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: 1756007
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation interval to the 2nd dose (some have gotten the vaccine in Jan2021); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation interval to the 2nd dose (some have gotten the vaccine in Jan2021)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation interval to the 2nd dose (some have gotten the vaccine in Jan2021)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation interval to the 2nd dose (some have gotten the vaccine in Jan2021)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Treatment information was not reported. The patients had gotten their 1st dose of the Moderna Covid-19 vaccine way longer than the CDC recommendation for the 2nd dose.

Other Meds:

Current Illness:

ID: 1756008
Sex: F
Age: 52
State: MS

Vax Date: 09/23/2021
Onset Date:
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: fever (102,3 ?F)

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Arm sore; fever (102,3 ?F); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore) and PYREXIA (fever (102,3 ?F)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm sore) and PYREXIA (fever (102,3 ?F)). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm sore) and PYREXIA (fever (102,3 ?F)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 102,3 ?f (abnormal) fever (102,3 ?F). No concomitant product was provided Medcial History of appendicitis after 1 dose of spikevax This case was linked to MOD-2021-332163 (Patient Link).; Sender's Comments: This case concerns a 52 years old female patient, with no reported relevant medical history, who experienced the non-serious expected events of Pyrexia and vaccination site pain. The events occurred after receiving second dose of Spikevax vaccine. The rechallenge was not applicable for the events as no additional dosing will be given. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1756009
Sex: U
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: missed the appointment for the second dose and wants to receive the second dose now, more than 42 days after the first one; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed the appointment for the second dose and wants to receive the second dose now, more than 42 days after the first one) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed the appointment for the second dose and wants to receive the second dose now, more than 42 days after the first one). In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed the appointment for the second dose and wants to receive the second dose now, more than 42 days after the first one) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1756010
Sex: F
Age:
State: NJ

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Sore arm after both shots; Tired; Couldn't stop shaking; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after both shots), TREMOR (Couldn't stop shaking) and FATIGUE (Tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced TREMOR (Couldn't stop shaking). On 20-Feb-2021, the patient experienced FATIGUE (Tired). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after both shots). On 20-Feb-2021, TREMOR (Couldn't stop shaking) had resolved. On 22-Feb-2021, FATIGUE (Tired) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm after both shots) outcome was unknown. Unknown Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1756011
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 02/25/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 102 F

Allergies:

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

Symptoms: Pain in her left thigh/left leg was nothing but pain/pain suddenly went into her right leg; Could hardly walk at all; Both of her knees were swollen/big ball in the back of her knee; Pain in her groin; Real bad chills, day and night; Pain in the muscle; Both of her knees hurt; Left leg got cramps; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Left leg got cramps), PAIN IN EXTREMITY (Pain in her left thigh/left leg was nothing but pain/pain suddenly went into her right leg), GAIT DISTURBANCE (Could hardly walk at all), JOINT SWELLING (Both of her knees were swollen/big ball in the back of her knee) and GROIN PAIN (Pain in her groin) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MUSCLE SPASMS (Left leg got cramps). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in her left thigh/left leg was nothing but pain/pain suddenly went into her right leg), GAIT DISTURBANCE (Could hardly walk at all), JOINT SWELLING (Both of her knees were swollen/big ball in the back of her knee), GROIN PAIN (Pain in her groin), CHILLS (Real bad chills, day and night), MYALGIA (Pain in the muscle) and ARTHRALGIA (Both of her knees hurt). At the time of the report, MUSCLE SPASMS (Left leg got cramps), PAIN IN EXTREMITY (Pain in her left thigh/left leg was nothing but pain/pain suddenly went into her right leg), GAIT DISTURBANCE (Could hardly walk at all), JOINT SWELLING (Both of her knees were swollen/big ball in the back of her knee), GROIN PAIN (Pain in her groin), CHILLS (Real bad chills, day and night), MYALGIA (Pain in the muscle) and ARTHRALGIA (Both of her knees hurt) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1756012
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: the vaccine made me pretty ill; rash; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (the vaccine made me pretty ill), RASH (rash) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (the vaccine made me pretty ill), RASH (rash) and PYREXIA (fever). At the time of the report, ILLNESS (the vaccine made me pretty ill), RASH (rash) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1756013
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/23/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Chills for two days post second dose; pain in injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (pain in injection site) and CHILLS (Chills for two days post second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Lymphedema. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site). On 13-Sep-2021, the patient experienced CHILLS (Chills for two days post second dose). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency; NAPROXEN for Pain, at an unspecified dose and frequency and PARACETAMOL for Pain, at an unspecified dose and frequency. On 15-Sep-2021, CHILLS (Chills for two days post second dose) had resolved. At the time of the report, VACCINATION SITE PAIN (pain in injection site) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1756014
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/02/2021
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: Pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the site of the injection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concurrent medical conditions included Diabetic, Hypertension, Myositis and Immunocompromised. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site of the injection). At the time of the report, VACCINATION SITE PAIN (Pain at the site of the injection) outcome was unknown. No concomitant medications reported. No treatment reported

Other Meds:

Current Illness: Diabetic; Hypertension; Immunocompromised; Myositis

ID: 1756015
Sex: U
Age: 53
State: NY

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 10/02/2021
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: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided by the reporter. Treatment medication was not reported. Vaccine was administered after 4days from first puncture of vial. Reporter did not allow further contact; Sender's Comments: This report refers to a case of Expired vaccine used for mRNA-1273, Lot# 037C21A with no associated AEs. Causality for this medication error is not applicable.

Other Meds:

Current Illness:

ID: 1756016
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: minimal discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (minimal discomfort) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (minimal discomfort). At the time of the report, DISCOMFORT (minimal discomfort) outcome was unknown. No treatment medication was reported. No Concomitant medication was reported. No lab data was provided. This case was linked to MOD-2021-329830, MOD-2021-335336 (Patient Link).

Other Meds:

Current Illness:

ID: 1756017
Sex: F
Age:
State: NY

Vax Date: 07/03/2021
Onset Date: 07/05/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: first 2 days -sore arm; first 2 days nauseous; stomach cramp; first 2 days - minor swollen glands; first 2 days tired; first 2 days - chemical taste fist few minutesday 2.5; first 2 days- intense itching scalp; 3 days excessive sweating; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 65-year) in right arm on 03Jul2021 at 02:30 PM as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient not tested COVID post vaccination. On 05Jul2021 at 07:30 PM the patient experienced first 2 days -sore arm, nauseous, stomach cramp, minor swollen glands, tired, chemical taste fist few minutes day 2.5, intense itching scalp and back, 3 days excessive sweating. It was reported that the patient had 10 days intense itching, 3 days perfuse sweating. The seriousness of the events was reported as non-serious. As reported seriousness criteria of the events not resulted in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient received no treatment for the adverse events. The clinical outcome of the events was resolving. Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.

Other Meds:

Current Illness:

ID: 1756018
Sex: M
Age:
State: CA

Vax Date: 08/05/2021
Onset Date: 08/01/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Oxygen level; Result Unstructured Data: Test Result: Unknown results.

Allergies:

Symptom List: Rash, Urticaria

Symptoms: burning in the back and front of his head/his arms were burning; ringing in his ears; burning in his ears; blurry vision; cannot sleep; visual acuity isn't the same; he has to squint more; pain from the burning; gastroparesis/all under control but after the vaccine it was exacerbated; gastroparesis/all under control but after the vaccine it was exacerbated; pain in the occipital and frontal areas of his head; increased stomach pain; losing weight; developed gastric reflux; coughing continuously; anxiety; depression; sick; This is a spontaneous report from a contactable consumer (patient) and nurse (patient's sister). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA7485, expiry date: 01Oct2021), via an unspecified route of administration on 05Aug2021 (at the age of 61 years old) as dose 1, single for COVID-19 immunization. Medical history included headaches, neck pain and gastroparesis, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced gastroparesis/all under control but after the vaccine it was exacerbated on an unspecified date in 2021, burning in the back and front of his head/his arms were burning, ringing in his ears on 05Aug2021, burning in his ears, blurry vision, cannot sleep, visual acuity isn't the same; he has to squint more, pain from the burning on an unspecified date in Aug2021, pain in the occipital and frontal areas of his head, increased stomach pain, losing weight, developed gastric reflux, coughing continuously, anxiety, depression and sick on an unspecified date in 2021. It was reported that the since the first dose of BNT162B2, the patient has had burning in his ears, burning in the back and front of his head as well as ringing in his ears. He also has reports of blurry vision. These symptoms are noted to be somewhat manageable during the day but when he lays down to sleep its unbearable and he cannot sleep. He noted that this has been a horrendous week he has had and wishes to get all the help he can so he can figure out how to get this squared away soon. He was currently taking Ibuprofen. The patient also experienced blurry vision. Stated that his visual acuity isn't the same; he has to squint more. It started right away after getting the vaccine and hasn't gotten any better. He got the 1st dose of the vaccine on 05Aug2021 in the afternoon. By the time he got home, his arms were burning, and when he went to bed that night his arms were burning and he had burning on the front and back of his head. He also had ringing in his ears. When he got up in morning, he noticed that his vision was blurry. That Saturday was worst day. And even last night his arms and head were burning and his ears were ringing. It has been terrible. He was hoping it would be gone in a week, but it hasn't gotten any better. During the day, it's somewhat manageable, but when he lays down he can't sleep at night because of the pain from the burning. He hasn't slept more than a few hours in the last week. Last night he slept for half an hour and woke up because his arms were burning, then got up and had to put ice on his head for the burning. Before he got the vaccine, he called his doctors and asked for recommendations on which of the vaccines to get for the least amount of side effects, and they said to get Pfizer. But now he can barely function with the pain from these side effects. He has been taking Ibuprofen 400mg twice a day, after lunch and at night because the pain was overbearing at night. On 23Sep2021, the patient's sister reported that the patient started having pain in the occipital and frontal areas of his head. The patient was having insomnia and has only slept about 2 hours a night for a month. He was also having increased stomach pain and increased pain. The patient has consulted with a doctor who has referred him to a neurologist. The patient has had cortisone injections. He did not want to take Klonopin but nothing else helps for sleep. He has also seen a gastrointestinal doctor and he will have a SmartPill test where her brother will swallow a capsule and the doctor is able to view what the capsule sees on a monitor. The patient was losing weight and he has developed gastric reflux and he was coughing continuously. The patient's sister has checked the patient's oxygen level and she doesn't think he has had the Covid 19 virus that she knows of. It was also reported that the patient has a history of gastroparesis and it was all under control but after the vaccine it was exacerbated and he was having insomnia, stomach, pain, increased pain and has only slept for about 2 hours a night for a month. He has seen a doctor, neurologist and GI doctor. They are calling to see if there is any help for him such as any programs or facilities that can offer support or assistance. The patient had blurred vision and had to see an ophthalmologist and still having blurred vision and they treat all of this. The patient also experienced anxiety and depression, and insomnia but they would not accept him because he didn't have COVID although he was having symptoms of COVID after the vaccine. The patient's sister stated that she just wanted to help her brother find better treatment because everyone throws their hands up in the air. The patient underwent lab tests and procedures which included oxygen level: unknown results on an unspecified date in 2021. The outcome of the events burning in the back and front of his head/his arms were burning, ringing in his ears, blurry vision, cannot sleep, visual acuity isn't the same; he has to squint more, pain from the burning was not recovered while the outcome of all other events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Gastroparesis, Condition aggravated (Gastroparesis) and suspect drug BNT162B2 cannot be excluded, but consider also possible contributory effects from patient's medical history. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1756019
Sex: F
Age:
State: CA

Vax Date: 08/02/2021
Onset Date: 08/01/2021
Rec V Date: 10/02/2021
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: Vomiting; Upset stomach; loss of appetite; she cannot have her on the school campus like that.; Nausea; This is a spontaneous report from a contactable nurse (patient's mother). A 16-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Aug2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Bnt162b2, Solution for injection) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 03Aug2021 she started vomiting. On an unspecified date in Aug2021, the patient experienced nausea, upset stomach, loss of appetite, she cannot have her on the school campus like that. She was still felt nauseous like she was going to throw up. Outcome of the events loss of appetite and she cannot have her on the school campus like that were unknown and outcome of rest all events were not resolved. Follow-up attempts had been completed and no further information was expected.

Other Meds:

Current Illness:

ID: 1756020
Sex: F
Age:
State: TN

Vax Date: 07/28/2021
Onset Date: 07/31/2021
Rec V Date: 10/02/2021
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: Extreme Flushing of face when active at all. Appears sunburned on face.; Sunburned on face; Headache daily that worsens throughout day.; Nausea; irritability; This is a spontaneous report from a contactable consumer (reported for herself). A 40-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 28Jul2021 at 18:15 (at the age of 40-years-old) as dose 1, single for covid-19 immunisation at Pharmacy. Medical history included impaired gastric emptying, schizophrenia, bipolar disorder, post-traumatic stress disorder and drug hypersensitivity (sulfa allergy), all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received geodon (ZIPRASIDONE MESILATE) and experienced drug hypersensitivity and paxil (PIROXICAM) and experienced drug hypersensitivity. On 31Jul2021 at 16:30, the patient experienced extreme Flushing of face when active at all. Appears sunburned on face. Headache daily that worsens throughout day. Nausea and irritability. The reporter stated the events result in Doctor's or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events included treatment with ibuprofen and appointment with her PCP (Primary Care Physician). The outcome of the events was not resolved. This follow-up is being submitted to notify theta 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: 1756021
Sex: M
Age:
State: CA

Vax Date: 08/08/2021
Onset Date: 08/01/2021
Rec V Date: 10/02/2021
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: Hives all over his body where his lymph node is located for the last couple of days; arm pits and groin area were not feeling great; arm pits and groin area were not feeling great; Muscle cramps; Headache; Has been in bed; terrible pain in both feet; This is a spontaneous report from a contactable Consumer or other non-HCP (mother of patient). A 26-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 08Aug2021 (at the age of 26-year-old), as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced terrible pain in both feet on an unspecified date in Aug2021, muscle cramps and headache on 09Aug2021, arm pits and groin area were not feeling great on 12Aug2021 and hives all over his body where his lymph node is located for the last couple of days on 13Aug2021. The patient had been in bed since Monday 09Aug2021. The clinical details of the events as follows: Caller stated her son who is 26 years old got first Pfizer Covid vaccine on Sunday, 08Aug2021 and has big hives near all lymph node areas of his body, and complaining of terrible pain to both his feet, he was also having other side effects and wanted to know if this was normal after the vaccine, knows they said that the major side effects would occur within 24 hours of the vaccine. Caller stated the patient noticed yesterday, 12Aug2021 his arm pits and groin area were not feeling great, noticed the hives today. Got the vaccine at Walgreens and stated her son has been in bed since Monday, stated he has had a headache and muscle cramps since Monday, 09Aug2021. Unknown anatomical location of injection stated she assumes it was on the left side since he is right-handed. Caller wanted to know if these are side effects reported after taking the Pfizer Covid vaccine and also asked how long these side effects supposed to last: response: In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days. There was no Investigation Assessment provided. The patient outcome of the events hives near all the lymph node areas on the body, terrible pain in both feet, Headache and Muscle cramps was not resolved and the outcome of the other 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: 1756022
Sex: F
Age:
State: FL

Vax Date: 08/10/2021
Onset Date: 08/01/2021
Rec V Date: 10/02/2021
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: genetic testing; Result Unstructured Data: Test Result:has one copy of the hemochromatosis genes; Comments: They also found a gene they are investigating for cancer, but she doesn't have cancer.

Allergies:

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

Symptoms: She developed a red spot around the injection site a day or two later; It is warm with some discoloration around the area; Fever; Headache; Almost sounded like infection to me; The one spot felt warm like a sunburn; It is warm with some discoloration around the area; The other part of her arm felt clammy; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (BNT162B2) solution for injection, dose 2 (Batch/Lot number was not reported) via an unspecified route of administration at arm left on 10Aug2021 (at the age of 40-years-old)as a single dose for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. There were no concomitant medications. Historical Vaccine BNT162B2 solution for injection, dose 1 (Batch/Lot number was not reported) via an unspecified route of administration at arm left on 21Jul2021 as a single dose for COVID-19 immunisation. Per reporter his wife and daughter received their Pfizer Covid 19 Vaccine two days early. Reporter reached out to the vaccination provider to ask if he could receive his Pfizer Covid 19 Vaccine one day early. Provider declined the request. Reporter asking if he can receive his second dose of the Pfizer Covid 19 Vaccine one day early due to his schedule. Reporter mentioned that he would like to take aspirin after receiving his second Pfizer Covid 19 Vaccine?. Reporter: Per reporter he takes a medication that kind of thins his blood. Reporter asked why was the following mentioned in the Fact Sheet?. Tell the vaccination provider about all of your medical conditions, including if you have a bleeding disorder or are on a blood thinner. Spoke from the attached document. When vaccinating Persons with Increased Bleeding Risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine should only be administered as an intramuscular injection. Per reporter after his wife received her Pfizer Covid 19 Vaccine she developed "a red spot around the injection site a day or two later. It's warm with some discoloration around the area. Almost sounded like infection to me. It's not a perfect circle. The other part of her arm felt clammy. The one spot felt warm like a sunburn. She had a fever the night of the vaccine. That has broken and has been under control. She also had a headache." Reporter asked if symptoms have been reported? Spoke from the PI under "Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include: injection site redness fever headache." LAB-Withheld Revised: 12Aug2021. Spoke from the attached document VR-Consumer Inquiry Management (Off-Label or No Info) in response to the question feeling warm. LAB-Withheld Revised: 12Aug2021. Reason for no lot number: of COVID vaccine: Complainant does not have the product with them at the time of call. His wife received the second COVID vaccine and developed a red spot that was warm to the touch a day or two after the vaccine. She had discoloration around the area. It was in the arm she received the injection in. He called asking if it had been reported it. It reminded him of a sunburn area. She also ran a fever the night after that, but it broke and has been under control since then. The reporter reporter confirmed the details provided by the transferring agent. He doesn't remember if the healthcare provider is a doctor or a NP. The doctor is unaware of this though. The office is 45 minutes away. He doesn't know the doctor's information at this time. She just got the second shot Tuesday 10Aug2021. The red spot started 11Aug2021. It was still there today/ He doesn't know if it has improved or not. She sent him a picture of it. It is a good portion of her upper shoulder where she got the shot in her left arm. It is probably 4 in by 3in. Her first dose was 21Jul2021. He thinks she got that one in her left arm. For treatment she rested and took aspirin and Tylenol. The fever broke. He thinks the fever was the night of 11Aug2021. Overall, she was improving but feels out of it. She went to work today. She has had genetic testing done. She has one copy of the hemochromatosis genes. He has two copies. They also found a gene they are investigating for cancer, but she doesn't have cancer. They are just following up over the years. Verbatim and Event Description: Swap from FC reporter wants to receive the 2nd dose of Covid vaccine 1 day early since it's the only option his schedule will allow, but vaccination providers have declined offering that. Reporter wife and daughter were given their 2nd dose 2 days early so reporter wants to know what the issue was. Read ISI Transferred to PMI Withheld CEP Withheld. The patient underwent lab tests and procedures which included gene mutation identification test has one copy of the hemochromatosis genes on an unspecified date they also found a gene they are investigating for cancer, but she doesn't have cancer. Outcome of the events was Vaccination site erythema not recovered, skin warm, skin discolouration, skin cold clammy, headache, infection, sunburn was unknown, and other event pyrexia was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1756023
Sex: F
Age:
State: IN

Vax Date: 08/13/2021
Onset Date: 08/14/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210814; Test Name: blood pressure; Result Unstructured Data: Test Result:Increased; Test Date: 20210814; Test Name: heart rate; Result Unstructured Data: Test Result:Very fast

Allergies:

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

Symptoms: Chest pain on left side- felt like my heart hurt; Very fast heart rate; Increased blood pressure; Body aches; Chills in the morning; Fever; hot flashes; headache; swollen lymph node in the left armpit; This is a spontaneous report from a contactable consumer(Patient). A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7484, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 13Aug2021 15:00 (age at vaccination 46 years) as dose 2, single for covid-19 immunisation. Medical history included arthritis, fibromyalgia, pcos, hypothyroidism, allergies: Penicillin. The patient previously took BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jul2021 04:00 (age at vaccination 46 years) as dose 1, single for covid-19 immunisation. Concomitant medication(s) included lisinopril (LISINOPRIL). 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. On 14Aug2021 08:30 the patient experienced chest pain on left side- felt like my heart hurt, very fast heart rate, increased blood pressure, body aches, chills in the morning, fever in the afternoon , hot flashes in the afternoon , headache , swollen lymph node in the left armpit. The patient underwent lab tests and procedures which included blood pressure measurement was increased on 14Aug2021, heart rate was very fast on 14Aug2021. The patient did not receive any treatment for reported events. The outcome of event was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1756024
Sex: M
Age:
State: NY

Vax Date: 07/27/2021
Onset Date: 07/31/2021
Rec V Date: 10/02/2021
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: 20210815; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: starting on 14Aug, have lost sense of smell and taste. Went for a covid test on 15Aug, which came back negative.; starting on 14Aug, have lost sense of smell and taste. Went for a covid test on 15Aug, which came back negative.; Second and third week after first dose, feeling unwell, constant cough, congestion.; Second and third week after first dose, feeling unwell, constant cough, congestion.; Second and third week after first dose, feeling unwell, constant cough, congestion.; Constant feeling of having a fever without having an elevated temperature; This is a spontaneous report received from a contactable consumer or other non hcp. A 51-years-old male patient received 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 27Jul2021 13:00 (age at vaccination 51years old) as single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and Other medications in two weeks prior to the COVID vaccine. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergies: PCN. The patient's concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19. The patient experienced constant feeling of having a fever without having an elevated temperature on 31Jul2021 16:00, and second and third week after first dose, feeling unwell, constant cough, congestion on Aug2021, starting on 14aug, have lost sense of smell and taste. went for a covid test on 15aug, which came back negative on 14Aug2021. The patient underwent lab tests and procedures which included sarscov-2 test: negative on 15Aug2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756025
Sex: M
Age:
State: OH

Vax Date: 08/14/2021
Onset Date: 08/14/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210814; Test Name: pulse rate; Result Unstructured Data: Test Result:68

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: experienced shortness of breath; pain all over his body; This is a spontaneous report from a Pfizer- sponsored program via a contactable consumer (patient's partner/wife). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14Aug2021 at 15:00 hours as DOSE 1, SINGLE (at the age of 48-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shortness of breath, and pain all over his body on 14Aug2021. The patient underwent lab tests and procedures which included pulse rate: 68 on 14Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1756026
Sex: M
Age:
State: FL

Vax Date: 08/07/2021
Onset Date: 08/18/2021
Rec V Date: 10/02/2021
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: headache; mall red raised bumps all over body, primarily on legs, spots inched and burned.; mall red raised bumps all over body, primarily on legs, spots inched and burned.; mall red raised bumps all over body, primarily on legs, spots inched and burned.; This is a spontaneous report from a contactable consumer. This 14-year-old male consumer (patient) reported for himself that: A 14-year-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration, administered in the right arm on 07Aug2021 at 13:00 (at the age of 14-year-old) as dose 1, single for COVID-19 immunisation at pharmacy or drug store. Medical history included headaches and covid-19. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for headache, start and stop date were not reported and paracetamol (TYLENOL) taken for headache, start and stop date were not reported. Patient reported past drug event as ibuprofen for known allergies as not until now ibuprofen. Patient was not received any other vaccine four weeks prior vaccination. On 18Aug2021 at 07:00 the patient experienced headache, shortly after developed small red raised bumps all over body, primarily on legs, spots inched and burned. Reported stated that took ibuprofen in the morning for a headache on 8/18. The same thing happened to mother. Since vaccination patient not tested for covid-19. The case assessed as non-serious by the reporter. Therapeutic measures were taken as a result of the events with with Otc Zyrtec. Waiting to see if paediatrician visit w. The clinical outcome of the events was reported as recovered with sequel on an unspecified date of 2021. Follow-up attempts are completed. No further information is expected

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

Current Illness:

ID: 1756027
Sex: M
Age:
State: TX

Vax Date: 08/17/2021
Onset Date: 08/18/2021
Rec V Date: 10/02/2021
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: Severe nosebleed less than 24 hours after vaccine; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 25 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 17Aug2021 14:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included dose 1 via an unspecified route of administration, administered in Arm Left on 26Jul2021 14:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; olive leaf [olea europaea leaf] (OLIVE LEAF [OLEA EUROPAEA LEAF]) taken for an unspecified indication, start and stop date were not reported; turmeric [curcuma longa rhizome] (TURMERIC [CURCUMA LONGA RHIZOME]) taken for an unspecified indication, start and stop date were not reported; docosahexaenoic acid (DHA) taken for an unspecified indication, start and stop date were not reported. The patient experienced severe nosebleed less than 24 hours after vaccine causing epistaxis on 18Aug2021 08:00 with outcome of unknown. Information on the Batch/Lot number has been requested.

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

Current Illness:

ID: 1756028
Sex: M
Age:
State: MD

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 10/02/2021
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: arm started hurting and he couldn't move it and it kept going out; arm started hurting and he couldn't move it and it kept going out; just had a sting and a pain in the injection site; just had a sting and a pain in the injection site; soreness; This is a spontaneous report from a contactable consumer (patient) reported that. A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 25Mar2021 (at the age of 59 years old) as dose 2, single for on an unspecified indication. The patient medical history was not reported. There were no concomitant medications. On 21Jun2021, the patient experienced arm started hurting and he couldn't move it and it kept going out. The patient had the arm sting (25Mar2021) and pain at the injection site ((25Mar2021)), he was just having that and soreness (unknown date in 2021). But then on 21Jun2021 his arm went out and he guesses that he is not able to use the muscle in his arm and it just goes out on him. Like if he does something, sometimes he will reach out to open the door and it completely goes out. The sting and the pain started the day he received the injection, the COVID vaccine, and that was 25Mar2021 and that has been lasting from then up until 21Jun2021 when his arm started going out. He still has a little still that sting and it will be sore as well. He confirms that this is ongoing but now his arm goes out and sometimes he can't move it out. He says the sting and pain has gotten somewhat better. The outcome of the event arm started hurting and he couldn't move it and it kept going out was not recovered and the event just had a sting and a pain in the injection site outcome was recovering, and the event soreness was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1756029
Sex: F
Age:
State: LA

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Within a hour heart palpitations have started; pain in kidney area; later evening body ache; muscle ache; fever; headache; extreme drowsiness; noise in ear; pain behind ear; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 12Aug2021 at 12:00 (At the age of 40-year-old) as single dose for COVID-19 immunization. Medical history of the patient included Graves disease, allergy to latex. Patient received concomitant/other medications [unspecified] in two weeks. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for covid post vaccination. Patient previously took Flagyl on an unspecified date and experienced allergy. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 22Jul2021 at 12:00 as single dose for COVID-19 immunization. On 12Aug2021 at 13:15 within an hour patient experienced heart palpitations have started and pain in kidney area, later evening body ache, muscle ache, fever, headache, extreme drowsiness waking up with headache, pain behind ear and noise in ear. Patient did not receive any treatment in response to the evets. Outcome of the events were Recovering. Information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1756030
Sex: M
Age:
State:

Vax Date: 07/29/2021
Onset Date: 07/29/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:clean

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: inflammation and rash in genital area; inflammation and rash in genital area and a skin rash on his whole body; This is a spontaneous report from a contactable consumer or other non hcp. A 27-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29Jul2021 (age at vaccination: 27 Years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: unknown) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced inflammation and rash in genital area on 29Jul2021 with outcome of not recovered, inflammation and rash in genital area and a skin rash on his whole body on 29Jul2021.The patient underwent lab tests and procedures which included blood test: clean on unspecified date. Therapeutic measures were taken as a result of inflammation and rash in genital area, inflammation and rash in genital area and a skin rash on his whole body was Benadryl for 2 weeks it was not working limited information was provided by the caller. The outcome of the events inflammation, rash was not recovered. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1756031
Sex: F
Age:
State: NC

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 10/02/2021
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: 2021; Test Name: X-rays; Result Unstructured Data: Test Result:everything was intact

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: stated that her right hip was in extreme pain; stated that her right leg was in extreme pain; stated that she was unable to walk overnight; stated that she pushed through it and continued to walk until she was limping; stated that she was not able to bear weight on her right leg; muscle pain; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 11Feb2021 as DOSE 2, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced stated that her right hip was in extreme pain, stated that her right leg was in extreme pain, stated that she was unable to walk overnight, stated that she was unable to walk overnight, stated that she pushed through it and continued to walk until she was limping, stated that she was not able to bear weight on her right leg, muscle pain, Stated that she walks almost three miles a day and has had no health issues, two weeks after the last vaccine her right hip and leg were in extreme pain and she was unable to walk overnight, she asked for X-rays because the pain was not going away which was two months of not being able to put weight on legs. Clarified that only one leg was affected and that was the right leg. The patient underwent lab tests and procedures which included x-ray: everything was intact on 2021. 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: 1756032
Sex: U
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 10/02/2021
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: soreness for at least 24 hours in her left shoulder/soreness was more than the 1st and 2nd shots; received dose 3, single of BNT162b2; received dose 3, single of BNT162b2; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A patient of unspecified age and gender received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in arm on an unspecified date as dose 3, single for COVD-19 immunisation. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported via an unspecified route of administration, administered in arm on an unspecified date as dose 1, single and experienced soreness of left shoulder and received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported via an unspecified route of administration, administered in arm on an unspecified date as dose 2, single for COVD-19 immunisation and experienced soreness of left shoulder. The patient medical history and concomitant medications were not reported. On an unspecified date, 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 all the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be re-quested during follow up.

Other Meds:

Current Illness:

ID: 1756033
Sex: F
Age:
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: She already received the first and second dose of the Pfizer COVID 19 and she will be having her eye surgery; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer received the first and second dose of the Pfizer COVID 19 Vaccine and she will be having her eye surgery next Wednesday. The outcome of event was unknown. The batch/lot 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: 1756034
Sex: F
Age:
State: MI

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

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

Lab Data: Test Date: 2021; Test Name: weight; Result Unstructured Data: Test Result:increased

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: a spot that never goes away and it has no scab,Spot on right arm where she received the 2nd dose of the Covid 19 vaccine; losing her hair; Spot on right arm where she received the 2nd dose of the covid 19 vaccine, round circle on her arm that itches; gaining weight; This is a spontaneous report from a contactable consumer (patient) or other non hcp reporting for herself. An 80-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in arm right on 01Apr2021 as dose 2, single for COVID-19 immunisation. Medical history included ongoing seasonal allergies, ongoing thyroid, feet and knees swell up. Arthritis pain cholesterol all from an unknown date and unknown if ongoing. Patient had car accident affected her spine, legs and hips. Concomitant medications included levothyroxine for thyroid, hydrochlorothiazide taken for swelling from an unspecified start date and ongoing; paracetamol (TYLENOL ARTHRITIS PAIN) taken for pain from an unspecified start date and ongoing, cobamamide (VITAMIN B12 [COBAMAMIDE]) taken for pain from an unspecified start date and ongoing; vitamin D3 taken for an unspecified indication from an unspecified start date and ongoing; fish oil taken for an unspecified indication from an unspecified start date and ongoing; cinnamomum verum (CINNAMON) taken for protect her pancreas, and help her cholesterol from an unspecified start date and ongoing; zinc taken for an unspecified indication from Aug2021 and ongoing; vitamin C [ascorbic acid] taken for an unspecified indication from an unspecified start date and ongoing and other Vitamins, Fruitful Antioxidant Extracts, Green foods complex , One a day vitamins for women over 50+, Myers brand. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EN6205) via an unspecified route of administration, administered in left ram on 11Mar2021 (First dose in the morning before 10:30am) as single dose for COVID-19 Immunisation. It was reported that patient received both doses first in March and second in April, had no side effects from the vaccine. The patient had a spot that never goes away, and it has no scab, it looks not even as big as a little finger fingernail and maybe less than a quarter inch around and no soreness, it looks like a mosquito bite but that she doesn't consider it a mosquito bite, rubber her arm, right arm exactly where she received her second dose, losing hair for quite a few weeks and never had that problem before, patient had no vaccination scarring on her left arm where she received her first dose even though both were Pfizer, within two weeks after her second vaccine she had no side effects and felt normal even for her age but this just began to show up and it shows like on top of peeling after a burn from the sun with slight pink discoloration in spots, no puss or liquid is coming out but it almost looks like a zit on her arm and has one little scar, it was also reported that she doesn't walk around much since the accident when that person hit her, and it affected her spine, legs and hips, has a hard time getting out of bed in the morning because she is so stiff and in pain, but she doesn't like to stay in bed. So, she takes the droppers of Vitamin B12 to help loosen up her spine and then once she gets out of bed she will sit on the couch with a heating pad on her back for a while, She has been gaining weight. When she went to the doctor's office in Jun2021, her weight was 154. States that were up from 150 at her previous appointment, she has gotten shorter over the years. Now she is about 4' 8 or 9. she hasn't been sick and there is no puffiness; she just noticed a round circle on her arm that itches. It looks like the leadings of a vaccination, can't walk very far without pain due to the injuries that affected her spine, legs and hips after a car accident, itching. Spot on right arm where she received the 2nd dose of the covid 19 vaccine, round circle on her arm that itches all on an unspecified date in 2021. The outcome of the events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

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

Current Illness: Seasonal allergy; Thyroid disorder

ID: 1756035
Sex: M
Age:
State:

Vax Date: 08/24/2021
Onset Date: 08/26/2021
Rec V Date: 10/02/2021
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: rash was all over his back, chest, arms and legs/widespread rash; This is a spontaneous report from a contactable pharmacist reported for her brother. A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported and Expiry Date of Covid 19 vaccine: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 24Aug2021 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. Concomitant medication(s) included Ibuprofen and Diazepam, both taken for an unspecified indication, start and stop date were not reported. On 26Aug2021, the patient experienced rash was all over his back, chest, arms and legs/widespread rash. The clinical details of the events as follows: She stated her brother is in (City Name) and she is in (State name) and her brother wanted to come visit her in (State name) but she told her brother he could not come unless he was vaccinated. Her brother and his wife received their first Covid 19 vaccine last Tuesday and now her brother has this rash. He was the only one she knew of who had this type of reaction. She reported she had a couple of patients faint after getting the Covid 19 vaccine. She was calling on behalf of her brother who received his first dose of the Covid 19 vaccine last Tuesday, 24Aug2021 and probably around Thursday night, 26Aug2021, her brother got a rash but not on the arm where the injection was. The rash was all over his back, chest, arms and legs. She was asking if it was safe for him to get the second dose of the Covid 19 vaccine. She stated that the reaction did not happen within the first 4 hours after the injection. Her brother sent her a picture of the rash and it was not the Covid arm at the injection site and it did not look like measles but it was widespread. She clarified from the beginning of the call when she stated the rash was not on the arm where he received the injection, she meant it was not the Covid arm associated with the injection site. Her brother asked her if he should go to the urgent care but the caller told her brother the urgent care would just suggest Benadryl and he was already taking that and Zyrtec during the day. Her brother wife did say the rash was looking better. When probing medical history and concomitant medications she stated he might just take an Ibuprofen every now and then and a Diazepam every now and then for his muscles. He was a mechanic and has been for 20 years so his body is pretty beat up. There was no investigation assessment provided. The patient outcome of the event was Resolving at the time of this report. No follow-up attempts are possible; information about lot/batch number not available for [vaccine/BNT162B2. No further information is expected.

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

Current Illness:

ID: 1756036
Sex: M
Age:
State: WY

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 202103; Test Name: Fever; Result Unstructured Data: Test Result:102; Comments: contracted a fever of 102 for 2 days; Test Date: 202103; Test Name: Covid test; Test Result: Positive ; Comments: Tested positive for Covid in March of 2021

Allergies:

Symptom List: Nausea

Symptoms: approximately 5 hours after administration I lost the use of my arm, contracted a fever of 102 for 2 days, had chills, severe headache (tylenol did not touch it), severe joint pain and muscle cramps.; approximately 5 hours after administration I lost the use of my arm, contracted a fever of 102 for 2 days, had chills, severe headache (tylenol did not touch it), severe joint pain and muscle cramps.; approximately 5 hours after administration I lost the use of my arm, contracted a fever of 102 for 2 days, had chills, severe headache (tylenol did not touch it), severe joint pain and muscle cramps.; approximately 5 hours after administration I lost the use of my arm, contracted a fever of 102 for 2 days, had chills, severe headache (tylenol did not touch it), severe joint pain and muscle cramps.; approximately 5 hours after administration I lost the use of my arm, contracted a fever of 102 for 2 days, had chills, severe headache (tylenol did not touch it), severe joint pain and muscle cramps.; approximately 5 hours after administration I lost the use of my arm, contracted a fever of 102 for 2 days, had chills, severe headache (tylenol did not touch it), severe joint pain and muscle cramps.; approximately 5 hours after administration I lost the use of my arm, contracted a fever of 102 for 2 days, had chills, severe headache (tylenol did not touch it), severe joint pain and muscle cramps.; Still have leg cramps and muscle fatigue; Still have leg cramps and muscle fatigue; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) administered in right arm via an unknown route of administration on 24Aug2021 at 13:00 (at the age of 69-year-old) as dose 2, single for COVID-19 immunization. Medical history included asthma, hypothyroidism. Known allergies included Sulfa, and patient relevant medical history included COVID-19 from Mar2021 to an unknown date Tested positive for Covid in March of 2021 so waited well over the recommended 90 days before I got the vaccine. Concomitant medications included levithyroxin (LEVOTHYROXINE SODIUM), singular (MONTELUKAST SODIUM), nexium (AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM), Flomax (TAMSULOSIN HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported. Covid was not tested post vaccination. The patient had known allergies to codeine, sulfa. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unknown route of administration on 03Aug2021 for covid-19 immunisation. No other vaccine was administered in four weeks. Prior vaccination COVID-19 tested as positive and since vaccination COVID test reported as no. On 24Aug2021 at 17:30pm, the patient experienced approximately 5 hours after administration i lost the use of my arm, contracted a fever of 102 for 2 days, had chills, severe headache (tylenol did not touch it), severe joint pain and muscle cramps and symptoms lasted approximately 4 days until patient regained normal feelings. Still patient had leg cramps and muscle fatigue. The patient underwent lab tests and procedures which included on Mar2021 body temperature was 102 contracted a fever of 102 for 2 days, sars-cov-2 test was positive, Tested positive for Covid in March of 2021. No treatment was received for the events. The clinical outcome of events was reported as recovered with lasting effects. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1756037
Sex: F
Age:
State: TX

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210614; Test Name: Electromyogram (EMG) Test; Result Unstructured Data: Test Result: Normal; Comments: Electromyogram (EMG) Test; Test Date: 20210730; Test Name: MRI - Cervical; Result Unstructured Data: Test Result: Normal; Comments: MRI - Cervical; Test Date: 20210614; Test Name: nerve conduction study (NCS) test; Result Unstructured Data: Test Result: Normal; Comments: Nerve Conduction Study (NCS).

Allergies:

Symptom List: Injection site pain

Symptoms: Bi-Lateral ulnar nerve entrapment; Covid vaccine details: Administration date: 07Jan2021, Administration time: 10.15 AM; This is a spontaneous report received from a contactable other healthcare professional (HCP) (patient) reporting herself. This is the second of two reports. This report concerns events occurred after the second dose of BNT162B2. A 39-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3248) via intramuscular route of administration in the left arm on 07Jan2021 10:15 (at the age of 39-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was reported as none. No prior history, no prior illness, no prior medication, no prior symptoms. There were no concomitant medications. Patient did not have Covid prior vaccination and patient did not tested Covid post vaccination. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within four weeks and did not receive any other medications in two weeks. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EK5730) via intramuscular route of administration in the left arm on 21Dec2021 at 10:30 (at the age of 39-year-old) as dose 1, single for COVID-19 immunisation and experienced following events: patient started having migraine issues (no prior history), intense pain in the head, sensitive to light, blurred vision, and not able to concentrate, numbness, pins and needle sensations from the elbow to fingers, extreme temperature differences in fingers, loss of strength in arms, extreme sharp pain in both elbows on 24Dec2021 15:00. It was reported that patient received covid vaccine details: administration date: 07Jan2021, administration time: 10.15 am. The patient experienced bi-lateral ulnar nerve entrapment on 14Jan2021. The event was reported as serious with seriousness criteria of persistent/significant disability/incapacity. The event required visit to physician office. Patient was currently having ongoing bi lateral ulnar nerve entrapment symptoms. The patient underwent lab tests and procedures which included electromyogram (EMG) on 14Jun2021: normal; MRI-Cervical on 30Jul2021: normal; nerve conduction study (NCS) test on 14Jun2021: normal. No test thus far has shown any damages, all normal. The reporter considered that BNT162B2 had a causal effect to the adverse event. The patient had not recovered from bi-lateral ulnar nerve entrapment, the outcome of the other event was unknown. Follow-up attempts are completed. No further information is expected. Follow-up (20Sep2021): New information reported from the same contactable other HCP (patient) included: route of administration of the 1st dose of the vaccine, information about patient medical history, updated information about lab data, route of administration of the suspect vaccine dose, new serious event (bi-Lateral ulnar nerve entrapment), causality.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event (bi-lateral ulnar nerve entrapment) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate ,Linked Report(s) : US-PFIZER INC-202101102588 Same reporter/SD, Different dose/AE

Other Meds:

Current Illness:

ID: 1756038
Sex: F
Age:
State:

Vax Date: 10/01/2020
Onset Date: 08/25/2021
Rec V Date: 10/02/2021
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: received coronavirus booster vaccine; sick; symptoms of arthritis flare in right arm; skin hot/ red around shoulder; skin hot/ red around shoulder; soreness; This is a spontaneous report from a contactable other hcp. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 25Aug2021 as dose 3, (BOOSTER) single for COVID-19 immunization (at the age of 56-year-old); tofacitinib citrate (XELJANZ XR), oral from 01Oct2020 (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included dose 1 and dose 2 of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified dates for COVID-19 immunization. The patient received coronavirus booster vaccine on 25Aug2021 and experienced sick, symptoms of arthritis flare in right arm, skin hot/ red around shoulder, soreness on an unspecified date in 2021. It was reported that, after start of therapy "rarely" missed a dose of xeljanz, took later than normal schedule (morning) over the last few weeks. Unknown if change in symptoms and received coronavirus booster vaccine on 25Aug2021 and was sick for 1 day/no fever, symptoms of arthritis flare in right arm/skin hot/red around shoulder, soreness for several days, better today. MD was unaware and encouraged to notify MD. No additional information/details provided. The outcome of the event sick and soreness was recovered on an unspecified date in 2021, and for symptoms of arthritis flare in right arm, skin hot/ red around shoulder, received coronavirus booster vaccine it was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1756039
Sex: F
Age:
State: MD

Vax Date: 08/14/2021
Onset Date: 08/01/2021
Rec V Date: 10/02/2021
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: Blood work; Result Unstructured Data: Test Result: Unknown Results; Comments: I had my blood work done, due to the chest pain.; Test Name: Fever; Result Unstructured Data: Test Result: Unknown results; Test Name: Echo; Result Unstructured Data: Test Result: Unknown Results; Comments: I had a echo done for the heart and head; Test Name: MRI; Result Unstructured Data: Test Result: Unknown Results; Test Name: X-Ray; Result Unstructured Data: Test Result: Unknown Results.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable healthcare professional and consumer. A 38-year-old female patient (Age at time of vaccination 38-years-old) received third dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 14Aug2021 at 12:00 (Batch/Lot Number: FA7484) as DOSE 3 (BOOSTER), SINGLE for Covid-19 immunisation. Medical history included allergic reaction to analgesics (known allergies: Some NSAIDS), hypertension, asthma and headache (I had a headache prior to the third vaccine). The patient received first (DOSE 1, SINGLE Lot Number: UNKNOWN) and second (DOSE 2, SINGLE Lot Number: UNKNOWN) doses of BNT162B2 both on unspecified dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen, colchicine, Azilsartan kamedoxomil (EDARBI) all taken for unspecified indications, start and stop dates were not reported. The patient experienced pseudotumor cerebri on 2021, ran a low grade fever on 17Aug2021, severe left chest pain/ chest pain on 17Aug2021, twitching started in left eye/twitching in my left, all of my left side of my body on Aug2021, ear pain on Aug2021, headache on 2021. It was reported that on 17Aug2021, the patient had a low grade fever for 1 week. On an unknown date in Aug2021, the next week, the patient had severe left chest pain and twitching started in his left eye and had not stop since and ear pain. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with unspecified over the counter pain medications and steroids. Consumer stated, "I am calling because I received the booster vaccine or the third shot on 14Aug2021 (not clarified). I went to my local # and they stated I qualified for the vaccine due to pseudotumor cerebri and 'after' getting a shot, I have been having, I have been at the emergency room and I have been having severe chest pain and twitching in my left, all of my left side of my body and they are saying that they do not see anything but since I had the shot, that has developed. So, I want to know what can I do because the chest pain have been going on full month and I had a headache prior to the third vaccine." As of 20Sep2021, the patient stated that she received her booster dose of the Pfizer BioNTech Covid-19 vaccine and ever since has been having left sided bad chest pain and eyes twitching. She also stated that it is hard to talk on an unspecified date because her chest hurts. She had been to the ED and they don't see anything that is wrong and told her to wait it out. The patient was seeking information if any HCP recommendations who maybe able to help her. The patient underwent lab tests and procedures which included Blood work (blood test): unknown results on an unspecified date (I had my blood work done, due to the chest pain), Fever (body temperature): unknown results on an unspecified date, Echo (echocardiogram): unknown results on an unspecified date (I had a echo done for the heart and head), MRI (magnetic resonance imaging): unknown results on an unspecified date and x-ray: unknown results on an unspecified date. Therapeutic measures were taken as a result of ran a low grade fever, severe left chest pain/ chest pain, twitching started in left eye/twitching in my left, all of my left side of my body and ear pain. Outcome of the event Ran a low grade fever was recovered on 24Aug2021. Outcome of pseudotumor cerebri, headache and hard to talk was unknown. Outcome of severe left chest pain/ chest pain, twitching started in left eye/twitching in my left, all of my left side of my body and ear pain was not recovered. Follow-up attempts are completed. No further information is expected. Amendment: This case is being submitted to notify that the follow-up information for this case was received by the company on 18Sep2021. Additional information received on 20Sep2021 from a contactable consumer includes event details (added hard to talk, deleted extra dose administered and off label use and course of events). 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: 1756040
Sex: M
Age:
State:

Vax Date: 03/19/2021
Onset Date: 06/01/2021
Rec V Date: 10/02/2021
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: 202108; Test Name: Humira Antibody Test; Result Unstructured Data: Test Result: Unknown result; Comments: There were lacking and no anti adalimumab antibodies; Test Date: 202107; Test Name: Covid antibody test; Test Result: Negative.

Allergies:

Symptom List: Tremor

Symptoms: On 28Aug2021, patient received third dose COVID-19 Vaccine; On 28Aug2021, patient received third dose COVID-19 Vaccine; Boil under armpit / Multiple Boils under right armpit; irritated/lump that had the same size with a ping pong ball; Skin irritation; This is a solicited report based on the information received by Pfizer from Regulatory Authority (Mfr. Control No.:21K-163-4067790-00) via a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 19Mar2021 (Batch/Lot number was not reported) (at the age of 62 years old) as single dose, and dose 3 intramuscular on 28Aug2021 (Batch/Lot number was not reported) (at the age of 63 years old) as booster dose, single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2017 (Batch/Lot number was not reported) to Jul2021, at 40 mg (1 in 2 wk.), then subcutaneous from 09Sep2021 (Batch/Lot number was not reported), at 40 mg (1 in 2 wk.) for moderate to severe rheumatoid arthritis and ankylosing spondylitis. Medical history included alcohol use: beer, occasionally (Started 1979), and no tobacco use. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 26Feb2021 (Batch/Lot number was not reported) (at the age of 62 years old) intramuscular as single dose for Covid-19 immunisation. Concomitant medications included lisinopril taken for high blood pressure; carvedilol taken for high blood pressure on; atorvastatin taken for high cholesterol; pantoprazole taken for acid reflux; all start and stop date were not reported. In Jun2021, the patient experienced boil under armpit/multiple boils under right armpit, irritated/lump that had the same size with a ping pong ball, and skin irritation. The patient first noticed that there was something bothering him in between his right armpit and was irritating. He noticed it became a lump that had the same size with a ping pong ball. He had it checked and physician said those were multiple boils under his right armpit. He was off of Humira 30 days before the removal of boils. His physician ran a Covid antibody test (Jul2021) and it came back negative. In Jul2021, the patient's boils under the armpit and lump had been removed at physician office. He was taking unspecified oral antibiotics for 10 days as part of his post-operative medication. In Jul2021, he was afraid to get infected on the surgical site after the procedure and just suspended taking Humira as of 13Sep2021 even if the physician reassured him that there was no need to do that. In Jul2021, the multiple boils under right armpit and irritated/lump that had the same size with a ping pong ball resolved. On 28Aug2021, patient received third dose Covid-19 vaccine. Humira antibody test in Aug2021: (unknown result) there were lacking and no anti Adalimumab antibodies. Outcome of the events was recovered in Jul2021. The reporter's causality for the event(s) of Boil under armpit with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Covid Antibody test came negative was not provided. Regulatory Authority opinion is that there is a reasonable possibility that the event of Boil under armpit is related to HUMIRA(ADALIMUMAB). RA's opinion is that there is no reasonable possibility that the event of Covid Antibody test came negative is related to HUMIRA (ADALIMUMAB). The reporter's causality for all adverse events with suspect product BNT162B2 was not reported at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts were possible, information about lot/batch number cannot be obtained. No further information was expected. Amendment: This follow-up report is being submitted to amend previously reported information: updated company causality for events Furuncle and SARS-CoV-2 antibody test negative with regard to Pfizer suspect product. Follow-up (17Sep2021): New information received by Pfizer from Pfizer from Regulatory Authority (Mfr. Control No.:21K-163-4067790-00) via the same contactable consumer (patient) includes: concomitant medications, new events (irritated/lump that had the same size with a ping pong ball, and skin irritation), reaction data (event onset date and event outcome), and lab data. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: HUMIRA

Current Illness:

ID: 1756041
Sex: U
Age:
State: WA

Vax Date: 09/13/2021
Onset Date: 09/01/2021
Rec V Date: 10/02/2021
Hospital: Y

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: Pressure in her spine/Feels like spinal fluid pressure/When she tries to look up, down, left, right, it feels like her spinal fluid is pressurized; like it is going to start shooting out; Tension in the neck and the back; Feeling bad/run down; Headache/ excruciating painful to turn my head look up and down; Difficulty swallowing; Increased pain with swallowing; Pain is not only in mid-upper back, its up to my brain stem area and then kinda goes to my scalp; Pain is not only in mid-upper back, its up to my brain stem area and then kinda goes to my scalp; When she "turns her head it fires, feels like a nerve fire or spasm and is very uncomfortable; Feels like cannot swivel head around, has to look with whole body; Weird, almost muscular pain sensation; Feels inflamed, almost swollen; My right like muscle around my eye were like twitching a lot; I have had like intrusive pressure it like it feels like my brain stem ever since, it just starts to really start getting hurt."; Feels inflamed, almost swollen; This is a spontaneous report from a contactable consumer reporting for self, from a Pfizer sponsored program with Regulatory Authority Support. A 39-years-old patient of an unspecified gender (reported as non-binary) received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 13Sep2021 (Batch/Lot Number: FE3592; Expiration Date: 30Nov2021) as dose 1, single dose (at the age of 39 years old), for COVID-19 immunisation. The patient's medical history was none. Concomitant medication(s) included estradiol (ESTRADIOL), 2 mg taken as hormone replacement therapy, start and stop date were not reported. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Right after the vaccine (13Sep2021) the patient started feeling bad, run down with a headache. That evolved to where the patient has been laying around and not doing much of anything; taking it easy. Then, yesterday (15Sep2021) into today (16Sep2021), patient started feeling tension in the neck and the back as well as pressure in spine. This morning (16Sep2021) around 0200 the patient was up and felt like the spinal fluid pressure. Stated it was very uncomfortable. Feels like there was a weird, almost muscular pain or sensation; it felt inflamed, almost swollen. The patient didn't want to move too much. Stated it was very uncomfortable and alarming. The pain was not only in mid-upper back, it was up to the brain stem area and then "kinda goes to my scalp." The reporter described the feeling as the weirdest sensation, sometimes jolting. The reporter also described that when turning their head "it fires, feels like a nerve fire or spasm" and was very uncomfortable, making the patient not want to look up, down, or left or right. When the patient looked up it felt like they were straining; like their spine fluid was pressurized; like it was going to start shooting out. "My spinal fluid feels like its just been bursting out between my vertebrae. I am not felling well. It's just gonna kill me." The patient felt like they cannot swivel their head around; they had to look with their entire body. The patient reported having difficulty swallowing and increased pain with swallowing; it was getting increasingly painful and hard to swallow. Also reported that first day, the right like muscle around the eye was like twitching a lot; it was kind of coming and going and the patient didn't know why the right eye is twitching it never does that. Denied any labs, testing, or treatments relevant to events and wanted to know if this was a common side effect noted and what to do regarding symptoms. The reporter initially stated they hadn't gone to the hospital yet (as of 16Sep2021); no doctors visit or emergency room visit was required. In response to being advised to contact nearest healthcare professional in case of any emergency, the reporter then stated "Hospital, Well, I guess that thing that Vaccine side effect put me in the hospital and I gonna be on bill that's like I can't afford that if I know it was this bad I would not have taken the vaccine. I really feel that I suffered some sort of injury, I don't know if this will last forever but I really feel really messed up like I am really frightened and I am kind of angry because of how, just in like I have never felt that like in my life". The reporter felt like there was poison in their body, their body was also freaked out, they felt very like 'awkward,' excruciatingly painful to turn the head, look up and down, and that was very weird and the patient stated the "biofluid was getting a spine buzzing explode." The reporter also described intrusive pressure, "it felt like the brain stem ever since," it just started to really start getting hurt. The outcome of the events were unknown. Follow-up (21Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds: ESTRADIOL

Current Illness:

ID: 1756042
Sex: M
Age:
State: GA

Vax Date: 03/24/2021
Onset Date: 04/01/2021
Rec V Date: 10/02/2021
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: Test Name: CAT scan normal; Result Unstructured Data: Test Result:Normal x3; Test Name: X-ray; Result Unstructured Data: Test Result:?????; Comments: They can't find anything wrong with him.

Allergies:

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

Symptoms: very dizzy; severe pressure in the head and jaw; severe pressure in the head and jaw; feeling very nauseated all the time; ringing in the ears; confusion; confusion; vertigo; chills; affected his ability to drive; every day the headaches kept getting worse; long-term allergic reaction to the Pfizer Covid-19 Vaccine; This is a spontaneous report from a contactable Consumer (patient). A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number-unknown, Expiry date-unknown) via an unspecified route of administration, administered in arm left on 24Mar2021 at before 11:00, probably 10:00 (at the age of 70-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient medical history included tree and weed allergy from an unknown date and unknown if it is ongoing. Family history was none. Patient concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number-unknown, Expiry date-unknown) via an unspecified route of administration, administered in arm left as DOSE 1, SINGLE on 03Mar2021 for covid-19 immunisation. Patient received both doses at Pharmacy. Patient had not received any other vaccine prior Vaccinations within 4 weeks to the first administration date of the suspect vaccine. The patient was not hospitalized. Two weeks after the second dose he started getting headaches and every day the headaches kept getting worse. By 01May2021 he was having ringing in his ears, severe pressure in the head and jaw, feeling very nauseated all the time, very dizzy, vertigo, chills and confusion. He has become confused in his thinking and its affected his ability to drive. A few days he didn't think he was going to the make it and that's why he went to the ER. He had been to the ER twice, primary care doctor three times, neurologist and allergist. He states he's been through the ringer but no one can find anything wrong. He was just given headache pills and stuff for vertigo. He stated every day it seems to get worse. Time of Onset for allergic reaction was 24-hour clock. He believed he was having a severe allergic reaction to the vaccine, On 6May2021, he went to his primary care doctor and he put him on antibiotics because he thought it was his inner ear. The allergy Doctor found normal allergies to trees trees and weeds. By the middle of Aug2021 or end of Aug2021 events worsened like this. He can hardly drive; he can't do anything. He has been seen in the doctor's offices and been to the emergency room twice, but had not been admitted to the hospital at any time related to these events. Patient had 3 cat scans, allergy testing and in the emergency room twice at (Name)Hospital. He even went to the dentist to get x-rays of his teeth to make sure nothing was going on with his teeth. They can't find anything wrong with him. Treatment: Headache Pills, Butalb, and Stuff Vertigo, Meclizine, Steroid Pills. The outcome of headaches, ringing in his ears, confusion, nausea, vertigo and chills, affected his ability to drive were not recovered and severe pressure in the head and jaw, dizziness were unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1756043
Sex: F
Age:
State: IN

Vax Date: 02/19/2021
Onset Date: 03/01/2021
Rec V Date: 10/02/2021
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: 202107; Test Name: CT scan of her whole shoulder; Result Unstructured Data: Test Result:showed nothing/negative; Test Date: 202108; Test Name: they put liquid in the vein to see if there was a clog; Test Result: Negative ; Test Date: 2021; Test Name: test to see if had a blood clots; Test Result: Negative

Allergies:

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

Symptoms: left arm also started swelling, it slowly swelled over time; It did pain her sometimes because it was heavier than her right arm but it did not pain her, all the time, it's sore.; It did pain her sometimes because it was heavier than her right arm but it did not pain her, all the time, it's sore.; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received second dose of BNT162B2 (Pfizer product), lot number EM9810 with expiration date 30Jun2021, via an unspecified route of administration in the left arm on 19Feb2021 as single dose for COVID-19 immunization. The patient previously received the first dose on 26Jan2021 and experienced egg-shaped raised area on the left arm/recalled it being hard on Jan2021 to unspecified date in 2021 (lot number EL3247 with expiration date 31May2021). Facility of vaccine administration: major hospital. Medical history included diabetic type 2, a lot of allergies to different drugs, allergies: she can't take penicillin, she was allergic to a lot of antibiotics, and sulfa. That's about all. Concomitant medication included apixaban (ELIQUIS; lot number 1817734 with expiration date Jan2024) as blood thinners. The patient received the first dose of the Pfizer Covid-19 vaccine on 26Jan2021 and the second dose on 19Feb2021. Both doses were administered in the left arm. After the first (reported as second; discrepancy) dose of the Pfizer Covid-19 vaccine, the patient experienced an egg-shaped hard bump and swelling. She was asking if swelling is a side effect of the Pfizer Covid-19 vaccine. She wanted to get the booster dose of the Pfizer Covid-19 vaccine and was asking if it should be given in the right arm due to the side effects she experienced in her left arm after the first dose. After her first shot, she got both shots in the left arm, she got this thing that was kind of an egg-shaped hard bump on her arm, it was big. After both shots in Mar2021, the left arm also started swelling, it slowly swelled over time. She has had 5 different procedures done and they didn't know what's wrong with her arm, she had to learn to live with it. The first 3 doctors she saw said it has nothing to do with the Pfizer shot. The last doctor that she saw which was like a vein specialist said that because they didn't know enough about the shot, it could be from that. She stated that now she cannot get blouses, they have to be tapered on left arm because it was so big. They were fitting her for a compression sleeve and that was all they can do with it. She was pretty sure it had to do with the Pfizer shot. She had a lot of allergies to different drugs. Since after this happening with the Pfizer shot, she would still get the shot even if she knew this was going to happen. Now she had to buy different clothes. It did pain her sometimes because it was heavier than her right arm but it did not pain her, all the time, it's sore in 2021. She obtained her covid vaccine card. She knew she got it in Mar2021 but on the card it said the first dose as 26Jan2021 and the second dose as 19Feb2021. She went to the hospital to receive the vaccine, she didn't know why they had the date mixed up. She later confirmed vaccine dose dates on her covid card were correct and she had mistaken it for being sometime in Mar2021. Her primary care doctor knew about her arm. The egg-shaped raised area came the day after, the swelling she didn't notice because it was so slow, she recalled that she went to family doctor in May2021 and by then it was swelled up, the doctor didn't think it was important. The egg-shaped area started at the end of Jan2021. She didn't know when but it slowly went away. She recalled it being hard. She knew the swelling was present in May2021 but she didn't know when it started. It has just gotten bigger over the month, she thinks it stopped growing but it's not going down, it's just the same right now. She was diabetic type 2. She was taking blood thinners but she didn't think she was asking the blood thinner when she got the shots , it's called Eliquis she thinks it was prescribed after the covid vaccine but was not positive Eliquis (Lot 1817734 and Exp Jan2024). Investigation: In Jun2021 or Jul2021, she took a test to see if had a blood clots and that was negative. In Jul2021, she had a CT scan of her whole shoulder and it showed nothing. In Aug2021, she went to the vein specialist in which they put liquid in the vein to see if there was a clog and that was negative. All 3 procedures were negative. Treatment: There was nothing she can do about it. She did all the tests and nothing was wrong. The last thing she was fitted for was a compression sleeve, she was being fitted for it now. She has had to see physicians but has not had to go to the emergency room. Prior to ending the call, she asked that she would like to get the booster shot, should she get it in the same arm or in the right. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1756044
Sex: F
Age:
State: VA

Vax Date: 08/20/2021
Onset Date: 09/04/2021
Rec V Date: 10/02/2021
Hospital: Y

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: Chest Xray; Result Unstructured Data: Test Result:Normal; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Name: Pulse; Result Unstructured Data: Test Result:80

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Heart attack; almost fainted; Palpitations; Chest pain; Feeling abnormal; Lightheadedness; Numbness; Tingling of extremity; Eye discomfort; Pulse abnormal; Vertigo; Abdominal pain; Blood pressure high; Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in arm right on 20Aug2021 at 16:30 (age at vaccination 37-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history included IBS (irritable bowel syndrome) from an unknown date and unknown if ongoing. Concomitant medications included calcium carbonate, colecalciferol (VITAMIN D 2000), ascorbic acid, calcium pantothenate, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium sulfate, manganese sulfate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, zinc sulfate (PRENATAL-H) and ascorbic acid (VITAMIN C ACID) in two weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had a sore arm and was fine for two weeks. On 04Sep2021 at 13:30, the patient had crushing chest pain, feeling of something popping inside her body, lightheaded, almost fainted, numbness and tingling in left arm and leg, felt something travel behind right eye and push it forward. The patient could see her abdomen pulse with heart beat and went to the Emergency Room thinking she was having a heart attack. The patient had chest X-ray and ekg (electrocardiogram) which were normal, pain in chest continued for a week. The events vertigo, dizziness, abdominal pain/bloating have continued. The patient had high BP, palpitations, and a pulse that wouldn't go below 80. The patient had continued chest pain and feeling generally unwell. The patient was currently running tests with a cardiologist. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness criteria of the events was reported as hospitalization, medically significant. The patient did not received treatment for adverse events. The outcome of all events was not resolved. 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

Current Illness:

ID: 1756045
Sex: M
Age:
State: CA

Vax Date: 04/06/2021
Onset Date: 04/20/2021
Rec V Date: 10/02/2021
Hospital: Y

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

Lab Data: Test Date: 20210909; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: swelling lead to a superficial clot and later a DVT; left leg started to swell on occasion and go back down; swelling lead to a superficial clot and later a DVT; This is a spontaneous report from a contactable consumer or other non-healthcare professional reporting for himself (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EWO158, expiry date unknown) via an unspecified route of administration in left arm on 06Apr2021 (at the age of 49-year-old) as dose 2, single for covid-19 immunization at a Public Health Clinic/Military Administration facility. The patient medical history included severe case of COVID in Jan2021 on an unknown date and was allergic to sulfa. Patient's concomitant medications included carvedilol and levothyroxine sodium (SYNTHROID). The patient previously took first dose of BNT162B2, formulation: solution for injection, Lot Number: ENG208, expiration date: unknown) via unknown route of administration in left arm on 16Mar2021 (at the age of 49-year-old) as dose 1, single for covid-19 immunization. No other vaccines were administered within four weeks. On 20Apr2021, patient stated after second dose in Apr2021 his left leg started to swell on occasion and go back down (Thrombophlebitis leg). He started going to the doctor in Jun2021. This swelling lead to a superficial clot and later a Deep vein thrombosis (DVT). The patient hospitalized due to the events and AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test (PCR; Nasal swab) negative on 09Sep2021. Therapeutic measures were taken as a result of events and treatment included Advil then Xarelto. The outcome of all events was recovering. Follow-up attempts are completed. No further information is expected.

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

Current Illness:

ID: 1756046
Sex: F
Age:
State: DE

Vax Date: 08/27/2021
Onset Date: 09/17/2021
Rec V Date: 10/02/2021
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: Due to an administration error patient received the second dose of Moderna instead of Pfizer today; This is a spontaneous report from a contactable contactable Nurse. A 61-years-old female patient received first dose ofNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; (Batch/Lot Number: FD8448; Expiration Date: Oct2021)) via intramuscular, administered in Deltoid Right on 27Aug2021 at (at the age of 61 years old) as, 0.3 mL, Single dose for COVID-19 immunisation; Patient received Second dose of covid-19 vaccine (mrna 1273) (MODERNA COVID-19 VACCINE, Solution for injection,(Batch/Lot Number: 006D21A; Expiration Date: 21Apr2022)),via intramuscular administered in Deltoid Right on 17Sep2021at (at the age of 61 years old), 0.5 mL Single dose for COVID-19 immunisation. Patient had no medical history. Patient had no allergies There were no concomitant medications. he patient experienced due to an administration error patient received the second dose of moderna instead of pfizer today. The patient did not receive any treatment for the events.; Sender's Comments: Based on the reported information ,a causal relationship between the event and suspected drug cannot be excluded.

Other Meds:

Current Illness:

ID: 1756047
Sex: F
Age:
State: NH

Vax Date: 05/01/2021
Onset Date: 05/14/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Biopsy; Result Unstructured Data: Test Result:small fiber neuropathy; Test Date: 2021; Test Name: Blood tests; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: EMG; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Pain in extremity

Symptoms: I have had months of horrible neuropathy that is spreading very quickly. I was diagnosed with small fiber neuropathy via biopsy; I also nowhave vision and balance issues; I also nowhave vision and balance issues; This is a spontaneous report from a contactable consumer or other non-health care professional. A adult female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not reported, Expiry: Not Reported) via an unspecified route of administration on an unspecified date in May2021 as dose 2, single for covid-19 immunisation. It was unknown whether the patient was pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not reported, Expiry: Not Reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was unknown that whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown that whether the patient has been tested for COVID-19 since the vaccination. It was unknown if covid prior vaccination. It was unknown if covid tested post vaccination. It was unknown if patient had any known allergies. It was unknown whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient reported that the patient had an adverse reaction to the second Pfizer shot. The patient had months of horrible neuropathy (medically significant) on 14May2021 that is spreading very quickly on. The patient was diagnosed with small fiber neuropathy via biopsy, but all blood tests/MRI/EMG are normal. The patient had been to so many doctors and no one knows how to treat this or help. The patient had trying to get to a specialist. There are many others that are suffering with similar or worse symptoms. The patient also had vision issues on an unspecified date in 2021 and balance issues on 14May2021. Symptoms started 12 hours after the second shot on 14May. Vision issues began 5 weeks after second shot. Patient said she had been dealing with medical issues prior to the shot. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included biopsy: small fiber neuropathy on unspecified date in 2021, blood test: normal on unspecified date in 2021, electromyogram: normal on unspecified date in 2021, and magnetic resonance imaging: normal on an unspecified date in 2021. It was unknown whether the patient received any treatment for the adverse event. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1756048
Sex: M
Age:
State: AZ

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

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

Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: his feet feel like they are 4 times their size, and it was not like that before; ringing in his ears; numbness in his feet; coldness in his feet; her feet getting more nerve; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported), via an unspecified route of administration, administered in Right Arm in 2021 (at the age of 66-years-old) at dose 1, single and via an unspecified route of administration, administered in Arm Left in 2021 at dose 2, single for covid-19 immunization. Medical history included allergies, hay fever, allergic to sodium nitrate in all meats, allergic to gin. There were no concomitant medications. The patient previously took statins and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He got the vaccines six months ago. After first dose, patient reported that he had ringing in his ears and his feet were numb and cold, he felt his feet were 4 times the size they really were, and these got worsened after the second dose of the vaccine. He described that he has extreme numbness and coldness in his feet and his doctor has not been able to do anything to help it. He was asking if there was any information on those side effects and if there was anything that could help. He also stated that his feet felt like they were 4 times their size and was not like that before. He also experienced a worsening of his feet getting more nerve. He already had the issue, but it got worse. It was a nerve thing just like his ears. His feet were numb and cold. It was getting worse. It is about the same feeling. He didn't realize it was related. With the numbness and coldness in feet, his feet felt 4 times the size they really were. They were getting worse instead of better. He has received acupuncture and went to a chiropractor, and nothing has made it better. He went to a neurological doctor who couldn't get anything better either. The vaccine was not administered at military facility. The events resulted in physician office visit. Patient underwent lab tests and procedures included brain MRI with unknown results. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1756049
Sex: F
Age:
State: MO

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 10/02/2021
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: blood pressure; Result Unstructured Data: Test Result:High; Test Name: Has had 5 negative Rapid COVID tests; Test Result: Negative

Allergies:

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

Symptoms: sick again; one day she had a fever; she was very ill; chills; body aches; just felt terrible; had discomfort that settled in her neck; now feels like she has a respiratory infection; feels like she has a severe sinus infection; coughing up yellow greenish phlegm with blood in it, coming out of nasal passages; stomach issues; weakness; a nose bleed with a blood clot from her right nostril; severe diarrhea; chest kind of hurt; feeling very tired; coughing/dry cough; heart palpitations; dizzy; mild headache; heart was beating a little fast; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Right on 27Aug2021 (at the age of 56-years-old) at dose 1, single for covid-19 immunization. Medical history included allergies and high blood pressure but no major health issues or diseases. The patient's concomitant medications were not reported. When she first had her first shot, she didn't really have symptoms, she felt fine. On 27Aug2021, she had a mild headache and heart was beating a little fast and had some dizziness, heart palpitations, she knew it was from that vaccine, it was something new in her system. She stated she does not know if she has recovered completely, she has recovered, but not completely, she doesn't know if the symptoms are going to reoccur, she can't give a specific time, she still has some of symptoms. She stated she has a titanium rod in her neck and has had discomfort that has settled in her neck. On 04Sep2021, she felt very tired, was dizzy, was coughing, her chest kind of hurt, is ongoing, has gotten worse. She has fever, very ill; chills, body aches, just felt terrible on an unspecified date. On 05Sep2021 she had dizziness, weakness, headache, she was at work, and all of a sudden she had a gushing nose bleed, she's never had a nose bleed, she hasn't had one in 10 years, she had a sudden nose bleed with a blood clot that discharged from right nostril, then it stopped, She had a severe headache, had dizziness, started having stomach issues with severe diarrhea, she felt very fatigued, severe diarrhea to the point she had to leave her job, that happened and carried on through 10Sep2021, she felt better then and went back to work. She was fine 11Sep2021, 12Sep2021, and 13Sep2021. On 14Sep2021, she started feeling like she had a respiratory infection and she's gotten worse. She had to take off her job for the last 4 days. She called her physician, and it feels like in her head she has a severe sinus infection, it was in her chest, she has a cough, she was coughing up like when she gets a sinus infection, that yellow greenish phlegm with blood in it, coughing it up, it came up out of her nasal passages. She stated now she has a dry cough, she takes Nyquil. She did finally get ahold of her physician who never called her back, she had to call the on-call doctor that people use for emergencies and that doctor sent her in an antibiotic, she double dosed it to get it in her system, and that was yesterday. She took a dose yesterday and she was sure it will take a couple of days. Caller does not provide any further information about the antibiotic she was taking. She stated she had another Covid test, she has had 5 rapid Covid tests from her facility, she has to have it before she returns to her job. All her tests have come back negative. She was scheduled for her second shot and she was concerned if she is still ill or having symptoms if she should have the shot. She understands about the coughing or what now, she thought it was allergies, maybe a virus that's going around. The outcome of the events (dizzy, coughing/dry cough, feeling very tired, chest kind of hurt, feels like she has a respiratory infection) was not recovered, stomach issues got recovered and rest of the events were unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1756050
Sex: F
Age:
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient, cardiovascular technologist). A 46-year-old female patient received second dose of bnt162b2 (COMIRNATY (COVID 19 Vaccine, Mrna), Solution for injection, Lot Number: EW0185; Expiration Date: 01Oct2021), via unspecified route of administration on 09Sep2021 (at the age of 46-year-old), in right arm as single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (COMIRNATY (COVID 19 Vaccine, Mrna), Solution for injection, Lot Number: EW0164, expiration date Aug-2021), in right arm on 19Aug2021, at single dose for COVID-19 immunization. The patient's medical history included anemia from heavy periods and takes iron supplements for this. On 11Sep2021, patient had heavy menstrual bleeding. The patient reported that on an unspecified date in 2021, her period became very irregular and had been very heavy with lots of big clots coming out of her. Usually it lasts for 5 days. She says the first three days it was very heavy, the fourth it slowed and stopped and on day five. she was done but still she was spotting, with heavy bleeding and spotting that was not going away. She reported that she is anemic to begin with, and she cannot afford to bleed like this. She says her job had her get the vaccine because she is in the medical field, so now she is calling to find out if this was a side effect. The patient was taking Pfizer COVID-19 vaccine as her job demanded it. The patient reporter that she does not have one yet since she moved. The patient reported that she did not receive treatment. Her period was doing what it does for those days and the problem was not stopping and continued with the heavy clotting. She had never seen clots like this. The patient wanted to be sure, her situation was not to be ignored. The patient wanted to know if this could be a side effect of the vaccine. The patient stated that she had not seen a health care professional because she had no insurance. The patient stated that she has been having cycle for years and this was something different. Her heavy bleeding always stops on the fifth day. The patient was asking if this ever going to stop. The clinical outcome of events heavy clots coming out of her and irregular menstruation was reported as unknown and remaining events as not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756051
Sex: M
Age:
State: NY

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

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

Lab Data: Test Date: 20210910; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Vomiting

Symptoms: Severe headache/Headaches still persist on today's date 6 weeks later; Stiff neck; Intestinal cramps; This is a spontaneous report from a contactable other hcp (patient). A 52-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date not reported), via an unspecified route of administration, administered in right arm on 09Aug2021 13:00 (at the age of 52 years) as dose 1, single for covid-19 immunization. The patient's medical history was not reported. Patient did not have covid prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); and sertraline (SERTRALINE), both taken for an unspecified indication, start and stop date were not reported. On 10Aug2021 13:00, the patient experienced severe headache, stiff neck and intestinal cramps. It was reported that, headaches still persist on today's date 6 weeks later. Patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient underwent lab tests and procedures which included nasal swab test for covid: negative on 10Sep2021. The outcome of all the events 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

Current Illness:

ID: 1756052
Sex: F
Age:
State: WA

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

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

Lab Data: Test Date: 2020; Test Name: stress test; Result Unstructured Data: Test Result:Mitral Valve Prolapse; Test Date: 2021; Test Name: stress test; Result Unstructured Data: Test Result:Mitral Valve Prolapse; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Unknown Results

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Mitral Valve Prolapse; Get out of breath easily on my regular walks and hikes.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EL926) dose 2 via an unspecified route of administration, administered in the left arm on 01Feb2021 09:45 (at the age of 69 years old) as dose 2, single for COVID-19 immunisation at hospital. Medical history included asthma, Gluten allergey. Patient previously took bnt162b2 (BNT162B2, solution for injection, Lot Number: EK9231) dose 1 via an unspecified route of administration, administered in the left arm on 11Jan2021 09:30 as dose 1, single for COVID-19 immunisation. Concomitant medication was not reported. Patient received asthma inhalers within 2 weeks of vaccination. No other vaccines were given within 4 weeks. 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 underwent Covid test post vaccination type by nasal swab.On 02Feb2021 the patient experienced mitral valve prolapse, get out of breath easily on my regular walks and hikes. AE resulted in physician office visit. No treatment was given. The patient underwent lab tests and procedures which included cardiac stress test resulted mitral valve prolapse on an unspecified date of 2020, cardiac stress test resulted mitral valve prolapse on an unspecified date of 2021, sars-cov-2 test resulted unknown results on an unknown date. The clinical outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1756053
Sex: F
Age:
State: MI

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 10/02/2021
Hospital: Y

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: evidently attacked my immune system and sent my RA into overload; taking out my ability to walk or stand; pain in my knees and legs.; RA into overload; I felt excruciating pain below my knees/ Knees were swollen and very painful; My knees were swollen and very painful; I couldn't walk/ very unstable walking as my legs give out; couldn't move my legs; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non- pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186), via unspecified route of administration on 17May2021 (at the age of 62-year-old) and non-pregnant at the time of vaccination, as dose 2 in left arm, single for COVID-19 immunization. The patient medical history included hypertension, fibromyalgia, rheumatoid arthritis, epstein-barr virus infection. The Concomitant medication(s) included Amlodipine, Methotrexate. The patient previously took Bactrim and experienced drug hypersensitivity, Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0175), via an unspecified route of administration on 26Apr2021 at 10:30 as dose 1, single in left arm for covid-19 immunisation. On 17May2021 at 23:15 patient experienced couldn't move my leg, my knees were swollen and very painful, I couldn't walk/ very unstable walking as my legs give out, evidently attacked my immune system and sent my RA into overload, taking out my ability to walk or stand, pain in my knees and legs, RA into overload, I felt excruciating pain below my knees/ knees were swollen and very painful. Seriousness criteria (hospitalization, disability). The patient was hospitalized from 18May2021 to 20May2021. Therapeutic measures were taken as a result of couldn't move my legs, my knees were swollen and very painful, I couldn't walk/ very unstable walking as my legs give out, evidently attacked my immune system and sent my RA into overload, taking out my ability to walk or stand, pain in my knees and legs, RA into overload, I felt excruciating pain below my knees/ knees were swollen and very painful. AE treatment included Pain medications, tests, drained fluid off right knee. The patient had no covid prior vaccination, nor tested post vaccination. The clinical outcome of the events were recovering. Follow-up attempts are completed. No further information expected.

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

Current Illness:

ID: 1756054
Sex: F
Age:
State: MN

Vax Date: 09/05/2021
Onset Date: 09/05/2021
Rec V Date: 10/02/2021
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: Internal itching on extremities mainly arms hands and face. Sometimes feet and legs.; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non-pregnant female patient received 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 05Sep2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation. Medical history included Factor V, PCOS, Type 2 Diabetes. Concomitant medication included clonazepam (KLONOPIN) and metformin taken for an unspecified indication. Patient had no known allergies and no past drug event. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 05Sep2021 the patient experienced internal itching on extremities mainly arms hands and face, sometimes feet and legs. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for the event with Zyrtec (once a day). Since the vaccination the patient was not tested for COVID-19. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

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

Current Illness:

ID: 1756055
Sex: F
Age:
State: TX

Vax Date: 09/14/2021
Onset Date: 09/15/2021
Rec V Date: 10/02/2021
Hospital:

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

Lab Data: Test Date: 20210915; Test Name: Fever; Result Unstructured Data: Test Result:up to 101.7

Allergies:

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

Symptoms: heart rate averaging 15 to 20bpm; left arm extremely painful hot; whole upper arm is itchy going under my armpit up my neck; stiff neck; insomnia; diarrhea; red rash on left arm; migraine; headaches; extremely hot; chills; fever up to 101.7; body aches; nausea; difficulty breathing /issues with breathing; stuffy nose; pain in injection site; feeling exhausted; This is a spontaneous report from a contactable consumer (patient). A 35-Year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: 301458a) via an unspecified route of administration, administered in arm left on 14Sep2021 05:30 PM (age at vaccination was 35 years and she was not pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation at pharmacy/ drug store. The patient's medical history included asthma and known Allergies of citalopram, CT dye. There was no other vaccine administered in four weeks. The patient's concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), salbutamol sulfate (VENTOLIN HFA), ranitidine hydrochloride (ZANTAC), Ibuprofen, soolantra. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Fd8448) via an unspecified route of administration, administered in arm left on 24Aug2021 06:30 PM (age at vaccination was 34 years) as dose 1, single for covid-19 immunisation. On 15Sep2021 (at 05:15 PM), 24 hours after second dose out of no where she got chills and a fever up to 101.7, body aches, nausea, difficulty breathing, stuffy nose, pain in injection site, feeling exhausted, on 16Sep2021, fever through morning with headaches, body aches, nausea afternoon arm was more sore at injection site and firm and extremely hot, issues with breathing and on 17Sep2021, insomnia, diarrhea, red rash on left arm, migraine and on 18Sep2021, left arm extremely painful hot where red rash was, whole upper arm was itchy going under her armpit up her neck, stiff neck and body aches, heart rate averaging 15 to 20bpm recorded on Apple Watch. The patient did not receive treatment for adverse events. Information of covid prior vaccination and covid tested post vaccination were unknown. The patient underwent lab test and procedure included body temperature and resulted into fever upto 101.7 on 15Sep2021. The outcome of all adverse events was recovering. Follow-up attempts were completed. No further information was expected.

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

Current Illness:

ID: 1756057
Sex: F
Age:
State:

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

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

Lab Data: Test Date: 202109; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown results; Test Date: 202109; Test Name: Echo; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210914; Test Name: CBC; Result Unstructured Data: Test Result:Unknown Results; Test Date: 202109; Test Name: MRI; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20210914; Test Name: CMP; Result Unstructured Data: Test Result:Unknown results; Test Date: 202109; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: Headache; Confusion; Bilateral lower extremity weakness; Shaking; This is a spontaneous report from a contactable nurse (patient sister). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0151; Expiration Date: 31Oct2021), via an unspecified route of administration, administered in Arm Left on Sep2021 as dose 3, single for covid-19 immunisation. Medical history included trigeminal neuralgia, neutropenia, anxiety and sleep disorder from an unknown date and unknown if ongoing. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE via an unspecified route of administration, on unspecified dates as dose 1 and dose2 , single for covid-19 immunisation. Concomitant medication included gabapentin, Trizedon, paracetamol (TYLENOL,) all taken for trigeminal neuralgia, bupropion taken for anxiety, all start and stop date were not reported. The patient had confusion, bilateral lower extremity weakness and like she gonna 'eat them pretty much' (Not clarified), shaking and a headache was admitted in the hospital on Tuesday (14Sep2021), she was still in the hospital. It was reported that patient was in hospital because of possibly related to booster vaccine. Patient was treated with IV steroid, she is going physiotherapy and for headache they gave her tore ball. The patient underwent lab tests and procedures which included on Sep2021 computerised tomogram, echocardiogram, full blood count, x-ray, magnetic resonance imaging: unknown results and on 14Sep2021 Complete blood count (CBC), comprehensive metabolic panel (CMP): unknown results. The outcome of the event was recovering.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of bnt162b2 administration to the events, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: GABAPENTIN; TYLENOL; BUPROPION

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am