VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1682067
Sex: F
Age: 65
State: GA

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 09/08/2021
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: MRI dye, latex, doxy, levaquin, PCN

Symptom List: Dysphagia, Epiglottitis

Symptoms: at night after vaccination, had chest tightness, tachycardia 140 with sob and oxygen 91% on pulse ox (with fever and flu like sx). still feels winded with exertion 9/7/21

Other Meds: topical HRT, tramadol, lexapro, PPI

Current Illness:

ID: 1682068
Sex: F
Age: 56
State: GA

Vax Date: 03/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: CT, EGD, C SCOPE, labs

Allergies: augmentin

Symptom List: Anxiety, Dyspnoea

Symptoms: developed chronic pancreatitis with poor po intake and pain impacting QOL

Other Meds:

Current Illness:

ID: 1682069
Sex: M
Age: 75
State: CT

Vax Date: 09/02/2021
Onset Date: 09/03/2021
Rec V Date: 09/08/2021
Hospital: Y

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: NO INFO

Allergies: NONE

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

Symptoms: WIFE CAME IN 5 DAYS AFTER PATIENT RECEIVED VACCINE AND REPORTED THE NEXT DAY PATIENT WAS ADMITTED TO HOSPITAL WITH A VERY VERY HIGH BLOOD SUGAR (WIFE SAID 1500?) AND IS ON RESPIRATOR. PATIENT'S ENDOCRINOLOGIST STATED PATIENT SHOULD OF NEVER GOTTEN BOTH VACCINES AT THE SAME TIME

Other Meds: CREON, LISINOPRIL, TAMSULOSIN, PLUS PATIENT GETS MEDS AT HOSPITAL

Current Illness: DIABETES

ID: 1682070
Sex: F
Age: 79
State: MI

Vax Date: 01/31/2021
Onset Date: 09/05/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies: nkda

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Breakthrough-Hospitalized

Other Meds: unknown

Current Illness: unknown

ID: 1682071
Sex: F
Age:
State: NJ

Vax Date: 08/24/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
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: Headache with no fever; Coughing; muscle pains; chest discomfort; mucus; Diarrhea; mouth was like glue; got a weird smell and it was a nauseating smell; burning in her stomach; burning in her stomach,and she had some reflux; burning in her mouth; leg muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3182), via an unspecified route of administration, administered in right deltoid (Right shoulder) on 24Aug2021 (at the age of 65-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient did not had any medical history and family history. The concomitant medication(s) included oxycodone (OXYCODONE) 5 mg taken 4 times daily taken for an unspecified indication started 7 years ago and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: PAG780), via an unspecified route of administration, administered in left shoulder on 03Aug2021 (at the age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation and the patient experienced sore arm and hot flashes that lasted a couple of days. The patient did not had any prior vaccination within a four weeks. On 24Aug2021, the patient experienced had some burning in her stomach and she had some reflux anyway and then, some burning in her mouth, and then it was gone. She went home and had some leg muscle aches and chills. She wants to know, her chills lasted for two days. Two days after she got a weird smell and it was a nauseating smell. It could have been the mucus. She clarified as a day later at 2 in the morning Thursday the 26Aug2021. Then everything went away, now yesterday. On 29Aug2021, the patient mouth was like glue. On an unspecified date, the patient reported headache with no fever. All subsided after a few days yesterday the night of the 30Aug2021 and she had a mouth breather and she will take a drink of water and it will be gone. She woke up on Monday night and it was like glue. On 01Sep2021, the patient had diarrhea and on unspecified date, she reported muscle pains, coughing, mucus, chest discomfort, and just sore. Patient reported going for a covid test tomorrow be-cause maybe it was covid. Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of event for burning in her stomach,and she had some reflux, burning in her mouth, Chills, got a weird smell and it was a nauseating smell, was recovered on Aug2021 and, headache was recovered on 30Aug2021 and outcome of rest all events were unknown.

Other Meds: OXYCODONE

Current Illness:

ID: 1682072
Sex: F
Age: 46
State: GA

Vax Date: 01/20/2021
Onset Date: 02/10/2021
Rec V Date: 09/08/2021
Hospital: Y

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: Ceclor, phenol, formaldehyde

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

Symptoms: Other specified abnormal uterine and vaginal bleeding [fibroid] (Final) - Disseminated intravascular coagulation [defibrination syndrome] (Final) - Acute posthemorrhagic anemia (Final) -Subserosal leiomyoma of uterus (Final).

Other Meds: Taytulla (norethindrone acetate and ethinyl estradiol 1mg)

Current Illness: None

ID: 1682073
Sex: F
Age: 53
State: NJ

Vax Date: 04/09/2021
Onset Date: 04/12/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: N/a

Allergies: Seasons allergies - Pollen

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Upper extremity tingling/pins and needles sensation 1 round soluMedrol pack

Other Meds: Valtrex Loratadine Multi Vit Vit D Probiotic CoQ 10 Fish Oil CholestOff Fiber Gummies

Current Illness:

ID: 1682074
Sex: M
Age: 13
State: AZ

Vax Date: 09/03/2021
Onset Date: 09/03/2021
Rec V Date: 09/08/2021
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: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Severe, Additional Details: Provider ordered CT, EKG, and ran bloodwork.

Other Meds:

Current Illness:

ID: 1682075
Sex: M
Age: 34
State: CA

Vax Date: 08/26/2021
Onset Date: 08/28/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: NONE

Allergies: Seafood

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: "SWOLLEN, TENDER AXILLARY, R SUPRACLAVICULAR, AND R ANTERIOR CERVICAL LYMPH NODES GREATER THAN 5 DAYS. IMPROVING WITH MOTRIN 800 mg TID AND WARM COMPRESS"

Other Meds: motrin

Current Illness: N/A

ID: 1682076
Sex: F
Age: 58
State: PA

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1682077
Sex: M
Age: 16
State: MD

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/08/2021
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: Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Mild, Systemic: Weakness-Mild, Additional Details: Patient received vaccine and immediately after complained of dizziness, weakness, feeling nauseated and sweatiness. Pharmacist on duty gave patient water and some candy and some sugar, in case of low blood sugar. Patient diabetic. Patient waited 15-20 minutes; stated he felt better and went home. We asked that he call the pharmacy later this evening if he had any other issues regarding the vaccination today.

Other Meds:

Current Illness:

ID: 1682078
Sex: F
Age: 68
State: CT

Vax Date: 08/28/2021
Onset Date: 08/28/2021
Rec V Date: 09/08/2021
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: Site: Redness at Injection Site-Medium

Other Meds:

Current Illness:

ID: 1682079
Sex: F
Age: 69
State: TX

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/08/2021
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: Error: Booster Given Too Early-

Other Meds:

Current Illness:

ID: 1682080
Sex: F
Age: 63
State: TX

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 09/08/2021
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: Error: Booster Given Too Early-

Other Meds:

Current Illness:

ID: 1682081
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 09/08/2021
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: no appetite; diarrhea; vomiting; muscle pain; joint pain; nausea; tiredness; chills; feeling unwell; This is a spontaneous report from a contactable consumer. A 77-year-old female patient reported that she received second dose of BNT162B2 (Pfizer Covid 19 Vaccine, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on 01Apr2021, as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient received first dose of BNT162B2 (Pfizer Covid 19 Vaccine, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on unknown date, as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced reoccurring muscle pain, joint pain, nausea, diarrhea, tiredness, chills, vomiting, tiredness, no appetite and feeling unwell. At the time of this report the outcome of the events were unknown. The lot number for BNT162B2, was not provided and would be requested during follow up.

Other Meds:

Current Illness:

ID: 1682082
Sex: F
Age:
State: IL

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: unable to walk; cant talk; dizziness; double vision; shakiness; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Mar2021, the patient experienced dizziness, double vision, shakiness. On an unspecified date, unable to walk, can't talk. It was reported that patient had dizziness inability to talk inability to walk double vision inability to walk shakiness double vision shaky extremities can't talk couldn't walk done. The outcome of all events was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1682083
Sex: F
Age:
State:

Vax Date: 04/17/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Nasal swab; Test Result: Negative

Allergies:

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

Symptoms: Menstrual period has changed. Cycle is shorter and bleeding can last up to 15 days.; Menstrual period has changed. Cycle is shorter and bleeding can last up to 15 days.; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Apr2021 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of the vaccination and other vaccines within 4 weeks prior to the vaccination. On an unknown date in 2021, the patient experienced menstrual period has changed. Cycle is shorter and bleeding can last up to 15 days. It was reported that the patient used to be very regular and 28-day cycle. This changes after vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, in 2021 the patient underwent COVID-19 test via nasal swab test and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events menstrual period has changed. Cycle is shorter and bleeding can last up to 15 days were not resolved at this time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1682084
Sex: F
Age:
State: AR

Vax Date: 08/28/2021
Onset Date: 08/29/2021
Rec V Date: 09/08/2021
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: experiencing burning pain at the vaccine injection site; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 28Aug2021 (age at vaccination was 19-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was included covid 19 infection in May/end of April. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 04Aug2021 (age at vaccination was 19-year-old) as dose 1, single for COVID-19 immunisation. Caller reports that since this Sunday (29Aug2021), she has been experiencing burning pain at the vaccine injection site. Caller reports that specifically it doesn't feel like its on the outside but feels like its on the inside. At the time of this report event outcome was unknown. Lot number for the vaccine, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1682085
Sex: M
Age:
State:

Vax Date: 06/22/2021
Onset Date: 06/01/2021
Rec V Date: 09/08/2021
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: tightness in his abdomen; constipation; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself) via Medical Information Team. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 22Jun2021 as dose 1, single for COVID-19 immunization. Patient medical history included blood pressure. The concomitant medications included blood pressure pills. Patient received the first dose of the Pfizer COVID vaccine around 22Jun2021 and within that same day he had a tightness in his abdomen on 22Jun2021. He stated the only thing he can compare this to was the sensation of overeating and feeling that tightness and when you take a full deep breath you cannot get full expansion without feeling resistance. He stated it increased the next day and lasted for maybe a total of three in a half four days and he also had constipation on an unspecified date in Jun2021 that lasted the same time frame. He stated he would like to know if this had been reported previously and he had asked other people and they said no but the proximity of the COVID vaccine is something that he could not ignore. He stated he spoke to his doctor and he already waived him off saying this was nothing. He stated could his side effects been an interaction although he was not really taking much medications but he takes a blood pressure pill and he was already told that would not been a problem. He was informed that Pfizer cannot assess causality between what he has experienced as being directly related to the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1682086
Sex: M
Age:
State:

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 09/08/2021
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: felt like his tinnitus that he normally has and has had for years has gotten worse; felt like his tinnitus that he normally has and has had for years has gotten worse; This is a spontaneous report from Pfizer sponsored with Regulatory Authority Support. A contactable consumer reported that a 62-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Batch /lot number: not reported) via an unspecified route of administration, On 09Apr2021 as single dose for COVID-19 immunization. Medical history included tinnitus. Concomitant medications were not reported. On an unknown date in 2021, Patient did not get the second dose because he felt like his tinnitus that he normally has and has had for years has gotten worse. It was reported that Caller states that he got his first dose of the Pfizer COVID vaccine on 09Apr2021 and did not get the second dose because he felt like his tinnitus that he normally has and has had for years has gotten worse. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1682087
Sex: F
Age:
State:

Vax Date: 08/30/2021
Onset Date: 08/31/2021
Rec V Date: 09/08/2021
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: chest was tight; wheezy /wheezing; headache; exhaustion; chills; lung being foggy; woke up sweating; mild fever; This is a spontaneous report from a contactable consumer (patient herself). A 53-years-old female patient received bnt162b2 (BNT162B2; Lot number was not reported, Expiry date: Unknown), via an unspecified route of administration, as dose 1 single on 30Aug2021(at the age of 53 years) for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 31Aug2021, the patient experienced chest was tight, wheezy like a mild allergic reaction, but had no trouble breathing. This was the same reaction she has when she eats certain types of avocado. On an unspecified date in 2021, other symptoms she experienced included headache, exhaustion and chills. The patient described what she experienced post-vaccine as wheezing, lung being foggy, no pain but just mild wheezing and it did go away. She had to miss work yesterday and today. She woke up sweating and reported mild fever last night. Patient would like to know if her symptoms will be worse with the second dose of the Pfizer COVID-19 vaccine. The outcome of the events were reported as unknown. The lot number/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1682088
Sex: F
Age:
State:

Vax Date: 08/25/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 202105; Test Name: Covid; Test Result: Positive ; Comments: I had covid in May.

Allergies:

Symptom List: Unevaluable event

Symptoms: throat sore; feeling like losing her voice; congested; very thirsty; can't swallow; This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she took Pfizer COVID vaccine first dose on 25Aug2021, since then experiencing few symptoms but main thing, throat sore and feeling like losing her voice and it was reported as she no longer is feeling this way, "she was congested and very thirsty for one day, drank more water than usual and tired all weekend Saturday and Sunday and can't swallow all on an unspecified date in 2021, she went to get the shot on last Wednesday and she had COVID in May." On an unspecified date in May2021, the patient underwent lab tests and procedures which included COVID test was positive. The outcome of the events was unknown. The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1682089
Sex: F
Age:
State:

Vax Date: 08/04/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
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: Broke out in a rash/all over your arms and legs and torso; woke me up in the middle of night; This is a spontaneous report from a contactable consumer or other non hcp(patient).A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number- not reported), via an unspecified route of administration on 04Aug2021 as DOSE 1, SINGLE for covid-19 immunization.The patient's medical history and concomitant medications were not reported.It was reported that patient received her first dose of the Pfizer COVID vaccine on 04Aug2021 and was wondering if she can skip the second shot and receive the third shot if she qualifies .She was also asking how many weeks was it until she should get the second dose.She also stated, she had a side effect after 2 weeks on Aug2021 after the 1st dose on 04Aug2021. I broke out in a rash while I was sleeping and it woke me up in the middle of the night. I was contributing it to possibly the vaccine. I wanted to ask you if that was typical in side effects all over your arms and legs and torso 2 weeks later on Aug2021 . Should I get the 2nd dose after this adverse effect from the first dose.She also wondering if the second dose will have more severe side effects than the first dose.Patient stated it has been 4 weeks instead of 3 weeks since her first dose and was wondering if that is ok.The oucome of events was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1682090
Sex: F
Age:
State: FL

Vax Date: 08/30/2021
Onset Date: 08/31/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Diarrhea; hot flashes; body aches; nausea; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Aug2021 at 12:00 (at the age of 18-year-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Aug2021 at 00:00, the patient experienced diarrhea, hot flashes, body aches and nausea. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events diarrhea, hot flashes, body aches and nausea was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1682091
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: tingling in the arm and spine; Rash on both chest and stomach with bumps only on the chest.; injection site soreness; injection site redness; headache; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration Date: Unknown) via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, she had tingling in the arm and spine. Rash on both chest and stomach with bumps only on the chest. She experienced injection site soreness/redness and headache and noted that she felt that was normal. She has reached out to HCP and was told it does not sound normal and advised her to take Benadryl. Outcome of events was unknown. Information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1682092
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: My dad has been on Pfizer vaccine and he passed away from the complications because of it; He passed away, because of your vaccine; your vaccine, that doesn't work; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on an unspecified date, my dad has been on Pfizer vaccine and he passed away from the complications because of it, he passed away, because of your vaccine. Reporter stated, he passed away, because of your vaccine. He never went to other house. Nobody came to his house. Last time he left the house when he got the vaccine and he died from it. Reporter want all to hold up to your vaccine because your vaccine, that doesn't work. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: My dad has been on Pfizer vaccine and he passed away from the complications because of it; He passed away, because of your vaccine

Other Meds:

Current Illness:

ID: 1682093
Sex: F
Age:
State:

Vax Date: 08/31/2021
Onset Date: 09/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: severe pain; vomiting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (COMIRNATY,solution for injection,Batch/Lot number was not reported,expiry date was not reported), dose 2 via an unspecified route of administration on 31Aug2021 16:30, as DOSE 2,SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient previously took first dose of the vaccine 25 days ago bnt162b2 (COMIRNATY,solution for injection,Batch/Lot number was not reported,expiry date was not reported), via an unspecified route of administration on 06Aug2021 , as DOSE 1, SINGLE for covid-19 immunisation. It was reported that caller felt fine before the receiving the dose and feeling fine until 4:00am 01Sep2021 and the patient experienced severe pain, vomiting, diarrhea. Caller reported experiencing similar symptoms as after the first dose and said she has a telemedicine appointment in the morning and is trying to make sure she have done all her research. The hospital beds are so full and she is afraid and have a hard time getting admitted without proof. Caller said she was trying to find out if anyone has had these symptoms. The clinical outcome of the events were unknown. That information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

Date Died: 08/31/2021

ID: 1682094
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/31/2021
Rec V Date: 09/08/2021
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: My best friend just dies after taking the Pfizer Covid shot; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported and concomitant medications were not reported. On 31Aug2021, It was reported his best friend just dies after taking the pfizer covid shot. The outcome of event was fatal.; Reported Cause(s) of Death: My best friend just dies after taking the Pfizer Covid shot

Other Meds:

Current Illness:

Date Died:

ID: 1682095
Sex: F
Age:
State: UT

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: my friend's grandmother died; This is a spontaneous report from a contactable consumer reported for friend's grandmother via a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that her friend's grandmother died with the Pfizer COVID 19 vaccine on an unspecified date. It was not reported if an autopsy was performed. The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: my friend's grandmother died

Other Meds:

Current Illness:

ID: 1682096
Sex: F
Age:
State: GA

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210812; Test Name: Blood pressure; Result Unstructured Data: Test Result:shot up; Comments: At: 09:45

Allergies:

Symptom List: Nausea

Symptoms: Heaviness came over body; Blood pressure shot up; Very nervous and over; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1070) via an unspecified route of administration on 12Aug2021 at 09:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure abnormal (B/P), blood cholesterol abnormal and shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 12Aug2021 at 09:45, the patient had heaviness which came over body and blood pressure shot up. This made her very nervous and over. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included additional time watch after blood pressure taken by registered nurse. The clinical outcome of the event heaviness came over body, blood pressure shot up and very nervous and over were resolved on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1682097
Sex: U
Age:
State:

Vax Date: 08/31/2021
Onset Date: 09/01/2021
Rec V Date: 09/08/2021
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: 20210901; Test Name: Heart beat; Result Unstructured Data: Test Result:Fast; Comments: My heart is beating like little bit more fast

Allergies:

Symptom List: Injection site pain

Symptoms: My heart kind of hurts; Diarrhea; I am nauseous; I feel like vomiting; My heart is beating like little bit more fast; I feel very tired and sleepy and no energy; I feel very tired and sleepy and no energy; I feel very tired and sleepy and no energy; 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 VAC-CINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Sep2021, the patient experienced my heart kind of hurts diarrhea, nauseous; and feel like vomiting, heart is beating like little bit more fast, feel very tired and sleepy and no energy. It was reported that patient experienced side effects and don't know if i can go to work tomorrow. I received my dose of vaccine tomorrow and I have side effects today. How can I work tomorrow. I have diarrhea and I am nauseous, I have diarrhea and my heart kind of hurts and I feel very tired and sleepy and no energy. I feel like vomiting, like my body is not reactive to this dose of vaccine and this is my first dose I had yesterday and this is how I feel today and my heart is beating like little bit more fast than usual. The patient underwent lab tests and procedures which included heart rate: fast on 01Sep2021, my heart is beating like little bit more fast. 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: 1682098
Sex: F
Age:
State: PA

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210902; Test Name: Heart rate; Result Unstructured Data: Test Result:Slowing down some; Test Date: 20210831; Test Name: Heart rate; Result Unstructured Data: Test Result:Rapid; Comments: at 12:00

Allergies:

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

Symptoms: Heart palpitations; Rapid heart rate; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 31Aug2021 at 18:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included aortic valve replacement (AVR), asthma, hypertension, diabetes, high cholesterol and allergy to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 09Aug2021 at 18:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient previously received levofloxacin (LEVAQUIN) and amiodarone (MANUFACTURER UNKNOWN) and experienced drug allergy. On 31Aug2021 at 12:00 about 6-8 hours after injection, the patient had heart palpitations and rapid heart rate. It still happened on the day of report, but the heart rate was slowing down some. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rapid heart rate and heart palpitations were not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1682099
Sex: F
Age:
State:

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 09/08/2021
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: Lymph nodes swelling and have like 6 tumors; concerned getting Booster dose because don't want agitating lymphatic system and Irritation/she got lymph nodes; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer or other non HCP (Patient) reported that A female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation; Solution for Injection), dose 2 via an unspecified route of administration on 05Feb2021 (Batch/Lot Number: EL9264) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lymphoma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on an unspecified date (Batch/Lot Number: EL3302) for COVID-19 immunisation. It was reported that the "Patient called after her second dose of the Pfizer Vaccine (Covid-19 Vaccine) she got lymph nodes like lymph nodes are swelling and she was little bit concerned about getting her booster dose (Covid-19 Vaccine) because she already had lymphoma. She didn't want agitating her lymphatic system, so she just wanted to report this as well and just wanted the information about her lymphatic system and patient wanted to know if it same or expected irritation, lymph nodes have like 6 tumors, patient was trying to reduce lymph nodes swelling because she didnt want anything happened with her Lymphatic system.". The outcome of events reported as unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1682100
Sex: F
Age:
State: KY

Vax Date: 06/28/2021
Onset Date: 06/28/2021
Rec V Date: 09/08/2021
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: Abscessed tooth; Numbness around left eye; Swollen left side of face; Numbness around left eye and upper left side of lip; Swelling next to my eye; Sore jaw that hurt all day/ excruciating pain in jaw; Felt overall achy; Dose 1: 12Mar2021 and Dose 2 : 28Jun2021; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 28Jun2021 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, anxiety, restless leg syndrome and walnuts allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and bisoprolol/hydrochlorothiazide (MANUFACTURER UNKNOWN); for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 12Mar2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. On 29Jun2021 (Tuesday) and 30Jun2021 (Wednesday), the patient felt overall achy. On 01Jul2021 (Thursday), the patient woke up with a sore jaw that hurt all day. On 02Jul2021 (Friday), the patient woke to a swollen left side of face, excruciating pain in jaw, numbness around left eye and upper left side of lip. The patient could not move the numb areas and went to a dentist who said it was an abscessed tooth. On 03Jul2021 (Saturday), the patient woke up to more pain and swelling. She went to the walk-in clinic since it was the weekend. That doctor said she did not think it had anything to do with her teeth. She prescribed steroids which finally provided some relief. Two months later, the patient still had some swelling next to her eye. She had seen another dentist since, who said there was nothing wrong with her teeth. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with steroids (unspecified) and over the counter (OTC) (unspecified) pain relief. The clinical outcome of the event swelling next to my eye was not resolved. The clinical outcome of the events felt overall achy, sore jaw that hurt all day/excruciating pain in jaw, swollen left side of face, numbness around left eye and upper left side of lip and abscessed tooth were resolved with sequelae (also reported as resolved with lasting effects) on an unknown date in 2021.

Other Meds: Bupropion; Bisoprolol; Hydrochlorothiazide

Current Illness:

ID: 1682101
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: given an undiluted dose, so she got 6 times the intended dose.; This is a spontaneous report from a contactable consumer. A 20-years-old female patient (reporter's daughter) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 01Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient was given an undiluted dose, so she got 6 times the intended dose. She weighed 90 pounds, and caller was asking what she needs to be concerned about and look out for. Asked if she needs to take her to the ER (emergency room). The outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1682102
Sex: F
Age:
State: GA

Vax Date: 08/06/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
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: Broke into a skin rash over entire body; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Aug2021 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, heart murmur and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Jul2021 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Aug2021, within 18 hours of second vaccination, the patient broke into a skin rash over entire body. The adverse event did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with Ibuprofen (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL). The clinical outcome of the event broke into a skin rash over entire body was resolved on an unknown date in 2021.

Other Meds: IBUPROFEN

Current Illness:

ID: 1682103
Sex: F
Age:
State: OH

Vax Date: 08/30/2021
Onset Date: 09/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: palpitations; nausea; sore arm; fever; throwing up; eyes were hurting; This is a spontaneous report from a contactable consumer via medical information team. A 15-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number was not reported, expiry date was not reported) via an unspecified route of administration on 30Aug2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Sep2021, the patient the patient experienced some side effects such as palpitations, nausea, sore arm, and a little fever. She said she was throwing up, and her eyes were hurting. The reporter wants to know if that was normal, and how long they last. She also mentioned that her granddaughter was already starting to get better. The outcome for the events was recovering. The lot number for [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1682104
Sex: M
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: cold or flu; being achy; little bit of fever; cold or flu; This is a spontaneous report from a contactable other hcp. This consumer (patient's wife) reported for a male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date 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 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and first dose was fine. The patient experienced cold or flu, being achy, little bit of fever on an unspecified date. The patient's wife reported that she was calling to find out if this is a normal reaction or something that she needs to be concerned with. She says she wanted to know if it was a common side effect, which she kind of looked online but can't find this side effect listed. she was wondering if her son should have the second dose or not. Caller says that the rest of us did not experience anything like this, the first dose was fine, then for the second they had the regular symptoms of like cold or flu, being achy, a little bit of fever; but he of course has to be different. She says that her son is supposed to go back on the 15th to get his second one. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1682105
Sex: F
Age:
State: SC

Vax Date: 05/13/2021
Onset Date: 05/16/2021
Rec V Date: 09/08/2021
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: 2021; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Extreme fatigue.; Was sleeping about 16 hours a day; 4 days after vaccine, rash began on both inside of both forearms. The rash was raised red bumps, they spread to wrist over a period of 4 or 5 days; 4 days after vaccine, rash began on both inside of both forearms. The rash was raised red bumps, they spread to wrist over a period of 4 or 5 days; Severe itching and burning; Severe itching and burning; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 13May2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included genital herpes, migraines, mild arthritis and allergy to penicillin and Wheat. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamins unspecified from unknown date for an unknown indication and unknown if ongoing. The patient previously received levofloxacin (LEVAQUIN) and topiramate (TOPAMAX); both on unknown date for unspecified indication and experienced drug allergy. On 16May2021, 4 days after vaccine, the patient experienced rash on (both) inside of both forearms, the rash was raised red bumps, they spread to wrist over a period of 4 or 5 days and severe itching and burning and no blisters. It was cleared up in week 4. On 07Jun2021, the patient experienced extreme fatigue, was sleeping about 16 hours a day. Lasted about 3 weeks. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent COVID-19 test via Nasal Swab and the result was Negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rash on both inside of both forearms, the rash was raised red bumps, they spread to wrist and severe itching and burning and extreme fatigue, was sleeping about 16 hours a day was recovered on unknown date in Jun2021.

Other Meds:

Current Illness:

ID: 1682106
Sex: M
Age:
State: CA

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/08/2021
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: Dizziness within 30 minutes of injection; headache and severe muscle pain within 1 hour of injection; headache and severe muscle pain within 1 hour of injection; Low fever within 2 hours of injection; Fatigue and exhaustion within 6 hours of injection; Blurred vision within 12 hours of injection; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC 3183) via an unspecified route of administration in the right arm on 01Sep2021 at 11:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, COVID- 19 and allergic to peanuts and corn. Concomitant medications taken within two weeks of vaccination included salbutamol (ALBUTEROL), budesonide (MANUFACTURER UNKNOWN) and formoterol (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Sep2021, the patient experienced dizziness within 30 minutes of injection, headache and severe muscle pain within one hour of injection, low fever within two hours of injection, fatigue and exhaustion within six hours of injection, blurred vision within 12 hours of injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness within 30 minutes of injection, headache and severe muscle pain within one hour of injection, low fever within two hours of injection, fatigue and exhaustion within six hours of injection, blurred vision within 12 hours of injection was resolving at the time of this report.

Other Meds: ALBUTEROL [SALBUTAMOL]; BUDESONIDE; FORMOTEROL

Current Illness:

ID: 1682107
Sex: M
Age:
State: GA

Vax Date: 04/26/2021
Onset Date: 05/01/2021
Rec V Date: 09/08/2021
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: Started seeming like hearing was a bit muffled to ringing in the ear; Started seeming like hearing was a bit muffled from what it should be.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the left arm on 26Apr2021 at 02:00 (at the age of 51-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 17May2021 at 14:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and pre-diabetic. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications in two weeks, but it was unspecified. On an unknown date in May2021, the patient started seeming like hearing was a bit muffled from what it should be, then lead to about two weeks later to ringing in the ear that had not gone away. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event started seeming like hearing was a bit muffled from what it should be, then lead to about two weeks later to ringing in the ear was not recovered at the time of this report.

Other Meds:

Current Illness:

ID: 1682108
Sex: F
Age:
State: IL

Vax Date: 08/04/2021
Onset Date: 08/04/2021
Rec V Date: 09/08/2021
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: 2021; Test Name: Inflammatory marker test; Result Unstructured Data: Test Result:UNKNOWN RESULT; Comments: inflammatory markers checked; Test Date: 2021; Test Name: MRI Brain; Result Unstructured Data: Test Result:UNKNOWN RESULT; Comments: mri of brain done; Test Date: 20210817; Test Name: COVID-19 antibody test; Test Result: Positive

Allergies:

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

Symptoms: Became confused; Had transient global amnesia which lasted about 10 hours; Severe headaches; Eye pain; Feeling very tired; Dizziness; Right hand weakness; Facial numbness; Difficulty speak; Brain fog; Body aches; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169) via intramuscular route of administration in the right arm on 04Aug2021 at 09:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19 on an unknown date (prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications included losartan (MANUFACTURER UNKNOWN) and Hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On 04Aug2021 at 10:00, half hour after receiving the first dose of vaccine, the patient became confused, then had transient global amnesia which had lasted about 10 hours, severe headaches with eyes pain, felt very tired, dizziness, right hand weakness, some facial numbness and difficulty to speak, brain fog and body ache. On 17Aug2021, the patient underwent COVID-19 antibody test and the result was positive. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent Magnetic Resonance Imaging (MRI) of brain and inflammatory markers were checked and the results were unknown. Therapeutic measures were taken as a result of the events and included treatment with aspirin 81 mg daily for 1 week. The clinical outcome of the events confused and transient global amnesia were resolved on 04Aug2021, while the clinical outcome of the events, severe headaches, eye pain, felt very tired, dizziness, right hand weakness, facial numbness, difficulty to speak, brain fog and body ache were resolving at the time of this report.

Other Meds: LOSARTAN; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1682109
Sex: M
Age:
State: CO

Vax Date: 05/12/2021
Onset Date: 05/14/2021
Rec V Date: 09/08/2021
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: Reddish raised bump on wrist/ Reddish bumps appearing on stomach/ break out on elbow area with many bumps on both arms at this point/ bumps all over arms, legs, back, stomach, chest, all over body with many areas complete raised red area.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 12May2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was not aware of the known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the right arm on 21Apr2021 at 15:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 14May2021 (Friday night), the patient noticed a reddish raised bump on wrist. On 15May2021 (Saturday morning), the patient had multiple reddish bumps on the wrist area and that evening noticed the reddish bumps appearing on stomach. On Saturday night, the patient had break out on elbow area with many bumps on both arms at that point. On 16May2021 (Sunday morning), the patient had bumps all over arms, legs, back, stomach, chest and all over body with many areas complete raised red area (bumps combined together). On Sunday evening, the patient started taking prednisone. On 17May2021 (Monday evening), the bumps started reducing and by Wednesday into Thursday were pretty much gone. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported event which included treatment with prednisone (MANUFACTURER UNKNOWN) 20 mg, one every 10-12 hours. The clinical outcome of the event reddish raised bump on wrist/ reddish bumps appearing on stomach/ break out on elbow area with many bumps on both arms at this point/ bumps all over arms, legs, back, stomach, chest, all over body with many areas complete raised red area was resolved on an unknown date in May2021.

Other Meds:

Current Illness:

ID: 1682110
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 08/21/2021
Rec V Date: 09/08/2021
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: 20210817; Test Name: COVID-19 test; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: consistent headache since 3rd vaccination; consistent headache since 3rd vaccination; consistent headache since 3rd vaccination; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had been tested for COVID-19. On 17Aug2021, the patient underwent COVID-19 test via nasal swab and the result was negative. From 21Aug2021 at 12:00, the patient experienced consistent headache since third vaccination. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event consistent headache since third vaccination was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1682111
Sex: M
Age:
State:

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: fatigue; nausea; no taste; headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (Comirnaty, Formulation: solution for injection, Lot/Batch not provided, expiry date not provided), via an unknown route of administration, administered on 24Aug2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose on 24Aug2021, Since then consumer confirms that since vaccination he has experienced fatigue, nausea, no taste and a headache. He was still experiencing these symptoms to date and he confirms he would like to know if this is normal. The patient also enquired whether should he got tested for the actual virus. The outcome of events was not recovered. That information on the Lot/batch number has been requested

Other Meds:

Current Illness:

ID: 1682112
Sex: F
Age:
State: GA

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Soreness, Aching; Headache; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the right arm on 01Sep2021 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL) and unspecified birth control medication; taken for unknown indication from unknown dates and unknown if ongoing. On 01Sep2021, the patient experienced soreness, aching and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events soreness, aching and headache was not resolved at the time of report.

Other Meds: TYLENOL

Current Illness:

ID: 1682113
Sex: F
Age:
State:

Vax Date: 04/06/2021
Onset Date: 04/15/2021
Rec V Date: 09/08/2021
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: Crohn's disease aggravated; This is a solicited report from non-Pfizer sponsored program, received from a contactable consumer, the patient, based on information received by Pfizer (21K-163-4051022-00). A 62-year-old adult female received the first dose of intramuscular BNT162b2 (TOZINAMERAN, solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on 06Apr2021 (at 62-years-old) for COVID-19 immunisation. The patient also started to receive subcutaneous adalimumab (HUMIRA, solution for injection in pre-filled pen, citrate free; batch/lot and expiry information not provided) unspecified dose at an unspecified frequency from an unspecified date for moderate to severe adult Crohn's disease. There was no medical history or concomitant medications reported. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (TOZINAMERAN, solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on 16Mar2021 (at 62-years-old). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 15Apr2021, the patient experienced Crohn's disease aggravated. The action taken with adalimumab was unknown. The outcome of the event Crohn's disease aggravated was recovered on an unspecified date in 2021. The reporter's assessment of the causal relationship of the event with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's causality for the event(s) of CROHN'S DISEASE FLARE UP AFTER COVID 19 VACCINE with HUMIRA(ADALIMUMAB) was a reasonable possibility. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information, the event chron's disease aggrevated is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.

Other Meds:

Current Illness:

ID: 1682114
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: chest ache (not feeling well in chest area)/ chest was aching; Dull cramp in the chest; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number not reported) via an unspecified route of administration on an unknown date as dose 1, single for COVID- 19 Immunisation. Relevant medical history and concomitant medications was not reported. On an unknown date, the patient had her "first dose of the Pfizer COVID-19 vaccine and experienced chest ache (not feeling well in chest area) which felt like a dull cramp in the chest which was constant and did not go away". Further, the patient mentioned that she was feeling fine but her chest was aching." The patient wanted to know if this had been reported as a side effect with the Pfizer COVID-19 vaccine. The report was considered as non serious. The outcome of the event of dull cramp in the chest was recovered on an unknown date and other event of chest pain was unknown. Lot number of the vaccine (BNT162B2) was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1682115
Sex: F
Age:
State: MI

Vax Date: 08/01/2021
Onset Date: 08/28/2021
Rec V Date: 09/08/2021
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: Nausea; Vomiting; Headache; Clavicle tenderness; Arm pain; Fatigue; This is a spontaneous report from a contactable nurse, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 07:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and clindamycin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 28Aug2021 at 16:45, the patient experienced nausea, vomiting, headache, clavicle tenderness, arm pain and fatigue. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, vomiting, headache, clavicle tenderness, arm pain and fatigue were resolving at the time of this report.

Other Meds:

Current Illness:

ID: 1682116
Sex: F
Age:
State: FL

Vax Date: 08/28/2021
Onset Date: 08/29/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sense of taste has been affected/ taste buds were markedly dulled at breakfast Sunday morning/Sense of taste still has not returned. The difference between her sense of taste before and after 2nd shot is substantial; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fc3182) via an unspecified route of administration in the left arm on 28Aug2021 at 17:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, nickel sensitivity, serious side effects from some medications; internal bleeding and hyponatremia. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any new medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fc3180) via an unspecified route of administration in the left arm on 07Aug2021 at 17:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. On 29Aug2021 at 09:00, the patient experienced sense of taste has been affected. The patient received 2nd shot at approximately 18:00 on Saturday, and was shocked to find that the taste buds were markedly dulled at breakfast Sunday morning. It was reported that the patient was writing this at 06:00 Tuesday morning and the sense of taste still has not returned. The difference between her sense of taste before and after the 2nd shot is substantial, which alarms the patient. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sense of taste has been affected/ taste buds were markedly dulled at breakfast Sunday morning/Sense of taste still has not returned. The difference between her sense of taste before and after 2nd shot is substantial were not resolved at the time of this report.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am