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: 1647570
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: vertigo; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. This female consumer reported receiving her first injection of covid-19 vaccine, manufacturer unknown. She looked at her vaccination card but did not see a manufacturer name but noticed it did have EL8982 on it. The patient experienced vertigo which started about 2-3 days ago on an unspecified date and was continuing. She was scheduled to receive her second dose of the covid-19 vaccine on Friday. She asked was it still OK for her to get the second shot? The patient said, she does not think her vertigo is due to the covid-19 vaccine. The outcome of event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647571
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: third dose of the vaccine; Off-label use; arm pain; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age (Age:91; Unit: Unknown) received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration was not reported), via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated they had a clinic today and gave someone a third dose of the vaccine. He asked if there was any information on this, including any issues that should be looking for. Response received does state the following In a Phase I/II study of COVID-19 mRNA vaccines in adults, different strength doses of COVID-19 mRNA Vaccine BNT162b2 were given. This means that some people in the trials have already received higher doses of a similar vaccine (BNT162b1) than the currently recommended dose. The trial showed that although a stronger dose (100 micrograms) was not harmful, the recipients experienced more local reactions with very painful arms being reported. Participants who received 58 micrograms of COVID-19 mRNA Vaccine in clinical trials did not report an increase in reactogenicity or adverse events. If a person is given more than the recommended dose, they should be monitored and treated for any symptoms as required. They should be reassured that this is not harmful but that they may be more likely to experience pain in their injected arm. The clinical outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647572
Sex: M
Age:
State:

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210209; Test Name: fever; Result Unstructured Data: Test Result:101 Fahrenheit

Allergies:

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

Symptoms: nigh time developed fever 101F; sore arm at injection site; next day feel tired; This is a spontaneous report from a contactable consumer or other non HCP (Patient, self-reporting). A 58-year-old male patient received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL3247 and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021 at 09:30 AM (age at vaccination 58-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccine in four weeks. On 09Feb2021 at 19:00 after vaccination patient experienced by night time developed fever 101F, sore arm at injection site, next day feel tired and fever subsided after taking 400 mg Tylenol. The did not visited the emergency room or physician office visit. The patient did not receive treatment for the adverse events except fever. No COVID prior to vaccination and not tested COVID post vaccination. The patient underwent lab test and procedure which include body temperature: 101F. The outcome of the patients event was recovering at the of report. Follow-up (13May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647573
Sex: U
Age:
State: NY

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210209; Test Name: Body temperature; Result Unstructured Data: Test Result:sharply went up to 101.5 Fahrenheit; Comments: sharply went up to 38.6C (101.5F); Test Date: 202102; Test Name: Body temperature; Result Unstructured Data: Test Result:dropped to 100.8 Fahrenheit; Comments: dropped to 38.2C (100.8F)

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: I got chills; shaking; the temperature sharply went up to 38.6C (101.5F).; but I got terrible headache; didn't sleep; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was unknown if patient had covid prior vaccination and unknown if tested for covid post vaccination. It was reported that after receiving the second dose of vaccine on 09Feb2021, the patient called out of work for a sick day as patient thought he/she was having a reaction to the vaccine shot and stated that 12 hours after the shot he/she got chills and was literally shaking, the temperature sharply went up to 38.6C (101.5F). It was like this the whole night, now it dropped to 38.2C (100.8F), but he/she got terrible headache. Patient did not think he/she will be able to work since he/she practically didn't sleep that day. Patient will stay home, hopefully get some sleep and will call in for the meetings. It was unknown if patient received any treatment for AE. The patient underwent lab tests and procedures which included body temperature which was sharply went up to 101.5 Fahrenheit (38.6 C) on 09Feb2021 and dropped to 100.8 Fahrenheit (38.2C) on Feb2021. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.

Other Meds:

Current Illness:

ID: 1647574
Sex: U
Age:
State: NY

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: have been up all night with a fever; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as UNK, single for COVID-19 immunization. The patient medical history was not reported. The patient previously received the first dose of bnt162b2 (BNT162B2). The patient's concomitant medications were not reported. It was unknown if the patient had any other vaccines in four weeks. It was unknown if the patient had COVID prior to vaccination. It was unknown if COVID was tested post vaccination. On 09Feb2021, the patient experienced have been up all night with a fever (pyrexia). The clinical outcome of the event was unknown. No follow-up attempts are possible. Information on lot/batch number could not be requested. No further information is expected.

Other Meds:

Current Illness:

ID: 1647575
Sex: F
Age:
State: MI

Vax Date: 01/27/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: chills; runny nose; Herpes Simplex 1; Upper respiratory feeling; This is a spontaneous report from a consumer. This 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unknown route of administration on 27Jan2021 at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that her first dose vaccine was given on 27Jan2021 and on an unknown date in 2021, she had chills went into runny nose, Herpes Simplex 1. Upper respiratory feeling. HCP indicated immune response. Put her on antivirals. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647576
Sex: M
Age:
State: TX

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: headache; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9267; Expiration Date: May2021, NDC number was unknown), via an unspecified route of administration, administered in left arm on 09Feb2021 at 11:00 hours as dose 2, single (at the age of 54-years-old) for COVID-19 immunisation. Patient had no medical and family medical history. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262; Expiration Date: May2021 and NDC number was unknown), via an unspecified route of administration, administered in left arm on 21Jan2021 at 13:00 hours as dose 1, single (at the age of 54-years-old) for COVID-19 immunisation. There were no concomitant medications received by the patient. Patient had no prior vaccinations (within 4 weeks). On 10Feb2021, when patient woke up, he experienced headache and wants to take Tylenol and asked if he can take pain killer. Patient stated that it is little better now. Patient had no physician or emergency room visit and no relevant tests were performed. The outcome of the event was recovering. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647577
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: red bumps on both legs, both arms, both shoulders and back of shoulders and again are extremely itching; itching; rash; lower entire back was red as can be like I had a sunburn; This is a spontaneous report from a non-contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Feb2021 (at the age of 72 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Feb2021 (also reported as a week ago Monday that afternoon), the patient experienced a bad reaction, lower entire back was red as can be like patient had a sunburn, and bumpy when hands ran over it, and itched like crazy. 02Feb2021 (also reported as by Tuesday and still ongoing), patient had red bumps on both legs, both arms, both shoulders and back of shoulders and again are extremely itching. The patient reported that it goes in streaks, its itchy then it stops and 4 hours later, it was itchy again. The patient wanted to know if she can get the second dose. The patient had an appointment with her doctor and prescribed her with prednisone not related to this issue before seeing her. The patient also reported that with her skin doctor, she went to see him and showed him the rash and said that it was related to the COVID shot and prescribed a salve to apply. The patient spoke to her primary doctor and said that it was not enough salve and prescribed prednisone. The doctor also told the patient that she should go where she got her shot as there as supposed to be people available to treat with something to prepare her for the second dose. Treatment of salve and prednisone was received as treatment of the events. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1647578
Sex: F
Age:
State: MI

Vax Date: 02/08/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Puffy/swelling in her face; she has blotchy rashes on her face/Red blotches/hives to her face; it is itchy/ itchiness to face; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EM9810) via an unspecified route of administration, administered in Arm Left on 08Feb2021 16:45 (at the age of 51-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on 18Jan2021 as single dose for COVID-19 immunization. On 09Feb2021 18:30 the patient experienced she has blotchy rashes on her face/red blotches/hives to her face, it is itchy/ itchiness to face, On 10Feb2021 05:30 the patient experienced puffy/swelling in her face. Therapeutic measures were taken as a result of she has blotchy rashes on her face/red blotches/hives to her face, it is itchy/ itchiness to face, puffy/swelling in her face. Patient stated she has blotchy rashes on her face and has taken Benadryl because it is itchy and put some itch cream on it and asked if this is a common symptom. The outcome of event was not Recovered. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647579
Sex: M
Age:
State: NJ

Vax Date: 02/09/2021
Onset Date: 02/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202012; Test Name: CT scan of head; Result Unstructured Data: Test Result:Unknown results; Comments: He had a CT scan of his head in Dec2020 because he had severe headaches.; Test Name: Covid; Test Result: Negative ; Comments: Caller was tested for Covid and was negative; Test Date: 20210105; Test Name: Covid; Test Result: Positive ; Comments: He had symptoms in late Dec2020/ He tested positive on 05Jan2021

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: fatigue; nausea; headache; fever; This is a spontaneous report from a contactable consumer, the patient. A 33-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 09Feb2021 (age at vaccination: 33-years-old) (Batch/Lot Number: EL9264) as DOSE 1, SINGLE for covid-19 immunization/ protection from Covid. Medical history included covid infection from an unknown date in Dec2020 to an unspecified date (caller reports that he had covid infection previously, had symptoms in late Dec2020, he was fully recovered from Covid four weeks ago), severe headaches from an unknown date and unknown if ongoing (had a CT scan of his head in Dec2020 because he had severe headaches). There were no concomitant medications. Patient wanted to know if he needed the second dose of the covid vaccine if he already had covid prior to his first vaccination dose and if he experienced side effects, which were likely a sign of already having some immunity, with administration of his first vaccine dose. Patient reported that he had covid infection previously but was then offered the covid vaccine and he received his first dose. He had since experienced fatigue, nausea, headache and fever following vaccination with the first dose and his family who had not had covid previously did not experience these side effects. Patient had Covid four weeks ago. He was required by his work to get the vaccine. He was fully recovered from Covid four weeks ago and his pulmonary system was not involved. Patient was tested for Covid and was negative. He had symptoms in late Dec2020 and tested positive on 05Jan2021. He used Tylenol and Proton Pump inhibitors for acid when he had Covid. He had a CT scan of his head in Dec2020 because he had severe headaches. The patient experienced fatigue, nausea, headache and fever on an unspecified date in Feb2021. The patient underwent lab tests and procedures which included CT scan of head: unknown results on Dec2020, Sars-Cov-2 test: negative on an unspecified date and was positive on 05Jan2021. The events were assessed as non-serious. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647580
Sex: F
Age:
State: IL

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 23Feb2020 tingling thru out mouth and tongue, thick tongue, film back of throat; red rash on both forearms/rash on forearms, inner thighs; numbness on nose and cheeks next to nose/numbness on lips and bridge of nose/cheeks; rash with pain on forearms; This is a spontaneous report from a contactable other-healthcare professional. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: E19261), via an unspecified route of administration, administered in arm left on 10Feb2021 at 13:45, as single dose for covid-19 immunization. Medical history included atrial fibrillation (Afib)/pacemaker (have duel chamber pacemaker), flax seed allergy and some antibiotics allergy. Concomitant medication's included dronedarone hydrochloride (MULTAQ), metoprolol succinate, apixaban (ELIQUIS) and alprazolam (XANAX). The patient previously took celebrex and cephalexin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Feb2021 at 02:15 patient experienced, rash on forearms, inner thighs, numbness on nose and cheeks next to nose, rash with pain on forearms, numbness on lips and bridge of nose/cheeks rash on inner thighs. On 23Feb2020 she experienced tingling thru out mouth and tongue, thick tongue, film back of throat, lips and bridge of nose/cheeks numb. AE resulted in Doctor or other healthcare professional office/clinic visit. As treatment she received antihistamine. Outcome was resolving for red rash on both forearms/rash on forearms, inner thighs and numbness on nose and cheeks next to nose/numbness on lips and bridge of nose/cheeks and other events were resolved on an unknown date in 2021. Follow-up (12May2021): Follow-up attempts completed. No further information expected.

Other Meds: MULTAQ; METOPROLOL SUCCINATE; ELIQUIS; XANAX

Current Illness:

ID: 1647581
Sex: F
Age:
State: MA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Injected the vaccine "pretty low about 4.5-5 inches from the top of my shoulder." vaccine was not administered in the deltoid muscle/ vaccine injected low in arm and not in the muscle; arm is pretty sore to lay on and the fatty tissue is sore; pain at the injection site; This is a spontaneous report from a Pfizer sponsored program from a contactable pharmacist, the patient. A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, administered in the left arm on Friday 05Feb2021(at the age of 34 years) as dose 1, single, for COVID-19 immunization, by a technician. Reason for not providing lot number was mentioned as patient was unwilling to complete the report. The patient's medical history and concomitant medications were not reported. On 05Feb2021, they injected the vaccine pretty low about 4.5-5 inches from the top of her shoulder (injected low in the arm and not in the muscle) and she believed that the vaccine was administered incorrectly, because it was not administered in the deltoid muscle (Vaccine administered at inappropriate site). She stated that, on unspecified date in 2021, her arm was pretty sore to lay on and the fatty tissue was sore, and she experienced pain at the injection site but did not experience any muscle soreness in her triceps or deltoid muscle. The outcome for the events was unknown at the time of report. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647582
Sex: F
Age:
State: MI

Vax Date: 02/06/2021
Onset Date: 02/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: hot flashes; getting "real warm"; Could not walk; Not feeling well; dizzy; This is a spontaneous report from a contactable consumer (patient). A 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 06Feb2021 11:00 as (at the age of 88-years-old) dose 1, single for COVID-19 immunization. Medical history included thyroid disorder from an unknown date and unknown if ongoing , stevens-johnson syndrome from an unknown date and unknown if ongoing, surgery from an unknown date and unknown if ongoing , rash from an unknown date and unknown if ongoing , ongoing overweight, nephrolithiasis from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing, immune system disorder from an unknown date and unknown if ongoing , respiratory disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, start and stop date were not reported; cefalexin monohydrate (KEFLEX [CEFALEXIN MONOHYDRATE]) taken for an unspecified indication from an unspecified start date to 10Feb2021; mirabegron (MYRBETRIQ) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRINA ADULTOS) taken for an unspecified indication, start and stop date were not reported; meclizine hcl (MECLIZINE HCL) taken for an unspecified indication, start and stop date were not reported. The patient previously took rifampin for infection, vancomycin for infection. Prior Vaccinations, no vaccine within 4 weeks. It was reported that an 88 years old and received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 06Feb2021. She explained feeling "really dizzy" this morning, around 2am. She added having "hot flashes" and getting "real warm" several times. Patient also mentioned she was taking "quite a few pills" and hasn't seen her HCP in a while. She asked if these symptoms were reported side effects of the COVID-19 vaccine. She had been alright, but starting today she was not feeling well, dizzy and could not walk. She asked if these events could be related to the vaccine. Starting on 10feb2021, around 02:00, as far as she was aware, she was in bed and got up and was so dizzy she could not walk. She did not dare try to walk down the hall because she was so wobbly she kept bumping up against the wall. She has a lady who helps her some so she called her thinking she would come and help her; but the lady told her to just go back to sleep. So she got back into bed and went back to sleep and she seems to be ok now; not wonderful, but events are improved. Regarding concomitant products and other medical conditions caller reported yes, lots of them; She was going to start Cephalexin 250mg now, since finished Keflex. Patient was unable to provide any further information on concomitant products or other medical conditions at time of the report other than that documented in formal fields. She was so absent-minded these days that she never knows what was going to happen. She has trouble remembering sometimes. Patient details Include surgical procedures and dates: Lots of allergies. Unknown what those allergies are. She remembers she had Stevens-Johnson syndrome-she got that; she had had breast surgery and they started giving her medication because she developed an infection right away; They gave her Rifampin and Vancomycin and she thinks they overdosed her because she spent 2-3 weeks in the hospital with the Stevens-Johnson syndrome with a rash she developed immediately. She was out of work for a couple of months. Her husband thought she was gonna die but she fooled him. Rifampin: About 2-3 weeks ago she woke in the middle of the night in extreme pain. She called an ambulance which took her away to (hospital name), (city name) where she was for 3 days. She has been taking medication for this. No Family History, she does not think so. Her family been gone so long now. Her mother died of breast cancer and her dad had a heart attack. Patient did not visited Emergency room or not visited physicians office. Patient was not hospitalized. The outcome for all events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: LEVOTHYROXINE; KEFLEX [CEFALEXIN MONOHYDRATE]; MYRBETRIQ; CYMBALTA; ASPIRINA ADULTOS; MECLIZINE HCL

Current Illness: Overweight (Illness/AE: Overweight Onset Date: Probably since 18 years of age Stop Date: Ongoing)

ID: 1647583
Sex: M
Age:
State: WI

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

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

Lab Data:

Allergies:

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

Symptoms: arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date at 13:30 as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included simvastatin (SIMVASTATIN) taken for cholesterol, start and stop date were not reported; metformin (METFORMIN) taken for diabetes, start and stop date were not reported. The patient received first dose on Sunday (unspecified date) at 13:30 and on an unknown date, the patient's arm was a little sore. The patient asking about pain relieving medication and also asking about efficacy. He was scheduled for second dose at day 25 and was told to 17-21 days. The outcome of event was unknown. Information on the lot batch number has been requested Follow-up attempts are completed. No further information is expected.

Other Meds: SIMVASTATIN; METFORMIN

Current Illness:

ID: 1647584
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 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: felt as if she had the flu; her head and throat hurts; her head and throat hurts; and that her fingers felt numb; This is a spontaneous report received from a non-contactable consumer (patient) via Medical Information Team. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after receiving the 1st dose, the patient felt as if she had the flu, her head and throat hurts, and that her fingers felt numb. The patient wanted to know if the reactions were associated with the vaccine. The outcome of the reported events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1647585
Sex: F
Age:
State: MN

Vax Date: 02/08/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210209; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever of 101; Test Date: 20210208; Test Name: Covid-19 test (nasal swab); Test Result: Negative

Allergies:

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

Symptoms: Fever of 101; chills; fatigue; sore throat; whole body hurts; left arm hurts bad; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-years-old female patient received bnt162b2 (BNT162B2, Lot Number: EN5318), dose 2 intramuscular, administered in arm left on 08Feb2021 at 14:15 (at the age of 31-years-old) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced drug allergy and bnt162b2 (Lot number: EL9261), dose 1 intramuscular, administered in arm left on 18Jan2021 at 14:30 (at the age of 30-years-old) as single for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. On 09Feb2021, the patient experienced fever of 101, chills, fatigue, sore throat, whole body hurts and left arm hurts bad. The patient underwent lab tests and procedures which included COVID-19 test (nasal swab): negative on 08Feb2021 and body temperature: fever of 101 on 09Feb2021. The patient reported that she have not felt that sick in years. The patient did not receive any treatment for the events. The outcome of all the events was not resolved. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647586
Sex: M
Age:
State: HI

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: By 10:45 pm the afforementoned affected area was significantly swollen causing some blockage of sight from my right eye; my right lower eyelid beginning to swell; This is a spontaneous report from a contactable other health care professional (Patient). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810, expiry date not reported), via intramuscular route, administered in Left Arm on 09Feb2021 at 09:45 (age at vaccination: 56 years) as dose 2, single for covid-19 immunisation. The patient medical history was None. There were no concomitant medications. Known allergies were reported as None. Patient did not receive other vaccines in 4 weeks. Patient did not receive other medications in 2 weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982, expiry date not reported), on 19Jan2021 at 9:45 AM via intramuscular route in left arm for covid-19 immunization. The patient reported his right lower eyelid beginning to swell on 09Feb2021 at 22:30 (in the morning), by 10:45 pm the afforementoned affected area was significantly swollen causing some blockage of sight from his right eye on 09Feb2021 at 22:45 . 2 Motrin and Ice Pack placed over right eye was given as treatment for the events. The outcome of the events was recovered on an unspecified date in 2021. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647587
Sex: F
Age:
State: MA

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: severe leg cramps; hard time walking; This is a spontaneous report from a contactable consumer (patient) reported for herself via Medical Information Team. A female patient of an unspecified age (70 unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 09Feb2021 (yesterday) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that today (10Feb2021) at around 9 AM started having severe leg cramps, had a hard time walking, was wondering if this could be related with the vaccine and was looking for information on taking ibuprofen for side effects of the vaccine. The outcome of the events was unknown. Information about Batch/Lot number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647588
Sex: F
Age:
State: IL

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Tongue started to hurt- the muscle and back of the tongue, like the base of it, not the surface; Arm also hurt; Neck hurt at the junction of her neck and jaw on the same side as she received the injection; Headache; Really tired; pain was at the injection site; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old female patient received BNT162B2, dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (age at vaccination 63-years-old) (Batch/Lot Number: EM9810) as DOSE 1, SINGLE, Solution for injection, for covid-19 immunisation. Medical history included ongoing allergies. She had general allergies for many years. Allergic asthma from Nov2018 and was ongoing for which she took an inhaler. She had other reactions to things like Gadolinium contrast with an MRI. She had injection in her shoulder. It swelled her shoulder joint and she was not able to move arm. She had a frozen shoulder. This was years ago maybe 10 years ago and she does not have the NDC, lot, or expiration date to provide. She had not had any blood tests in a few weeks. Concomitant medication included thyroid (ARMOUR THYROID) taken for thyroid disorder from an unspecified start date and ongoing. It was reported that she did not plan on getting the vaccine. She was taking her mother, who was in a wheelchair, to get it and they offered it to her as she was the caregiver. She did discussed her allergies and stuff with someone there, maybe a pharmacist. They could not advise her yes or no to getting the vaccine based on her allergies. They told her to consult her allergist, which she had already talked to him. On 09Feb2021, after the first dose her tongue started to hurt- the muscle and back of the tongue, like the base of it, not the surface. This occurred within 45 minutes of the injection. She was still waiting at the time as she waited longer than the 30 minutes. So when this occurred she went and talked to them. They sent her to the ER, as she was at the hospital already where she got the injection. They did an IV with steroids, Benadryl, and another antihistamine and it took care of it within 20 minutes. She was really tired from the Benadryl and probably with the injection itself. She thought this was part of the vaccine injection and part of the Benadryl. She does not have the lot number to provide for the Benadryl. It was IV and was given in the hospital. Her arm also hurt. Caller confirmed this was her left arm, the same arm that she got the injection. It has gotten bigger. At first the pain was at the injection site. Now her arm was tender about the size of her hand on her shoulder. She can tell when she moves it that it was sore like she lifted weights. She was overall unsure about the outcome. She experienced neck hurt at the junction of her neck and jaw on the same side as she received the injection. This ended yesterday. It would hurt for a little while. She did not feel the neck pain in the ER. It was aching then it stopped. It was like taking turns. But it ended. The headache was the last thing that happened. It was reported that she felt fine now. Her arm was still sore and she had a little headache but no other issues. At the time of this report, the outcome of events Tongue started to hurt- the muscle and back of the tongue, like the base of it, not the surface, Neck hurt at the junction of her neck and jaw on the same side as she received the injection was recovered on 09Feb2021, events Headache and Really tired was recovering and Arm also hurt and pain was at the injection site was unknown. Follow-up attempts completed. No further information expected.

Other Meds: ARMOUR THYROID

Current Illness: Allergic asthma (Verbatim: Allergic asthma Medications: Also takes an inhaler for her asthma.); Allergy (Verbatim: allergies Has had general allergies for many years)

ID: 1647589
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: I had either joint or muscle pain (on her back, just one side); I had either joint or muscle pain (on her back, just one side); This is a spontaneous report received from a contactable consumer. A 73-year-old female consumer (Patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, NDC Number, UPC Number, Expiry Date: Unknown), via an unspecified route of administration on 02Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the shot and she had either joint or muscle pain (on her back, just one side). She wanted to know if she could receive dose 2. She had received the Pfizer-BioNTech COVID-19 vaccine approximately 8 days ago, her first dose. She guessed that it was the vaccine, she did not have it (prior to vaccination). She experienced similar symptoms (joint pain and/or muscle pain) was not described as a contraindication to receive the 2nd dose. She was suggested to contact her Doctor, to mention the symptoms experienced and confirm if the 2nd dose should be administered. Already called her doctor, and she was waiting for a response. Consumer was not willing to proceed with the questions, hence limited information was available on the call. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647590
Sex: M
Age:
State:

Vax Date: 02/09/2021
Onset Date: 02/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: a tender arm; This is a spontaneous report from a contactable consumer. This 08-decade-old male patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown) via unspecified route of administration, on 09Feb2021, as dose 1, single for covid-19 Immunization. Medical history included covid-19 on an unknown date in Oct2020 and pneumonia. Concomitant medications were not reported. The patient stated that he heard that shouldn't take OTC medication for the side effects like headache after the vaccine. On an unknown date in Feb2021, the patient experienced tender arm which was normal. The patient was enquired about after the 2nd dose they may have side effect worse than the first. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647591
Sex: F
Age:
State: TN

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: fever; chills; ached all over; headache; diarrhea; This is a spontaneous report from a contactable Consumer. An elderly non-pregnant female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 03Feb2021 11:00 (Batch/Lot Number: EJ16986) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. On 04Feb2021, the patient started with headache in morning then diarrhea in the evening. On 05Feb2021, patient had fever, chills and ached all over. Next day felt much better. The patient did not receive treatment for AEs. The outcome of events was recovering. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647592
Sex: F
Age:
State: NJ

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EL3247), via an unspecified route of administration, administered at Arm Left on 09Feb2021 at 11:45 AM (age at vaccination was 32 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The medical history was not reported. No known allergies reported. The concomitant medication escitalopram from on an unspecified date as other medication given in two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL3247), via an unspecified route of administration on left arm on 19Jan2021 at 11:45 AM (age at vaccination was 32 years) as DOSE 1, SINGLE for covid-19 immunisation at facility type vaccine: Workplace clinic. The patient was not received other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Feb2021 at 07:00 AM, the patient experienced chills and fatigue. The patient did not receive any treatment for events. Outcome of the event was recovering. Upon follow-up received on 11May2021, it was reported that follow-up attempts completed. No further information expected.

Other Meds: ESCITALOPRAM

Current Illness:

ID: 1647593
Sex: F
Age:
State: RI

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:99.4; Comments: gone down; Test Name: temperature; Result Unstructured Data: Test Result:99.3; Test Date: 20210207; Test Name: temperature; Result Unstructured Data: Test Result:101.3

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: legs are cold; she started getting a temperature of 101.3; chills; loss of appetite; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was TL9262 via an unspecified route of administration on 06Feb2021 at 14:20 in left arm (age at the time of vaccination was 83-year-old) as single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. The patient did not receive prior vaccinations within 4 weeks. On 07Feb2021, the patient experienced, she started getting a temperature of 101.3, chills, loss of appetite. On 10Feb2021, the patient experienced legs are cold. It was reported that caller stated her sister-in-law, had the vaccine on Saturday. On Sunday, she started getting a temperature of 101.3, chills, and loss of appetite and took an Advil or Tylenol. The next day she was much better, her temperature had gone down (99.4) and didn't have chills. However, she has a temperature again, it was 99.3 now. They both got the shot on Saturday. Both were fine. On Saturday her sister-in-law started getting a temperature and chills. She also had no appetite. She took a couple of Advil and Tylenol. The next day her temperature went down from 101 to 99.4 degrees. She had temperature for two days. She slept good. Today her legs are cold. She does take any other medications. Patient underwent lab test and procedure which included Body temperature 99.4 gone down on unspecified date, Body temperature 99.3 on unspecified date, Body temperature 101.3 07Feb2021. Outcome of events she started getting a temperature of 101.3 and chills was recovering, while outcome of loss of appetite was recovered on 08Feb2021 and of legs are cold was unknown. Follow-up (12May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647594
Sex: M
Age:
State:

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: headaches; a bit of 'a punky feeling'; the left lymph node in his neck has 'blown up'. It has swollen all the way up to his left temple; affecting his hearing; When he presses on it he feels pressure on his ear/The right side was not as much; This is spontaneous report from a contactable consumer (patient). A male patient of an unknown age (Age: 61, Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 09Feb2021 at 16:00 as DOSE 2, SINGLE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on an unknown date dose 1, single for Covid-19 immunisation. It was reported that, patient received the second dose of the covid vaccine on 09Feb2021 at 4:00 PM (PST) and as the day progressed patient had headaches, a bit of 'a punky feeling', and the left lymph node in his neck has 'blown up'. It has swollen all the way up to his left temple, affecting his hearing. When patient presses on it he feels pressure on his ear. The right side was not as much. The outcome of the events was unknown. Information on Lot /Batch Number has been requested. Follow-up attempts are completed.

Other Meds:

Current Illness:

ID: 1647595
Sex: F
Age:
State: NC

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Headache; body aches/pains; chills; fatigue; This is a spontaneous report from a contactable other hcp (Patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL3247) via an unspecified route of administration (age at vaccination 45-year) in Left Arm on 09Feb2021 at 03:15 PM as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (Lot Number: EL3247) on 09Jan2021 at 03:00 PM in Left arm for COVID-19 immunization. No known allergies were reported. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On 09Feb2021 at 09:00 PM the patient experienced headache, body aches/pains, chills, fatigue. No treatment was received for the adverse events. The clinical outcome of the events was not recovered. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647596
Sex: F
Age:
State:

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: fever reaching; Result Unstructured Data: Test Result:100.7 Fahrenheit

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: fever reaching 100.7F; chills; not able to lift her arm or head and could not get up until midnight (described as flu-like symptoms); This is a spontaneous report from a contactable other HCP. A female patient of 52-year-old received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 30Jan2021, at unknown dose single for COVID-19 immunization. No medical history reported. No concomitant medications reported. On 30Jan2021 patient experienced at 9 in the evening was not able to lift her arm or head and could not get up until midnight (described as flu-like symptoms), fever reaching 100.7F which went down after 3-4 days, and chills. She wants to know how often these adverse effects happen on the first dose of the vaccine. The patient underwent Body temperature test. The outcome of Events for pyrexia was recovered and for other events was unknown. Information on Lot /Batch Number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647597
Sex: F
Age:
State:

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: headache; muscle aches; chills; feel nauseous; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (formulation: solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 (NDC number, Lot number and expiry date was not reported) as dose 2, single for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes first dose bnt162b2 for covid-19 immunisation. The patient got her second COVID Vaccine Yesterday (unknown date). Last night and this morning she started to experience headache, muscle aches, chills, feel nauseous on an unknown date. Stated she can breathe and all but, she had side effects. She wanted to know if she can take Tylenol. When informed patient would have to transfer to Medical Information to potentially address her question, she got very upset. Stated she had waited for an hour and just wants her question answered. She declined to continue with safety report. She stated she just wanted to know if it was okay to take Tylenol after the second dose. She wanted to know if Tylenol will diminish the effectiveness of the vaccine. The outcome of the events was not recovered. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647598
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer. A male patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, lot# not reported, expiry date: not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient vomited after receiving the BNT162B2 vaccine. The caller reported she might not be able to get her second dose of the BNT162B2 vaccine at 21 days due to a transportation issue. The caller wanted to know if she got the vaccine at 19 days, would that be ok. The caller reported the logistics for scheduling her vaccine appointment put the elderly and those without computers at a huge disadvantage. The caller heard from a healthcare worker that he vomited after receiving the BNT162B2 vaccine. The caller wanted to know more information on the side effect and wondered how long it would take for a severe allergic reaction to occur after the vaccine was administered. The caller heard on the news that patients are being watched for 15 minutes after the vaccine was given. The outcome of the event: unknown. Batch/lot number requested. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647599
Sex: M
Age:
State: MA

Vax Date: 02/09/2021
Onset Date: 02/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: sore arm; felt very lazy; fatigued; felt anxious/feels very nervous; felt hyper; tired; confused/feels like he wants to slap, bite, and wants to scream/feels like he needs to grind his teeth; Itching/itching in his legs and arm; This is a spontaneous report from a contactable consumer or other non hcp. A 59-year-old-male 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) via intramuscular, administered in Arm Left on 09Feb2021 12:15 as (at the age of 59-years-old) dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09Feb2021 the patient experienced sore arm and felt very lazy. On Feb2021 he experienced fatigued, felt anxious, felt hyper, tired, confused and itching. The caller asked, if his symptoms following his first vaccine are normal and what he should do about them. As he got the vaccine at around 12:15 in the afternoon, stayed for 20 minutes at the vaccination facility and 4 hours later he started having a sore arm, felt very lazy, wanting to go to sleep, went to sleep but when he woke up, he felt more fatigued and lazier. He stated that he like someone to stretch his legs, he felt anxious and had a lot of anxiety and felt hyper. He went back to sleep and got up in 5 hours and again felt anxious then fatigued and tired and confused. he also reports that he notices that he "eat a lot and then he was not burping". Caller asked how long he will feel like this. Upon fallow up received Caller said that he feels like he has fatigue, pain in his arm when he sleeps on it, feels like he needs to grind his teeth, and itching in his legs and arm. He said that he also feels like he wants to slap, bite, and wants to scream. It is bothering him. He said that he feels very nervous, but it is not because he was scared. He said that he feels bad and stated that he is tired and wants to sleep all day. Caller said that he feels fatigued along with his hands and his legs. He feels lazy and he is nervous. He said that no one has this with the first vaccine. He feels like something may have damaged his body. When asked about his concomitant medications, medical conditions and relevant tests, the caller said that he takes a lot of medications but provided no further information when queried. Patients second dose was scheduled for 02Mar2021.The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1647600
Sex: M
Age:
State: NY

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210210; Test Name: Fever; Result Unstructured Data: Test Result:100.0 Fahrenheit

Allergies:

Symptom List: Injection site pain

Symptoms: chills; fever (100.0F); headache; Fatigue; This is a spontaneous report from a contactable consumer. A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in left arm on 09Feb2021 at 13:30 (at the age of 31-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine included: first dose of BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: EL3247) as dose 1, single administered in left arm on 19Jan2021 (at the age of 31-years-old) for COVID-19 immunization. The patient medical and concomitant medication history were reported. COVID-19 prior vaccination was reported as no. Patient had no allergies. Patient did not received other vaccine in four weeks. Patient did not received other medications in two weeks. Facility type vaccine at Workplace clinic. Adverse event start on 10Feb2021 at 03:00 AM. The patient experienced chills, fever (100.0F), headache and fatigue. The patient underwent lab tests and procedures which included body temperature: 100.0 fahrenheit on 10Feb2021. COVID-19 tested post vaccination was reported as no. The outcome of the events were recovering. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647601
Sex: M
Age:
State:

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Caller reports that he is scheduled for his second dose on 27Feb2021 and he noticed that it is 17 days in between first dose.; Caller reports that he began to get dizzy shortly after receiving vaccine; This is a spontaneous report from a contactable consumer. A 89-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 as dose 1, single for covid-19 immunisation. Medical history included allergy to sulfa from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 10Feb2021 caller reports that he began to get dizzy shortly after receiving vaccine. Caller reports that he feels fine now. Caller reports that he is allergic to sulfa. Caller reports that he is scheduled for his second dose on 27Feb2021, and he noticed that it is 17 days in between first dose. Caller would like to know if that is okay. The outcome of the event dizzy was recovered and outcome of the event he noticed that it is 17 days in between first dose was unknown. information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647602
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 02/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: headache/headache that turned into a migraine; migraine/headache that turned into a migraine; vomiting/she is throwing up; This is a spontaneous report from a contactable consumer or other non hcp. A female patient (reporter's mother) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller spoken to safety before being transferred. Caller called on behalf of his mother. Caller stated my mom's got the second dose of the Pfizer Covid-19 vaccine. She developed a headache, migraine and vomiting post vaccination on 10Feb2021. Caller wants to know if it was safe to use excedrin an over the counter medication. Caller stated I was transferred several times. I had to give my information each time. His mom received the second shot of the covid vaccine. She woke up today with a headache which turned into a migraine. Now she was throwing up. Asking if it is safe to take generic Excedrin. He was on hold for a long time and was told we would be able to answer his question. He declined to complete a report and requested to be transferred to address question. The clinical outcome of events was unknown. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647603
Sex: M
Age:
State: MO

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: tinnitus; This is a spontaneous report from a contactable physician. A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL1284, Expiry date was not reported), age 37 year at the vaccination), via an unspecified route of administration, administered in Arm Left on 08Jan2021 08:00 as dose 2, single for COVID-19 immunization at hospital. The patient medical history was not reported. Concomitant medication(s) included sertraline was taken for an unspecified indication, start and stop date were not reported; bupropion.No other vaccine received in four weeks. No prior covid vaccination. Known allergies was reported as no. Other medical history were none. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EH989, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 18Dec2020 08:00 AM as dose 1, single for COVID-19 immunization. The patient experienced tinnitus on Jan2021. The outcome of the event was not recovered. Follow-up attempts completed. No further information expected.

Other Meds: SERTRALINE; BUPROPION

Current Illness:

ID: 1647604
Sex: F
Age:
State: IL

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

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

Lab Data: Test Date: 20210209; Test Name: Blood draw; Result Unstructured Data: Test Result:Unknown; Comments: Hew doctor had drawn her blood yesterday, because of the disorganized situation that happened when getting the vaccine; Test Name: Pain scale; Result Unstructured Data: Test Result:1; Comments: it's a 1 on the pain scale at the moment.

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Headache; Pain was located adjacent to her shoulder and collarbone and rotates between her left and right shoulder; Had a painful shoulder where injection side was on the left arm side back in the muscle down from the neck; Had a painful shoulder where injection side was on the left arm side back in the muscle down from the neck; Had a painful shoulder where injection side was on the left arm side back in the muscle down from the neck; Left shoulder was very painful; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration, administered in Arm Left on 26Jan2021 (at the age of 66-years-old) as dose 1, single for covid-19 immunization at drug store with a grocery store, she clarified that it was a pharmacy in the store. Medical history included high blood pressure and diabetes from an unknown date and unknown if ongoing. Concomitant medications included amlodipine besylate taken for hypertension, chlortalidone 25mg taken for blood pressure, lisinopril and atorvastatin calcium taken for an unspecified indication, start and stop dates were not reported. Caller stated the vaccination facility where she received her vaccine did not provide her with a vaccination card or any information regarding the vaccine she received. Caller stated she went back to the facility where she received the vaccine, and they have no record of her first dose. Caller stated the day she received the first dose of the vaccine she was at the facility picking her usual prescriptions and there was a crowd of people lined up at the facility. Caller stated she asked what was the crowd of people there for and they said they were there for the COVID vaccine. Caller stated she asked if she was eligible to receive the vaccine and they told her yes. Caller would like to know how to get more information regarding how to schedule for second dose of the vaccine. Caller stated after receiving the injection her left shoulder was very painful for four days and she had to use an ice pack. Caller stated the pain was located adjacent to her shoulder and collarbone and rotates between her left and right shoulder. Caller stated the pain comes and goes. Caller stated today she was also experiencing a headache. Caller stated today was also the first time she had been able to raise her hand to her hip. Caller stated she walks 8 miles a day. Caller was extremely frustrated. She was calling about the Pfizer Covid Vaccine. She was a person of color. Quite a few people of color, are cautious of injections because of past history. She was a person a color, we have now come further than this. She goes a drug store because she had 3 medications that she would pick up from there. She got in there and seen huge line of people to come in and get this vaccine, she asked was this for the covid vaccine, they said yes, she asked which on was it for, they told her it was Pfizer. She waited for 4 hours to get the vaccine, that was not the problem, she was retired she does not mind the wait. After getting the shot, they gave her nothing, no information, no vaccine card, absolutely nothing, she tried to talk to the manager day and night, she had gotten nothing. Caller continuously asked if this agent could give her information about what Lot number, specific name of the vaccine that she received. Caller was informed multiple times to refer back to the facility. Caller was still upset, caller was informed that Pfizer was a drug manufacture and distributes the product but she would have to refer to facility for where she got the vaccine administered for further questions. Caller was upset that Pfizer does not have a database of names and vaccine given. Caller responds that she had already done that, she had been on the phone with store manager, the manager just said that their vaccine roll out was different. Caller stated that she got the vaccine in the store, they gave her the vaccine. Caller states that in the past when they gave her vaccine, most of the time it was at schools, but even they would give a card with documentation with a date and time and when to come back. Caller asked does the vaccine come in two doses. She does not even know when she would go back for the second. Caller stated that she had side effects and all that. She had a painful shoulder. Her brother was doctor and even he got information after his vaccine. She really hurts. She explained that after the first dose on 26Jan2021, she had a painful shoulder where injection side was on the left arm side back in the muscle down from the neck, like in the nape of the shoulder an inch or 2. It was not as painful today as it was before. The patient underwent lab tests and procedures which included when she got the first dose and was upset due to not having documentation, her doctor said come on in, we will look at that spot, and we would look to see for sure by taking a blood sample to see if she got the shot. They did take blood on 09Feb2021. Caller clarified saying that it was pain at the injection site. She was a pain tolerant person, she had 3 kids naturally, for this situation the injection site was quite painful, when it first took place, as night went on, she was just so grateful for her icepack, it was a flat ice pack, that got her though, today pain has moved to the level on the top shoulder where the indentation was, her pain was not sharp, but she could feel it, it was a 1 on the pain scale at the moment. Treatment received for events vaccination site pain, myalgia, neck pain and arthralgia. The outcome of events vaccination site pain, myalgia, neck pain, arthralgia was recovering, and events headache and pain was unknown. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds: AMLODIPINE BESYLATE; CHLORTALIDONE; LISINOPRIL; ATORVASTATIN CALCIUM

Current Illness:

ID: 1647605
Sex: M
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: fever; This is a spontaneous report from a Non-contactable consumer. A elderly male patient (age not reported; above 65 years) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown, whether prior to the vaccination, the patient was diagnosed with COVID-19 or since the vaccination, the patient had been tested for COVID-19. On 09Feb2021, the patient experienced fever. It was unknown, whether patient received any treatment. Outcome of the event was unknown. No follow up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1647606
Sex: M
Age:
State: FL

Vax Date: 02/07/2021
Onset Date: 02/07/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:137/80

Allergies:

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

Symptoms: pain at the injection site; feeling unwell; felt a little, slight difficulty breathing; chills/slight chills, but it went away; tiredness/tiredness and run down; lightheadedness/head was lightheaded; Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: E19262, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:30 (at the age of 67-years-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included atenolol (ATENOLOL); atorvastatin (ATORVASTATIN); acetylsalicylic acid (ASPIRIN 81) all taken for an unspecified indication, start and stop date were not reported. Patient previously received FLU SHOT had about 4-6 hours of arm pain or any adverse effects, and FLU SHOT second shot was about 2 hours of adverse events and there was not a reaction whatsoever after the 3rd. No other vaccines given the same day or 4 weeks prior. It was reported that patinet was upset that there was no data on the percentage of people who had reported having severe allergic reactions now that the vaccine has been given to people. He stated 10 percent of the state of (state name) have gotten the vaccine. That was enough for a clinical trial. There should be data on how many people have had a severe allergic reaction. Patinet stated, he was very very disappointed. when you are putting out a vaccine for people to take. He stated his neighbor said it will be a cold day in hell before she gets the Pfizer vaccine and the doctor said you are right about that decision. He stated, you need to have this information, or part of it, for the public or doctors to be informed. The doctors all say call Pfizer because they all say they don't know and don't have the vaccine. So you need to have the information for us. He stated, he just one of 300 million people, can you send an email to your superiors to get them to speed up or give an approximation of how long it will take to review the adverse events. Patient received the first dose of the vaccine (lot #E19262) and experienced pain at the injection site for one day. Two days later he got chills, tiredness, lightheadedness and was feeling unwell. He did not have a fever, although he turned the air conditioning on and started feeling a little better. He was not experiencing it right now. He called the emergency number, and they took his blood pressure (137/80) and they observed him for a few minutes and they determined he did not need to go to the hospital. The caller asked what should he expect with the second shot. He stated some people say the side effects will be greater after the second dose, if this true. He asked for the percentages of reports of each individual symptom after the first dose compared to the second. He asked about reports of shortness of breath and fast heart rate and what the reports were of people who had had severe allergic reactions. He stated on the television and internet there was data on how many people have passed away from the vaccine. He also stated the information that was handed to him about the vaccine was given to him after the vaccine when it should have been given to him before. He stated with the first flu shot that occurred 5 year ago he had about 4-6 hours of arm pain or any adverse effects, and the second shot was about 2 hours of adverse events and there was not a reaction whatsoever after the 3rd. On 07Feb2021 (Sunday) at 11:30am. Had the usual arm pain that lasted for 24 hours. The next yesterday, on 09feb2021, he was feeling the tiredness and run down. Had slight chills, but it went away. Had no joint pain, or redness or swelling at injection site, no swollen lymph nodes, no dizziness, no weakness. Had to call the paramedics because he felt a little, slight difficulty breathing and head was lightheaded. Wants to know how long will this condition last. Mentions weight was 135 and then clarifies it was 133. No further details provided. Mentions he had blood testing done and takes Atenolol, Atorvastatin, and a 81mg Aspirin. Does not provide any further details. Patient did not go to emergency room or not visited physicians office, but did call paramedics for slight difficulty breathing, head was lightheaded. The patient underwent lab tests and procedures which included blood pressure measurement: 137/80 on an unspecified date. The outcome of the events pain at the injection site and feeling unwell was unknown and for events chills/slight chills, but it went away, tiredness/tiredness and run down, pain in arm and felt a little, slight difficulty breathing was recovering. Follow-up attempts completed. No further information expected.

Other Meds: ATENOLOL; ATORVASTATIN; ASPIRIN 81

Current Illness:

ID: 1647607
Sex: F
Age:
State: NJ

Vax Date: 02/09/2021
Onset Date: 02/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Generalized body pain; sharp aching joints; Fatigue; Chills; This is a spontaneous report from a contactable nurse (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EM9809, Expiration date was not reported), via an unspecified route of administration (administered on the left deltoid) on 09Feb2021 at 12:00 (at the age of 41-years-old) as dose 1, 0.3 mL single for COVID-19 immunisation. Medical history included known allergies to PCN (penicillin) from an unknown date, asthma and COVID-19 both from Nov2020. The patient has no other concomitant medications in two weeks. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 11Feb2021 at 01:30, the patient experienced generalized body pain, sharp aching joints, fatigue, and chills. Therapeutic measures were taken as a result of the events which included home symptom management and time off work. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts are possible. No further information expected.

Other Meds:

Current Illness:

ID: 1647608
Sex: F
Age:
State: CA

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

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

Lab Data: Test Date: 20210208; Test Name: Fever; Result Unstructured Data: Test Result:99.2

Allergies:

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

Symptoms: Fever 99.2; chills; joint aches & woke up in a sweat; joint aches & woke up in a sweat; Gastric reflux; This is a spontaneous report from a contactable nurse. This 44-year-old female nurse reported for herself. A 44-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3248) via intramuscularly in arm right on 08Jan2021 09:30 as dose 2, single (age at Vaccination: 44 years) for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing, allergy from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL0140) via intramuscularly in arm right on 08Dec2020 10:30 AM as dose 1, single for COVID-19 immunisation. No Covid prior vaccination and did not tested covid post vaccination. On 08Feb2021, fever 99.2, chills, joint aches & woke up in a sweat, then gastric reflux for 3 days post vaccine. Treatment received was antacids & Tylenol. The patient underwent lab tests and procedures which included fever resulted 99.2 on 08Feb2021. The clinical outcome of the event gastric reflux on 11Feb2021 was resolved and the other events on Feb2021 was resolved. Follow-up attempts completed. No further information expected.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1647609
Sex: F
Age:
State: HI

Vax Date: 01/30/2021
Onset Date: 02/02/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sinus congestion/ stuffy head, nose and ears; stopped-up ears; scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 67-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN5318) via intramuscular on 30Jan2021 at 11:15 (at the age of 67-years-old) in right upper arm as a single dose for covid-19 immunization. Medical history included osteoarthritis, high cholesterol, and high blood pressure all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. The patient had no known allergies. Prior vaccinations were reported as none. Concomitant medication included lisinopril (LISINOPRIL); loratadine (LORATADINE); rosuvastatin (ROSUVASTATIN); ascorbic acid (VIT C); cyanocobalamin (B-12) and Mult all taken for an unspecified indication, start and stop date were not reported. The patient experienced sinus congestion, stuffy head, nose and ears, stopped-up ears, and scratchy throat on 02Feb2021 at 08:00. The events were reported as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with sinus medication (sinus rinse pseudoephedrine oxymetazoline). The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/ Lot number: EN6200) via intramuscular on 20Feb2021 at 11:15 in left upper arm as a single dose for covid-19 immunization. Relevant tests were reported as none. The outcome of all the events was resolving. Follow-up attempts are completed. No further information is expected.

Other Meds: LISINOPRIL; LORATADINE; ROSUVASTATIN; VIT C; B-12

Current Illness:

ID: 1647610
Sex: F
Age:
State: FL

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: she had a rapid onset of floaters in her left eye; her appetite kicked in which is unusual for her; felt unwell; she felt extremely hungry which is very unlikely of her.; she experienced extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), via an unspecified route of administration on 26Jan2021 16:30 (Tuesday) as Dose1, SINGLE for an unspecified indication. The patient's medical history and concomitant medications were not reported. On 27Jan2021 (Wednesday), the patient experienced extreme fatigue. She was able to carry out her work duties. On 28Jan2021 (Thursday), the patient felt unwell, she felt extremely hungry which is very unlikely of her, her appetite kicked in which is unusual for her. On 04Feb2021, she had a rapid onset of floaters in her left eye. She went to the eye doctor. She wanted to know if it is safe to take the second dose of the Pfizer COVID-19 vaccine on 16Feb2021. The outcome of all the events was unknown. There was no product quality complaint (PQC) present. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647611
Sex: M
Age:
State: NY

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210209; Test Name: Body temperature; Result Unstructured Data: Test Result:99.6 Fahrenheit

Allergies:

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

Symptoms: Chills; shakes; Slight fever (99.6 F); moderate fatigue; cold sweating; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 09Feb2021 11:00 (at the age of 28-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included one Kidney (his kidneys fused pre birth, fully funcitonal) and shellfish allergy. The concomitant medications for the patient were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19Jan2021 09:00 AM (at the age of 28-year-old) for COVID-19 immunization. The patient did not receive other vaccine in four weeks. The patient did not receive other medication in two weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On 09Feb2021 23:00, the patient experienced chills, shakes, slight fever (99.6 F), moderate fatigue, and cold sweating. No treatment was given for the events. The outcome of the events was reported as resolving. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647612
Sex: F
Age:
State: VA

Vax Date: 02/02/2021
Onset Date: 02/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Itchy rash spreading from left arm to neck, upper chest, and lower abdomen.; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an intramuscular route of administration on 02Feb2021 (Batch/Lot Number was not reported) as dose 2, single (at the age of 66 years old) for COVID-19 immunization. The patient's medical history included allergies with gadolinium contrast media (history of hives) and iodinated contrast media (causing anaphylactoid reaction); osteopenia, allergic rhinitis, and mild aortic regurgitation. Concomitant medications included butalbital, caffeine, paracetamol (FIORICET); sucralfate (CARAFATE), calcium carbonate (CALTRATE); and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH); all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2, intramuscularly on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility type vaccine where the patient received the vaccine was unknown. On 05Feb2021, the patient experienced itchy rash spreading from left arm to neck, upper chest, and lower abdomen. The result of the adverse event was doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as the result of the event included recommendation to take second generation antihistamine which the patient declined. Outcome of the event was recovered on Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: FIORICET; CARAFATE; CALTRATE [CALCIUM CARBONATE]; EXCEDRIN EXTRA STRENGTH

Current Illness:

ID: 1647613
Sex: F
Age:
State: WA

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

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

Lab Data:

Allergies:

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

Symptoms: Arm soreness; This is a spontaneous report from a contactable Other HCP (patient). A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL1283) intramuscular in left arm on 19Jan2021 at 09:00 (at the age of 43-year-old) as single dose for COVID-19 immunization at Doctor's office/urgent care. Medical history of the patient included depression and anxiety. Concomitant/other medications received within two weeks included lamotrigine (LAMICTAL), fluoxetine hydrochloride (PROZAC), monascus purpureus (RED YEAST RICE), curcuma longa (TURMERIC), boswellia serrata (BOSWELLIA), acacia catechu wood, chondroitin sulfate sodium, glucosamine hydrochloride, hyaluronic acid, maltodextrin, methylsulfonylmethane, scutellaria baicalensis root (GLUCOSAMINE CHONDROITIN), VITAMIN D3, CHROMIUM PICOLINATE all taken for unspecified indications. No other vaccine was received within four weeks of suspect vaccine. Patient had no known allergies. Patient did not have COVID prior vaccination and was not tested for Covid post vaccination. On an unspecified date in 2021 after the first dose, patient experienced arm soreness and nothing else. Patient did not receive any treatment in response to the event. Outcome of the event was resolving. Follow-up attempts completed. No further information expected.

Other Meds: LAMICTAL; PROZAC; RED YEAST RICE; TURMERIC [CURCUMA LONGA]; BOSWELLIA; GLUCOSAMINE CHONDROITIN ADVANCED; VITAMIN D3; CHROMIUM PICOLINATE

Current Illness:

ID: 1647614
Sex: M
Age:
State: NY

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210210; Test Name: fever; Result Unstructured Data: Test Result:99.5 deg. Fahrenheit

Allergies:

Symptom List: Vomiting

Symptoms: Chills; headache; fever 99.5 deg.F; This is a spontaneous report from a non-contactable consumer (Patient). A adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. It was unknown if patient received other vaccines in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19 was unknown, and COVID-19 tested post vaccination was also Unknown. On 10Feb2021, the patient experienced chills, headache, fever 99.5 deg. Fahrenheit. It was unknown if patient received treatment for adverse events. It was reported that colleague within the report communicated to me in informal conversation the AE post second dose for the COVID vaccine. His/Her understanding was his boost was on 09Feb2021 and presented with the symptoms in the document the following day, 10Feb2021. His/her awareness date was 10Feb2021. The patient underwent lab tests and procedures which included body temperature: 99.5 deg. fahrenheit on 10Feb2021. The outcome for the events was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1647615
Sex: M
Age:
State: UT

Vax Date: 01/22/2021
Onset Date: 01/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210205; Test Name: Slava test; Test Result: Negative ; Comments: Covid test name post vaccination=Slava test

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: feeling body aches; chills; low energy; symptoms started getting worse; sharp pains in throat; sharp pains in ears; coughing; This is a spontaneous report from a contactable consumer or other non hcp. A 28-years-old male patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 22Jan2021 15:00(age at vaccination: 28 Years) as SINGLE DOSE for covid-19 immunisation (at pharmacy). Patient didn't receive other vaccines within 4 weeks prior to vaccination. Medical history and concomitant medications were not reported. Patient had no allergies. Patient didn't had covid-19 prior to vaccination. On 24Jan2021 13:00 the patient experienced feeling body aches, chills, low energy, symptoms started getting worse, sharp pains in throat, sharp pains in ears, coughing. No therapeutic measures were taken for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 05Feb2021 Covid test name post vaccination was Slava test. Patient was not tested to covid-19 to post vaccination. The outcome of the events pain, chills, asthenia, oropharyngeal pain, ear pain, cough was not recovered, the outcome of the event condition aggravated was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647616
Sex: M
Age:
State:

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: headache; head cold; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored program. A 63-year-old male patient received 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 09Feb2021 (at the age of 63-year-old) 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 for COVID-19 immunization and advil [ibuprofen] for sinus headache/neck aches. On 09Feb2021, patient experienced headache, head cold. Patient again stated a week before his first Pfizer Covid vaccine, he was on a course of Advil to treat sinus headache/neck aches. He heard on the news that taking these medications could decrease the immune response and made the vaccine less effective. He wanted to know if this was true. Patient wanted to know if there would be a 3rd booster shot to take to address the new variants/strains of Covid 19 and inquired if he could take advil after the vaccine. The clinical outcome of events was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647617
Sex: F
Age:
State:

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: fever; aches/pains; chills; This is a spontaneous report from a contactable consumer (patient husband). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 09Feb2021 (age at vaccination 60-year-old) as dose 2 single for COVID-19 Immunization. Medical history and Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunization. It was reported that patient had fever, aches, pains, and chills after the second dose of the vaccine yesterday 09Feb2021. The outcome of events was unknown. Information on the lot/batch number has been requested. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1647618
Sex: M
Age:
State:

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Noticed face swelling; This is a spontaneous report from a contactable Consumer. A 53-years-old male patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EL9267), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 14:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergy, covid-19. Other medical history none. Concomitant medication(s) included enalapril (ENALAPRIL); atorvastatin (ATORVASTATIN); hydrochlorothiazide (HYDROCHLOROTHIAZIDE). On 10Feb2021 21:00 patient noticed face swelling. No treatment for event. The outcome of event was not recovered. Follow-up (17May2021): Follow-up attempts completed. No further information expected.

Other Meds: ENALAPRIL; ATORVASTATIN; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1647619
Sex: U
Age:
State: IL

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies: Peanut allergy

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 20-year-old patient, of unspecified gender, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, lot# EN6201, expiry date: unknown), at vaccination age of 20, via unspecified route of administration, right arm, on Feb 9, 2021, at 17:00, single dose, for COVID-19 immunisation. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, lot# and expiry date: unknown), via unspecified route of administration, on unspecified date, single dose, for COVID-19 immunisation. Facility type vaccine was other. Medical history included peanut allergy, from an unspecified date and unknown if ongoing. Concomitant medications: none. There was no other vaccine in four weeks and no other medications in two weeks. On Feb 9, 2021, at 20:00, patient experienced rash over entire body. AE resulted in doctor or other healthcare professional office/clinic visit. AE treatment given: Benadryl. Patient did not have COVID-19 prior vaccination, and was not tested for COVID-19 post vaccination. The outcome of event: recovering. Follow-up (May 12, 2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am