patient agreed that she did not want to give anybody any more to battle (health wise). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not visit the emergency Room and physician Office. The patient did not had any relevant tests. Patient not received treatment for events. The outcome of event injection site erythema and peripheral swelling was not recovered, pain in extremity was recovering and pyrexia was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: LEVOXYL

Current Illness:

ID: 1812200
Sex: F
Age:
State: IL

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

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

Lab Data:

Allergies:

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

Symptoms: Headache; This is a spontaneous report from a contactable physician. An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient also received upadacitinib (RINVOQ, Batch/Lot number was not reported), oral from an unspecified date to an unspecified date for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. It was reported that solicited report by a consumer of an adult female with an event of non-serious headaches after covid vaccine with RINVOQ (Upadacitinib). On an unknown date, the patient experienced headaches after covid vaccine. COVID-19 VACCINE was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer. Causality for RINVOQ(Upadacitinib). The reporters causality for the event of headaches after covid vaccine with RINVOQ(Upadacitinib) was no reasonable possibility. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: RINVOQ

Current Illness:

ID: 1812201
Sex: F
Age:
State: MI

Vax Date: 04/27/2021
Onset Date: 04/27/2021
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: getting a tickle down at the bottom of our throat to our chest; coughing our heads off; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0172) via an unspecified route of administration in arm right on 27Apr2021 14:00 (age at time of vaccination 66-year-old), as single dose for COVID-19 immunization. Medical history included diabetic. The patient's concomitant medications were not reported. The patient historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0150) via an unspecified route of administration in right shoulder on 06Apr2021 (age at time of vaccination 66-year-old), as single dose for COVID-19 immunization. On 27Apr2021 at 15:00, the patient experienced getting a tickle down at the bottom of our throat to chest and coughing our heads off. The seriousness of the events was unspecified. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021515082 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1812202
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: unpredictable hives ( burn skin reaction for whole body) almost every day, any time; Whole body has burning feelings, usually started with ears , hands and few minutes became everywhere; Whole body has burning feelings, usually started with ears , hands and few minutes became everywhere included the face; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that side effects (already after 1st vaccination, the patient did already 2). The patient was started to have unpredictable hives (burn skin reaction for whole body) almost every day, any time (can be nights, mornings, inside outside), which was not related to patient's food, or any make up (reaction can be after 16 hours, the patient did not eat anything). Whole body has burning feelings, usually started with ears, hands and few minutes became everywhere included the face. Never ever had anything like that before and would like to report it. After taking Benedryl sides effects gone (usually for 1 hour). Sometimes can be very very burning reaction, sometimes can be better only light burning. Thank you for any help and advice. The outcome of the events was unknown. Information about batch no/lot no has been requested. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1812203
Sex: M
Age:
State: GA

Vax Date: 05/01/2021
Onset Date: 05/02/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210502; Test Name: Body temperature; Result Unstructured Data: Test Result: Fever; Test Date: 20210503; Test Name: he tested negative for Covid-19; Result Unstructured Data: Test Result: Negative.

Allergies:

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

Symptoms: severe joint aches; muscle spasms; severe diarrhea; severe pain in his knees; pain in his shoulders; cold; chills; fever; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority Support from a contactable consumer or other non HCP (patient) via medical information team. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on 01May2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on 08Apr2021 with no problems. The patient's medical history and concomitant medications were not reported. On 02May2021 the patient reports severe joint aches and muscle spasms and severe diarrhea. He says that he bent down at work and was in severe pain in his knees, and they didn't even want to push me back up and that he can be sitting, watching TV and if he moves, he can hear his knee joints grinding. He also reports pain in his shoulders. Patient experienced cold, chills and fever. He's been seen by his HCP and tested negative for Covid infection. The doctor told him that it will go away in 72 hours. He also asked the pharmacist at local store, and he was told that other people had cramps. He called in to know if it is normal and when it will go away or if other people experience the same. First dose of the vaccine was given 08Apr2021. He also mentioned that after the first dose he felt that he did not have the shot. The patient underwent lab tests and procedures which included body temperature results into fever on 02May2021, sars-cov-2 test results as negative on 03May2021. The outcome for the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812204
Sex: M
Age:
State:

Vax Date: 04/05/2021
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: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result: abnormal; Comments: abnormal.

Allergies:

Symptom List: Nausea

Symptoms: Steatorrhea / oily stools; Defecation frequency increased / defecate three times a day; Fatigue; Stomach discomfort; Blood test abnormal / unspecified blood works showed that signs or indicators of past exposure to tuberculosis/but did not mean that had active or positive tuberculosis; This is a Spontaneous report based on the information received by Pfizer from Regulatory Authority, (Manufacturer Control No: 21K-163-3878931-00) from a non-contactable consumer (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6205, and Expiration date: Unknown), intramuscular on 05Apr2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization. The patient received co-suspect adalimumab (HUMIRA), subcutaneous from 2014 (Batch/Lot number was not reported) and ongoing, at 40 mg, 1 in 2 week for psoriatic arthritis. The patient medical history included stiffness, fingers were puffy, joints were sensitive/could not put hand inside pocket, soreness, non-smoker, abstains from alcohol, penicillin allergy manifested by swelled up, cardiac disorder, diabetes, bipolar, high blood pressure, psoriatic arthritis, worsened achiness on the whole body (occurred in 2014, recovered in 2014. Again, occurred in 2014), unspecified blood works showed that signs or indicators of past exposure to tuberculosis (but did not mean that had active or positive tuberculosis). Concomitant medication included methotrexate (METHOTREXATE) taken for psoriatic arthropathy, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for cardiac disorder, atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) taken for cardiac disorder, ticagrelor (BRILINTA) taken for cardiac disorder, clopidogrel bisulfate (PLAVIX) taken for cardiac disorder, isosorbide mononitrate (ISOSORBIDE MONONITRATE) taken for cardiac disorder, nitroglycerin (NITROGLYCERIN) taken for cardiac disorder, cyanocobalamin (VITAMINE B12) taken for supplementation therapy, folic acid (FOLIC ACID) taken for an unspecified indication, insulin lispro (HUMALOG) taken for diabetes mellitus, lamotrigine (LAMICTAL) taken for an unspecified indication, insulin glargine (LANTUS) taken for diabetes mellitus, lithium (LITHIUM) taken for bipolar disorder, losartan (LOSARTAN) taken for hypertension, metoprolol (METOPROLOL) taken for hypertension, ranolazine (RANEXA) taken for cardiac disorder, trazodone (TRAZODONE) taken for an unspecified indication, and colecalciferol (VITAMINE D) taken for supplementation therapy. The patient previously took oxycodone and experienced hypersensitivity (oxycodone manifested by allergy stroke). On 09Apr2021, the patient experienced fatigue and stomach discomfort. On 18Apr2021, the patient experienced "steatorrhea / oily stools" and "defecation frequency increased / defecate three times a day". On an unspecified date in 2021, the blood test abnormal / unspecified blood works showed that signs or indicators of past exposure to tuberculosis/but did not mean that had active or positive tuberculosis. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient was treated with ZOFRAN and ZANTAC. The events were reported as non-serious. The outcome of events fatigue and stomach discomfort was reported as resolving. The outcome of events "steatorrhea / oily stools" and "defecation frequency increased / defecate three times a day" was reported as not resolved. The outcome of event blood test abnormal was unknown. The reporter's causality for the events of fatigue, stomach discomfort, oily stools and defecate three times a day with HUMIRA 40mg/0.8ml(adalimumab) was no reasonable possibility. The reporter's causality for the events of worsened achiness on the whole body onset in 2014 and worsened achiness on the whole body onset in 2014 with HUMIRA 40mg/0.8ml(adalimumab) was a reasonable possibility. The reporter's causality for the events of unspecified blood works showed that signs or indicators of past exposure to tuberculosis/but did not mean that had active or positive tuberculosis was not provided. No follow-up attempts are possible. No further information is expected.

Other Meds: Methotrexate; Aspirin [Acetylsalicylic Acid]; Lipitor [Atorvastatin Calcium]; Brilinta; Plavix; Isosorbide Mononitrate; Nitroglycerin; Vitamin B12; Folic Acid; Humalog; Lamictal; Lantus; Lithium; Losartan; Metoprolol; Ranexa; Trazodone; Vit

Current Illness: Psoriatic arthritis

ID: 1812205
Sex: F
Age:
State: NH

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Joint and muscles aches/Joint and muscle pain lasting over a week/progressivenly worsening/Pain worsened; Joint and muscles aches/Joint and muscle pain lasting over a week/progressivenly worsening/Pain worsened; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EW0176) via an unspecified route of administration, administered in left arm on 28Apr2021 12:15 (age at vaccination 33 years) as dose number unknown, single for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD). The patient had no known allergy. The patient was not pregnant at the time of vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). Patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient experienced joint and muscles aches/joint and muscle pain lasting over a week/progressively worsening/pain worsened over the course of a week and seems to get worse daily on 28Apr2021 13:00. This was still occurring 7 days after receiving vaccine. The patient was not taking any treatment for events. Outcome of events was not resolved. No follow-up attempts are needed. No further information is expected.

Other Meds: ADDERALL

Current Illness:

ID: 1812206
Sex: M
Age:
State:

Vax Date: 04/26/2021
Onset Date: 04/26/2021
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: LA

Lab Data: Test Name: unspecified blood works; Result Unstructured Data: Test Result:signs or indicators of past exposure to tuberculos; Comments: but did not mean that had active or positive tuberculosis; Test Name: Blood test; Result Unstructured Data: Test Result:unknown results

Allergies:

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

Symptoms: Pain on right side of stomach; This is a spontaneous report from a non-contactable consumer (patient) received by Pfizer from AbbVie Pharmacovigilance, (Manufacturer Control No: 21K-163-3878931-00). A 64-year-old male patient (reported as 57-year-old male) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER8734, expiration date was not reported), via intramuscular on 26Apr2021 as dose 2, single for covid-19 immunization. The patient also received adalimumab (HUMIRA, Solution for injection in pre-filledpen, Batch/Lot number was not reported, expiration date was not reported, 40 mg/0.8ml,1 in 2 wk) via subcutaneous from 2014 and ongoing for psoriatic arthritis. The patient medical history included stiffness, fingers Were Puffy, joints were sensitive/could not put hand inside pocket, soreness, non-smoker, abstains from alcohol, penicillin allergy manifestate by swelled up, jumped around, worsened achiness (In 2014, the patient experienced worsened achiness on the whole body and worsened achiness on the whole body.In 2014, the worsened achiness on the whole body resolved), heart. Concomitant medications included methotrexate taken for psoriatic arthritis, acetylsalicylic acid (ASPIRIN (E.C.)) taken for heart, atorvastatin calcium (LIPITOR ORIFARM) taken for heart, ticagrelor (BRILINTA) taken for heart, clopidogrel bisulfate (PLAVIX) taken for heart, isosorbide mononitrate taken for heart, nitroglycerin taken for heart, cyanocobalamin (VITAMINE B12) taken for supplement, folic acid taken for an unspecified indication, insulin lispro (HUMALOG) taken for diabetes, lamotrigine (LAMICTAL) taken for an unspecified indication, insulin glargine (LANTUS) taken for diabetes, lithium taken for bipolar, losartan taken for high blood pressure, metoprolol taken for high blood pressure, ranolazine (RANEXA) taken for heart, trazodone taken for an unspecified indication, colecalciferol (VITAMINE D) taken for supplement. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6205, expiration date was not reported), via intramuscular on 05Apr2021 as dose 1, single for covid-19 immunization and experienced fatigue, stomach discomfort on 09Apr2021 and steatorrhea, defecation frequency increased on 18Apr2021. The patient previously took oxycodone, experienced allergy stroke and took penicillin for unknown indication. It was reported that on 26Apr2021 the patient experienced pain on right side of stomach. Covid-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient underwent lab tests and procedures which included unspecified blood works (blood test): signs or indicators of past exposure to tuberculos (but did not mean that had active or positive tuberculosis) on an unspecified date, blood test abnormal: unknown results on an unspecified date. The patient was treated with ZOFRAN and ZANTAC. Therapeutic measures were taken as a result of pain on right side of stomach. The reporters causality for the event of pain on right side of stomach with HUMIRA 40mg/0.8ml(adalimumab) was a reasonable possibility. Causality as per reporter (drug/vaccine Humira 40MG/0.8ML) for event pain on right side of stomach was probable. Causality as per reporter (drug/vaccine COVID-19 VACCINE) for event pain on right side of stomach was not reported. The action taken in response to the event for adalimumab was not applicable. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: METHOTREXATE; ASPIRIN (E.C.); LIPITOR ORIFARM; BRILINTA; PLAVIX; ISOSORBIDE MONONITRATE; NITROGLYCERIN; VITAMINE B12; FOLIC ACID; HUMALOG; LAMICTAL; LANTUS; LITHIUM; LOSARTAN; METOPROLOL; RANEXA; TRAZODONE; VITAMINE D

Current Illness: Ache

ID: 1812207
Sex: F
Age:
State:

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

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

Lab Data: Test Name: Hemoglobin; Result Unstructured Data: Test Result:Low; Test Name: Hemoglobin; Result Unstructured Data: Test Result:11.5; Comments: Before shot

Allergies:

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

Symptoms: my arms still red in that spot, feels like a knot; My face is red, nose, chin and cheeks; Arm sore and red and has a knot; arms still red in that spot, feels like a knot; This is a spontaneous report from a contactable consumer or other non hcp. A 52-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 24Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included meniere's disease. This has caused her trouble in her left ear from hearing and was probably diagnosed in 2008 or 2009. Concomitant medication(s) included atenolol (ATENOLOL) taken for blood pressure. On an unspecified date patient reported that her arm was still red and the spot where they gave it to her still has a knot. The patient states that her face has also been red, like her nose and cheek and chin have been red. The arm was sore and red and had a knot. The arm was really sore the first two days but it was like it went away or she did not really see it and then the last few days she sees it a lot. Face was red for about four or five days. The patient adds that her arm was sore, but she saw redness, not quite as bad, not as bad as it was. It is worse now than when she first got the vaccine. The patient's nose, cheek, and chin on both sides were red. Investigations: The patient states she had lab work before she got the shot, because her blood was low. Her haemoglobin was low but it was back up to 11.5 before she got the shot. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No adverse events following prior vaccinations. The events outcome was reported as unknown. No follow-up attempts are needed. No further information is expected. .

Other Meds: ATENOLOL

Current Illness:

ID: 1812208
Sex: M
Age:
State: NV

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: chills; fever; This is a spontaneous report received from a contactable consumer (Patient wife) via Medical Information Team. A male patient of unspecified age had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient had experienced fever and chills. The clinical outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812209
Sex: F
Age:
State: IL

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

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

Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:99; Comments: fever of 99

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: flu like symptoms; fever of 99; chills; nausea; Ache; sick; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on 23Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes patient previously took first dose of bnt162b2 for covid-19 immunization. Reporter is calling about the Pfizer Covid-19 RNA vaccine on behalf of her niece. Reporter stated she is calling for her niece who experienced side effects flu like symptoms fever chills, nausea 10 days after the second dose. she is 19 years old and caller wanted to know if side effects were reported 10 days later. The patient got the second shot on 23Apr2021 at her school. The patient started getting sick after 10 days. The patient had chills, ache, nausea and a fever of 99. The caller was looking online, and it indicates that side effects usually start 1-2 days after the vaccine. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1812210
Sex: M
Age:
State: CA

Vax Date: 05/01/2021
Onset Date: 05/01/2021
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: husband experienced body aches the following day after administration; in the middle of that night her husband started vomiting/Throwing up; the next day he had a fever; diarrhea; had gas that didn't want to expel and put pressure on his stomach, which made him very uncomfortable; her husband has not been eating because every time he eats, he has diarrhea right after; Kind of pinkness in his arm where the shot it was administered; Chills; real sick; Shoulder plexus area, if he takes a deep breath it hurts in that area; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP who reported for her husband. A 61-years-old male received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was ER8729 and expiration date was an unspecified date in Jul2021) via an unspecified route of administration on 01May2021, administered in right arm (age at the time of vaccination was 61-years-old) as a DOSE 1, SINGLE dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 02May2021, the patient experienced husband experienced body aches the following day after administration, in the middle of that night her husband started vomiting/Throwing up, the next day he had a fever, diarrhea, had gas that didn't want to expel and put pressure on his stomach, which made him very uncomfortable, her husband has not been eating because every time he eats, he has diarrhea right after, Kind of pinkness in his arm where the shot it was administered and chills. On an unspecified date in May2021, the patient experienced Shoulder plexus area, if he takes a deep breath it hurts in that area and real sick. The caller called on behalf of her husband, who received the first dose of the Pfizer COVID-19 vaccine on 01May2021, states that her husband experienced body aches the following day after administration. She reports in the middle of that night, her husband started vomiting. She stated that the next day he had a fever, body aches, diarrhea, and had gas that didn't want to expel and put pressure on his stomach, which made him very uncomfortable. She stated that her husband has not been eating because every time he eats, he has diarrhea right after. She stated her husband has described a deep pain in the solar plexus area whenever he takes a deep breath, but that has subsided a little compared to this morning. She stated the body aches have also subsided some. She was asking if these were normal side effects to experience. Additional Information: The reporter stated that she was actually calling on behalf of her husband. She stated, he took his COVID shot on 01May2021, this last Saturday and he started having symptoms on the following day and by that time he was throwing up and he had gas in his stomach that wouldn't come out so it was hurting his stomach, putting lot of pressure to his stomach and today was Wednesday so he was having a symptoms if he eats then he is having a diarrhea right after he eats. When probed if looking for medical assistance, reporter stated she did not know his concern is he was still feeling that bad, he doesn't have insurance so he haven't seen a doctor in a long time. About other medical conditions she stated, were not that well aware like she said he hasn't went to the doctor in a long time but you know. When probed for the other medication she stated he is taking take acetaminophen and Ibuprofen for fever and pain (further clarification unknown).About event details start date, he got the vaccine on Saturday and started experiencing problem from 02May2021 (not clarified for all the events).He was still experiencing, kind of pinkness in his arm where the shot it was administered but his main problem is in his shoulder plexus area, if he takes a deep breath it hurts in that area and he eats he have diarrhea right after he eats. She stated he was not nauseous, he threw up on second night after the shot he was real sick after then and he has some fever and some chills so that has improved, he was not throwing up or not nauseous the main problem now is he is avoiding eating because if he eat, he need to be by toilet. When probed for anything else help, she stated she was just wondering were the symptoms adverse events in the normal range, should he wait to see it go away does he need to see a doctor. No treatment was received for adverse events. The clinical outcome of the next day he had a fever and chills was Recovering, the clinical outcome of diarrhea and her husband has not been eating because every time he eats, he has diarrhea right after, Kind of pinkness in his arm where the shot it was administered, Shoulder plexus area, if he takes a deep breath it hurts in that area and real sick was Not recovered, while the clinical outcome of husband experienced body aches the following day after administration, in the middle of that night her husband started vomiting/Throwing up and had gas that didn't want to expel and put pressure on his stomach, which made him very uncomfortable was unknown. Information on Lot/Batch number was available. No further information is expected.

Other Meds:

Current Illness:

ID: 1812211
Sex: F
Age:
State: CA

Vax Date: 04/22/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210430; Test Name: SARS CoV-2 test; Test Result: Negative ; Comments: Nasal swab test

Allergies:

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

Symptoms: Fatigue; Chills; Severe diarrhea: needed to use bathroom every hour or two, including throughout the nights; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female 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 22Apr2021 at 12:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included oxitriptan (5-HTP) 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 an unknown date in Apr2021, the patient experienced fatigue, chills and severe diarrhea which needed to use bathroom every hour or two, including throughout the nights. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event diarrhea and included treatment with loperamide hydrochloride (IMMODIUM). Since the vaccination, the patient had been tested for COVID-19. On 30Apr2021, the patient underwent nasal swab test, SARS CoV-2 test and the result was negative. The clinical outcome of the event severe diarrhea: needed to use bathroom every hour or two, including throughout the nights was resolved on an unspecified date in 2021, after a duration of 5 days; while that of the events fatigue and chills were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: OXITRIPTAN

Current Illness:

ID: 1812212
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Severe joint and muscle pain.; Severe joint and muscle pain.; Sore arm were shot was administered; Sore and swollen lymph nodes in the right armpit; Sore and swollen lymph nodes in the right armpit; Low-moderate fever; Chills/shivers; Headache; Lethargy/exhaustion; Lethargy/exhaustion; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 29Apr2021 at 16:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, anxiety / depression, eczema and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amfetamine aspartate / amfetamine sulfate / dexamfetamine saccharate / dexamfetamine sulfate (ADDERALL), intrauterine contraceptive device (MANUFACTURER UNKNOWN) and loratadine (CLARITIN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received bupropion (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. On 30Apr2021 at 06:00, the patient had severe joint and muscle pain, sore arm where shot was administered, sore and swollen lymph nodes in the right armpit, low-moderate fever, chills/shivers, headache, lethargy and exhaustion. 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 severe joint and muscle pain, sore arm where shot was administered, sore and swollen lymph nodes in the right armpit, low-moderate fever, chills/shivers, headache, lethargy and exhaustion was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds: ADDERALL; INTRAUTERINE CONTRACEPTIVE DEVICE; CLARITIN [LORATADINE]

Current Illness:

ID: 1812213
Sex: M
Age:
State:

Vax Date: 05/03/2021
Onset Date: 05/05/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: the needle site was bruised; felt exhausted; This is a spontaneous report received from Pfizer sponsor program reported from a non-contactable consumer (patient). A 27-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 03May2021 (at the age of 27-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on unspecified date (at the age of 27-years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 05May2021, the day after get-ting second shot the patient felt exhausted and noted "the needle site was bruised". He considered these symptoms to be "Very mild". The outcome of the events unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1812214
Sex: F
Age:
State: CA

Vax Date: 04/29/2021
Onset Date: 04/30/2021
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: Extremely sore arm; Body aches; Headache; Tiredness; Fatigue; 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: ER8736) via an unspecified route of administration in the left arm on 29Apr2021 at 16:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines 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: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 02:00, the patient experienced extremely sore arm, body aches, headache, tiredness and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely sore arm, body aches, headache, tiredness and fatigue were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812215
Sex: F
Age:
State:

Vax Date: 03/16/2021
Onset Date: 03/23/2021
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: Approximately one week after vaccine, my existing tinnitus ramped up significantly and has not changed; This is a spontaneous report from a non-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: EN6207) via an unspecified route of administration in the right arm on 16Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos, graves, asthma, allergies, tinnitus and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included azelastine (MANUFACTURER UNKNOWN), fluticasone propionate (FLONASE), fexofenadine hydrochloride (ALLEGRA) and fluticasone propionate (FLOVENT); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received cefuroxime axetil (CEFTIN) 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 23Mar2021, the patient experienced existing tinnitus ramped up significantly and had not changed (was still significantly more tinnitus than had before) and the patient could hear it over most noises now. 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 existing tinnitus ramped up significantly and had not changed was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds: AZELASTINE; FLONASE [FLUTICASONE PROPIONATE]; ALLEGRA; FLOVENT

Current Illness:

ID: 1812216
Sex: F
Age:
State: CA

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: Dizzy/woozy; Heavy head pressure; Headache; High pitched ringing in right ear, off and on; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW969) via an unspecified route of administration in the left arm on 15Apr2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included fish oil (MANUFACTURER UNKNOWN), oenothera biennis oil (PRIMROSE OIL), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 16Apr2021 at 10:00, the patient experienced dizzy, woozy, heavy head pressure, headache, constant high-pitched ringing in right ear (on and off) and extreme fatigue began the day after first vaccine and had continued ever since, the ear ringing had become more constant. 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, dizzy, woozy, heavy head pressure, headache, constant high-pitched ringing in right ear (on and off) and extreme fatigue began the day after first vaccine and had continued ever since, the ear ringing had become more constant were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: FISH OIL; PRIMROSE OIL; CALCIUM; MAGNESIUM; VITAMIN D NOS.

Current Illness:

ID: 1812217
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: swollen lymph nodes under left arm; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 30-year-old male 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 an unknown date and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 28Apr2021(at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced swollen lymph nodes under left arm. 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 event swollen lymph nodes under left arm was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1812218
Sex: M
Age:
State: KY

Vax Date: 04/11/2021
Onset Date: 04/13/2021
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: Joint pain in both knees and both elbows; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 11Apr2021 at 14:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP), cholesterol and known allergies to non-steroidal anti-inflammatory drugs (NSAIDs). 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 COVID vaccine. On 13Apr2021, the patient experienced joint pain in both knees and both elbows. 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 joint pain in both knees and both elbows 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: 1812219
Sex: F
Age:
State: FL

Vax Date: 04/27/2021
Onset Date: 04/27/2021
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: Fever; Headache; Body aches; Pain, swelling, and bruising at injection site.; Pain, swelling, and bruising at injection site.; Pain, swelling, and bruising at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 34-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 right arm on 27Apr2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included degenerative disc disease, gallbladder removed, tonsils, allergies and known allergies to sulfa drugs and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol/levonorgestrel (CAMRESE LO) and montelukast sodium (SINGULAIR); both 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: ER2613) via an unspecified route of administration in the right arm on 06Apr2021 at 15:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Apr2021 at 15:15, the patient experienced pain, swelling, and bruising at injection site. On 28Apr2021, the patient experienced fever, headache and body aches that began the next day and lasted until that night. 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 pain, swelling, and bruising at injection site was resolved on an unknown date in 2021; while that of the events fever, headache and body aches was resolved on 28Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds: CAMRESE LO; SINGULAIR

Current Illness:

ID: 1812220
Sex: F
Age:
State:

Vax Date: 04/28/2021
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: SYR
Vax Site: LA

Lab Data: Test Date: 202104; Test Name: Body temperature; Result Unstructured Data: Test Result:101; Comments: 101 fever

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: On second day woke up with red rash on my face (no where else).; Next morning felt like every bone was broken in entire body; Acheyness started 6 hours after shot; 101 fever for 24 hours; On day 3 of diarrehea, violently threw up for 24 hours (pulled muscle in shoulder and sore ribs); On day 3 of diarrehea, violently threw up for 24 hours; Pulled muscle in shoulder and sore ribs; Pulled muscle in shoulder and sore ribs; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 28Apr2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome (PCOS), allergy to intravenous pyelogram (IVP) dye. 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 vitamin d nos (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); both from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 07Apr2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously received azithromycin (Z-PAK) and codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 28Apr2021 at 17:00, 6 hours after shot the patient experienced acheyness. On 29Apr2021, next morning the patient felt like every bone was broken in entire body. On Apr2021, the patient experienced 101 fever for 24 hours, on day 3 of diarrhea, violently threw up for 24 hours (pulled muscle in shoulder and sore ribs). On 30Apr2021, on second day woke up with red rash on my face (no where else). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 101 (units unspecified) fever for 24 hours was resolved on Apr2021, while that of the event violently threw up for 24 hours was resolved on an unknown date in Apr2021. The clinical outcome of the events achiness started 6 hours after shot, next morning felt like every bone was broken in entire body, on second day woke up with red rash on face and no where else and on day 3 of diarrhea, and pulled muscle in shoulder and sore ribs was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds: VITAMIN D [VITAMIN D NOS]; LEVOTHYROXINE

Current Illness:

ID: 1812221
Sex: F
Age:
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: Nausea; Lightheaded; Dizziness; Fever; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the right arm on 30Apr2021 at 15:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included syncope vasovagal. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. 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: ER8729) via an unspecified route of administration in the right arm on 09Apr2021 at 13:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient previously received metronidazole (FLAGYL) and experienced drug allergy. On 01May2021 at 00:00, the patient experienced nausea, lightheaded, dizziness and fever. 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 nausea, lightheaded, dizziness and fever were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1812222
Sex: F
Age:
State: NV

Vax Date: 04/22/2021
Onset Date: 05/01/2021
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: Day nine after second shot experienced chills; headache; nausea; Puked from 3am-1am every 15-30 min; Around 2 PM "my" arms started vibrating. It was a very strong sensation, "I" put my arms up and rotated in effort to release; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female 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 22Apr2021 at 08:30 (at the age of 49-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. 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. 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 01Apr2021 at 10:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. On 01May2021 at 03:00, day nine after second shot, the patient experienced chills, headache, nausea, puked from 3:00 to 1:00 (as reported) every 15-30 minutes, could only find relief in a hot bathtub, around 14:00 her arms started vibrating. It was a very strong sensation, she put her arms up and rotated in effort to release. 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 chills, headache, nausea, puked, arms started vibrating 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: 1812223
Sex: M
Age:
State: UT

Vax Date: 04/21/2021
Onset Date: 04/28/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210428; Test Name: Pain scale; Result Unstructured Data: Test Result:7/10; Comments: Pain is 7/10

Allergies:

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

Symptoms: Stomach discomfort/ pain; Stomach discomfort/ pain; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient 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 21Apr2021 at 09:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included famotidine (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and fluticasone (MANUFACTURER UNKNOWN); all for unknown indications, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines 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: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 09:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021, about a week after the second dose, the patient experienced stomach discomfort, stomach pain and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 28Apr2021, the patient underwent lab tests and procedures included pain scale and the result was 7/10 (Pain is 7/10). Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events stomach discomfort, stomach pain and diarrhea were not recovered at the time of this report.

Other Meds: FAMOTIDINE; IBUPROFEN; GABAPENTIN; FLUTICASONE

Current Illness:

ID: 1812224
Sex: F
Age:
State:

Vax Date: 04/02/2021
Onset Date: 04/03/2021
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: "I" have been getting consistent headaches that "I" have never experienced before.; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on 02Apr2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. On 03Apr2021, after getting the second dose of the Pfizer vaccine the patient had been getting consistent headaches that she had never experienced before. The adverse event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event consistent headaches was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am