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: 1751964
Sex: F
Age: 59
State: MN

Vax Date: 07/26/2021
Onset Date: 07/26/2021
Rec V Date: 10/01/2021
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: Bump in arm; Big red whelp; mild ache in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Bump in arm), RASH (Big red whelp) and ARTHRALGIA (mild ache in shoulder) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced ARTHRALGIA (mild ache in shoulder). On 16-Aug-2021, the patient experienced PERIPHERAL SWELLING (Bump in arm) and RASH (Big red whelp). At the time of the report, PERIPHERAL SWELLING (Bump in arm), RASH (Big red whelp) and ARTHRALGIA (mild ache in shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant and treatment information were reported by the reporter This case was linked to MOD-2021-329763 (Patient Link).

Other Meds:

Current Illness:

ID: 1751965
Sex: F
Age:
State:

Vax Date: 09/07/2021
Onset Date:
Rec V Date: 10/01/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Small side effects), FATIGUE (Tiredness), VACCINATION SITE PAIN (Injection site hurt), MYALGIA (Aches) and PYREXIA (Fever for a day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Small side effects), FATIGUE (Tiredness), VACCINATION SITE PAIN (Injection site hurt), MYALGIA (Aches) and PYREXIA (Fever for a day). At the time of the report, VACCINATION COMPLICATION (Small side effects), FATIGUE (Tiredness), VACCINATION SITE PAIN (Injection site hurt) and MYALGIA (Aches) outcome was unknown and PYREXIA (Fever for a day) had resolved. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1751966
Sex: F
Age:
State: OH

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Local reaction at the site of the injection/ delayed reaction that started a week after getting the vaccine; Pain comes with pressure / Pain when moving the arm; Pain at the injection site and when moving the arm / local reaction at the site of the injection that is painful/ is painful when she touches it or lays on it at night/ when she rubbs it, feels pains in the whole area; Glands were sore under arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (Local reaction at the site of the injection/ delayed reaction that started a week after getting the vaccine), PAIN IN EXTREMITY (Pain comes with pressure / Pain when moving the arm), VACCINATION SITE PAIN (Pain at the injection site and when moving the arm / local reaction at the site of the injection that is painful/ is painful when she touches it or lays on it at night/ when she rubbs it, feels pains in the whole area) and LYMPHADENOPATHY (Glands were sore under arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE REACTION (Local reaction at the site of the injection/ delayed reaction that started a week after getting the vaccine), PAIN IN EXTREMITY (Pain comes with pressure / Pain when moving the arm), VACCINATION SITE PAIN (Pain at the injection site and when moving the arm / local reaction at the site of the injection that is painful/ is painful when she touches it or lays on it at night/ when she rubbs it, feels pains in the whole area) and LYMPHADENOPATHY (Glands were sore under arm). At the time of the report, VACCINATION SITE REACTION (Local reaction at the site of the injection/ delayed reaction that started a week after getting the vaccine), PAIN IN EXTREMITY (Pain comes with pressure / Pain when moving the arm), VACCINATION SITE PAIN (Pain at the injection site and when moving the arm / local reaction at the site of the injection that is painful/ is painful when she touches it or lays on it at night/ when she rubbs it, feels pains in the whole area) and LYMPHADENOPATHY (Glands were sore under arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient had vaccine 5 and a half weeks ago and had a local reaction at the site of the injection that was painful when she touched it or laid on it at night. At the time her glands were sore under her arm and had pain at the injection site and when moving the arm. That was delayed reaction that started a week after getting the vaccine and it's been going on for weeks. The pain comes with pressure, when she rubs it, felt pain in the whole area. No concomitant medications were reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1751967
Sex: F
Age: 64
State: FL

Vax Date: 01/31/2021
Onset Date: 02/01/2021
Rec V Date: 10/01/2021
Hospital: Y

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

Lab Data: Test Date: 20210429; Test Name: ECHO; Result Unstructured Data: Test was performed on 16th March; Test Date: 20210429; Test Name: Pulse Rate; Result Unstructured Data: Irregular pulse of 130 or 140; Test Date: 20210429; Test Name: Platelet level; Result Unstructured Data: abnormal platelet level 105,000 on 7th March 2021; Test Date: 20210429; Test Name: platelets count; Result Unstructured Data: platelets count of 137,000 [normal level: 150,000-450,000] on 6-JUN-2021; Test Date: 20210429; Test Name: Troponin; Result Unstructured Data: 0.0033 [Normal: lower than 0.045]

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Ventricular Tachycardia (VTach); Atrial Fibrillation (AFib); Hot to touch; she has had abnormal level of her liver function; Painful at the Injection site; Irregular heart beat; Vitamin D decreased; Platelet count decreased; Arm was swollen; Redness; thought it was cellulitis; This spontaneous case was reported by a patient and describes the occurrence of VENTRICULAR TACHYCARDIA (Ventricular Tachycardia (VTach)) and ATRIAL FIBRILLATION (Atrial Fibrillation (AFib)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Overweight. Concomitant products included DIPHTHERIA VACCINE from 09-Mar-2021 to an unknown date for an unknown indication. On 31-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE CELLULITIS (thought it was cellulitis), VACCINATION SITE SWELLING (Arm was swollen) and VACCINATION SITE ERYTHEMA (Redness). On 07-Mar-2021, the patient experienced VENTRICULAR TACHYCARDIA (Ventricular Tachycardia (VTach)) (seriousness criteria hospitalization and medically significant), ATRIAL FIBRILLATION (Atrial Fibrillation (AFib)) (seriousness criteria hospitalization and medically significant), PLATELET COUNT DECREASED (Platelet count decreased) and VITAMIN D DECREASED (Vitamin D decreased). On 17-May-2021, the patient experienced HEART RATE IRREGULAR (Irregular heart beat). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to touch), HEPATIC FUNCTION ABNORMAL (she has had abnormal level of her liver function) and VACCINATION SITE PAIN (Painful at the Injection site). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) ongoing since an unknown date for Vaccination site cellulitis, at a dose of 1 dosage form; MUPIROCIN ongoing since an unknown date for Vaccination site cellulitis, at a dose of 1 dosage form; ACRIVASTINE (BENADRYL ALLERGY RELIEF) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form; APIXABAN (ELIQUIS) ongoing since an unknown date for Atrial fibrillation, at a dose of 1 dosage form, blood thinner; VITAMIN D NOS ongoing since an unknown date for Vitamin deficiency, at a dose of 1 dosage form and METOPROLOL ongoing since an unknown date for Adverse event, at a dose of 25 mg as required. On 07-Mar-2021, VENTRICULAR TACHYCARDIA (Ventricular Tachycardia (VTach)) and ATRIAL FIBRILLATION (Atrial Fibrillation (AFib)) had resolved. At the time of the report, HEART RATE IRREGULAR (Irregular heart beat), VACCINATION SITE CELLULITIS (thought it was cellulitis) and VITAMIN D DECREASED (Vitamin D decreased) had resolved and VACCINATION SITE WARMTH (Hot to touch), PLATELET COUNT DECREASED (Platelet count decreased), HEPATIC FUNCTION ABNORMAL (she has had abnormal level of her liver function), VACCINATION SITE PAIN (Painful at the Injection site), VACCINATION SITE SWELLING (Arm was swollen) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Echocardiogram: normal (normal) Test was performed on 16th March. On 29-Apr-2021, Heart rate: 130 or 140 (abnormal) Irregular pulse of 130 or 140. On 29-Apr-2021, Platelet count: 105,000 (abnormal) abnormal platelet level 105,000 on 7th March 2021 and low (abnormal) platelets count of 137,000 [normal level: 150,000-450,000] on 6-JUN-2021. On 29-Apr-2021, Troponin: 0.0033 (normal) 0.0033 [Normal: lower than 0.045]. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient went on to consult with her HCP thought of vaccination site was Cellulitis and it had Infiltrated the tissue at injection site. Patient stated that she has had abnormal level of her liver function. The doctor performed a CAT scan and blood work and was diagnosed with Arrhythmia with Atrial Fibrillation and Ventricular Tachycardia. On 09 Mar 2021, Patient was told to get the Pneumonia Vaccine along with DPT [diphtheria] vaccine. Patient received both of the vaccine in each arm. Patient had no idea which vaccine was given on the left arm. But again her left arm was swollen, redness, and painful. She stated that in the past never had blood work done. But since the incident, her blood work had been abnormal. Particularly her platelets had been dropping. So patient said her blood work was done on March 7, March 9, April 29th (platelets level were 105,000 then normal), May 3, May 12, and May 17th. She had followed up with Hematologist who informed her that this go eventually go away and it can come back to normal level. She also confirmed that they did not take any medicine or over the counter medicine prior to receiving COVID-19 vaccine and said that her HCP are looking into to see if she can potentially get the 3rd dose or not of the Moderna COVID-19 vaccine. Patient stated that she had risk factor of Over weight. This case concerns a 65-year-old female patient with no details on previous relevant medical history, who experienced the unexpected serious events of Atrial fibrillation and Ventricular tachycardia and the non-serious AESI of Platelet count decreased with other associated non serious events after (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The onset of the events occurred approximately 1 month and 8 days after the second dose. The rechallenge is not applicable, since the events occurred after the second dose. The benefit-risk relationship of vaccine is not affected by this report. This case was linked to MOD-2021-330876 (Patient Link).; Sender's Comments: This case concerns a 65-year-old female patient with no details on previous relevant medical history, who experienced the unexpected serious events of Atrial fibrillation and Ventricular tachycardia and the non-serious AESI of Platelet count decreased with other associated non serious events after (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The onset of the events occurred approximately 1 month and 8 days after the second dose. The rechallenge is not applicable, since the events occurred after the second dose. The benefit-risk relationship of vaccine is not affected by this report.

Other Meds: DIPHTHERIA VACCINE

Current Illness:

ID: 1751968
Sex: M
Age: 69
State: PA

Vax Date: 02/02/2021
Onset Date: 08/11/2021
Rec V Date: 10/01/2021
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: went back into Afib.; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (went back into Afib.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 016M20A and 027C21A) for COVID-19 vaccination. The patient's past medical history included Atrial fibrillation and Heart valve replacement. Concomitant products included TACROLIMUS (PROGRAF), BUPROPION HYDROCHLORIDE (WELLBUTRIN), LEVOTHYROXINE SODIUM (SYNTHROID), LINAGLIPTIN (TRADJENTA), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), ROSUVASTATIN, AMLODIPINE, POLYCARBOPHIL CALCIUM (FIBER), ASPIRIN [ACETYLSALICYLIC ACID] and VITAMINS NOS for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced ATRIAL FIBRILLATION (went back into Afib.) (seriousness criterion medically significant). The patient was treated with WARFARIN for Atrial fibrillation, at an unspecified dose and frequency and METOPROLOL for Atrial fibrillation, at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (went back into Afib.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On the day after receiving the third shot, he went into Afib again. Husband is scheduled for a chock on Friday. This case concerns a 70 year-old male patient with medical history of atrial fibrillation and heart value replacement x2, who experienced the unexpected serious event of Atrial fibrillation. The event occurred 1 day after the third dose of mRNA-1273 vaccine. The event is Medically significant based on reported treatment with medications. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact; Sender's Comments: This case concerns a 70 year-old male patient with medical history of atrial fibrillation and heart value replacement x2, who experienced the unexpected serious event of Atrial fibrillation. The event occurred 1 day after the third dose of mRNA-1273 vaccine. The event is Medically significant based on reported treatment with medications. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds: PROGRAF; WELLBUTRIN; SYNTHROID; TRADJENTA; FLOMAX [MORNIFLUMATE]; ROSUVASTATIN; AMLODIPINE; FIBER; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMINS NOS

Current Illness:

ID: 1751969
Sex: M
Age:
State: NM

Vax Date: 07/16/2021
Onset Date: 07/16/2021
Rec V Date: 10/01/2021
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: Test Date: 20210630; Test Name: cholesterol; Result Unstructured Data: Test Result:205; Test Date: 20210716; Test Name: headache; Result Unstructured Data: Test Result:low grade

Allergies:

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

Symptoms: was on couch coughing; felt like crap; right calf is swollen beyond belief; whole body feels like it has a temperature, but he does not have a temperature; low grade headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FA6780, Expiry date was not reported) via an unspecified route of administration, administered in arm left on 16Jul2021 11:00 (at the age of 74-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The reporter states that 4 weeks prior on 30Jun2021 he received a Shingles shot, but unable to provide NDC, Lot, or expiry for Shingles shot. Has had flu shots, pneumonia shots, and shingles shots, but no rabies shots yet. Unable to provide NDC, Lot, or expiry for any past shots. No Additional Vaccines Administered on Same Date with the Pfizer vaccine considered as suspect. The reporter reported that, he received the Pfizer COVID vaccine dose on Friday (16Jul2021) at 11am. On 16Jul2021 15:00 he was on the couch coughing and from last Friday evening, Saturday, and Sunday he felt like crap. His right calf was swollen beyond belief, and he was on the way to the hospital after this phone call. His whole body feels like it has a temperature, but he did not have a temperature. He also had a low-grade headache. The patient underwent lab tests and procedures which included blood cholesterol: 205 on 30Jun2021, headache: low grade on 16Jul2021. The outcome for the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1751970
Sex: F
Age:
State:

Vax Date:
Onset Date: 07/13/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Date: 20210714; Test Name: Nasopharyngeal culture; Test Result: Negative ; Test Date: 20210714; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and can't eat But a few bites of food here and there. Lost over 16 lbs . I took first dose of pfizer; Severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and can't eat But a few bites of food here and there. Lost over 16 lbs . I took first dose of pfizer; Severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and can't eat But a few bites of food here and there. Lost over 16 lbs . I took first dose of pfizer; Severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and can't eat But a few bites of food here and there. Lost over 16 lbs . I took first dose of pfizer; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-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 an unspecified date as dose 1, single for covid-19 immunisation. Medical history included allergy to latex, all forms of formaldehyde. The concomitant medications of patient were not reported. The patient previously took formaldehyde and experienced drug hypersensitivity. Patient did not have Covid prior vaccination and Covid was tested post vaccination. On 13Jul2021, the patient experienced severe projectile vomiting for 6 days and 2 weeks later still feeling nauseous and cannot eat but a few bites of food here and there. She lost over 16 lbs. The patient underwent lab tests and procedures which included pharyngeal abscess: negative on 14Jul2021 and Nasal Swab: on 14Jul2021 and result was negative. Patient did not receive any treatment for adverse events. The outcome of all events was recovered with sequelae on an unspecified date of Jul2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1751971
Sex: M
Age:
State: LA

Vax Date: 07/26/2021
Onset Date: 07/27/2021
Rec V Date: 10/01/2021
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: body hurts; This is a spontaneous report from a contactable consumer (patient's mother). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0164, expiry date: unknown) via unspecified route of administration, in right arm on 26Jul2021 (age at vaccination: 17-years), as dose 1, single for covid-19 immunisation. Vaccination facility type was physician office. Patients medical history included anxiety from an unspecified date and unknown if ongoing.. Concomitant medications included ongoing multivitamins 1DF daily, taken for unspecified indication. Patient experienced "body hurts" on 27Jul2021. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Her son also received the second part of his 16-years-old shots yesterday. He had to wait until he was 17 to get the second part. The outcome of event was unknown. Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness: Anxiety

ID: 1751972
Sex: F
Age:
State:

Vax Date: 07/26/2021
Onset Date: 07/27/2021
Rec V Date: 10/01/2021
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: dizziness; nausea; headache; chills; tired; fevers all day; everything hurts; she still feels bad and she doesn't know how long it will take for her to not feel bad; This is a spontaneous report received from a contactable consumer or other non hcp. A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration on 26Jul2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Jul2021 the patient experienced dizziness, nausea, headache, chills, tired, fevers all day, everything hurts, she still feels bad, and she doesn't know how long it will take for her to not feel bad. Clinical course was reported as 29-year-old female, received the Pfizer COVID-19 Vaccination 2 days ago. She feels bad with dizziness, nausea, headache, chills, tired, as well as fevers all day yesterday. She also reports everything hurts. She will get others sick due to her symptoms she is experiencing after her vaccination. She starts working on Friday. She asks if she will have to go to work on Friday if she is not feeling well still. She does not want to get others sick. The clinical outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1751973
Sex: M
Age:
State: FL

Vax Date: 07/26/2021
Onset Date: 07/27/2021
Rec V Date: 10/01/2021
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: Severe diarrhea for the past 4 days; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jul2021 16:00 (age at vaccination 61 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to 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 vaccines within four weeks prior to the vaccination. Patient visited doctor or other healthcare professional office/clinic visit. The patient had no allergies. The patient experienced severe diarrhea for the past 4 days on 27Jul2021 8 hrs hours after vaccine application. Patient received treatment for reported event (Prescription). The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1751974
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 10/01/2021
Hospital: Y

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

Lab Data: Test Name: CAT scan; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID test; Test Result: Positive

Allergies:

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

Symptoms: Some pressure sores on my backside; Infected; shortness of breath; I have blood clots in both my lungs and legs; I have blood clots in both my lungs and legs; blood in my stool; taking medication to coat her stomach because I was having terrible pains; COVID; This is a spontaneous report from a contactable consumer reported for herself via a Pfizer-sponsored program. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) single dose for COVID-19 immunization, palbociclib (IBRANCE, strength: 100 mg) 100 mg for secondary malignant neoplasm of right lung; all other information included route, frequency and start date were unspecified. Medical history included secondary malignant neoplasm of right lung. The patient's concomitant medications were not reported. The patient stated that on an unspecified date, they had COVID at the house, all three of them had it. She hadn't been able to go to her oncology appointment. Patient also stated that she was taking care of the other members of her household that were sicker than her. Patient reported right now was in the hospital, was having some battles. She had COVID in July. She was vaccinated and got a mild case of it. She got the Pfizer vaccine. Since then, she wasn't feeling too great. She went on the 30th and had some pressure sores on her backside and It got infected. The doctor told her to discontinue palbociclib until the infection was handled. Patient was feeling shortness of breath and had a CAT scan. She had blood clots in both her lungs and legs, was put on blood thinners and ended up with blood in her stool. She was taking medication to coat her stomach because she was having terrible pains. Patient stated they were talking about keeping her on blood thinners for the rest of her life and It's overwhelming. Lab test also included: positive COVID test. The action taken for palbociclib was temporarily withdrawn and the outcome of the events were unknown. No follow-up attempts are needed. No further information is expected. Follow-up (15Sep2021): New information received from a Pfizer-sponsored program from a contactable consumer (patient) reported that: product detail, new suspect product (BNT162B2), new events (some pressure sores on her backside and It got infected, shortness of breath, blood clots in both her lungs and legs, blood in her stool, taking medication to coat her stomach because she was having terrible pains).

Other Meds:

Current Illness:

ID: 1751975
Sex: U
Age:
State: CA

Vax Date: 08/11/2021
Onset Date: 08/01/2021
Rec V Date: 10/01/2021
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: slight fever; diarrhea; sneezing; stuffy; feeling "yucky"; sores in mouth; swollen mouth; sore throat; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender 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 11Aug2021 at single dose for COVID-19 immunisation. Medical history included had COVID-19 in 2020. The patient's concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced slight fever, diarrhea, sneezing, stuffy, feeling yucky, sores in mouth, swollen mouth and sore throat. Event took place after use of product. The clinical outcome of events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1751976
Sex: M
Age:
State: FL

Vax Date: 08/02/2021
Onset Date: 08/07/2021
Rec V Date: 10/01/2021
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: Loose very foul smelling stool.; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 74-years-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 02Aug2021 14:00 (at the age of 74-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included none. The patient concomitant medications were not reported. Patient had no known allergies. Patient received vaccine facility in pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced loose very foul smelling stool. on 07Aug2021. Treatment was received for the event as pepto bismol per label. The outcome of the event was reported as recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1751977
Sex: M
Age:
State: TX

Vax Date: 08/13/2021
Onset Date: 08/14/2021
Rec V Date: 10/01/2021
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: I have a real bad pain in my neck at the bottom by my shoulder on the same side of the vaccine; It can't move my head that hurts it is excruciating pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Aug2021 (at the age of 60 years old) as dose 2, single for COVID-19 immunisation. Medical history included osteoarthritis from an unknown date and unknown if ongoing, bipolar from an unknown date and unknown if ongoing. Patient had concomitant medication (patient stated, "Yes" (Further clarification unknown)). Patient historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Jul2021 (at the age of 60 years old) as single for COVID-19 immunisation. The patient experienced as, i have a real bad pain in my neck at the bottom by my shoulder on the same side of the vaccine, it can't move my head that hurts it is excruciating pain on 14Aug2021. Reporter stated, It was the Pfizer Covid-19 Vaccine, the second dose. Patient had both shot. Patient got the shot last night and when he woke up in morning he have a real bad pain in his neck at the bottom by his shoulder on the same side of the vaccine. It ca not move my head that hurts it was excruciating pain. Event start date: patient stated "14Aug2021(Confirmed as 14Aug2021) less than 24 hours later". No treatment were received for the events (Consumer stated, "For my pain, no"). Outcome of all the events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1751978
Sex: F
Age:
State: NY

Vax Date: 06/04/2021
Onset Date:
Rec V Date: 10/01/2021
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: didn't feel well; couldn't work for several days; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on 04Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 infection prior to getting the COVID vaccine from Jun2021 to an unknown date. The patient's concomitant medications were not reported. The patient mentioned that she was not able to get the second dose on her scheduled date as she had a lot going on and thought that she may have had antibodies enough since she already had COVID-19 infection before aside from the vaccine. On an unspecified date, the patient mentioned that she didn't feel well and couldn't work for several days after the vaccine but nothing out of the ordinary. The patient wanted to know if she can still get the second dose of the Pfizer BioNTech COVID-19 vaccine because she was worried about the Delta variant. She called today to question about getting the second dose of the vaccine and it being past six weeks. She was planning on getting this second dose. The patient wanted a clear answer regarding the effectiveness of the 2nd shot of the vaccine once administered past 6 weeks. It was just they have no information on how effective it would be. Outcome for all the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up. Follow-up activities completed. Batch/lot number not available for [Vaccine BNT162B2], No further information is expected.

Other Meds:

Current Illness:

ID: 1751979
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: has a spotted skin rash all around her body; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date in 2021 (Lot number and Expiry Date was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Lot number and Expiry Date was not reported) as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced a spotted skin rash all around her body, occurred two weeks after the second dose. The seriousness of the events was considered as non-serious. The outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1751980
Sex: U
Age:
State:

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 10/01/2021
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: soreness at the injection site; tiredness; occasional nauseous; gassiness; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Aug2021 as dose 1, single for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported as a Pfizer Employee, patient received the first dose of the Pfizer Vaccination on Tuesday 10Aug2021. Patient instructed to expect symptoms very similar to an Influenza vaccination that would last a 1-2 days. Patient would like to report on 10Aug2021 extended tiredness and gassiness (flatulence) more than 48 hours after receiving the first Covid-19 dose. also experienced soreness at the injection site, which radiated through the front and back of shoulder as well as occasional nauseous. The soreness and nausea have subsided, but the tiredness and gassiness has not. symptoms are worse in the evening/night than they are in the morning and afternoon. did not experience these symptoms until approximately 7 hours after the first injection was administered. Outcome for the event soreness at the injection site and occasional nauseous was resolved on unspecified date in 2021 and for remaining events outcome was reported as not resolved at the time of this report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up (29Sep2021): This follow-up is being submitted to notify that the 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:

Current Illness:

ID: 1751981
Sex: F
Age:
State: FL

Vax Date: 05/07/2021
Onset Date: 07/01/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Date: 20210719; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: I get small, red circular bumps that are extremely itchy; I get small, red circular bumps that are extremely itchy; hives; At first I thought I may just be allergic to a dye in the tablets but my son developed the same type of reaction after receiving his first covid vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 07May2021 at 16:15 (04:15 PM) (at the age of 33-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included rheumatoid arthritis, COVID-19 (if COVID prior vaccination Yes). The patient received concomitant medication in two weeks which included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was COVID tested post vaccination. The patient previously took ibuprofen (was not previously but now ibuprofen) and experienced drug allergy; first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 16Apr2021 at 03:45 PM as dose 1, single for COVID-19 immunization. On 01Jul2021 at 20:00 (08:00 PM), the patient experienced I get small, red circular bumps that are extremely itchy, hives, at first I thought I may just be allergic to a dye in the tablets but my son developed the same type of reaction after receiving his first covid vaccine. Adverse event: Developed an allergy to ibuprofen. Everytime I take ibuprofen I develop hives. I get small, red circular bumps that are extremely itchy. At first I thought I may just be allergic to a dye in the tablets but my son developed the same type of reaction after receiving his first covid vaccine (and he takes a different brand of ibuprofen). The patient underwent lab tests and procedures which included SARS-COV-2 test was negative (nasal swab) on 19Jul2021. The patient received Benadryl (just self-medicated with Benadryl each time) as treatment medication for all the events. Outcome of all the events was recovered with sequelae (recovered with lasting effects). Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1751982
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/18/2021
Rec V Date: 10/01/2021
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: had a breakthrough infection; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on 18Aug2021 the patient experienced had a breakthrough infection. 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: 1751983
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: Swelling of his throat; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported, expiry date was unknown), via an unspecified route of administration, administered in the right arm on an unspecified date as dose 1, single for COVID-19 immunization. Patient also received ceftriaxone sodium (ROCEPHIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced swelling of his throat on an unspecified date. Since unspecified date patient was allergic to Rocephin and it was not ongoing. Outcome of the event was unknown. Follow-up attempts are completed. No further information is expected

Other Meds:

Current Illness:

ID: 1751984
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 08/19/2021
Rec V Date: 10/01/2021
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: Heart palpitations; a strange hard beating in his chest; panic attack; This is a spontaneous report from a contactable consumer (Patient's wife). This consumer reported for her husband. A 41-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration, administered in Arm on an unspecified date in 2021 (at the age of 41-year-old ) as single dose for COVID-19 immunisation. The patient medical history was reported as none. About family history she has not heard of anything and is not 100 percent sure. Concomitant medications were not reported. Prior Vaccinations, the patient had not received any other vaccine within 4 weeks. No additional vaccines was administered on same date of the Pfizer suspect. Patient historic vaccine included first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date (at the age of 41-year-old) as single dose for covid-19 immunisation. On 19Aug2021 (guessing in the afternoon), the patient experienced heart palpitations, a strange hard beating in his chest and panic attack. As per the report, caller is a Pfizer employee calling on behalf of her husband. It is only suspected, but the call is regarding the Pfizer Covid-19 vaccine. She is actually reporting it today because he just suspected it today. He did get the vaccine back in Apr2021. He is getting some heart palpitations and does not know if it a true correlation. Today. Today was the day he told her he was feeling this way. He was just informing her today that he felt heart palpitations. It was like a strange hard beating in his chest. It was kind of like a panic attack. That is how he described it. Started today, she is guessing in the afternoon. He didn't give too many details. He has always been fully healthy. States they were vaccinated around the same time and that it was probably May2021 or Apr2021. States that he had both doses. She is unsure if he got the vaccines in the right or left arm. Patient was concerned and was going to probably see a heart doctor which to her, felt very concerning. Patient did not visit to emergency room or physician office due to adverse event. No relevant test was performed. The outcome of events was unknown. Follow-up attempts are completed. No further information expected.

Other Meds:

Current Illness:

ID: 1751985
Sex: U
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: experienced soreness for at least 24 hours in her left shoulder; COVID Vaccine 3rd Dose Booster; COVID Vaccine 3rd Dose Booster; This is a spontaneous report from a contactable consumer (patient). A patient of an unknown age and gender received T162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: unknown), via an unknown route of administration in left arm on an unknown date as dose 3, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: unknown) on an unknown date as historical vaccine as dose 1 and 2, single for COVID-19 Immunization. On an unknown date, the patient experienced soreness for at least 24 hours in her left shoulder. This soreness was more than the 1st and 2nd shots. There were no other unusual symptoms. Event took place after use of product. 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: 1751986
Sex: F
Age:
State: NM

Vax Date: 05/16/2021
Onset Date: 05/17/2021
Rec V Date: 10/01/2021
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: X-ray; Result Unstructured Data: Test Result:X-ray showed no arthritis

Allergies:

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

Symptoms: mild back spasm in morning and severe back spasm by evening; sudden stabbing pain; spasm in her left calf; spasm in her left calf; difficult to walk; unusual aches in legs/feet; severe pain in her right knee; This is a spontaneous report from a contactable consumer (patient). A 62-year-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0183), via an unspecified route of administration, administered in right arm on 16May2021 at 13:00 as dose 2, single for COVID-19 immunisation (age at vaccination was 62 years). The patient was not pregnant at time of vaccination. The patient medical history included ACL repair on left knee, hypothyroidism from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing, has not bothered her. She had no known allergies. She was not diagnosed with COVID-19 prior to vaccination, and not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccine in four weeks prior COVID vaccine. Concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported, cobamamide (VITAMIN B12 (COBAMAMIDE)) taken for an unspecified indication, start and stop date were not reported and Beta vulgaris, Brassica spp., Cyanocobalamin, Folic acid, Pyridoxine hydrochloride, Saccharomyces cerevisiae (VEGAN B12) taken for an unspecified indication, start and stop date were not reported. The patient's concomitant medication included Levothyroxine, vitamin B12, Vegan (in two weeks). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0176), via an unspecified route of administration, administered in right arm on 25Apr2021 13:00 (age at vaccination was 62 years) as dose 1, single for COVID-19 immunization. On 17May2021 at 19:00, the patient experienced mild back spasm on waking the morning of the vaccine, she had a severe back spasm by the evening. It made her scream when she walked as it was a very sudden stabbing pain. The next day or 2 it disappeared. The patient developed a spasm in her left calf so that it was difficult to walk. That went on for about a week. For the past 3 months, she had unusual aches in legs/feet and severe pain in her right knee. The patient underwent lab tests and procedures which included X-ray: X-ray showed no arthritis on an unspecified date. No therapeutic measures were taken as a result of events. The patient visited to doctor or other healthcare professional office/clinic as a result of events. The outcome of the events mild back spasm in morning severe back spasm by evening, sudden stabbing pain, spasm in her left calf and difficult to walk was recovered on an unspecified date in May2021. The outcome of the events she had unusual aches in legs/feet and severe pain in her right knee was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1751987
Sex: F
Age:
State: WA

Vax Date: 07/12/2021
Onset Date: 07/12/2021
Rec V Date: 10/01/2021
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: Start Date/Time: [Pfizer] 4May2021 03:00 PM/Start Date/Time: [Pfizer] 12Jul2021 04:30 PM; Start Date/Time: [Pfizer] 4May2021 03:00 PM/Start Date/Time: [Pfizer] 12Jul2021 04:30 PM; my entire body became flush; I was hot to the touch; felt very tired; headache; This is a spontaneous report from a contactable Other HCP (patient). A 37-year-old female patient received bnt162b2 (BNT162B2; solution for injection, Batch/Lot number, Expiration date was not provided), via an unspecified route of administration in the right arm on 12Jul2021 04:30 (Age at vaccination: 37-years) as dose 2, single for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included latex allergy. Patient is allergic to latex but unaware of any other allergies. Patient concomitant medications included Subutex taken for unknown indication, start and stop date unknown. Historical vaccine included BNT162bs (BNT162B2; solution for injection, Batch/Lot number, Expiration date was not provided) on 04May2021 at 03:00 PM in arm left as dose 1, single for covid-19 immunization. On 12Jul2021, within seconds of receiving the second dose, patient stood up to exit the vaccine area and her entire body became flush, she was hot to the touch and then felt very tired and a headache. When she woke up after eight hours, most side effects were gone from the event, still experiencing extreme tiredness. Ae treatment: Self-treatment with Benadryl. The outcome of the events her entire body became flush, she was hot to the touch and then felt very tired and a headache was recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1751988
Sex: F
Age:
State: FL

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Date: 20210817; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Comments: She took her blood pressure and that was ok; Test Date: 20210817; Test Name: heart rate; Result Unstructured Data: Test Result:100's; Comments: her heart rate was elevated in the 100's. Then it got better

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Her nose was really stuff and she was congested a bit; Fever; Body aches; dizzy; heart palpitations; vision got blurry; Hives; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTEHC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 17Aug2021 at 08:20 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTEHC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation and experienced hives. On 17Aug2021, the patient experienced heart palpitations, vision got blurry, hives and dizzy. On 18Aug2021, the patient experienced fever, body aches and nose was really stuff and she was congested a bit. It was reported that she was dizzy and her vision got blurry maybe 10-15 minutes after getting this shot. This got better about 30 minute after the shot, the dizzy and blurred vision didn't last. she also had heart palpitations. This started at the same time and she had this for about 4 hours. It wasn't completely consistent but there were some episodes that were uncomfortable and that were bad. She took her blood pressure and that was ok but her heart rate was elevated in the 100's. Then it got better and after 12 hours it went away completely. She also had hives this started 30 minutes after getting the second dose. It resolved completely after 2 hours, it didn't get much worse and then left completely. Patient got Fever This started around 2am. it didn't get high, it was low graded. it lasted until 10pm on the 18Aug2021, it would down when she took Tylenol and then finally went away. Body aches started at 2am on 18Aug2021 and resolved around 1pm that afternoon. Her nose was really stuff and she was congested a bit, this was not very long and started around 08:30am and resolved around 11pm. The patient underwent lab tests and procedures which included heart rate: 100's on 17Aug2021 (her heart rate was elevated in the 100's, then it got better), blood pressure measurement: normal on 17Aug2021. Therapeutic measure was taken as a result of fever.. Outcome of the events heart palpitations, vision got blurry, hives, dizzy was recovered on 17Aug2021 and other events was recovered on 18Aug2021. No follow up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1751989
Sex: F
Age:
State:

Vax Date: 08/19/2021
Onset Date:
Rec V Date: 10/01/2021
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: mensural bleeding; Bleeding with the clump; one side clump; soreness on the arm; This is a spontaneous report from a contactable nurse (patient). A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administrated in Deltoid Left on 19Aug2021 (age at the time of vaccination 58-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, via an unspecified route of administration on 07July2021 (age at the time of vaccination 58-years-old), as a single dose for COVID-19 immunization and patient experienced mensural bleeding; Bleeding with the clump; one side clump. On an unspecified date, the patient experienced mensural bleeding; Bleeding with the clump; one side clump; and soreness on the arm. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up (01Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1751990
Sex: F
Age:
State: TX

Vax Date: 08/18/2021
Onset Date: 08/01/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: blood work; Result Unstructured Data: Test Result:had the Antibody

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: I received, the third booster shot 2 days ago; I received, the third booster shot 2 days ago; I am having some swelling underneath my arm pit area; It's just swollen underneath my arm pit; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number:SC3181, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 18Aug2021 (age at vaccination 63 years) as dose 3 booster, single for covid-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included nifedipine (NIFEDIPINE) 30 mg orally, twice a day taken for hypertension, start and stop date were not reported. Patient had first dose of bnt162b2 (BNT162B2, formulation: solution for injection, lot number: EL9262, expiration date: not reported), via an unspecified route of administration, administered in Arm right on 18Jan2021 single for covid-19 immunization. Patient had second dose of bnt162b2 (BNT162B2, formulation: solution for injection, lot number: EL9266, expiration date: not reported), via an unspecified route of administration, administered in Arm right on 23Feb2021 single for covid-19 immunization. Patient did not have prior vaccination within 4 weeks. On an unspecified date in Aug2021, the patient mentioned "i am having some swelling underneath my arm pit area, it's just swollen underneath my arm pit, i received, the third booster shot 2 days ago". The patient underwent lab tests and procedures which included blood test: had the antibody on 2021. Patient did not have any treatment for the events. Clinical outcome of the events was reported as not recovered for am having some swelling underneath my arm pit area, it's just swollen underneath my arm pit and unknown for rest events. Follow-up attempts are completed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1751991
Sex: F
Age:
State: AZ

Vax Date: 08/21/2021
Onset Date:
Rec V Date: 10/01/2021
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: her back started to hurt/a lot of back pain/increased back pain after receiving the third dose; This is a spontaneous report from a contactable consumer and in response to mail trail sent regarding the confirmation of below mentioned query. This 68-year-old female nurse (patient, reported for self). A 68-year-old female patient received third dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: FC3181), via an unspecified route of administration, administered in left arm as dose 3 (booster), single on 21Aug2021 (at the age of 68-year-old) for covid-19 immunisation. Medical history included patient had back pain since she was 27, mitral valve defect and replacement when she was 10 and insomnia (Insomniac) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had earlier received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EV9899 or EN9899), via an unspecified route of administration, administered in left arm as dose 1, single on 20Dec2020 (at the age of 67-year-old) for covid-19 immunisation and experienced first dose she slept for like 3 days, sore arm and severe fatigue; second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3247), via an unspecified route of administration, administered in left arm as dose 2, single on 18Jan2021 (at the age of 67-year-old) for covid-19 immunisation and experienced no side effects and also took flu shots on unspecified date(s) and experienced sore arm. Patient was a nurse and work night shift, they get a few COVID patients and so they were at risk. Reporter (patient) stated she just had her third injection of the Pfizer on 21Aug2021 (on Saturday) and she was well/fine before she didn't really have side effects the first 2 times, but this time she had a lot of back pain. On unspecified date in 2021, patient experienced increased back pain after receiving the third dose Pfizer Covid 19 Vaccine. Patient had back pain previously but it worsened lately, didn't know if it was increased pain. She stated that the back pain was normal for her but that its worse, she does not think that the back pain was related to vaccine as she has had back pain since she was 27 years old and now 68 years old. She also stated that she had a mitral valve defect and replacement when she was 10. The patient can't really say when it began after receiving the third dose Pfizer Covid 19 Vaccine, was not thinking about it until the point where the patient wanted to take something for the pain. The patient stated the back pain was a chronic condition made little worse but thought this was because she usually takes Aspirin at least twice a day for her back but hasn't been since the third dose Pfizer Covid 19 Vaccine on Saturday as she read that you weren't supposed to take it before or after. The patient was about to the point of had to take Aspirin, because the back pain was that bad. The patient stated she was not blaming the Pfizer Covid 19 Vaccine. Patient wanted to know when it would be okay for her to take Aspirin or pain medication. The patient usually, up until the Covid 19 Vaccine, just went ahead and took Aspirin when the patient's back hurt, regardless of the Pfizer Covid 19 Vaccine. The patient didn't know there could be a connection. Patient googled last night read not to take Aspirin or Tylenol, doesn't know if it will effect the Pfizer Covid Vaccine or not. Therapeutic measures were taken as a result of her back. The Pharmacist that gave her the injection said to take Tylenol or Aspirin or whatever she normally takes. Patient stated she took Aspirin because Tylenol doesn't work for her. Patient stated she was reading that Ibuprofen, Tylenol, or Aspirin shouldn't be taken after the vaccine because it might interfere. Patient stated she was wondering if that was true, it seems like it was, it was put out by news. Patient stated she thought Pfizer was doing a wonderful job and grateful for the Pfizer Covid 19 Vaccine. The event was non-serious. At the time of this report, the outcome of event was not recovered. Causality: Not necessarily, probably not. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1751992
Sex: F
Age:
State: WA

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 10/01/2021
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: Became lightheaded, dizzy; WEAK; HOT FLASH; anxiety; feeling foggy; heavy to achy feeling in my heart for 6 hours after dose; headache; nausea; arm pain for the next three days.; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 30-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0183, Expiry date: Unknown) via an unspecified route of administration in Arm Left on 20Aug2021 13:45 as dose 1, single (at the age of 30-years-old) for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. There were no known allergies and no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not have other medication in two weeks. Patient was not tested for COVID post vaccination. No COVID prior vaccination. On 20Aug2021 13:45, the patient experienced lightheaded, dizzy and weak 15sec after dose, followed by hot flash, this occurred four times within one hour, had prolonged anxiety, feeling foggy and heavy to achy feeling in my heart for 6 hours after dose and also experienced headache, nausea and arm pain for the next three days. Patient didn't receive treatment for the events. The outcome for events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1751993
Sex: F
Age:
State: FL

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 10/01/2021
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: was having leg pain; This is a spontaneous report received from a contactable consumer or other non hcp.A 84-years-old female patient received bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on 12Aug2021, as Dose number unknown,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced she was having leg pain on 12Aug2021.She stated her dosage changed from 100mg to 75mg 2 wk on and 2wk off.The outcome of the event was unknown.The patient didn't received any treatment for the event. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1751994
Sex: F
Age:
State:

Vax Date: 08/06/2021
Onset Date: 08/01/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: lump on her neck; lymph nodes on her neck that are still swollen; tired; mild headache; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 06Aug2021 (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. Medical history included she had COVID-19 at the beginning of March. The patient concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced lymph nodes on her neck that are still swollen, tired, mild headache and lump on her neck on 09Aug2021. It was reported that patient was due to receive her second dose of Pfizer Covid-19 Vaccine on an unspecified date (Friday). She still had lymph nodes on her neck that are still swollen. She received her first dose on Friday, 06Aug2021. That Saturday she felt ok. She was tired a little and had a mild headache. On Monday, she experienced a lump on her neck, and she went to emergency room, and it was actually going down now. The patient was asking what she experienced normal and should she get her second dose of the Pfizer Covid-19 Vaccine on Friday or not. Received call from consumer regarding the Pfizer COVID vaccine. She took the first dose and goes back this Friday to take second dose. After the first dose, she had lymph nodes on her neck swollen. It has not gone down and needs to go down some more. She wants to know if it will be ok to get second dose with this still swollen. She stated that she has friends that were fully vaccinated in mid-March and February and today, they have caught COVID-19. They experienced no symptoms, and they were all fine. Investigation Assessment was not provided. The case was reported as non-serious. She did not wish to complete report and did not wish to provide a date of birth or address. No further details provided. The patient outcome of the events was Unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1751995
Sex: F
Age:
State: MO

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 10/01/2021
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: feels like she is high, like under the influence; This is a spontaneous report received from a contactable consumer or other non hcp. A 23-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown, Expiration Date: unknown) via an unspecified route of administration in Arm Right on 24Aug2021 14:00 (age at vaccination 23years old) as single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Valtrex she has been on this for a couple of months on unspecified date. On 24Aug2021 the patient experienced feels like she is high, like under the influence. Additional information provided she feels like she is high, like under the influence. She is feeling began 20-25 minutes after she had the vaccine today, 24Aug2021. She had to wait 15 minutes after the vaccine and then she sat in the parking lot for another 20 minutes to make sure she was understanding her body correctly. She had to go home, and she doesn't have anybody out where she lives so she was driving as careful as she could. She feels so high in her body. She can't stop crying because she is so high. The clinical outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1751996
Sex: M
Age:
State: NC

Vax Date: 08/10/2021
Onset Date: 08/01/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Name: D-Dimer; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: Lower extremity swelling bilaterally; This is a spontaneous report from a contactable Physician. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via intramuscular route of administration at arm right, on 10Aug2021 (age at vaccination: 13 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes asthma and ADHD. The patient concomitant medications include albuterol, beclometasone dipropionate (QVAR), cetirizine and fluticasone propionate (flonase). The patient previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via intramuscular route of administration at arm right, on an unspecified date in Jul2021, age at vaccination: 13 years), as a dose 1, single for COVID-19 immunization. On an unspecified date in Aug2021, the patient had lower extremity swelling bilaterally. Reportedly the patient D-Dimer test was normal. The patient visited Emergency room/department or urgent care as a result of adverse event. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. Outcome of the event was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1751997
Sex: F
Age:
State: NY

Vax Date: 08/24/2021
Onset Date: 08/01/2021
Rec V Date: 10/01/2021
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: cramping; more discomfort; This is a spontaneous report received from a contactable consumer or other non hcp. A 50-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Left on 24Aug2021 (age at vaccination 50years old) as single dose for covid-19 immunisation. The most recent COVID-19 vaccine was administered in hospital. The patient has known allergies reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination reported as none. Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Batch/lot number: EW0165) via an unspecified route of administration in Arm Left on 03Aug2021 at 02:30 PM (age at vaccination 50years old) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced cramping, more discomfort on unspecified date in Aug2021. She reported events as change in menstrual cycle. Her period had ended two days prior to my 1st dose. It started again right after her injection and lasted from the 03Aug -19Aug an ultra-tampon was soaked right after insertion. Her period finally ended on the 19Aug and began again right after my 2nd dose, which was 24Aug cramping and more discomfort than usual, as if she was a young woman. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1751998
Sex: F
Age:
State: PA

Vax Date: 08/13/2021
Onset Date: 08/15/2021
Rec V Date: 10/01/2021
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: Drug eruption rash over breasts; This is a spontaneous case received from a contactable physician. A 27-year-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 13Aug2021 (age at vaccination 27-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient medical history and concomitant medication was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Aug2021, the patient experienced drug eruption rash over breasts. Since the vaccination, the patient had not been tested for COVID-19. Event resulted to visit doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Seriousness of the event was reported as non-serious. Therapeutic measures were taken as a result of the events with topical steroids and antihistamine. The outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected

Other Meds:

Current Illness:

ID: 1751999
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: I have an autoimmune disease.; Rash around eyes; Itchy AF; Headaches; Mental-Confirmed dx of PTSD.; Fatigue; Decreased appetite; Loss of taste; bouts of extreme agitation; nasty cough; Depression; Unable to work in previous profession; anxiety; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date as Dose number Unknown, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had an autoimmune disease. This case is serious (medically significant). On an unspecified date, the patient had rash around eyes, itchy, headaches come and go, mental-confirmed dx of PTSD (post-traumatic stress disorder), fatigue, decreased appetite, loss of taste, bouts of extreme agitation, nasty cough, depression, unable to work in previous profession and anxiety. The patient had no more UTI so far. It was reported that flu like symptoms have decreased but still have a nasty cough. The patient starting to have full memory, writing in normal handwriting again for longer periods of time. The eyesight was getting slightly better. It comes and goes. The patient took 4 new daily pharmaceutical medications. The patient had multiple threats of eviction, shitty credit due to unpaid bills. The patient was paying out the ass for medical bills and neurologist/psychiatrist. Currently looking for new place to live since moratorium ends soon. The patient was unemployment and applied and appealed multiple times. The vaccine messed me up in so many ways but thank goodness and was blessed to be a fighter. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number was not provided and would be requested during follow up.

Other Meds:

Current Illness:

ID: 1752000
Sex: F
Age:
State: NJ

Vax Date: 08/22/2021
Onset Date: 08/22/2021
Rec V Date: 10/01/2021
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: I experienced moderate fever and mild headache 12-14 hrs post dose.; I experienced moderate fever and mild headache 12-14 hrs post dose.; I received the 3rd booster shot yesterday; I received the 3rd booster shot yesterday; This is a spontaneous report from a contactable consumer (patient) reported herself. A 45-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration on 22Aug2021 as dose 3, single for COVID-19 immunization at hospital. The patient's medical history included autoimmune condition. Concomitant medication was not reported. The patient received BNT162B2 on an unknown date as historical vaccine as dose 1 and dose 2, single for covid-19 immunization. On 22Aug2021, the patient experienced moderate fever and mild headache 12-14 hrs post dose. I received the 3rd booster shot yesterday. Event took place after use of product. 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: 1752001
Sex: F
Age:
State: IL

Vax Date: 04/08/2021
Onset Date: 05/18/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Name: Antibiotics; Result Unstructured Data: Test Result:positive; Comments: Antibiotics after testing positive for the Campyl

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Loose stools for several months; This is a spontaneous report from a contactable consumer (patient) or other non hcp (patient). A 66-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021, at 11:00 (at the age of 66-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included omeprazole (PRILOSEC [OMEPRAZOLE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced allergies. Other medications in two weeks Prilosec. Patient did not have covid prior to vaccination. Patient was not tested for covid prior or post vaccination. Patient did not receive any vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left (at the age of 66-Years-old) on 09Mar2021 at 11:00 as DOSE 1, SINGLE for covid-19 immunisation. On 18May2021, at 12:00 AM the patient experienced loose stools for several months which resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included investigation and showed positive on Antibiotics after testing positive for the Campyl on an unspecified date. Therapeutic measures were taken as a result of loose stools for several months. At the time of this report, the outcome of 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: 1752002
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: Gout attack; This is a spontaneous report from a contactable other Health Care Professional. A 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date at the age of 84-years-old as DOSE 1, SINGLE for Covid-19 immunization.The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. There were no concomitant medications. The patient experienced gout attack .The outcome of 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: 1752003
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported) via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history included DiGeorge's syndrome. The patient's concomitant medications not reported. Historical vaccines included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose; and the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunisation. Patient stated after the third COVID-19 shot, "I was sick for 2 days." The outcome of sickness recovered on unspecified date. The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1752004
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: I got it on Friday and Under my arm, My arm pit is going to swollen.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender 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 unknown date in 2021 as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced arm pit was going to swollen. The outcome of event 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: 1752005
Sex: F
Age:
State: MN

Vax Date: 03/26/2021
Onset Date: 03/30/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: near fainting; dizziness; exercise intolerance; extreme nausea; migraines; vision changes; brain fog; shakiness; adrenaline surges; general weakness; neck pain; shortness of breath; general fatigue; orthostatic intolerance; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733, Expiry date: not reported), via an unspecified route of administration, administered in right arm on 26Mar2021 16:30 (at the age of 28 years) as dose 2, single for covid-19 immunisation. The patient medical history was none and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199, Expiry date: not reported), via an unspecified route of administration, administered in right arm on 05Mar2021 16:30 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Mar2021 06:00, the patient experienced near fainting, dizziness, exercise intolerance, extreme nausea, migraines, vision changes, brain fog, shakiness, adrenaline surges, general weakness, neck pain, shortness of breath, general fatigue, orthostatic intolerance. Event resulted to visit Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1752006
Sex: M
Age:
State: OK

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Date: 20210824; Test Name: urinary analysis; Result Unstructured Data: Test Result:codeine in urine analysis; Comments: had codeine in my system

Allergies:

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

Symptoms: codeine in my urine analysis; I had my 3rd shot of the Pfizer covid vaccine; I had my 3rd shot of the Pfizer covid vaccine; This is a spontaneous report received from a contactable consumer or other non hcp via Product Quality Complaint Group. A 47-years-old male patient received bnt162b2 (Comirnaty, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0170, expiry date unknown) via an unspecified route of administration on 23Aug2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date unknown) via unspecified route on an unknown date (at the age of 47-Year-Old) as dose 1, single and BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date unknown) via unspecified route on an unknown date (at the age of 47-Year-Old) as dose 2, single for COVID-19 immunization. On 23Aug2021 patient stated 'I had my 3rd shot of the Pfizer covid vaccine' and codeine in my urine analysis'. Patient stated he needed information on the ingredients of the Pfizer covid vaccine. He had a urinary analysis done. Patient stated ?I had codeine in my system. On 23Aug2021 I had my 3rd shot of the Pfizer covid vaccine. On 24Aug2021 I had a urine analysis which presented codeine in my urine analysis'. Patient was asking if codeine was in the Pfizer covid vaccine. The patient underwent lab tests and procedures on 24Aug2021 which included Urine analysis: codeine in my urine analysis. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1752007
Sex: F
Age:
State: MN

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:154/86; Comments: elevated blood pressure. (154/86 and staying between 140-152/70-88 over the next 5 days)

Allergies:

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

Symptoms: Within 30 minutes- flushing, mild hives; Within 30 minutes- flushing, mild hives; Within 6 hours- headache mild visible facial swelling, Teeth pain (like after a root plaining); Within 6 hours- headache mild visible facial swelling, Teeth pain (like after a root plaining); Within 6 hours- headache mild visible facial swelling, Teeth pain (like after a root plaining); Next morning- eye irritation, elevated blood pressure. (154/86 and staying between 140-152/70-88 over the next 5 days); Next morning- eye irritation, elevated blood pressure. (154/86 and staying between 140-152/70-88 over the next 5 days); Day 3 -left lower abdominal quadrant cramping and noted an increased amount of hair loss; Day 3 -left lower abdominal quadrant cramping and noted an increased amount of hair loss; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 27Aug2021 at 15:00 (at the age of 43-years-old) as single dose for covid-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome (PCOS), history of appendectomy, tonsillectomy and pelvic floor reconstruction. Patient had known allergies to penicillin, keflex, mild egg allergy food allergy from an unknown date and unknown if ongoing known allergy to penicillin, Keflex and mild egg allergy. Concomitant medications included levothyroxine, multivitamins, paracetamol (TYLENOL), loratadine (CLARITIN [LORATADINE]) and fish oil. The patient previously took keflex [cefalexin] and experienced drug allergy. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. On 27Aug2021 at 15:15, patient experienced within 30 minutes- flushing, mild hives, within 6 hours- headache mild visible facial swelling, teeth pain (like after a root plaining), next morning- eye irritation, elevated blood pressure (154/86 and staying between 140-152/70-88 over the next 5 days). On day 3, patient experienced left lower abdominal quadrant cramping and noted an increased amount of hair loss. The patient underwent lab tests and procedures which included blood pressure measurement which was 154/86 and staying between 140-152/70-88 over the next 5 days). Therapeutic measures were taken due to the events and patient self-medicated with benadryl on the evening of 27Aug2021. The outcome of all the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1752008
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: four people just got the booster and they are still sick four days later from Pfizer; four people just got the booster and they are still sick four days later from Pfizer; four people just got the booster and they are still sick four days later from Pfizer; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received bnt162b2 (COMIRNATY; Solution for injection, Batch/Lot Number: not provided) via an unspecified route of administration on an unknown date, as dose 3, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2) on an unknown date as dose 1, single and second dose of bnt162b2 (BNT162B2) on an unknown date as dose 2, single both for COVID-19 immunization. The reporter reported that there were four people just got the booster and they were still sick four days later from Pfizer on an unspecified date. The outcome of event sick was not recovered. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1752009
Sex: M
Age:
State:

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 10/01/2021
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 Name: Covid Test; Test Result: Negative ; Comments: Patient took two Covid tests on Sunday and received two negative test results back so far.; Test Name: Covid Test; Test Result: Negative ; Comments: Patient took two Covid tests on Sunday and received two negative test results back so far

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: tired; received a booster shot of the Pfizer Covid vaccine; received a booster shot of the Pfizer Covid vaccine; a deep chesty cough; cold; sore throat; flu like symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative reported for himself. A 37-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, batch/lot number: unknown), via an unknown route of administration on 26Aug2021 as dose 3, single for Covid-19 immunisation. The patient's medical history included immunocompromised. Concomitant medication was not reported. The patient received BNT162B2 (COMIRNATY, Solution for injection, batch/lot number: unknown), on an unknown date as historical vaccine as dose 1 and 2, single for Covid-19 immunisation. The patient received a booster shot of the Pfizer Covid vaccine on Thursday, 26Aug2021. He felt somewhat tired on Friday, but then experienced many more symptoms starting on Sunday and continuing to today 01Aug. Patient reports that symptoms have increased in severity since Sunday. Symptoms include a deep chesty cough, cold, sore throat and other flu like symptoms. Event took place after use of product. Patient took two Covid tests on Sunday and received two negative test results back so far. The outcome of events was unknown. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1752010
Sex: M
Age:
State: CA

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/01/2021
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: arm swelling; a little bit of a fever; rash; immunocompromised received his booster dose on 1Sep2021; immunocompromised received his booster dose on 1Sep2021; administered his booster shot into the triceps muscle and they administered it subcutaneously; joint pain; This is a spontaneous report from a contactable nurse via Pfizer-sponsored program. A nurse (wife) reported for (husband) 39-year-old male patient that: A 39-year-old male patient received third (booster) dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: Either EW0171 or EWO171, Expiry date: Unknown), via subcutaneous route of administration on 01Sep2021 at 10:30 (at the age of 39-year-old) as DOSE 3, SINGLE for covid-19 immunisation. Medical history included immunocompromised from an unknown date. Concomitant medication includes taking biologic. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EH9899, Expiry date: Unknown), via unspecified route of administration on 21Dec2020 (at the age of 38 year old) as single dose for covid-19 immunisation and experienced sore arm and second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: Either EL3246 or EL324G, Expiry date: Unknown), via unspecified route of administration on 12Jan2021 (at the age of 38 year old) as single dose for covid-19 immunisation and experienced sore arm. Patient's wife reported behalf of patient (husband), It was reported that immunocompromised received his booster dose on 01Sep2021, developed arm swelling, swelling didn't start until last night, 02Sep2021, that is not her concern necessarily. She is concerned because she believes that the vaccine was administered subcutaneously instead of intramuscularly and that it was administered by the triceps instead of the deltoid. Dates for experienced arm swelling with the booster shot and he also has had the same symptoms that he had with the last two doses of the Pfizer COVID vaccines was on 02Sep2021. She says that for the symptoms that her husband experienced with the first 2 doses she didn't see swelling around his arm, but he said that he had some arm soreness on the first 2. It started the next day and it was not as late. The only thing that is a different side effect is that he had joint pain with this dose, within minutes beginning on 01Sep2021 and he hasn't complained anymore about it so she thinks it may be gone, the joint pain yesterday just mainly his arm being in pain, and he had a rash and a little bit of a fever, but nothing too serious. Reporter also stated that the band aid was lower and off to the back of his arm. It looks like administered in the triceps and not in the deltoid. A lot of the symptoms that he had usually with the other ones came a little bit sooner but yesterday it had come around, 7:00. Reporter stated he was still experiencing but it was not bad enough to take him to the emergency room or anything like that. Reporter queried that Should he be reposed with the booster vaccine if it was given subcutaneously or by the wrong muscle. The ACIP notes that if an authorized COVID-19 Vaccine is administered via the incorrect route (e.g., subcutaneous) or at the incorrect site (i.e., site other than the deltoid muscle [preferred site] or anterolateral thigh [alternate site]), do not repeat the dose. Inform the recipient of the potential for local and systemic adverse events.3 If the dose given in error is the first dose, a second dose should be administered at the recommended interval (21 days [Pfizer-BioNTech] or 28 days [Moderna]). If this dose is the second dose, the series is complete, and no additional doses are needed. Please note that Pfizer is independent of these recommendations. Reporter learned that a vaccine injected into the fat may metabolize differently and he might not get the same B and T cell response. Reporter also queried was there any antibody test or titer that could be checked to see if he had appropriate immunity and should he receive an additional dose besides the booster. Antibody testing is not recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing has not been established. With regards to COVID-19 vaccine immune response and effectiveness in moderately and severely immunocompromised people the following is mentioned:2 The utility of serologic testing or cellular immune testing to assess immune response to vaccination and guide clinical care (e.g., as part of need assessment for an additional dose) has not been established. Serologic testing or cellular immune testing outside of the context of research studies is not recommended at this time. The additional mRNA COVID-19 vaccine dose should be the same vaccine product as the initial 2-dose mRNA COVID-19 primary vaccine series (Pfizer-BioNTech or Moderna). If the mRNA COVID-19 vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine product may be administered. A person should not receive more than three mRNA COVID-19 vaccine doses. Caller reporting AE/ MI following her husband receiving the booster dose of the COVID vaccine and mentioned that he is taking biologics and if he unfortunately got COVID 3 months down the road she doesn't want the vaccine to not be effective and have to take him to the hospital because it was administered into the triceps muscle instead of the deltoid and they administered it subcutaneously instead of intramuscular. Seriousness: It is not life threatening she doesn't think and. As far as the side effects being serious, it would just be serious if it wasn't given correctly because of the importance of the vaccine and everything that is happening right now with the delta variant then maybe it would be more serious. Outcome of the event arm swelling was not recovered and rest all were unknown.. Causality: Yes, because all of the side effects are the same ones he got with the first two doses, there was nothing major just the sore arm but that may be because it was administered into a more tender site. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1752011
Sex: F
Age:
State: FL

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 10/01/2021
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: stabbing, throbbing pain in and around my left ear; This was my 3rd shot; This was my 3rd shot; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 38-years-old non pregnant female received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was FC3180) via an unspecified route of administration, administered in right arm on 02Sep2021 at 13:45, administered in right arm (age at the time of vaccination was 38-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization (off label use). The patient's medical history included Psoriatic Arthritis, Anxiety, Sinus Tachycardia, Asthma. The concomitant medications included Humira (ADA-LIMUMAB), Sulfasalazine, Tizanidine, Alprazonam and Zyrtec allergy (CETIRIZINE HYDROCHLORIDE) for an unspecified indication, within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. The patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. Previously, the patient received second dose of 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 2, SINGLE for COVID-19 immunization; and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On 02Sep2021, the patient experienced stabbing, throbbing pain in and around left ear (reported as: stabbing, throbbing pain in and around my left ear). No treatment was received for adverse events. The clinical outcome of the events stabbing, throbbing pain in and around left ear was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1752012
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 10/01/2021
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: Booster vaccination; Booster vaccination; Mouth sore- lasted 2 days; Dry mouth; Absolutely no energy; Exhausted; This is a spontaneous report from a contactable Nurse. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 1 single and second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 2 single for COVID-19 immunization for COVID-19 immunization. Patient had no known allergies. The patient reports mouth sore- lasted 2 days and gets one every once in a while and goes away comes back for a day- it comes and goes with a dry mouth, after covid booster vaccination. Patient said that knocked her out the next day, just exhausted and absolutely no energy on an unspecified date in May2021. The outcome of events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1752013
Sex: M
Age:
State: AR

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: feeling tired; had a sore arm at the injection site; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date in 2021 as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization and patient received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunization. On 2021, the patient reported that he received a third COVID vaccination yesterday and was feeling tired and had a sore arm at the injection site. 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:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am