VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1652832
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Rash. Looks like bug bites, had lasted over a week and spreading, started on arms and now all over; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old, female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 39-year-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on left arm an unknown date (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications include unspecified birth control medications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced rash which looked like bug bites, had lasted over a week and spreading, started on arms and now all over. The doctor said it was a reaction to the shots. The event resulted in in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash looked like bug bites, had lasted over a week and spreading, started on arms and now all over 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: 1652833
Sex: F
Age:
State: MS

Vax Date: 06/16/2021
Onset Date: 06/16/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Continual headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Jun2021 at 14:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included pneumonia, hypothyroidism, polycystic ovaries, pseudotumor cerebri and COVID-19. The patient had unspecified allergies. The patient received unspecified concomitant medications within two weeks of the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Jun2021, at 15:00, the patient experienced continual headache and fatigue. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with unspecified pain medication and rest. The clinical outcome of the events continual headache and fatigue was not recovered at the time of this report. The batch number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1652834
Sex: F
Age:
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: after the first dose I just have like slight nausea sort of that for couple of hours; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown, Expiration date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 39-year-old) as dose 1, single for COVID-19 immunization. Medical history was none provided. Concomitant medication(s) included omeprazole (PROTONIX [OMEPRAZOLE]); quetiapine fumarate (SEROQUEL); bupropion hydrochloride (WELLBUTRIN); meloxicam; budesonide (NASOCORT); diphenhydramine hydrochloride (BENADRYL); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and propranolol taken for an unspecified indication, start and stop date were not reported; metoprolol taken for heart medication, start and stop date were not reported and that's like a longer acting one so she only take either one or the other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported that family medical history related to adverse event was no reported. Patient reported that she did not remember when she received the first one but the second dose, she received on 09Apr and we have received that one at work. Reported that date of first shot she was trying to find. On an unspecified date, patient experienced after the first dose I just have like slight nausea sort of that for couple of hours. Therapeutic measures (antibiotic) were taken as a result of after the first dose I just have like slight nausea sort of that for couple of hours. The clinical outcome of event was unknown. Information about lot/batch number has been requested.

Other Meds: PROTONIX [OMEPRAZOLE]; SEROQUEL; WELLBUTRIN; MELOXICAM; NASOCORT; BENADRYL; ADDERALL; PROPRANOLOL; METOPROLOL

Current Illness:

ID: 1652835
Sex: F
Age:
State: CA

Vax Date: 06/14/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; This is a spontaneous report from a non-contactable healthcare professional. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 14Jun2021 at 10:00 (at the age of 40-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 24May2021 at 14:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included multivitamins, lysine (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN), glutathione (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D) all for an unknown indication on an unknown date. The patient previously received fexofenadine HCL (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. On an unknown date in 2021, the patient experienced Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of all the events except dizziness was recovered on an unknown date in 2021, after the duration of 3 days; dizziness was recovering at the time of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: LYSINE; BIOTIN; GLUTATHIONE; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1652836
Sex: U
Age:
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: shoulder injury related to vaccine administration; experiencing is shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck; experiencing is shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck; experiencing is shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck; experiencing is shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck; This is a spontaneous report from a contactable consumer via Team. This consumer reported for a patient (reporter's friend) that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that his friend and he has been experiencing the same symptoms and they have been going on long term after having the vaccine. The reporter and his friend experiencing shoulder pain it goes down in to arm some goes down in to back and lower part of ribs and some going to neck. Reporter been trying physical therapies. Reporter have been trying Chiropractic to help with it. Reporter have been trying Tylenol and Ibuprofen and it gives very mild relief. The patient was referring SIRVA meaning to shoulder injury related to vaccine administration. He stated that he was really hoping that it was not SIRVA. Therapeutic measures were taken as a result of experiencing was shoulder pain it goes down in to my arm some goes down in to my back and lower part of my ribs and some going to my neck. The outcome of the events was unknown. Follow-up attempts are completed. Batch/lot number not available.

Other Meds:

Current Illness:

ID: 1652837
Sex: U
Age:
State:

Vax Date: 06/16/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: feel like little thing is swollen in armpit goes to neck/ I can feel that, like a little swelling and pain in arm pit, under armpit, close to neck; I am already hurting; feel like little thing is swollen in armpit goes to neck/ I can feel that, like a little swelling and pain in arm pit, under armpit, close to neck; This is a spontaneous report from a contactable consumer. This consumer reported that: An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported, Solution for injection), dose 1 via an unspecified route of administration, on 16-JUN-2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced a feel like little thing is swollen in armpit goes to neck/ I can feel that, like a little swelling and pain in arm pit, under armpit, close to neck and I am already hurting in Jun2021. The patient further stated that there is a thing, site, where I took the vaccine, I can feel that, like a little swelling and pain in my arm pit, under my armpit and close to my neck. I think it is a swollen node. The outcome of events is unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1652838
Sex: M
Age:
State: CA

Vax Date: 02/17/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: got like Brutal pain in the areas; hard to sleeping; got a like a rash, close to my under arm and on my lower back on the right side and it is lot of red/not directly on the arm pit, the rash close to it; getting lot of pain around the rash; Red dots, dark red and then the area around it turn orange or light red; painful like a burn on both of my arm pits more toward the back with 2 of those dots almost in the back going toward my back bone kind of in the middle; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EC8302), dose 2 via an unspecified route of administration on 17Feb2021 (at the age of 76years old) as dose 2, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine patient received BNT162B2 (Batch/Lot Number: EK4176), dose 1 via an unspecified route of administration on 27Jan2021 (at the age of 76years old) as dose 1, single for Covid-19 immunisation and had no side effects after the first dose of the vaccine. After 2nd dose, the patient reported no other side effects at this time other than red dots, dark red and then the area around it turned orange or light red and its painful like a burn on both of my arm pits more toward the back with 2 of those dots almost in the back going toward his backbone kind of in the middle in Jun2021. When he tried to sleep, he lay on it and wait an hour before the pain goes away. On 14Jun2021, the patient got a like a rash, close to his under arm and on my lower back on the right side and it was lot of red, it was not directly on the arm pit, the rash close to it. On 14Jun2021, the patient got the brutal pain in the areas and had hard to sleeping, and that was why he used this medication cream NEOSPORIN (start date: 17Jun2021), and it didn't do the great result. He was getting lot of pain around the rash and it was turning red, and it had red dot, he thought it will help but it didn't help. The patient didn't think it was serious, but it was getting painful. The patient also took ASPIRIN, it was a very low dose, he told to reduce with the pain, its 81 mg and confirmed it as treatment to treat the adverse effect. Therapeutic measures (NEOSPORIN and ASPIRIN) for all the events except hard to sleeping. The outcome for got a like a rash, close to my under arm and on my lower back on the right side and it is lot of red/not directly on the arm pit, the rash close to it; red dots, dark red and then the area around it turn orange or light red; and getting lot of pain around the rash was not recovered; and for rest all was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1652839
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: She thought it may be mass on her breast because there is pain right under her breast; there's nothing wrong with her; She thought it may be mass on her breast because there is pain right under her breast; there's nothing wrong with her; This is a spontaneous report received from a contactable consumer (Patient's friend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on an unspecified date as unknown single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient thought it may be mass on her breast because there is pain right under her breast; there's nothing wrong with her. It was reported that, patient got her mammogram because she thought it may be mass on her breast because there was pain right under her breast and there was nothing wrong with her but she was having these symptoms on left side where she got the shot. The outcome of events was unknown. The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442419 same reporter/ product, different patient

Other Meds:

Current Illness:

ID: 1652840
Sex: M
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: tiredness; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported last Thursday), the patient experienced tiredness. The outcome of the event was not recovered/not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1652841
Sex: F
Age:
State: AR

Vax Date: 06/13/2021
Onset Date: 06/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: eye had swelled up; eyelid had swollen and underneath her eyelid, her face was swollen; eyelid had swollen and underneath her eyelid, her face was swollen; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on 13Jun2021 (Sunday) as dose number unknown, single (at the age of 60-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Jun2021, probably about Tuesday, patient eye swelled up, eyelid had swollen and underneath her eyelid, her face was swollen. Patient talked with her doctor and she just want to see what she needs to do. The outcome of all the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1652842
Sex: F
Age:
State: FL

Vax Date: 06/18/2021
Onset Date: 06/19/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Induration; Redness; Injection site pain; warmth; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 18Jun2021 at 19:00 (at the age of 42-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included osteoarthritis. The concomitant medications of the patient included ascorbic acid (VIT C). The relevant past drug history was reported as no. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 28May2021 at 19:00 (at the age of 42-years-old) as single dose for COVID-19 immunisation. 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 not been tested with covid-19. On 19Jun2021 at 07:45, the patient experienced induration, redness, injection site pain and warmth. Therapeutic measures were taken as a result of events that included patient took Motrin 200mg, Tylenol. The outcome of the events was reported as not resolved. Information on the lot/batch number has been requested.

Other Meds: VIT C

Current Illness:

ID: 1652843
Sex: F
Age:
State: TX

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Shoulder pain; Arm still hurts; Can't throw a ball or move my arm quickly; with limited range of motion at times; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via intramuscular route of administration in the right arm/shoulder on 25Feb2021 at 15:00 (Batch/Lot Number: EN6202, at age 53-years-old at vaccination) as a single dose for COVID-19 immunisation at a civic center (non-military facility). Medical history included diabetes mellitus from 2017 and ongoing, hypertension from 2017 and ongoing. There was no known allergies. The patient did not have COVID-19 prior to vaccination. The concomitant medication taken within two weeks of the BNT162B2 vaccine were unspecified. There was no other vaccine taken within four weeks of vaccination. On 25Feb2021 at 15:00, the patient received the first dose of the BNT162B2 vaccine. On 26Feb2021 at 07:00, the patient experienced shoulder pain, arm hurting and cant throw a ball or move my arm quickly. Clinical course: The first vaccine shot was given high up on the right shoulder. The pain started within 24hrs and never went away. It hurts off and on with limited range of motion at times. The pain stops her from doing normal things. She can't throw a ball or move her arm quickly. On 18Mar2021 at 15:00, she received the second shot in the left arm, which was sore the next few days and then went back to normal, but the right arm where she received the first shot still aches. The right arm still aches like this for about 5 months. It was hurting less now but still certain movements cause pain and she still cannot move her arm to throw anything. It does however feel better than a month ago (4 months after the first shot). The patient didn't seek medical attention because of the cost and was just hoping it would heal. The arm still hurts. She cannot throw without a popping sound inside the muscle. Certain movements are very painful and she has to be careful how she moves it. Seriousness criteria was reported as persistent, significant disability and incapacity. No treatment was received. The patient did not test for COVID-19 post vaccination. The outcome of events shoulder pain, arm hurting and can't throw a ball or move arm quickly, limited range of motion at times was not recovered. Follow-up attempts are completed: no further information is expected.

Other Meds:

Current Illness: Blood pressure high; Diabetes

ID: 1652844
Sex: F
Age:
State: FL

Vax Date: 05/08/2021
Onset Date: 05/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: developed pityriasis rosea patch a couple of week after getting the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0182) via an unspecified route of administration in the left arm on 08May2021 at 14:00(at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. Patient had no known allergies to food, medications or other products. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8735) via an unspecified route of administration in the left arm on 17Apr2021 at 14:00(at the age of 19-years-old) as a single dose for COVID-19 immunisation. 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 vaccines within four weeks prior to the COVID vaccine. On 24May2021, the patient experienced a pityriasis rosea patch a couple of weeks after getting the vaccine. There was no other changed in lifestyle nor any new medication. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event developed pityriasis rosea patch was recovering, at the time of this report.

Other Meds:

Current Illness:

ID: 1652845
Sex: M
Age:
State: OR

Vax Date: 05/29/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Numbness and tingling in the arm that received the dose; Numbness and tingling in the arm that received the dose; This is a spontaneous report from a contactable consumer (patient's wife) reported for a male patient (husband) that a 41-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EW0187, Expiration date: not reported), via an unspecified route of administration in upper left arm on 29May2021 as single dose for COVID-19 immunisation at pharmacy and received second dose of BNT162B2 on 19Jun2021. The patient's medical history was reported as none. Concomitant medications were not reported. On an Unspecified date in 2021, after the first dose, the patient experienced numbness and tingling in the arm that received the dose which has not gone away. The reporter report a side effect that 'after' her husband (patient) receiving the second dose of the Pfizer vaccine (COVID 19 Vaccine) yesterday, she have the card in front of her so she have the number of the LOT that was administered both the first time and the second time. He actually had the side effect from the first dose as well so, she wanted to report for both the shots." The outcome of the events was not recovered. Follow-up attempts are needed. Information on Lot/Batch number was available, additional information has been requested.

Other Meds:

Current Illness:

ID: 1652846
Sex: M
Age:
State: OR

Vax Date: 06/19/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202106; Test Name: Fever; Result Unstructured Data: Test Result:101 and half

Allergies:

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

Symptoms: Running a 101+ Fever; Running a 101 and half fever; Arm hurts, site of the injection hurts; Severe headache at the base of his skull; Arm hurts, site of the injection hurts; This is a spontaneous report form a contactable consumer. This consumer (patient wife) reported for a 41-year-old male patient that. A 41-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration, administered in Arm Left on 19Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on an 29May2021, as DOSE 1, SINGLE for covid-19 immunization and experienced Numbness and tingling in the arm. The patient experienced running a 101 plus fever, running a 101 and half fever, arm hurts, site of the injection hurts, severe headache at the base of his skull, and arm hurts, site of the injection hurts on Jun2021. Reporter stated He was running a 101 plus Fever at this time and he got it yesterday and his arm hurts but that was obviously normal, the site of the injection hurts but that was normal for any vaccine. But he was running a 101 and half fever and a severe headache at the base of his skull." For the side effects he took Excedrin Migraine on the day of this report in morning (stated as this morning). That Excedrin was a brand over the counter medication, which specialize in Migraine headache." Dosage: Reporter stated, "she thinks it is 500 mg but I am sure, it is an recommended dose for adults." Frequency was stated as "2, that is the recommended dose. Reporter wanted to know does Pfizer recommend any further action if the symptoms do not abate. The patient underwent lab tests and procedures which included body temperature: 101 and half on Jun2021. The outcome of events was unknown. Follow-up attempts were completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1652847
Sex: M
Age:
State: GA

Vax Date: 06/18/2021
Onset Date: 06/18/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dose 2: pale red urine color; This is a spontaneous report from a contactable consumer. A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 18Jun2021 (age at vaccination 35 years) as dose 2, single for covid-19 immunisation. Medical history included headache from an unknown date and unknown if ongoing (Occurred in the evening on Monday or Tuesday before the vaccine, he was not really sure. He states maybe 6:14-6:15pm for onset. Complete recovery the same day). Concomitant medication included paracetamol (TYLENOL) taken for headache, start and stop date were not reported. The patient previously took dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0186) on 28May2021 (age at vaccination 35 years) left arm dose 1 single for covid-19 immunization. The patient experienced dose 2: pale red urine colour on 18Jun2021. Reporter stated, He was seeing his urine colour as red after the vaccine. He was having the problem still today. Every time when he passes urine, he sees the colour red. Red colour urine has been ongoing since Friday night. He was not sure if what he was experiencing is a normal side effect of the vaccine. he has seen this before when he has had a beet root, but for the past two days he has never had a beet root. The outcome of event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: TYLENOL

Current Illness:

ID: 1652848
Sex: F
Age:
State: NJ

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

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

Lab Data: Test Date: 20210611; Test Name: Heart rate; Result Unstructured Data: Test Result:140; Comments: HR ranging between 120 to the 140s; Test Date: 20210611; Test Name: Heart rate; Result Unstructured Data: Test Result:120; Comments: HR ranging between 120 to the 140s; Test Date: 20210611; Test Name: Body temperature; Result Unstructured Data: Test Result:103.9; Comments: had a 103.9 temp

Allergies:

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

Symptoms: Extreme fatigue; Low grade fever/Body temperature 103.9; Heart rate ranging between 120 to the 140; Chills; This is a spontaneous report from a contactable consumer, the parent. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 10Jun2021 at 15:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included reactive airway in childhood. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 20May2021 at 15:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. 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 vaccines within four weeks prior to the vaccination. On 10Jun2021, the first night of vaccination, the patient experienced low grade fever and chills. On 11Jun2021, the second day after vaccination, the patient had a temperature of 103.9 with heart rate ranging between 120 to 140. On 12Jun2021, the third day after vaccination, the patient had no fever and palpitation but experienced extreme fatigue. On 13Jun2021, the fourth day, the patient had no symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever of 103.9 and heart rate ranging between 120 to 140 were resolved on 12Jun2021, while fatigue and chills were resolved on 13Jun2021.

Other Meds:

Current Illness:

ID: 1652849
Sex: F
Age:
State: PA

Vax Date: 06/17/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: she is tired; having nausea; weak; Headache; shoulder pain; body ache; neck pain; She received the vaccine on her left arm and felt some pain; a loss of appetite; wanting to throw up; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on left arm on 17Jun2021 (Thursday) single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date of 2021 the patient was tired, having nausea, weak, and had headaches. She was just wondering what is going on, how long is that supposed to play a part, she thought it was like 2 days. if this is normal. Patient also experienced shoulder pain as well as body ache and neck pain. Patient also described feeling a loss of appetite sometimes and wanting to throw up. She said that it had been going into the third day already and wants to know if the side effects she have mentioned are normal. The outcome of the events was recovered on unspecified date of 2021. The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1652850
Sex: M
Age:
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Intense skin rash specially in the face area in the shape of a mask from the forehead to mid cheek area reminiscent of a sunburn. Some in the arms, legs and back as well; This is a spontaneous report from a contactable consumer, the parent. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the arm right on 08Jun2021 at 15:30 (at the age of 12-year-old), as a single dose for COVID-19 immunisation. Medical history included allergy to chemicals (allergic to methyl isobutyl ketone), since unknown date. Concomitant medications were not reported. 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 vaccines within four weeks prior to the COVID vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the arm left on 03May2021 at 15:30 (at the age of 12-years-old), as a single dose for COVID-19 immunisation. On 10Jun2021 at 06:00, the patient experienced intense skin rash specially in the face area in the shape of a mask from the forehead to mid cheek area reminiscent of a sunburn. Some in the arms, legs and back as well. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of intense skin rash and included treatment with unspecified steroids and unspecified allergy medicine. The clinical outcome of the event intense skin rash specially in the face area in the shape of a mask from the forehead to mid cheek area, arms, legs and back was recovered on an unknown date in Jun2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1652851
Sex: U
Age:
State: LA

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

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

Lab Data:

Allergies:

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

Symptoms: Soreness; Swelling; Swollenness like a lump in the area, it was itchy, very itchy and I have a lump like where the injection site is; Swollenness like a lump in the area, it was itchy, very itchy and I have a lump like where the injection site is; It is like it is a nut right in the injection site; This is a spontaneous report from a contactable consumer (patient). A 45-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included none. Concomitant medication included multivitamin (Vitamins Nos) for unspecified indication, start and stop dates were not reported. Investigation assessment and prior vaccinations (within 4 weeks) included none. The patient had the Pfizer vaccine on Monday (unspecified date) in right arm and experienced some soreness and some swelling, but at the time of this report patient was experiencing swollenness like a lump in the area, it was itchy, very itchy and had a lump like where the injection site was. So, was real concerned about that, after reading the material that was given to patient about the vaccine, didn't know if should be really concerned because it was like it is a nut right in the injection site. Didn't know if patient should put like a lump compress on it. Consumer was informed about Pfizer Medical Information department and provided with the number. Patient received no treatment for the events. Clinical outcome of events was unknown. Information on lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds: MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1652852
Sex: F
Age:
State:

Vax Date: 06/14/2021
Onset Date: 06/16/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bronchitis; coughing was so bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and experienced no reaction. On 16Jun2021, the patient experienced bronchitis, coughing was so bad. she was not tested for Covid-19 at her urgent care visit. Reporter stated that, before the vaccine everything was fine. The patient had to go to the urgent care because the coughing was so bad and it was not really letting up at all. Patient was asking what she should do about her symptoms. Therapeutic measures were taken as a result of bronchitis, coughing was so bad. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1652853
Sex: F
Age:
State: FL

Vax Date: 02/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Blood work done; Result Unstructured Data: Test Result:Normal; Comments: Had an EKG and blood work done and they couldn't find anything.; Test Date: 2021; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Comments: Had an EKG and blood work done and they couldn't find anything.

Allergies:

Symptom List: Unevaluable event

Symptoms: pain in my throat; chest; down my arms each morning.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain in my throat, chest and down my arms each morning on an unknown date in Mar2021 (In March the patient began experiencing pain in my throat, chest and down my arms each morning. It doesn't last all day and sometimes it lasts longer than others and sometimes it's really bad). The patient underwent lab tests and procedures which included blood test: normal on an unknown date in 2021 (Had an EKG and blood work done and they couldn't find anything), electrocardiogram: normal on an unknown date in 2021 (Had an EKG and blood work done and they couldn't find anything). The patient have been to the ER twice. Outcome of the events was unknown. Information on batch/lot no. has been requested.

Other Meds:

Current Illness:

ID: 1652854
Sex: F
Age:
State: TX

Vax Date: 06/18/2021
Onset Date: 06/19/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: right ovary pain mild; nausea; arthritis pain on my feet; itching in the joints; I felt itching in the joints and swelling and heat.; I felt itching in the joints and swelling and heat.; I have arthritis pain on my feet on Saturday. It was so strong I couldn't walk.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0168) via an unspecified route of administration in the right arm on 18Jun2021 at 08:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The medical history of the patient included polycystic ovary syndrome (PCOS), possibly celiac and gluten sensitivity. The 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. On 19Jun2021 at 13:00, next day of vaccination, the patient experienced right ovary pain mild. On 20Jun2021, the patient had stronger pain in the ovary. On 21Jun2021, it intensified and had severe ovary pain plus nausea. The patient also had arthritis pain on feet on19Jun2021. It was so strong that she couldn't walk. The patient also felt itching in the joints and swelling and heat. Therapeutic measures were not taken as a result of the events. The adverse event did not result in a visit to the doctors 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. The clinical outcome of the events, right ovary pain, nausea, arthritis pain on feet, itching in the joints, swelling and heat was not recovered at the time of this report.

Other Meds:

Current Illness:

ID: 1652855
Sex: F
Age:
State: OK

Vax Date:
Onset Date: 01/07/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Fever; Chills; Nausea; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 77-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL1284; Expiration Date: Apr2021) (at the age of 77-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 07Jan2021, the patient experienced fever, chills and nausea. There was no treatment received for reported events. The clinical outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1652856
Sex: F
Age:
State: NY

Vax Date: 04/21/2021
Onset Date: 04/23/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: swollen lymph nodes; nose bleeds; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration on 21Apr2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 21Mar2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021, the patient experienced swollen lymph nodes and nose bleeds. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event(s). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of swollen lymph nodes and nose bleeds were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1652857
Sex: F
Age:
State: OR

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

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

Lab Data:

Allergies:

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

Symptoms: Extreme and intense hot flashes resumed within two days of receiving first vaccine; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 52-year-old non-pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150 and expiration date was not reported), via an unspecified route of administration, in Right Arm on 02Apr2021 08:30 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration in Left Arm on 23Apr2021 8:30 (at the age of 52-years-old), as dose 2, single for covid-19 immunisation. The patient medical history included Heart from an unknown date and unknown if ongoing. The patient concomitant medications included acetylsalicylic acid (BAYER ASPIRIN, 325 MG) by oral route of administration taken for Heart from an unspecified start date and ongoing. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination. Since the vaccination, the patient has not been tested for Covid-19. The patient did not received treatment for adverse events. On 03Apr2021, the patient experienced extreme and intense hot flashes resumed within two days of receiving first vaccine. The outcome of the event was not recovered.

Other Meds: BAYER ASPIRIN

Current Illness:

ID: 1652858
Sex: F
Age:
State: FL

Vax Date: 06/19/2021
Onset Date: 06/20/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210620; Test Name: Body temperature; Result Unstructured Data: Test Result:101.3; Comments: Fever 101.3

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Fever 101.3; Chills; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 19Jun2021 at 14:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included General Anxiety Disorder (GAD) and depression. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) and trazodone (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient previously took septra and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 29May2021 at 14:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. 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 vaccines within four weeks prior to the vaccination. On 20Jun2021 at 04:45, the patient experienced fever 101.3 and chills, on the same day at 05:15, 07:30 and 09:15 the patient experienced vomiting. The patient had skipped fluoxetine that morning due to vomiting. Therapeutic measures were taken as a result of fever and included treatment with Motrin. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever and projectile vomiting were resolved on 20Jun2021 and chills was resolved on an unspecified date in Jun2021.

Other Meds: FLUOXETINE; TRAZODONE

Current Illness:

ID: 1652859
Sex: F
Age:
State: GA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: About 10 minutes after she felt like she had sun burn all over her body and side. The feeling was described as hot with face, legs, and arms burning.; feeling really warm; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). An 81-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, at the age of vaccination 81 years), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. She received the first dose of the Pfizer BioNtech covid 19 vaccine on 17Feb2021. About 10 minutes 17Feb2021 after she felt like she had sun burn all over her body and side. The feeling was described as hot with face, legs, and arms burning, feeling really warm. The outcome of events was recovering. Information on the lot/batch number has been requested

Other Meds:

Current Illness:

ID: 1652860
Sex: F
Age:
State: TN

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

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

Lab Data:

Allergies:

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

Symptoms: nauseous; sick; This is a spontaneous report from a contactable consumer or other non health care professional (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient wanted to call and report her reaction to the Pfizer Biontech Covid 19 vaccine. The patient reported that she had a little bit of reaction to the first shot, she was nauseous and sick on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1652861
Sex: F
Age:
State: AR

Vax Date: 06/18/2021
Onset Date: 06/18/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:101-102; Test Date: 20210619; Test Name: Fever; Result Unstructured Data: Test Result:102.5

Allergies:

Symptom List: Nausea

Symptoms: Fever; Hives; Chills; severe body aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 18Jun2021 at 12:00 (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included LBS, Gastroperesis diverticulosis disease and chronic fatigue syndrome. The patient was allergic to Alpha-gal. The concomitant medications of the patient included linaclotide (LINZESS) and alprazolam (XANAX). The patient previously received first dose of BNT162B2 (solution for injection, Batch/Lot number: UNKNOWN) as single dose for COVID-19 immunisation. 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. Since the vaccination, the patient not been tested with covid-19. On 18Jun2021 at 22:00, the patient experienced hives, chills, severe body aches and also experienced fever on 19Jun2021 at 04:00. The patient underwent lab tests and procedures which included fever: 101-102 on an unspecified date and fever: 102.5 on 19Jun2021. Therapeutic measures were taken as a result of hives and fever that included rotated Tylenol and ibuprofen to reduce fever and Benadryl for hives. The outcome of all the events was reported as not resolved. Information about lot/batch number has been requested.

Other Meds: LINZESS; XANAX

Current Illness:

ID: 1652862
Sex: F
Age:
State: AZ

Vax Date: 04/06/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: bloodwork; Result Unstructured Data: Test Result:Unknown; Test Name: CT sinuses; Result Unstructured Data: Test Result:Unknown; Test Date: 2021; Test Name: weight; Result Unstructured Data: Test Result:lost 10 pounds; Comments: lost 10 pounds

Allergies:

Symptom List: Injection site pain

Symptoms: had a metallic taste in her mouth; that it is interfering with her eating; lost 10 pounds; Everything tastes awful; This is a spontaneous report from a contactable consumer(patient) via medical information team. A 68-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, lot number: EW0150) via an unspecified route of administration, administered in Arm Right on 06Apr2021 (at the age of 68-year-old) as dose 2, single for COVID-19 vaccination. Medical history included ongoing rheumatoid arthritis (reported as about 9 years ago it became pronounced enough that she needed medication), ongoing hypothyroidism (reported as she did not get diagnosed until 6 or 7 years ago), ongoing atrial fibrillation (reported as she had that since she was 24) and COVID-19. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. Historical vaccine included bnt162b2 (Solution for injection, lot number: EN6207) via an unspecified route of administration, administered in arm right as dose 1, single on 13Mar2021 (at the age of 68-year-old) for Covid-19 immunization and experienced metallic taste in mouth. The patient had Covid and she lost her sense of taste and smell, but it was coming back. Patient had the second vaccine on 06Apr2021, and the metallic taste got so severe to the point she could barely eat. The reporter stated metallic taste got worse within a week of getting the second dose. Everything tastes awful. She had lost 10 pounds. Patient was wondered if Pfizer had any information about it and if anything, they learned can help her to get over this. Patient just continued to lose weight. Patient had Covid, but she was told she had no antibodies in her blood. On unknown date in 2021, the patient experienced a metallic taste in her mouth that it was interfering with her eating, lost 10 pounds, everything tastes awful. Patient had regular bloodwork because of her arthritis and doctor sent her to an ENT doctor who did a CT scan of her sinuses to see if there was anything wrong that could affect her smell and taste. Outcome for event lost 10 pounds was not recovered while unknown for rest of the event. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: AFib (She has had that since she was 24.); Hypothyroidism (She didn't get diagnosed until 6 or 7 years ago.); Rheumatoid arthritis (About 9 years ago it became pronounced enough that she needed medication.)

ID: 1652863
Sex: F
Age:
State: NY

Vax Date: 06/01/2021
Onset Date: 06/18/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Numbness in pointer finger, back and arm on the right side where vaccine was administered.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO187) via an unspecified route of administration in the right arm on an unknown date in Jun2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 16May2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Jun2021, the patient experienced numbness in pointer finger, back and arm on the right side where vaccine was administered. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event numbness in pointer finger, back and arm on the right side was unknown at the time of this report.

Other Meds:

Current Illness:

ID: 1652864
Sex: F
Age:
State: KY

Vax Date: 05/24/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210614; Test Name: Blood test; Result Unstructured Data: Test Result:Normal; Test Date: 20210614; Test Name: platelets; Result Unstructured Data: Test Result:14-JUN-2021; Comments: she later clarified and mentioned the PTT was a little elevated, but nothing concerning .

Allergies:

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

Symptoms: itching and bruising all over her legs; itching and bruising all over her legs; This is a spontaneous report from a contactable consumer or other non-HCP. A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Left Arm on 24May2021 as DOSE 1, SINGLE (at the age of: 21-year-old) for covid-19 immunization. Medical history and Family Medical History Relevant to AE(s) reported as none. There were no concomitant medications. Vaccine was not Administered at Military Facility. No Additional Vaccines Administered on Same Date of Suspect. On an unspecified date of May2021, the patient experienced itching and bruising all over her legs. The patient underwent lab tests and procedures which included blood test: normal on 14Jun2021, platelet count increased: 14Jun2021 on 14Jun2021 she later clarified and mentioned the PTT was a little elevated, but nothing concerning. Patient had her blood test done a week ago from Monday, clarified as last Monday. She further explained, a bunch of test were done and there was nothing concerning. The blood test came back normal. The platelets and all that was checked. However, she later clarified and mentioned the PTT was a little elevated, but nothing concerning. The outcome of all event was recovering. Follow-up (20Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1652865
Sex: F
Age:
State: TX

Vax Date: 01/12/2021
Onset Date: 02/23/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: sprained ankle in sleep; dislocated finger when barely caught on grocery cart, patellar and shoulder subluxation; been having loose ligaments since the shots; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, second dose) solution for injection intramuscular in the right arm on 12Jan2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical and past drug history included known allergies: pine nuts and levofloxacin (LEVAQUIN). Concomitant medications included cetirizine hydrochloride (ZYRTEC) and esomeprazole sodium (NEXIUM). Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 22Dec2020 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I have been having loose ligaments since the shots (23Feb2021). Began 6 weeks after second shot but I didn't realize I had problem. Since then I have sprained ankle in sleep (02Mar2021 at 02:00), and dislocated finger when barely caught on grocery cart, patellar and shoulder subluxation (23Feb2021). Just would like to know if others are reporting this. I'm a medical provider so I'm just wondering. I did not see doctor as I know how to treat these symptoms. Just seems like so many coincidences." No treatment was provided for the events. The outcome of the events was not recovered. The patient has not been tested for COVID post vaccination. The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow up.; 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: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; NEXIUM [ESOMEPRAZOLE SODIUM]

Current Illness:

ID: 1652866
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Rash under both arms and in elbow 'crease'; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Jun2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. Concomitant medication included mesalazine (MESALAMINE) taken within two weeks of vaccination. The patient previously took ciprofloxacin (CIPRO) and experienced drug allergy. The patient previously also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. 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 vaccines within four weeks prior to the vaccination. On 08Jun2021, the patient experienced rash under both arms and in elbow 'crease'. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event rash under both arms and in elbow 'crease' was resolved on an unknown date in Jun2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: MESALAMINE

Current Illness:

ID: 1652867
Sex: F
Age:
State: TN

Vax Date: 06/18/2021
Onset Date: 06/19/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rash; still has hives on her legs; I was sick on Saturday (19Jun2021) but worse on Sunday; splotches; did not have the energy to get up; really sick; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 18Jun2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunization and had nauseous and sick as reactions. On an unknown date, patient stated that, I had a little bit of reaction to the first shot, I was nauseous and sick. I had vaccination on second last Friday 18Jun2021, was observed for 15 minutes and did not make a connection at first, but the next day, I was really sick. I started getting splotches on me. I was sick on Saturday 19Jun2021 but worse on Sunday 20Jun2021, I did not have the energy to get up. I still have the rash today 21Jun2021. I still have hives on my legs. I just need to report it. I hope it goes away. The outcome of all events was reported as an unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1652868
Sex: F
Age:
State: NC

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Heart racing; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0176) via an unspecified route of administration in the left arm on 21Jun2021 at 14:30(at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included emtricitabine, tenofovir alafenamide fumarate, bictegravir sodium (BIKTARVY) for unknown indication from an unknown start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 21Jun2021 at 22:45, the patient experienced heart racing. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event heart racing was not recovered at the time of this report.

Other Meds: BIKTARVY

Current Illness:

ID: 1652869
Sex: M
Age:
State: IL

Vax Date: 06/18/2021
Onset Date: 06/19/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210619; Test Name: Body temperature; Result Unstructured Data: Test Result:102; Comments: Fever of 102 at: 04:00

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: 16 hours after 2nd shot (4 am on 6/19) fever of 102.; Felt flu like symptoms; This is a spontaneous report from a non-contactable consumer, the parent. A 15-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0178) via an unspecified route of administration in the arm left on 18Jun2021 at 12:00 (at the age of 15-year-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0180) via an unspecified route of administration in the arm left on 27May2021 at 11:45 (at the age of 15-year-old), as a single dose for COVID-19 immunisation. 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 vaccines within four weeks prior to the vaccination. On 19Jun2021 at 04:00, 16 hours after second shot, the patient experienced fever of 102. "Acetaminophen used very 4-6 hours until 9:15pm then took ibuprofen and fever finally broke at 11:30ish pm on 6/19". The patient felt flu like symptoms all day. The patient still ate, drank lots of fluids, had popsicles as reported by the parent. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of fever and flu like symptoms which included treatment with acetaminophen (MANUFCATURER UNKNOWN) every 4-6 hours until 21:15, then took ibuprofen (MANUFCATURER UNKNOWN). The clinical outcome of the events felt flu like symptoms was recovered on 19Jun2021 and fever of 102 was recovered on 19Jun2021 at 23:30. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1652870
Sex: F
Age:
State: NY

Vax Date: 06/20/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Black stool; Very strong odoured stool; sharp pain in right arm; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in left arm on 20Jun2021 at 08:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included asthma and high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of the vaccination. The patient previously received isopropyl alcohol and experienced anaphylaxis. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 21Jun2021 at 23:15, the patient experienced black and very strong odor stool and also had a sharp pain in right arm. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events black and very strong odor stool and sharp pain in right arm was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1652871
Sex: F
Age:
State: MI

Vax Date: 06/20/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Severe muscle pain in lower back and shoulders/Site injection arm pain in the form of muscle soreness; Severe joint pain in lower back and shoulders; injection site arm pain; fatigue; Stimulated immune response (more than normal) of arthritis already diagnosed between L4 and L5 of the spine; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the left arm on 20Jun2021 at 16:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and possible degenerative disc disease. Concomitant medications included duloxetine hydrochloride (CYMBALTA), ethinylestradiol, levonorgestrel (AVIANE), cetirizine hydrochloride (ZYRTEC) and omeprazole (PRILOSEC); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took Ceclor and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jun2021, at 08:00 the patient experienced severe muscle and joint pain in her lower back and shoulders, stimulated immune response (more than normal) of arthritis already diagnosed between L4 and L5 of the spine, injection site arm pain in the form of fatigue and muscle soreness. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of severe muscle and joint pain in her lower back and shoulders, stimulated immune response (more than normal) of arthritis already diagnosed between L4 and L5 of the spine, injection site arm pain in the form of fatigue and muscle soreness were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: CYMBALTA; AVIANE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PRILOSEC [OMEPRAZOLE]

Current Illness:

ID: 1652872
Sex: F
Age:
State: PA

Vax Date: 05/19/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Severe muscle fatigue in arms and legs; numbness and tingling started in feet and hands; tingling started in feet and hands, tingling in thighs; vibration in chest replaced by pain in same spot; painful joints, wrists; short lived headaches on right temple; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, lot number: EW0182) via an unspecified route of administration, administered in Arm Right on 19May2021 at 11:45 (at the age of 41-year-old) as dose 1, single for COVID-19 immunisation. The patient had no medical history. The patient's concomitant medications included Multi vitamin, vitamin D, B12, C and probiotic (other medications within 2 weeks of vaccination). Allergies to medications, food, or other products were reported as no. 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 22May2021 at 10:00, the patient experienced severe muscle fatigue in arms and legs on day 4 after shot and on an unknown date May2021 (reported as 10 days after shot), the patient experienced numbness and tingling started in feet and hands, tingling in thighs, vibration in chest replaced by pain in same spot, painful joints and wrists, short lived headaches on right temple. The patient did not receive treatment for the adverse events. Since the vaccination the patient was not tested for COVID-19. Outcome of the events were recovering. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1652873
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Very sore shoulder after the vaccine and still dealing with it.; Slight weakness; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced very sore shoulder after the vaccine and still was dealing with it and slight weakness was also present. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very sore shoulder after the vaccine and still dealing with it and slight weakness were recovered with sequelae. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1652874
Sex: F
Age:
State: PA

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

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

Lab Data:

Allergies:

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

Symptoms: Sore throat; Sniffles; She got sick the next day; This is a spontaneous report from a contactable consumer(reporter's sister). A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller states she has another sister with health conditions. Her sister with health issues got the vaccine and her arm wasn't even sore. She got sick the next day. Caller clarifies her sister was sick for a couple days with a sore throat and sniffles and that, but her arm wasn't sore at all because she laughed at the caller. Information about Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1652875
Sex: F
Age:
State: GA

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: CAT scan; Result Unstructured Data: Test Result:Unknown; Comments: they found that she has gallstones and kidney stones

Allergies:

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

Symptoms: she can't stand; It's hard to talk; Abdominal pain; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 66-year-old female 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 14Jun2021 11:15 as DOSE 1, SINGLE (at the age of 66-years-old) for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing, aneurysm from an unknown date and unknown if ongoing, hip arthroplasty from an unknown date and unknown if ongoing left about 8 years ago, arthritis from an unknown date and unknown if ongoing diagnosed 5-6 years ago, spondylitis from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing left, cholelithiasis from an unknown date and unknown if ongoing, nephrolithiasis from an unknown date and unknown if ongoing. States that she doesn't know her biological father. Concomitant medications included meloxicam (MELOXICAM) taken for arthritis from an unspecified start date and ongoing; mirabegron (MYRBETRIC) taken for incontinence from an unspecified start date and ongoing; gabapentin (GABAPENTIN) taken for sciatica from an unspecified start date and ongoing; tramadol (TRAMADOL) taken for pain from an unspecified start date and ongoing; cetirizine (CETIRIZINE) taken for pruritus from an unspecified start date and ongoing; hydrocodone (HYDROCODONE) taken for pain from an unspecified start date and ongoing. Patient didn't have any vaccinations within 4 weeks. It was reported that, on 14Jun2021 (same day of vaccination), within 3-4 hours, the patient experienced abdominal pain , she can't stand (dysstasia), it's hard to talk (speech disorder). Additional information includes; She got her first dose and 3-4 hours later she was doubled over with abdominal pain. States that the pain in her lower abdomen was not like she was going to have diarrhea, it was just a sensation. And the pain in her upper abdomen wasn't just like nausea, it was also a sensation. Clarified that she did feel like she needed to throw up, but she didn't need to throw up. States that her 1st dose was on Monday, 14Jun2021. And now she has to go back in 3 weeks and get more of that poison shit put into her body. States that everyone told her to report this because what happened to her was not in the list of symptoms. Clinical course of events includes; The abdominal pain started the same day he got the vaccine, about 3-4 hour later. States that it's still there, just feels funky, but she is not having severe pains that she can't stand. The patient stated that it's hard to talk. she feels like the Covid Vaccine wasn't tested enough because of people being on different medications; that's why she was conflicted about it. Stated that she takes a blood pressure medication, but doesn't remember the name of it. She takes it for preventative reasons because she has an aneurysm. She takes 1/2 a tab once daily. States that she wasn't allowed to do her allergy shots for a week after getting her Covid Vaccine. Had a CAT scan to check the size of her aneurysm, which is steady, but they found that she has gallstones and kidney stones. Patient stated that they have developed within the last 18 months. The patient underwent lab tests and procedures which included computerised tomogram: unknown on they found that she has gallstones and kidney stones. Outcome for the events abdominal pain was recovering and outcome for the events dysstasia, speech disorder was unknown. Information on the lot/batch number has been requested.

Other Meds: MELOXICAM; MYRBETRIC; GABAPENTIN; TRAMADOL; CETIRIZINE; HYDROCODONE

Current Illness:

ID: 1652876
Sex: F
Age:
State: TX

Vax Date: 04/07/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Heart palpitations; Muscle spams; Ringing in ears; Headache; Tingling in hands, feet, and legs; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 at 13:30 as 2nd dose, single for COVID-19 immunization (at the age of 36-years). The patient medical history, family history and concomitant medications were not reported. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EP6955; expiration date: unknown, NDC Number: unknown) via an unspecified route in Left arm on 16Mar2021 for covid-19 immunization. Patient did not receive any additional vaccines administered on same date of the Pfizer suspect. Also, she did not receive any prior vaccinations (within 4 weeks). On an unspecified date, the patient experienced about 2 weeks after the second dose of the Covid Vaccine she began experiencing ringing in her ears and this was continued. Reporter stated that she had other symptoms as well. She had tingling in her hands, feet, and legs that is continuing. She had muscle spasms that was continuing. She had heart palpitations; states they continue as she had some today. States that she had headaches. The patient has been to a couple of ear, nose and throat doctors, the emergency room, her primary care doctor, and the urgent care. The outcome of headache was recovered on an unspecified date in 2021, while outcome of other events was not recovered. Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected. Follow up attempts are needed; Additional information has been requested.

Other Meds:

Current Illness:

ID: 1652877
Sex: M
Age:
State: ME

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Chest discomfort for 3 weeks after first shot; This is a spontaneous report from a contactable physician. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 15Apr2021 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced chest discomfort for 3 weeks after first shot. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event chest discomfort was recovered on an unknown date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1652878
Sex: F
Age:
State: OH

Vax Date: 06/15/2021
Onset Date: 06/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Swelling, approximately 4.5 cm wide; 6 cm high; warm to the touch, approximately 4.5 cm wide; 6 cm high; Redness, approximately 4.5 cm wide; 6 cm high; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the right arm on 15Jun2021 at 13:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. It was reported that the patient participated in Non-Pfizer study, phase 1. Received first dose on 15Sep2000; subsequent injections were placebo. Once results were unblinded, she had an COVID antibodies test which was negative. Concomitant medications included duloxetine hydrochloride (duloxetine HCL) (MANUFACTURER UNKNOWN), paracetamol (TYLENOL 8 HR) and diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL). 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. On 22Jun2021 at 09:00, the patient experienced swelling, warm to the touch and redness; approximately 4.5 cm wide; 6 cm high. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events swelling, warm to the touch and redness; approximately 4.5 cm wide; 6 cm high were not recovered at the time of this report.

Other Meds: DULOXETINE HCL; TYLENOL; BENADRYL

Current Illness:

ID: 1652879
Sex: M
Age:
State: MD

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

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

Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:Unknown; Test Name: MRI; Result Unstructured Data: Test Result:Unknown; Comments: MRI of his C-spine

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: tired; felt like, just tired, or tuckered out feeling; soreness in his arm, injection site tenderness; kind of warm; Malaise; This is a spontaneous report from a contactable consumer reported for himself a 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: FL3302; Expiration date was not reported), via an unspecified route of administration, in Left Arm on 28Jan2021 09:00 (at the age of 56-years-old) as DOSE 1, SINGLE for covid-19 immunisation at vaccine clinic. The patient administered second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6203, Expiration date: Unknown), via an unspecified route of administration on 23Feb021 for Covid-19 immunisation. Patient took vaccine just because he wanted to make sure he was protected, and the clinic was offering it. He had an underlying condition, Diabetes, and being that he had this he wanted to make sure he got it. The patient medical history included ongoing diabetes mellitus, ongoing tremors from an unknown date, visual impairment (caller did not provide specific dates), weight decreased, from an unknown date and unknown if ongoing. States he had been losing weight and it had been coming down. He was trying to get back to where it was. Caller confirmed this occurred prior to the vaccine and he just started paying attention to what he was eating, it was not from the vaccine at all, and it was just paying attention. For medical conditions, caller stated not really, unless Pfizer could reverse the aging process and fix macular degeneration. Caller stated he did not know if it was macular degeneration, there were no vision changes in his visual fields and his retinas are good. As he got older, he needed glasses. His vision changes might be due to age, he was not sure. The patient concomitant medications included insulin detemir (LEVEMIR) taken for diabetes mellitus from an unspecified start date and ongoing; losartan potassium (LOSARTAN POTASSIUM) taken for hypertension (blood pressure); omeprazole (OMEPRAZOLE ABBOTT) taken for gastrooesophageal reflux disease; (TOPIRAMATE ACCORD) and tramadol (TRAMADOL) taken for tremor from an unspecified start date and ongoing; metformin (METFORMIN); insulin (INSULIN) taken for diabetes mellitus, start and stop date were not reported; topiramate; atorvastatin (ATORVASTATIN); magnesium oxide (MAGNESIUM OXIDE); acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported. Patient had been Losartan Potassium on for like 7 years probably. Magnesium Oxide was given to patient with the heavy hitter dose, for to replace magnesium. He was not entirely up on that one tho. He had been taking for a year and a half. Aspirin regimen was given to make sure his blood stays good. They said he might as well because of his weight. Omeprazole was given for GERD, but he does not think that was what it was, he had to discuss it with his doctor. He had been on this for about 6 months. Caller stated no medications, just his Metformin, Atorvastatin, Insulin and his meds for diabetes and cholesterol. Levemir was 80 units but then brought down to 70 units 2 months ago because his sugars have been under control since losing weight. He spoke to his endocrinologist and reduced doses. Topiramate of 25 mg, 3 tablets BID so 75 in the morning, 75 in the evening and this is for tremors from the heavy water with Benzene and Tetrachloride and Carbon. He had been on it for about 2 years since he started getting really bad, but even with taking this stuff he still shakes. Caller did not see the Manufacturer on the bottle and did not confirm whether it was in pharmacy or manufacturer bottle when asked several times. Caller stated the NDC was 76282-0278-10 and it just said discard after 06APR2022. There was a patient sheet. He did not see manufacturer or any additional information, non-Pfizer product. Taking Tramadol Primidone 50 mg, 2 of them, for his tremors and started this on the same time as topiramate. Maybe it was 6 months, he was not really sure. The patient previously took flu shot and experienced vaccination site pain. The nurse comes and gives it to him. They just give him his flu vaccine, every 2 years pneumovax, and shingles he has not gotten around to that. Caller does not know additional information. Additional Vaccines Administered on Same Date of the Pfizer Suspect, prior Vaccinations (within 4 weeks), AEs following prior vaccinations, family medical history relevant to AE included none. The patient experienced malaise, tired, felt like, just tired, or tuckered out feeling at 17:30, soreness in his arm, injection site tenderness, kind of warm on 28Jan2021. Events did not require a visit to Emergency Room or Physician Office. Patient reported that he received both doses in February and all he had was a little general malaise, soreness in the arm but he gets that with the flu shot, and he was tired in the evening, but he thought that was because he was old. On 28Jan2021, around 16:30 to 17:00 hr, he had tenderness that was not really painful but just tenderness and kind of warm like when he gets the flu shot. Not bad or anything, just like when he gets the flu shot. At 17:30 hr, he started feeling more tired than he usually feels. He felt like mushad - if he was allowed to say that - just tired or tuckered out feeling. It was his left arm where it was injected and where he had the soreness. He always took it in his non-dominant arm. He woke up the next morning and was fine. The patient underwent lab tests and procedures which included electrocardiogram, magnetic resonance imaging with unknown results on an unspecified date. Caller does not provide additional information or whether or not he received this test due to his symptoms. They just did an MRI of his C-spine to see what is going on there to see if it is neurological or coming from the brain. Caller does not provide additional information or know specific test results as of yet. He was calling regarding whether he can get an additional series of vaccines because he had 2 doses and the federal government, and his state do not talk so he can go get another series and they will not know about it. Caller wanted to know if he can get another series of vaccines, so 4 instead of 2. Caller stated he was always happy to help and will file report. He stated sure there were minor side effects like injection site tenderness like with the flu shot. Caller stated those were not major side effects. Caller stated he was not calling to report, he was just asking about receiving a second set of inoculations. Clinical outcome of the events was recovered on 29Jan2021. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds: LEVEMIR; LOSARTAN POTASSIUM; METFORMIN; ATORVASTATIN; MAGNESIUM OXIDE; ASPIRIN (E.C.); TOPIRAMATE ACCORD; TRAMADOL; OMEPRAZOLE ABBOTT; PRIMIDONE

Current Illness: Diabetes (he has known he is a diabetic for about 10 years)

ID: 1652880
Sex: M
Age:
State: NV

Vax Date: 05/18/2021
Onset Date: 06/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pain in my left hip and thigh; pain in my left hip and thigh; painful rash developed from the left side of my lower back, left hip/thigh all the way down to my toes; Shingles; This is a spontaneous report form a contactable consumer (patient) reported for herself. A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 18May2021 at 12:00 pm (age at vaccination was 54 years) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ramipril, simvastatin, acetaminophen and aspirin [acetylsalicylic acid] all taken for an unspecified indication. The patient previously took Penicillin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Jun2021 at 08:00 am, the patient experienced pain in his left hip and thigh, painful rash developed from the left side of his lower back, left hip/thigh all the way down to his toes and shingles. 18 days after receiving the first dose, the patient began having pain in his left hip and thigh then a painful rash developed from the left side of his lower back, left hip/thigh all the way down to his toes. He was diagnosed by two separate doctors as having Shingles. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment with Valacyclovir, Prednisone and Gabapentin. The outcome of the events was not resolved. Follow up attempts are needed. Further information has been requested.

Other Meds: RAMIPRIL; SIMVASTATIN; ACETAMINOPHEN; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1652881
Sex: F
Age:
State: SC

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

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

Lab Data:

Allergies:

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

Symptoms: I'm sick and need to reschedule.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that I was sick and need to reschedule on an unspecified date. The outcome of the event was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am