VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1790759
Sex: U
Age:
State: OK

Vax Date: 08/07/2021
Onset Date: 08/16/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210716; Test Name: TB Skin test; Result Unstructured Data: Test Result:Negative; Comments: On 19Jul2021 = got read

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: AWFUL ITCHY RASH AFTER 2ND SHOT; Severe all over the body rash; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old patient of unspecified gender received second dose of BNT162B2 (Pfizer-Biotech covid-19 vaccine, Solution for injection, Batch/lot number: FA7485) via an intramuscular route of administration, administrated into arm left on 07Aug2021 (age at the time of vaccination 49-years-old), as a single dose for COVID-19 immunization at Pharmacy or Drug store. The patient medical history and concomitant were not reported. The patient previously took first dose of BNT162B2 (Pfizer-Biotech covid-19 vaccine, Solution for injection, Batch/lot number: FA7484) via an intramuscular route of administration, administrated into arm left on 17Jul2021 (age at the time of vaccination 49-years-old), as a single dose for COVID-19 immunization and experienced arm soreness. On16Aug2021 the patient experienced awful itchy rash after 2nd shot, and 3weeks now all over the body. On 16 Jul2021 the patient underwent lab test and procedures which included TB Skin test, Tuberculin test and diagnosed with negative results on 19Jul2021 got read. Therapeutic measures were taken for the AE and treatment included with Zyrtec and Pepcid still no change after taken meds so on 14Sep2021 went to PRIVACY after patient tried self-care with everything didn't work so urgent care i go. Prednisone and hydroxyzine HCL have been given, when rash was getting somewhat better before taking these meds over and treated With Hazel, Equate, Triderma Psoriasis control, Ivarest Poison IVY itch cream, Eucerin Intensive repair lotion, Equate Baby oil gel, Equate 1% Hidrocortisone, hibiclens, olene zing cleaner, hydrocortisone cream 1%, hydrocortisone cream, Allergy, Lomalux eczema pill, Pepcid complete. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790760
Sex: F
Age:
State: CA

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 10/16/2021
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: really tired; injection I got a big lump there; my arm hurts and it's itching; my arm hurts and it's itching; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on Aug2021 (age at the time of vaccination 64-years-old), as a single dose for covid-19 immunization. Medical history included, had allergic reactions, not to vaccines but to IV antibiotics, anaphylactic reaction, type 1 diabetes mellitus, and cardiac failure congestive, from an unknown date and unknown if ongoing. patient had a lot of underlying things. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on an unspecified date (age at the time of vaccination 64-years-old), as a single dose for COVID-19 immunization and experienced mild chill, little bit of body aches. Patient had her first dose of Pfizer Covid-19 Vaccine a month ago, and her second dose of Pfizer Covid-19 Vaccine a week ago today. After the first dose of Pfizer Covid-19 Vaccine she was fine, it doesn't matter, but she had a mild chill and a little bit of body aches for an hour and then she was good. After the second dose of Pfizer Covid-19 Vaccine she felt pretty good, just really tired at first, but no other symptoms for either first or second doses, not even arm pain. She has been feeling ok. On an unspecified date Aug2021, the patient experienced really tired, injection I got a big lump there, my arm hurts and it's itching. Caller's daughter is a nurse and said she hadn't heard of that with Pfizer Covid-19 Vaccine. Patient son was immunocompromised, and his physician ordered Covid antibody tests to see if it worked. It came back negative. was there any test that's recommended to see if it worked? Son was 30 years of age. He received both doses of product. Negative antibody test that the lab provides to see if you have been exposed to covid or have covid and created antibodies. Patient was told by the lab that it was not recommended. Special needs and immunocompromised patient, the antibody test came back negative. Patient sister had a different vaccine (Moderna) and she had a reaction "covid arm", rash red all the way down after the fact. Started yesterday out of the blue, day 6. Itching a bit. patient was allergic to everything, have had anaphylaxis to several important things. Symptom wise product seemed to be the best. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up. Follow-Up (11Oct2021): Follow-up activities closed. Batch/lot number not available for [Vaccine BNT162B2].

Other Meds:

Current Illness:

ID: 1790761
Sex: F
Age:
State: VA

Vax Date: 09/04/2021
Onset Date: 09/05/2021
Rec V Date: 10/16/2021
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: Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Having these like crying spells out of nowhere; Mood swings; Emotional wreck; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF2588; Expiration date was not reported), intramuscular on the left deltoid on 04Sep2021 (13:00) as dose 1, single, for COVID-19 immunization at the pharmacy/drug store. Medical history included ongoing anxiety from 16Dec2014; ongoing depression from 16Dec2014; post-partum depression; and a family history of heavy flow and clotting at time of menses and swollen cervix (patient's sister). There were no concomitant medications. On 05Sep2021 (09:00), the patient was having these like crying spells out of nowhere, and mood swings. On 05Sep2021, the patient had an emotional wreck. On 11Sep2021, the patient's menstrual cycle was a week early with unusually heavy flow, and clotting and pain. The events were reported to be serious (important medical event), and had led to an emergency room visit. The patient did not receive any treatment for 'having these like crying spells out of nowhere' and emotional wreck. The outcome of the events was not recovered for mood swings; and was unknown for all the other events. The patient believed that there was a correlation between the COVID-19 vaccine and the reported female hormonal changes.

Other Meds:

Current Illness: Anxiety; Depression

ID: 1790762
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Really bad breaking out of her skin; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN (she does not have her card available at this time), Expiry Date: UNKNOWN) via an unspecified route of administration on an unspecified date in 2021 (about a month ago) (at the age of 63 years-old), as a single dose for COVID-19 immunization. The patient medical history (including any illness at time of vaccination) was none. No concomitant medications (other products) were reported. Family medical history relevant to adverse events was none. The report was not related to a study or programme. The vaccination facility type reported as grocery store. The vaccination facility address was unknown. Additional vaccines administered on same date of the Pfizer suspect was none. Prior Vaccinations (within 4 weeks) and adverse events following prior vaccinations was none. On an unspecified date in 2021, the day after she got the shot, patient experienced really bad breaking out of her skin (It has been about a month since she took the first covid vaccine). The patient was not visited to emergency room and physician office. No investigation assessment. No treatment was taken, she assumed that it would go away. It was reported that action taken with drug was unknown. Patient is due to receive the second vaccine, but she doesn't know if she should get it or not. Reporter (patient) questioned about the getting second vaccine. Reporter wants to know if there have been any reports of breaking out of the skin with the Pfizer COVID-19 vaccine. The outcome of event was recovering. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1790763
Sex: F
Age:
State: CO

Vax Date: 07/25/2021
Onset Date:
Rec V Date: 10/16/2021
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: body rash; had bumps all over; This is a spontaneous report from a contactable consumer (patient reporting for self). A 62-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25Jul2021 at 12:00 (noon) as DOSE 1, SINGLE (at the age of 62-years-old) for covid-19 immunization. Medical history included vegetarian from an unknown date (She has been a vegetarian for 42 years). There were no concomitant medications. Patient did not take prior vaccination within 4 weeks. She got her first dose of the Pfizer COVID 19 vaccine. She has had a body rash since. She didn't know exactly when the rash started because it wasn't really itchy. She noticed it probably a week later. She had bumps all over. It went back in forth between improving and worsening both occurred on an unknown date in 2021. She wanted to know if rash had been reported in vegetarians, had bumps all over. Patient was wondering if there was something in the vaccine with extra protein that would cause a reaction in a vegetarian. She didn't have a prescribing doctor. Patient was scared for the second one because she didn't know if this was a reaction. She hasn't had any skin problems or rashes in her life and was pretty healthy. Events were not resulted in visiting of emergency or physician office. The outcome of the events was not recovered. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790764
Sex: M
Age:
State:

Vax Date: 08/17/2021
Onset Date: 08/20/2021
Rec V Date: 10/16/2021
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: loss of taste and sense of smell; loss of taste and sense of smell; This is a spontaneous report from a contactable other hcp. A 14-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration on 17Aug2021 (age at vaccination 14-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Aug2021, the patient experienced loss of taste and sense of smell. The patient was scheduled for 2nd dose of the vaccine on 07sep2021 whereas patient completed the ten days of quarantine. The clinical outcome of the event was unknown. The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1790765
Sex: F
Age:
State: VA

Vax Date: 02/10/2021
Onset Date: 03/28/2021
Rec V Date: 10/16/2021
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: 20210121; Test Name: Nasal Swab; Test Result: Positive ; Comments: Day after covid 1st Dose of vaccine.

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: some foods now taste like chemicals; Allergic reactions where none existed before/ new allergies keep popping up/ having allergies left and right, its like my body is in hyperactive state; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 29Sep2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 10Feb2021 13:00 (Batch/Lot Number: EN5318) (at the age of 50-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included polycythaemia vera from May2019 and ongoing, allergies: antihistamines, steroids, allergic to different meds, environmental allergy, and allergic to different foods (bananas taste like a weird sweet chemical and other food) from unknown dates and unknown if ongoing. Concomitant medications included probiotics and multivitamains taken for an unspecifed indication, start and stop date were not reported. Patient was not pregnant at time of vaccination. The vaccination was performed in a nursing home/ senior living facility. The patient had no prior vaccination received within 4 weeks prior to the COVID-19 vaccine. The patient previously took antihistamines and steroids and experienced allergies. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19) intramuscular, administered in the left arm on 20Jan2021 11:00 (Batch/Lot Number: EL3249) (at the age of 50-years-old) as DOSE 1, SINGLE for COVID-19 immunization and experienced nasal swab positive/ Covid test result: positive on 21Jan2021. On 28Mar2021, the patient experienced allergic reactions where none existed before/ new allergies keep popping up/ having allergies left and right, its like my body is in hyperactive state/ sudden onset of allergies On 29Mar2021, some foods now taste like chemicals. The patient reported within 4 weeks of 2nd dose of Pfizer vaccine, she had been having allergies left and right, its like her body was in hyperactive state. Even allergic to antihistamines, steroids and different meds and food. Allergist did not know what to do, she cannot take allergy shots, nothing. If she did not have allergic reactions to the food, different foods taste like chemical. Bananas taste like a weird sweet chemical and other food. The events were considered serious due to significant disability/ incapacity. The events required emergency room, physician's office visit, and treatment (had to see allergist, still had no answers). The patient underwent nasal swab: positive on 21Jan2021 day after COVID 1st dose of vaccine. The outcome of the events was not recovered. No Follow-up attempts are needed. No further information is expected.

Other Meds: PROBIOTICS

Current Illness: Polycythemia vera

ID: 1790766
Sex: F
Age:
State: NY

Vax Date: 09/02/2021
Onset Date: 09/03/2021
Rec V Date: 10/16/2021
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: get a sore; Pruritus; she has an ongoing blister that is filling up every time; weakness; This is a spontaneous report from a contactable nurse (Patient). A 55-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration in Deltoid Left on 02Sep2021 (age at the time of vaccination 55-years-old), as a 0.3 ml single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The Patient did not used other products. The Patient was not received other medications in two weeks. The patient was not received other vaccine in four weeks. The Patient was not diagnosed with COVID-19 prior vaccination and patient did not test COVID-19 post vaccination. It was mandatory patient taking COVID-19 vaccine. On 03Sep2021, the patient experienced pruritus, she has an ongoing blister that is filling up every time, weakness, and on an unspecified date get a sore. The caller has extensive side effects and has pictures of it. The caller was trying to report it online but decided to call and report it instead. The caller doesn't want to bust the blister on unspecified date she gets a sore. But the blister deflated yesterday and left drainage on the pillow. But if you leave it alone, it inflates again. The caller's body keeps feeding the blister water. The caller considers the event criteria as moderate seriousness. The Patient had not received treatment for events Pruritus, Ongoing blisters, weakness. The outcome for the events Pruritus, she has an ongoing blister that is filling up every time, weakness was not recovered, and event get a sore was unknown. The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1790767
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: 20210728; Test Name: Nasal swab; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: My second shot also had fever and chills and greatly inflamed tendonitis in my elbow which also has yet to go away.; My second shot also had fever and chills and greatly inflamed tendonitis in my elbow which also has yet to go away.; My second shot also had fever and chills and greatly inflamed tendonitis in my elbow which also has yet to go away.; This is a spontaneous report from a contactable consumer (Patient). A 54-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date (age at the time of vaccination 54-years-old), as a single dose for covid-19 immunization. Medical history included glaucoma, allergy to Sulfa drugs, and COVID-19. There were no concomitant medications. The patient previously took historical vaccine first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 703-288), via an unspecified route of administration, administrated in Left arm on 06Jun2021 12:00 PM (age at the time of vaccination 54-years-old), as a single dose for covid-19 immunization and on 06Jun2021 06:00 PM patient experienced Weird Stinging sensation behind my right knee, high fever, and chills. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On an unspecified date, the patient experienced my second shot also had fever and chills, and greatly inflamed tendonitis in my elbow which also has yet to go away. On 28Jul2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative, Nasal Swab. No treatment was received in response to the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was tested for COVID-19. The outcome of the events was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790768
Sex: M
Age:
State: IN

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 10/16/2021
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: Muscle aches; Also ran a temperature and didn't feel good; Flu like symptoms; Also ran a temperature and didn't feel good; Muscle aches in his arm for 2-3 days, which kind of radiated up into his neck and back of head; This is a spontaneous report from a contactable consumer (parent). This is Report 3 of 3. A 20-years-old male patient received bnt162b2 ((PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Aug2021 12:00 (at the age of 20-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Neurofibromatosis (Verbatim: Neurofibromatosis, type 1 (von Recklinghausen's disease) diagnosed at 14 years old). There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0182) administered in left arm on 03Aug2021 11AM (at the age of 20-years-old) for covid-19 immunisation and patient experienced a dead arm in the injection arm, which was the right arm as reported. Could not lift arm because it hurt. Felt like was punched in the arm. Was continuous. It was reported that, second dose was administered a little over three weeks. On 26Aug2021, the patient experienced muscle aches in his arm for 2-3 days, which kind of radiated up into his neck and back of head. It was faded. Patient did break his arm in that area twice. Also ran a temperature and did not feel good. Felt Flu-ish or Flu-like symptoms on the same day. He never got sick. It was reported that all symptoms subsided in 48 hours. Outcome of events were recovered on an unspecified date in Aug2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Neurofibromatosis, type 1 (von Recklinghausen's disease) (Verbatim: Neurofibromatosis, type 1 (von Recklinghausen's disease), diagnosed at 14 years old)

ID: 1790769
Sex: U
Age:
State: WA

Vax Date: 08/02/2021
Onset Date: 08/01/2021
Rec V Date: 10/16/2021
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: is very painful; The numbness started on the right arm where I received the shot; The numbness started on the right arm where I received the shot , it started travelling to other parts of my body; I started having symptoms of rash; itchy skin and eyes; itchy skin and eyes; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 02Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced i started having symptoms of rash, itchy skin and eyes. On an 07Aug2021, the patient experienced is very painful, the numbness started on the right arm where i received the shot, it started travelling to other parts of my body. Reportedly, the patient received the first Pfizer Coved 19 shot 02Aug2021, less than a week later the patient started having symptoms of rash, itchy skin and eyes and then on the 5th day numbness, the numbness started on the right arm where the patient received the shot, it started traveling to other parts of the patient body and as of 5 weeks later, all numbness had not gone away and was located at 7 seven locations of the patient body and was very painful. The patient(s) General PC asked the patient to see the Neurologist. The patient needed help a little sooner than 27Sep. The outcome of the events I started having symptoms of rash, itchy skin and eyes was unknown. The outcome of the events is very painful, the numbness started on the right arm where i received the shot and it started travelling to other parts of my body and was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1790770
Sex: F
Age:
State:

Vax Date: 09/04/2021
Onset Date: 09/05/2021
Rec V Date: 10/16/2021
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: chills; body aches/ pain all over her body; congestion; sneezing; headache; ear pain; she has a lot of mucus; her throat hurts; This is a spontaneous report from a contactable consumer (parent). A 16-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 04Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration on 07Aug2021 as dose 1, single for covid-19 immunisation. The caller reported that, the patient was supposed to get the second dose on 28Aug2021, however the patient received second dose until Saturday 04Sep2021. On Sunday (05Sep2021), the patient started having chills, body aches, pain all over her body, congestion, sneezing, headache and ear pain, she has a lot of mucus and her throat hurts. The caller took the patient to a clinic but came back because the waiting list was 2 hours. The outcome of all the events as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1790771
Sex: M
Age:
State: SC

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient' medical history and concomitant medications not reported. The patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization and experienced high temperature/fevers. On an unspecified date, patient had discomfort in the right kidney and tachycardia. Reportedly, to date he continues to present these symptoms. He mentioned the pain in the kidney is frequent and greater; while tachycardias are also more frequent and particularly when he is in motion. The outcome of the events: not recovered.

Other Meds:

Current Illness:

ID: 1790772
Sex: M
Age:
State: SC

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Test Name: temperature fevers.; Result Unstructured Data: Test Result:High; Comments: high temperature fevers

Allergies:

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

Symptoms: high temperature fevers.; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: Unknown) via unknown route of administration on an unknown date as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. After first dose of the vaccine, the patient developed high temperature fevers. The lab data included body temperature was high (high temperature fevers) on an unknown date. The outcome of the event was unknown. 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 completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790773
Sex: F
Age:
State: CA

Vax Date: 06/09/2020
Onset Date: 06/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: develop 4 nodules with distinctive borders; swelling; redness under both eyes; lymphadenopathy bilateral jaw; This is a spontaneous report based on the information received by Pfizer from Facility (Reference Number: GL-082521-20503). This is a spontaneous report from a contactable physician. A 44-year-old female patient received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), dose 2 via an unspecified route of administration on 05May2021 (at 44-years age) as dose 2, single for covid-19 immunisation and hyaluronic acid (RESTYLANE), via an unspecified route of administration from 09Jun2020 (Batch/Lot Number: 17327; Expiration Date: 31May2022) to an unspecified date, at 0.5 mL, via an unspecified route of administration from 31Jul2020 (Batch/Lot Number: 17327; Expiration Date: 31May2022) to an unspecified date, at 0.5 mL, via an unspecified route of administration from 02Mar2021 (Batch/Lot Number: 18439; Expiration Date: 31Mar2023) to an unspecified date, at 0.5 mL for an unspecified indication. Medical history included, had Versa to lips on 16Feb2021 with no issues. The patient's concomitant medications were not reported. Patient has not had any other vaccinations, illnesses, or dental procedures in the last 6-12 months. Patient previously received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on 14Apr2021 (at 44-years age) as dose 1, single for covid-19 immunisation. In Jun2021, patient reported that she started to develop 4 nodules with distinctive borders, swelling, redness under both eves, she lymphadenopathy bilateral jaw. HCP reported patient was seen in Urgent Care in the second week of August and prescribed 6 days prednisone taper. HCP reported the patient then presented to her on 17Aug2021 reporting no improvement with prednisone. HCP reported that she treated the patient with 900U hyaluronidase and Doxycycline. Nodules are 90% improved, still some swelling, redness and lymphadenopathy bilateral jaw but improving. She treated with another 600U hyaluronidase and another week of Doxycycline. Action taken for hyaluronic acid (RESTYLANE) was unknown. The outcome of the events was resolving. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: RESTYLANE

Current Illness:

ID: 1790774
Sex: M
Age:
State: PR

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: small rush; fatigue; This is a spontaneous report from contactable consumer (patient). A male patient of an unspecified age received (BNT162B2, formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported he mentioned that when he received the first dose he manifested a small rush and fatigue for two days, on an unspecified date. It was reported that addition to the effects reported on Monday the patient also suffered from a constipated throat that did not allow him to swallow and swelling in the heel and foot of the right leg. The clinical outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.

Other Meds:

Current Illness:

ID: 1790775
Sex: M
Age:
State: CA

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: constantly dropping things; Pain in eyes; motor function was slightly impaired; Extremely tired/extremely exhausted; Pain in his body; Weak and brain fog; Weak and brain fog; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in arm left on 16Aug2021 at 16:00 (Lot Number: FC3181) as dose 2, single (at the age of 35 years old) for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 26Jul2021 at 04:00 PM (Lot number: FA7484) via intramuscular administered in left arm as dose 1 (at the age of 35 years old) for COVID-19 immunization. No other vaccine in two weeks and four weeks. No COVID prior vaccination and was not tested post vaccination. No known allergies. The patient experienced extremely tired still, pain in his body, weak, and brain fog on 16Aug2021 at 16:30. It was reported that after second (2nd) shot a month later (as reported), patient still wake up extremely exhausted. On 16Aug2021 at 18:00, reported that she constantly dropping things now which never happened before. Further reported that patient experienced pain in eyes, motor function was slightly impaired, stated playing basketball now his precision accuracy were way off on 16Aug2021 at 18:00. Asked on how much longer will that last. No treatment was provided. The outcome of the events was not recovered No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790776
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: This is a spontaneous report from a contactable consumer. A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date: unknown), on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unknown date, patient wanted to know if coughing up from the lungs was natural. It started with a runny nose and injection site irritation. "Was that common? Should I get the second one or was that going to put me in the hospital?" The outcome of event: unknown. Sender's comment: Reporter type could not be probed as consumer hung up the call abruptly, hence reporter type captured as consumer or non-healthcare professional by default. Follow-up (Oct 4, 2021): This is a spontaneous follow-up report. Phone answered by the consumer who stated she does not want to be contacted any further.

Other Meds:

Current Illness:

ID: 1790777
Sex: F
Age:
State:

Vax Date: 09/09/2021
Onset Date:
Rec V Date: 10/16/2021
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: So, I am 34 weeks pregnant; arm hurt; When I touch it, it hurts. If I lay it hurts.; I feel like my body, like muscle pain; Flu; 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 MRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 09Sep2021, patient took Pfizer vaccine, about a week ago. Patient was 34 weeks pregnant (further clarification unknown. Hence, tab not checked). On an unspecified date she reported, she did not had any side effect, it's just that her arm was hurting, and it two days and then it did stop. Her arm started hurting again and she felt like her body, like muscle pain, like she is getting a flu. When she touches it, it hurts. If she lay it hurts. Now she felt like she is coming down with the flu. The mother reported she became pregnant while taking bnt162b2. The mother was 34 Weeks pregnant at the onset of the event. The mother was due to deliver on 26Sep2021. Outcome of all the events was unknown. No follow up attempts are needed. Information on batch/lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1790778
Sex: F
Age:
State: OK

Vax Date: 09/14/2021
Onset Date: 09/14/2021
Rec V Date: 10/16/2021
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: lightheaded feeling; intense itching and crawling feeling; intense itching and crawling feeling; cold, headache developed; Chills; cold, headache developed; odd feeling; Throat got scratchy but did not close; Skin flushed; Allergic reaction; nausea; Joints ache; Cough; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 58-years-old, intramuscular, administered in Arm Left on 14Sep2021 10:30 (Batch/Lot Number: FC3184) as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 24Aug2021 10:30 (Batch/Lot Number: FC3184) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included ongoing hypothyroidism and high cholesterol from Nov2005, seasonal and sulfa allergies, pinched nerve on Aug2021, acid reflux from 1993, gastric sleeve from 2014, Gallbladder removal in 2013, Hysterectomy and appendectomy in Nov2005, has allergies to eggs, peanuts, tomatoes, wheat from Mar2019 and ongoing. The patient also had amoxicillin allergy. The patient had no family medical history. Concomitant medication included baclofen taken for pinched nerve, pain from 02Sep2021 and ongoing; omeprazole taken for acid reflux from 2006 and ongoing; citalopram taken for mood depression from 2009 and ongoing; ezetimibe taken for high cholesterol from 2015 and ongoing; amitriptyline taken for mood depression, neuropathy peripheral from 2009 and ongoing; levothyroxine sodium taken for hypothyroidism from 2005 and ongoing; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for allergies from an unspecified start date and ongoing; naproxen taken for pinched nerve, pain from 02Sep2021 and ongoing. No other vaccine in four weeks. Within 5 min of getting the injection on 14Sep2021 10:35, he started with a lightheaded feeling, lips started itching which spread to whole body eye, palms, ears, everyplace intense, crazy itching and crawling feeling, cold, headache developed. She felt a chill or odd feeling wash over me a few times. It was 7pm and she still has itching and off/lightheaded feeling. She took 2 Benadryl and 2 Tylenol. She already had Zyrtec and Flonase in her system. She took Zyrtec the night before 25 mg Benedryl before shot, through the day she took 150 mg Benadryl. She also took Tylenol for headache that developed. Throat got scratchy but did not close. Skin on legs, arms, stomach flushed, no hives, had a little nausea (on 10:30), didn't vomit. Joints became achy within a few hours, stayed sore approximately 3 days. The patient has an allergic reaction, received multiple doses of Benadryl itched and coughed for 12 hours. Coughing started within an hour. The outcome of the event cough, chills, joints ache and allergic reaction was recovered while other events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: BACLOFEN; OMEPRAZOLE; CITALOPRAM; EZETIMIBE; AMITRIPTYLINE; LEVOTHYROXINE SODIUM; ZYRTEC ALLERGY; NAPROXEN

Current Illness: Blood cholesterol increased; Hypothyroidism

ID: 1790779
Sex: F
Age:
State:

Vax Date: 03/15/2021
Onset Date:
Rec V Date: 10/16/2021
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: atopic dermatitis; This is a spontaneous report based on the information received by Pfizer from Laboratorie (Case number: GL-090321-21301). A contactable 36-year-old female consumer (patient) reported. A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 15Mar2021 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took tacrolimus for dermatitis atopic. No other vaccines, illnesses, or dental procedures in the last 6-12 months. Patient was injected with a total of 1 ml of what she believes to be Restylane Kysse (Lot and exp Unknown) to tear troughs and upper and lower lips on 20Apr2021. She reported that she developed swelling under her right eye one day in Aug-2021 and the next day she woke up with swelling to both upper and lower eyelids and upper and lower lips, she reported they were very inflamed. She saw the HCP who administered certisone injections to both eyes and lips and prescribed her with a 5-day course of oral prednisone, swelling resolved. After finishing the oral prednisone, the swelling returned (02Sep2021). She contacted the HCP by phone and sent him photos of the swelling and he prescribed her lisinopril 5 mg daily and advised she take cetirizine dihydrochloride and fexofenadine. She reported that she is reluctant to take the lisinopril because its for high blood pressure. Event has not resolved, still has swelling and inflammation both eyes and upper and lower lips. The patient was diagnosed with atopic dermatitis around the eyes 6 weeks prior to injections, she was treated with Tacrolimus ointment which she had stopped about 2 weeks prior to injections. No other medical history, allergies, or medications. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790780
Sex: F
Age:
State: TN

Vax Date: 08/24/2021
Onset Date: 08/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result: Up; Test Name: heart rate; Result Unstructured Data: Test Result: Up; Test Date: 20210914; Test Name: Antibody test; Test Result: Negative.

Allergies:

Symptom List: Unevaluable event

Symptoms: panic attack; blood pressure was up; her heart rate was up; allergic reaction; she was upset; she had flu like symptoms and her neck was hurting; she had flu like symptoms and her neck was hurting; she began to have numbness on her left side of face and left side of tongue up to her left ear; she began to have numbness on her left side of face and left side of tongue up to her left ear; achy; headache; runny nose; something effected the nerve; This is a spontaneous report from a contactable consumer or other non HCP. A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19mRNA VACCINE, Solution for injection, Lot number: FA6780, Expiration date: unknown), via intramuscular route, administered in arm right on 24Aug2021 16:00 as dose 1, single for COVID-19 immunisation, prophylaxis. Medical history included asthma from an unknown date and unknown if ongoing Onset Date: Having trouble with Asthma for 4 years or longer, menopause from an unknown date and unknown if ongoing. Concomitant medication(s) included dupilumab (DUPIXENT) (300mg injections every two weeks) taken for asthma from Mar2020 to an unspecified stop date. The patient received her first dose of Comirnaty on 24Aug2021 and on 25AUG2021 at around 12:30 she began to have numbness on her left side of face and left side of tongue up to her left ear, she states she received the vaccine on her right side the day before at 4pm. On 25Aug2021, patient got off work early and did laundry and was feeling good. She did not have a runny nose or flu like symptoms that were common. All of a sudden, the left side of her face started going numb. It would not be numb to where she was droopy, but it was numb from her tongue, cheek, and all the way up to her ear. It scared her so patient called family doctor and receptionist wanted to know how quick she could get here. On unspecified date Patient said she was having a panic attack and her husband took her. Her blood pressure was up because she was upset and her heart rate was up because she was scared. Patient saw her primary doctor on 25Aug2021 and he didn't feel as though it was from the vaccine because that should have happened with in the first 20 minutes and it did not, he asked her what she had to eat and she mentioned Chic-fil-A with their sauce and he says it must be from the sauce not the vaccine. Primary doctor then told her she had a reaction to that. He asked if her EPI pen was up to date and he did not say if this gets worse, go to emergency room. She has never had any issues with Chik fil a sauce and has eaten it since then, with no issues. She left doctor's office with her face still numb. A few days later she went to another doctor for a second opinion about getting the second shot, which should have been yesterday 14Sep2021, and that doctor recommended her not to get the second dose because it sounds like something effected the nerve (unspecified date in Aug2021). He said it was an allergic reaction to the vaccine and said not to get the second dose. So yesterday, she was supposed to get second shot. She went to her local pharmacy and they did an antibody test to see if she had any antibodies because she has one dose already and they told her she had zero antibodies. She went to her allergy doctor before she got the vaccine and he said there would be no issues with the vaccine and the Dupixent that she takes for Asthma. She later stated they just told her to space her injections out and not to get them the same week and she did space them out. Asthma was her worse medical condition other than menopause. No further details provided. On 26Aug2021, and 27Aug2021, she had flu like symptoms and her neck was hurting; (unspecified date in Aug2021) patient was kind of achy, and had a headache, and runny nose. That just lasted two days, and after that, it was fine. On 14Sep2021 the patient underwent lab tests and procedures which included Antibody test (sars-cov-2 test) was negative; on an unspecified date blood pressure measurement: up and heart rate: up. No emergency room visit. Patient had visited the physician office. Patient was not hospitalized. The outcome of the event facial numbness, Flu like symptoms, Neck pain, was recovering; outcome of the events achy, headache, and runny nose was recovered and the rest of the events outcome was unknown. Pharmacist and both(doctor) said they felt it was related to the vaccine. No follow-up attempts are possible. No further information is expected.

Other Meds: Dupixent

Current Illness:

ID: 1790781
Sex: F
Age:
State: KS

Vax Date: 08/05/2021
Onset Date: 08/19/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:Unknown Results; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Unknown Results; Comments: More information available (Y/N): NO; Test Name: EKG; Result Unstructured Data: Test Result:Unknown Results; Comments: More information available (Y/N): NO; Test Name: Holter Monitor; Result Unstructured Data: Test Result:Unknown Results; Comments: More information available (Y/N): NO

Allergies:

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

Symptoms: She has had a low heart rate; she did not had a low heart rate prior to the vaccine; heart rate it was in 40 and now she runs 30's 40's it does go up but it stay significantly low; she started feeling light headed like she is gonna pass out; No energy; This is a spontaneous report from a contactable Nurse(daughter). A 17 year old female patient first dose of received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 05Aug2021 (age at vaccination 17 years) as single dose for COVID-19 immunization. The patient medical history and concomitant were not reported . It was reported that patient did not receive any vaccination within 4 weeks prior to vaccination. On 19 Aug2021 the patient had experienced a low heart rate; she did not had a low heart rate prior to the vaccine; heart rate it was in 40 and now she runs 30's 40's it does go up but it stay significantly low,No energy and feeling light headed like she is gonna pass out. On an unspecified date the patient underwent lab test and procedures which had included Blood test,Holter monitor , had echocardiogram for heart and EKG for her heart with diagnosis of unknown results for all tests. The clinical outcome of the events were not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790782
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: she is diabetic; Fever; Chills; Upset stomach; Fatigue; couldn't eat; Sick for two days; couldn't go to work; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever, chills, upset stomach, fatigue, couldn't eat, sick for two days and couldn't go to work on an unspecified date. The patient also reported that she is diabetic on an unspecified date. The outcome of the event was unknown. Follow-up attempts completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790783
Sex: F
Age:
State: TX

Vax Date: 09/08/2021
Onset Date: 09/08/2021
Rec V Date: 10/16/2021
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: Have not been able to sleep through the night since vaccine; Fatigued; Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Sep2021 at 12:00 (Batch/Lot Number: FC3181) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization at age of 51 years old. Medical history included hashimotos disease, thrombocytosis, hemochromatosis, anxiety. Concomitant medications included escitalopram oxalate (LEXAPRO); levothyroxine sodium (SYNTHROID); bupropion hydrobromide (APLENZIN); liraglutide (SAXENDA). The patient experienced have not been able to sleep through the night since vaccine, fatigued, and heart palpitations on 08Sep2021. The report was non-serious. No treatment received for the events. The patient did not have covid prior vaccination, and did not test covid post vaccination. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds: LEXAPRO; SYNTHROID; APLENZIN; SAXENDA

Current Illness:

ID: 1790784
Sex: F
Age:
State:

Vax Date: 08/27/2021
Onset Date:
Rec V Date: 10/16/2021
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: 2nd shot- Arm bled quite a bit after injection; Headache lasting a few days; Sore Arm; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FF2588), via an unspecified route of administration, administered in Left arm on 27Aug2021 at the age of 34-years-old as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concurrent conditions were none. The patient was not pregnant at the time of vaccination. There was no relevant past drug history. The patient's concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FA7484), via an unspecified route of administration, administered in Left arm on 03Aug2021 (at the age of 34-years-old) as single dose for covid-19 immunisation and experienced Horrible headache lasting 6 days, Chills, Nausea and Sore arm. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 19Sep2021. On an unspecified date in 2021, the patient experienced Arm bled quite a bit after injection, Headache lasting a few days and Sore Arm. Adverse events resulted in none of the above. No treatment was received for adverse events. The reporter assessed events as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of Headache lasting a few days was recovered on an unspecified date in 2021 and other events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790785
Sex: M
Age:
State: KY

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: Urine test; Result Unstructured Data: Test Result:Normal

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: I feel as outer gas; Extreme fatigue; This is a spontaneous report from a contactable consumer (patient) via . A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 11Feb2021 11:00 (at 58 years old) (Batch/Lot Number: EL9264) as DOSE 1, SINGLE for covid-19 immunisation. Patient has no relevant medical history. The patient's concomitant medications were not reported. The patient underwent lab tests and procedures which included blood test: normal on 2021, urine analysis: normal on 2021. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme fatigue on 12Feb2021 05:00 with outcome of not recovered. Since taking the vaccine have an increased to extreme amount of fatigued by the end of the day. Patient felt as outer gas and just can't so anymore. It is nearly everyday. No treatment given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The adverse event resulted in visit to Doctor or other healthcare professional office. Dose 2 was given on 03Mar2021,intramuscular Left arm; Lot number: EL1686. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790786
Sex: F
Age:
State: AR

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20201223; Test Name: Fever; Result Unstructured Data: Test Result:100.6; Test Date: 20210113; Test Name: Fever; Result Unstructured Data: Test Result:100.6

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Myalgia; Fever 100.6; Chills; Migraine; Nausea; Severe fatigue; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 04Oct2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient) via Pfizer-sponsored program. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscular, administered in Deltoid Left on 22Dec2020 10:00 (Lot Number: EJ1685) as DOSE 1, SINGLE for COVID-19 immunisation. The vaccine was administered at a hospital. Medical history included lupus (prior to vaccination), HPTN (hypertension) (prior to vaccination), and sleep (disorder). Concomitant medication(s) included trazodone (TRAZODONE) taken for sleep (disorder), start and stop date were not reported; losartan (LOSARTAN) taken for HPTN, start and stop date were not reported. The patient previously took ibuprofen and experienced allergy (allergic to ibuprofen). It was reported that the patient experienced myalgia, fever 100.6, chills, migraines, nausea and severe fatigue on 23Dec2020 00:30 (resolved with sequelae on 24Dec2020), then on 13Jan2021 21:00 (resolved with sequelae on 15Jan2021). It was reported that patient was allergic to ibuprofen, thus, she took Tylenol for symptoms. Therapeutic measures were taken as a result of the adverse events which included paracetamol (TYLENOL), taken from 22Dec2020 (as reported) to 24Dec2020, then from 13Jan2021 to 15Jan2021. Outcome of the events was first resolved with sequelae on 24Dec2020. The reporting nurse assessed the events as non-serious. It was reported that the patient received the second dose of (BNT162B2), intramuscular, administered in Deltoid Left on 21Jan2021 11:00 (Lot Number: EJ1686) as DOSE 2, SINGLE for COVID-19 immunisation. The patient also received a third dose on an unspecified date.

Other Meds: TRAZODONE; LOSARTAN

Current Illness:

ID: 1790787
Sex: F
Age:
State: CT

Vax Date: 08/29/2021
Onset Date: 08/31/2021
Rec V Date: 10/16/2021
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: Lymph nodes under arm were swollen/ lymph nodes went down, the bursa area of shoulder; Shoulder became swollen; Shoulder extremely painful; Limited mobility; Swollen muscle in my shoulder; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the right arm on 29Aug2021 at 07:50 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021 (reported as 48-72 hours after receiving first dose), the patient had a swollen muscle on her shoulder. On 31Aug2021, 48 hours after the injection, the patient's lymph nodes under the arm were swollen and the patient knew it was normal. However after, swelling in the lymph nodes went down, the bursa area of her shoulder became swollen and extremely painful, resulted in limited mobility. This pain had persisted from the original date of injection. Therapeutic measures were taken as a result of event shoulder extremely painful which included treatment with naproxen sodium (ALEVE) from an unknown date to alleviate the pain at that moment. No treatment was received for the events axillary lymph nodes enlarged, joint swelling and mobility decreased. The swelling had not gone down and the pain has not subsided. 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. Vaccination facility type was Doctor's office/Urgent care. Vaccine was not administered at military facility. The clinical outcome of the events lymph nodes under arm were swollen/ lymph nodes went down, the bursa area of shoulder, shoulder became swollen, shoulder extremely painful and limited mobility were not recovered at the time of this report and the outcome of the event swollen muscle in her shoulder was unknown. Seriousness criteria of the event swollen muscle in her shoulder was reported as persistent/significant disability/Incapacity. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the right arm on 21Sep2021 at 09:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The clinical course was reported as follows: 48-72 hours after receiving first dose I have had a swollen muscle in my shoulder and limited mobility. I have not gone to the hospital as I am uninsured and can not afford it. Follow-up attempts are completed. No further information is expected. Follow-up (12Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790788
Sex: F
Age:
State: NY

Vax Date: 09/20/2021
Onset Date: 09/21/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210921; Test Name: Heart rate; Result Unstructured Data: Test Result:140; Comments: Heart rate high like 140.

Allergies:

Symptom List: Nausea

Symptoms: both arms started shaking like having seizures on the outside; could not breathe good; heart rate high like 140; Headache; has been sleeping a lot ever since; This is a spontaneous report from a contactable nurse. A 56-years-old female patient (sister) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: FC318), dose 2 via an unspecified route of administration, administered in right arm on 20Sep2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included ongoing asthma which was diagnosed years ago. There were no concomitant medications. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number of FCJ183) via an unspecified route of administration, administered in right arm on 30Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. On 21Sep2021, the patient's both arms started shaking like having seizures on the outside which started at 01:00 to 02:00, could not breathe good, heart rate high like 140, headache and was sleeping a lot ever since. They had to call her doctor and they did some things that helped. She took Ibuprofen for headache and did breathing treatment. The patient underwent lab tests and procedures which included heart rate was 140 and heart rate high like 140 on 21Sep2021. The outcome of sleep disorder was not recovered; headache was recovering and all the other events wee recovered on 21Sep2021. There was product quality complaint (PQC) present. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Asthma (Verbatim: Asthma).

ID: 1790789
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: some oral issues; she got a golf ball size on her arm; she got a golf ball size on her arm with itching; redness somewhat there and it's going down; back of her tongue is now white with patches; 3rd shot felt a little different on the arm.; fatigue; pain in her joints; brain fog; papules on her mouth; This is a spontaneous report from a contactable other HCP (Patient). A 75-year-old immunocompromised female patient received bnt162b2 (BNT162B2 formulation; Solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included immunocompromised, chronic lyme and Low Antibodies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported and other products was not provided. Historical vaccine included first dose and second dose of bnt162b2 on an unknown date for covid-19 immunisation. It was reported that the patient antibodies were very low and her doctor was very concerned and told her to get the third dose as soon as she could as she was at high risk. The patient experienced some oral issues, she got a golf ball size on her arm with itching and redness somewhat there and it's going down, back of her tongue was now white with patches, 3rd shot felt a little different on the arm, fatigue, pain in her joints, brain fog and papules on her mouth on an unknown date. The patient got the third dose because the vaccine didn't give her the immunity as her doctor expected. The patient wanted to know if oral issues have been reported to see if the side effect she experienced was just a coincidence because she's also on a lot of different things and have a lot of other issues. The patient stated that her mouth isn't irritated. The patient glad that there were no major issues that popped up with the Comirnaty vaccine. The patient asked as anyone had oral issues with the 3rd shot, she didn't have it with the first 2 or was there a study saying people having this. The patient battling chronic Lyme (medical history) and was on a regime and was on natural things at the moment. The patient had different reaction than she did with the first 2 dose. The patient stated, she had fatigue and pain in her joints already so it's hard to tell if it's one thing or something else. Patient stated her mouth was something different and she had some irritation due to a change of one thing. States she needs to go to the dentist or if she was having problems not to go today. The patient stated its confusing right now. 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: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.

Other Meds:

Current Illness:

ID: 1790790
Sex: M
Age:
State: VA

Vax Date: 03/13/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: CATSCAN; Result Unstructured Data: Test Result:Unknown; Test Date: 202106; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Cracked and dry lips that will not healDry; Cracked and dry lips that will not healDry; Swollen tongue; dry tongue; Weakened muscle; Burning and affecting glands; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, in the arm on 13Mar2021 12:45 (at the age of 69-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included minor COPD. The patient's concomitant medications were not reported. The patient had no known allergies. No other vaccine was given in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced cracked and dry lips that will not heal, dry and swollen tongue, weakened muscle, burning and affecting glands. The patient underwent lab tests and procedures which included CATSCAN and sars-cov-2 test: negative in Jun2021. Therapeutic measures were taken as a result of the events. The outcome of all events was not recovered. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1790791
Sex: F
Age:
State: GA

Vax Date: 08/07/2021
Onset Date: 08/07/2021
Rec V Date: 10/16/2021
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: 20210820; Test Name: EMG; Result Unstructured Data: Test Result:nerve damage; Comments: EMG revealed nerve damage of questionable clinical significance thirteen days post vaccination; Test Date: 20210807; Test Name: Heart rate; Result Unstructured Data: Test Result:increased; Comments: increased heart rate; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:No underlying condition; Comments: MRI revealed no underlying condition; Test Date: 20210813; Test Name: Covid test; Test Result: Negative ; Comments: nasal swab

Allergies:

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

Symptoms: EMG revealed nerve damage/sensation of nervous system experiencing electricity/vibrations throughout body; Confusion; slurred speech; severe muscle spasms; tremors; sudden episodes of numbness in arms and legs; severe pressure in head; dizziness; tinnitus; heart palpitations; increased heart rate; shallow breathing; disturbance in menstrual cycle; sensation of nervous system experiencing electricity/vibrations throughtout body; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at age of 36 years, administered in arm left on 07Aug2021 12:30 (Lot Number: EW0183) as single dose for covid-19 immunisation. Medical history included allergies to Almonds. No covid prior vaccination. The patient's concomitant medications were none. No other vaccine in four weeks, no other medications in two weeks. The patient experienced Confusion/slurred speech, severe muscle spasms, tremors, sudden episodes of numbness in arms and legs, severe pressure in head, dizziness, tinnitus, heart palpitations, increased heart rate, shallow breathing, disturbance in menstrual cycle, and sensation of nervous system experiencing electricity/vibrations throughout body post vaccination. EMG (20Aug2021) revealed nerve damage of questionable clinical significance thirteen days post vaccination. MRI (2021) revealed no underlying condition. Covid test via nasal swab on 13Aug2021 and negative. The pharmacy does not recommend that patient receive the 2nd shot after her adverse reaction to the Pfizer Covid-19 vaccine. The pharmacy also guided she to the Pfizer website to report adverse reaction event. Adverse events start date was 07Aug2021 13:30 and resulted in Doctor or other healthcare professional office/clinic visit, no treatment was received. The outcome of the events was Recovered/Resolved with Sequel in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1790792
Sex: U
Age:
State:

Vax Date: 08/10/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: sugar; Result Unstructured Data: Test Result:sugar normal; Test Name: electrocardiogram; Result Unstructured Data: Test Result:2X EKG's shows everything is normal.; Test Name: HB; Result Unstructured Data: Test Result:HB normal; Test Name: Thyroid; Result Unstructured Data: Test Result:Thyroid normal

Allergies:

Symptom List: Tremor

Symptoms: Heart / Lung pain (not as bad ss in the beginning,); Brain fog (every morning, but get better during the day after Vimovo 500/20 medication); Heart / Lung pain (not as bad ss in the beginning,); Headaches; Shortness of breath; Extreme tiredness; my heartbeat raises; then my leggs get weak.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced Heart /Lung pain (not as bad as in the beginning), Headaches, Shortness of breath, Extreme tiredness (if just bend to pick up something from the floor the entire body started shaking inside. It's not visible from the outside, the heartbeat raises, then the legs get weak. so, the patient just goes back to bed), Brain fog (every morning, but get better during the day after Vimovo 500/20 medication). The 2X Electrocardiogram (EKG's) shows everything is normal. Sugar normal. Haemoglobin (HB) normal. Thyroid normal. The outcome of events was unknown. Therapeutic measures were taken as a result of brain fog included vimovo 500/20 medication.

Other Meds:

Current Illness:

ID: 1790793
Sex: M
Age:
State:

Vax Date: 03/01/2021
Onset Date: 08/24/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210824; Test Name: SARS-CoV-1 test; Result Unstructured Data: Test Result:Positive; Test Date: 20210917; Test Name: SARS-CoV-1 test; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: mild case of covid on August/ tested positive; mild case of covid on August; This is a spontaneous report received from a contactable consumer (spouse of patient) from a Pfizer-sponsored program. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 on Feb2021 (Batch/Lot number was not reported), and dose 2 via on Mar2021 (Batch/Lot number was not reported), both as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the 1st and 2nd doses on February and March. He got a mild case of COVID in August (24Aug2021, tested positive). He tested negative in 17Sep2021. The patient had an appointment to get the booster "today" (report date: 27Sep2021). The reporter was interested in knowing if it was not dangerous for the patient to get the booster. The reporter thought that maybe the patient's antibodies were still too high. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790794
Sex: M
Age:
State: WV

Vax Date: 02/11/2021
Onset Date: 03/11/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: hearing test; Result Unstructured Data: Test Result:has improved somewhat; Test Name: hearing test; Result Unstructured Data: Test Result:has improved somewhat; Test Name: MRI; Result Unstructured Data: Test Result:hey can't nail it down; Test Name: x-rays; Result Unstructured Data: Test Result:hey can't nail it down

Allergies:

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

Symptoms: lost my balance for 2 to 3 weeks; complete hearing loss in his left ear; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 73-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: EN6201) as DOSE 2, SINGLE for covid-19 immunisation at the age of 73-year-old. Medical history included ongoing high cholesterol (this was diagnosed in 1997 to 1998), suspected covid-19 at the very end of 2019 to beginning of 2020, he says there wasn't a lot of information back then when it hit this area. He says he was sick 2.5 days then he got out of bed and saw the doctor and he told him you have something bronchial, your lungs sound clear, and that they no idea what it was. He says they gave him antibiotic pills for cough treatment for it, then in the ensuing 3 months when COVID information came out he had had classic COVID symptoms. He says he recovered from that, it took quite a while, and it was almost a year before the vaccine was available to him. He says he had gone to the hospital 06 Jan 2020, and then he didn't get his first COVID vaccine until 21Jan2021. Historical vaccine included dose 1 of bnt162b2 (Batch/Lot Number: EL9261) on 21Jan2021 at the age of 73-year-old. The concomitants included three primary cardio related primary medications that he has been taking for a long time, including one for high cholesterol. The patient experienced complete hearing loss in his left ear on 11Mar2021 with outcome of recovering, lost the balance for 2 to 3 weeks on an unspecified date with outcome of not recovered. The clinical course was reported as: the patient received the second dose of the Pfizer Covid-19 vaccine on 11Feb2021 and experienced complete hearing loss in his left ear 30 days after the dose on 11Mar2021. He went to sleep 11Mar2021 and then woke up 12Mar2021 with no hearing in his left ear. He says this has improved somewhat, he has had two hearing tests, and is scheduled to take the third test 01Oct2021 to prepare for getting a hearing aid. He says prior to this he had no decline in hearing in his left ear, it just went out like a light. He says he has talked to four ENTs and had x-rays and MRIs (Magnetic resonance imaging) and they can't nail it down. He says he understands there is some other hearing loss associated with the vaccine. Along with the hearing problem on that particular day, he lost the balance for 2 to 3 weeks it was difficult to get up and go to the bathroom and to this day still have some balance issues. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: High cholesterol (this was diagnosed in 1997 to 1998.)

ID: 1790795
Sex: F
Age:
State: IN

Vax Date: 09/24/2021
Onset Date: 09/25/2021
Rec V Date: 10/16/2021
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: she has experienced prickling and tingling; She experienced dental paresthesia; sensitivity in her teeth; This is a spontaneous report from a contactable Pharmacist (patient). A 38-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Deltoid Left on 24Sep2021 16:45 (Batch/Lot Number: FF2587) as DOSE 1, SINGLE for covid-19 immunisation at the age of 38-year-old. There were no medical history and concomitant medications. On 25Sep2021, the patient experienced paresthesia feeling, experienced prickling and tingling sensation to both hands, fingers, and toes with outcome of not recovered, dental paresthesia and sensitivity in her teeth with outcome of recovered on 25Sep2021. The relatedness of Covid vaccine to a paresthesia feeling, prickling and tingling sensation to both hands, fingers, and toes was related. The required no visit to Emergency Room or Physician Office. Reporter seriousness for a paresthesia feeling, experienced prickling and tingling sensation to both hands, fingers, and toes was Medically significant. The clinical course was reported as: she received first dose of Pfizer Covid 19 vaccine last Friday and started experiencing side effects within 24 hours, she has experienced prickling and tingling early Saturday afternoon and this has been ongoing for 48 hours with no resolution. Does not know the long term effects of this. It could turn into neuropathy and it can be very serious. She experienced dental paresthesia, experienced sensitivity while eating a banana (it was not hot, cold or hard) on Saturday that has resolved. She was on the way to dental appointment for a teeth cleaning. She normally does not have sensitivity in her teeth. She is concerned that she will no longer be able to work and provide vaccinations to patients again. She explains she has friends and family that are vaccine hesitant. She is as well and plans to tell them she has experienced a neurological issue. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. Feels that the events she experienced there is no question in her mind are from the vaccine. Has not yet seen a physician, but if events do not stop she will seek physician care. she had routine blood work last Monday and an antibody testing on Thursday because if she had antibodies she was not going to get the vaccine, but she did not have any antibodies so she got the vaccine. The patient complained as a pharmacist, she trusted the information in package inserts and has heard this being reported and read about it in a different platform. The FDA and package insert information is something as a pharmacist she trusts, but this information is not in the package insert and it needs to be. Feels that the events she experienced (a paresthesia feeling, experienced prickling and tingling sensation to both hands, fingers, and toes) there is no question in her mind are from the vaccine.; Sender's Comments: Based on the information currently available,The casual association between the reported "paresthesia feeling, experienced prickling and tingling sensation to both hands, fingers, and toes" and suspected vaccine BNT162B2 cannot be completely excluded.

Other Meds:

Current Illness:

ID: 1790796
Sex: F
Age:
State: RI

Vax Date: 09/17/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Chest pain and soreness; Chest pain and soreness; her period had not come; Slight Headache; More Tired; Effecting her hormones; it is doing something; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 17Sep2021 09:30 (at the age of 41-year-old) as dose 2, single for COVID-19 immunization. Medical history included ovarian cancer and breast pain with her period when she was younger. The patient stated ovarian cancer just worried her because if it was having an effect on her sex organs. She stated she was hoping that the shot wasn't messing with her hormones and increasing her chance of any cancer. Family Medical History was none. There were no concomitant medications. There was no additional vaccine administered on same date of BNT162B2. The patient did not receive any other vaccine within 4 weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: FC3182) on 25Aug2021 (at the age of 41-year-old) as single dose for COVID-19 immunization and experienced headache, low grade fever of 99.6/ fever was not breaking 100.5, swollen lymph nodes, sore throat, muscle aches, swollen tonsils, body aches, sore arm, fatigue, body chills and a lot of discomfort. The patient stated she lost 5 pounds because she couldn't eat, her left tonsil was bleeding and it was very swollen so much that she couldn't swallow and when she spits, it was bloody / dry blood. The tonsil on the opposite side of injection was far more swollen noting it was blackish red and her tonsil was completely swollen and inflamed after first vaccination. The patient also woke up in the middle of the night after first vaccination. The patient stated following her second dose on 17Sep2021, her period was absent on 19Sep2021, she was having chest pain and soreness on 19Sep2021. She stated that she was of childbearing age, and she had always had regular periods. She stated the two vaccine series was completed and now her period had not come, clarifying it was a week late, which was abnormal for her on 19Sep2021. The patient stated she was also experiencing chest pain and soreness on 19Sep2021. She stated she spoke to her PCP about it because she was concerned, and she said it sounds like something that she should report. For chest pain and soreness, the patient stated she thought she was getting her period although she normally didn't get any breast pain with her period, but she used to when she was younger. The patient stated that it had stayed the same, it was a constant soreness. The patient stated that she wasn't given a choice to get the vaccine or not since she was a nurse. She stated it was effecting her hormones, it was doing something in Sep2021. The patient stated with the second one, she thought great, she only had the day of the vaccine a slight headache and she was more tired on 17Sep2021. The nurse considered the events chest pain and soreness, effecting her hormones; it is doing something, her period had not come as medically significant (serious) and considered the events slight headache and more tired as non-serious. She stated she had the vaccine in the morning at 9:30 and by the end of the night she was better. Treatment of the events included antibiotic. The events required a visit to physician office (Urgent Care and mentioned it to her doctor). The patient asked if missing periods was being reported as a side effect of the Covid vaccine or if it had shown to effect the hormones. The outcome of the events slight headache and more tired was recovered on 17Sep2021, of the other events was not recovered. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1790797
Sex: M
Age:
State: TX

Vax Date: 09/25/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Allergy test; Result Unstructured Data: Test Result:Unknown results; Comments: He had allergy testing where he received six pricks

Allergies:

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

Symptoms: his son received the whole vial of undiluted Pfizer BioNTech Covid-19 for his 2nd dose; his son received the whole vial of undiluted Pfizer BioNTech Covid-19 for his 2nd dose; Flu vaccine was given on 25Sep2021.; Flu vaccine was given on 25Sep2021.; Headache; He has a bull's eye redness on right hand; His arm is very heavy; He also feels drained out with weakness and tiredness; He also feels drained out with weakness and tiredness; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse reported for his son that a 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: 301308A), via an unspecified route of administration, administered in arm right on 25Sep2021 16:30 (at the age of 15-year-old) as dose 2, single for COVID-19 immunisation. Medical history included he had had asthma since he was little. He was born premature and got respiratory syncytial virus infection (RSV). He was in the hospital for a week. He had been asthmatic pretty much his whole life. He had allergy testing where he received six pricks. He acted weird to that. He was allergic to everything they did there. The wheals were humungous. The nurse clarified that his son had not had an allergic reaction to a vaccine. Concomitant vaccine included influenza vaccine administered in left arm taken for immunization on 25Sep2021. Concomitant medications included salbutamol (ALBUTEROL) taken for asthma (the patient used it at night or whenever he felt a little tight. Used it daily, either in the middle of night or morning. Usually once a day). The patient was taking montelukast sodium (generic SINGULAIR) but now he was doing allergy shots. Trying to transition him to the allergy shots to decrease his hypersensitivity. His son didn't take other medications. The primary care doctor said to start him on Pepcid. The reporter gave him one of those. He may have to continue that moving forward. The reporter clarified his son was on generic Singulair. He didn't have the product with him. He can't remember the name, but it started with an M. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: 301308A), on 04Sep2021 (at the age of 15-year-old) as single dose for COVID-19 immunization. The reporter stated that they received a call from (Pharmacy) that his son received the whole vial of undiluted Pfizer BioNTech Covid-19 for his 2nd dose on 25Sep2021. They called his son's primary care doctor this morning who called the CDC and the doctor's office called this morning to follow up and see how his son was doing. The reporter considered it was medically significant because they didn't know the long term effects. Right now they were on pins and needles. The reporter stated his son was having a headache and his arm was very heavy in Sep2021. He had a bull's eye redness about the size of a 50 cent piece on right arm. He received injection in right arm. He also felt drained out with weakness and tiredness in Sep2021. The patient had been alternating Tylenol (extra strength, 500mg, expiry: Feb2023, lot: 1DV1469) and Ibuprofen (lot: P141244, expiry: Jan2023, brand: HEB, Strength: 200mg) for the headaches. The reporter gave the anti-inflammatory, Motrin, and then Tylenol. The headaches had been unbearable. He became normal after taking Tylenol or Ibuprofen, or Motrin. When it wears off his son tells him. He was taking Motrin twice a day and Tylenol twice a day as needed for headache. The reporter kept his son under three grams of Tylenol daily (His son took two at a time) or the patient took 600mg of ibuprofen on full stomach. The outcome of the events was unknown.; Sender's Comments: Based on the temporal relation, the association between the events of headache, erythema, limb discomfort, asthenia and fatigue and the suspect product of BNT162B2 cannot be completely ruled out. These events were consequential to overdose and product preparation error. 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: INFLUENZA VACCINE; ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1790798
Sex: M
Age:
State: FL

Vax Date: 03/01/2021
Onset Date: 08/01/2021
Rec V Date: 10/16/2021
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: COVID; COVID; This is a spontaneous report from a contactable consumer (patient's daughter) via a Regulatory Authority. A 93-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, in Mar2021 (lot number not reported), as dose 1, single; then via an unspecified route of administration, in Mar2021 (lot number not reported), as dose 2, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 01Aug2021, the patient developed COVID-19 after being fully vaccinated. It was reported that the patient had a breakthrough (as reported) and the reporter asked if there is a waiting period after recovery before getting the booster shot. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1790799
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Incorrect product storage (unknown if vaccine was administered); This case is considered invalid as it is unknown if any patient received the incorrectly stored vaccine, no specified event reported. This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported that: Patient characteristics: Patient: Unknown Reaction(s)/Event(s): Reaction/event as reported by primary source: Excursion go from frozen to the core and we put in less then 30 minutes and then we put the vaccine back to the freezer Drug(s) Information: Characterization of drug role: Suspect Proprietary medicinal product name: Covid-19 vaccine Batch/Lot number: Unknown Action(s) taken with drug: Unknown Narrative case summary and further information: Case narrative: Submitted by Call Centre Selected Report Type: Initial Is the patient also the reporter? No Reporter type: Pharmacist Reporter telephone: # Primary / Prescribing Healthcare Professional Info HCP postal address: Dates for Excursion go from frozen to the core and we put in less then 30 minutes and then we put the vaccine back to the freezer: (From: Unspecified To: Unspecified) Is COVID 19 VACCINE a Pfizer product? Yes COVID 19 VACCINE manufacturer: Unspecified Dates for COVID 19 VACCINE: (Start: Unspecified Stop: Unspecified) NDC number of COVID 19 VACCINE: Unknown UPC number of COVID 19 VACCINE: Unknown Reason for no lot number: of COVID 19 VACCINE: Caller unwilling to complete the report Expiry Date of COVID 19 VACCINE: Unknown Additional Context: Concern: Pharmacist stated "Yeah. I am calling to get some information about the Pfizer product excursion." When asked that, Is the vaccine administered to anyone: Pharmacist stated, "Yes. So, this is Pfizer excursion go from frozen to the core and we put in less then 30 mins and then we put the vaccine back to the freezer so, what are we able to give that vaccine still." LOT NO: Pharmacist stated "No. Thank you. I will call you back." Pharmacist was informed about Pfizer Medical Information and telephone number was shared. Product details (LOT#, Expiration Date, NDC# and UPC#) and Pharmacy details could not be probed as Pharmacist hung up the call abruptly. Hence further probing could not be done. Limited information available over the call. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up. Follow-up (07Oct2021): 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 completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790800
Sex: F
Age:
State: CA

Vax Date: 09/21/2021
Onset Date: 09/21/2021
Rec V Date: 10/16/2021
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: extreme depression; Numbness on right side of face and right arm; headache; panic attacks; received first dose on 20Apr2021; recevied second dose on 21Sep2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in right arm on 21Sep2021 15:00 (at the age of 38-year-old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. Medical history included COVID-19 prior to vaccination. The patient had no other medical history. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccine within four weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ER8792), via an unspecified route of administration, administered in right arm on 20Apr2021 at 12:00 (at the age of 37-year-old) as single dose for COVID-19 immunization. The patient experienced extreme depression, numbness on right side of face and right arm, headache, panic attacks on 23Sep2021 03:00. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received as a result of the events. The patient had not been tested for COVID after vaccination. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1790801
Sex: F
Age:
State: IL

Vax Date: 09/08/2021
Onset Date: 09/21/2021
Rec V Date: 10/16/2021
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: 20210921; Test Name: heart beating; Result Unstructured Data: Test Result:out of rhythm

Allergies:

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

Symptoms: Passed out; A-Fib - heart beating out of rhythm.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3183), via an unspecified route of administration, administered in right arm on 08Sep2021 17:00 (at the age of 48-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history included ulcerative colitis and allergy to Sulfa. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO) . The patient did not received any other vaccines within four weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA7U8U), via an unspecified route of administration, administered in right arm on an unspecified date in Aug2021 at 17:00 (at the age of 48-year-old) as single dose for COVID-19 immunization. The patient experienced passed out - taken to ER where it was determined she was in A-Fib - heart beating out of rhythm on 21Sep2021. The events resulted in Emergency room/department or urgent care. The patient had not been tested for COVID after vaccination. Therapeutic measures were taken as a result of the events which included IV with fluids - put on beta blocker. The outcome of the events was recovering.

Other Meds: LEXAPRO

Current Illness:

ID: 1790802
Sex: M
Age:
State: CO

Vax Date: 04/16/2021
Onset Date: 04/26/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: shingles appeared on and around right thigh; pain in the right forearm; felt shoulder joint pain until now; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0170; Expiration date: not provided) via an unspecified route of administration on 16Apr2021 in left arm age at vaccination 53-year-old as dose 2, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8734; Expiration date: not provided) via an unspecified route of administration on 26Mar2021 in left arm age at vaccination 53-year-old as dose 1, single for Covid-19 immunization at hospital. 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 had not been tested for COVID-19. On 26Apr2021, 10 days after vaccination, shingles appeared on and around right thigh. He visited urgent care for both arm pain and thigh pain after shingles pain appeared on 26Apr2021 and told the doctor he recently got COVID19 vaccine. The doctor said that the arm pain was due to the problem with my working gesture, like using computer for long time, so there was no treatment for the arm pain. The thigh pain was caused by the sciatic nerve, so no treatment for it either. Four days later he visited the urgent care/ emergency room again, and told the doctor that his thigh pain might be due to the shingles. An adverse events resulted into emergency room visit. Therapeutic measures were taken as a result of shingles appeared on and around right thigh, pain in the right forearm, and felt shoulder joint pain until now. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1790803
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: allergic reaction; swelling of the tongue; hives; itching; This is a spontaneous report from a contactable pharmacist from a Pfizer sponsored program support. A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced allergic reaction, swelling of the tongue, hives, itching. Therapeutic measures were taken as a result of events. Events resulted in physician office visit. Pharmacist would like to know in the wake of the allergic reaction her patient had to the first dose of the Pfizer Covid 19 vaccine is there any information on interchangeability and could the patient get a dose of the Johnson and Johnson Covid 19 vaccine to complete the series? Patient actually ended up getting an Epi Pen. Patient got their first dose and afterwards ended up having allergic reaction. Is the patient able to get the Pfizer COVID-19 Vaccine again? Or can the patient receive a COVID-19 Vaccine from a different manufacturer? Patient got hives, itching, and swelling of the tongue right after the Pfizer COVID-19 vaccine. Patient's breathing was ok, just had the tongue swelling. Received treatment at an urgent care, not the ER. Patient went to see an allergist, who advised her she can get the Johnson and Johnson as a second dose. Patient received Benadryl at the Urgent Care. Is it ok for patient to receive the Johnson and Johnson COVID-19 Vaccine after the Pfizer COVID-19 Vaccine? Patient received the Pfizer COVID-19 Vaccine at a different facility. Patient wanted to receive the Johnson and Johnson COVID-19 vaccine at caller's facility. The outcome of events was unknown. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790804
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 04/08/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Date: 20210506; Test Name: Nasal Svab; Test Result: Negative

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Weeping eczema of toes started.Especial exacerbation began after second vaccination. Now it is crossing on fingers.; This is a spontaneous report from a contactable consumer(patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: ER 8736 and expiration date was not reported) at dose 1, single and via unspecified route of administration on an unspecified date (Lot Number and expiration date were not reported) dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included nifedipine (NIFEDIPINE); hydralazine (HYDRALAZINE); rivaroxaban (XARELTO). Patient had no known allergies. The patient experienced weeping eczema of toes and exacerbation began after second vaccination and it is crossing on fingers (hospitalization) on 08Apr2021 17:00. The patient was hospitalized for 5 days. Prior to vaccination, the patient was not diagnosed with COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included Nasal swab: PCR test: negative on 06May2021. The events resulted in Physician or other HCP visit. No treatment was given for events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: NIFEDIPINE; HYDRALAZINE; XARELTO

Current Illness:

ID: 1790805
Sex: F
Age:
State: NY

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 10/16/2021
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: Severe alergic reaction; a large swollen welt on left arm near injection site; swollen lymph nodes in arm pit with significant pain; swollen lymph nodes in arm pit with significant pain; fever; Chills; Nausea; severe headache; tingling down left arm; numb left fingers; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Sep2021 11:15 AM (Batch/Lot Number: 30130BA) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or drug store. The patient medical history was not reported. No other vaccine in four weeks. Concomitant medications included acetylsalicylic acid (BAYER ASPIRIN) taken for an unspecified indication, start and stop date were not reported; chondroitin sulfate sodium, glucosamine hydrochloride (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took KEFLEX [cefalexin monohydrate] and experienced drug hypersensitivity. On 07Sep2021 23:45 PM, the patient experienced severe allergic reaction resulting in a large swollen welt on left arm near injection site; swollen lymph nodes in arm pit with significant pain; fever, chills, nausea, severe headache, tingling down left arm and numb left fingers. The patient did not receive treatment for the events. The patient did not test covid post vaccination. The outcome of events was recovered in 2021.

Other Meds: BAYER ASPIRIN; GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]

Current Illness:

ID: 1790806
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 09/23/2021
Rec V Date: 10/16/2021
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 Date: 20210916; Test Name: Unknown- saliva test; Test Result: Negative

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: I have a rash at the injection site; Covid arm; This is the third shot; This is the third shot; This is a spontaneous report from a contactable physician (patient). A 38-years-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date of 2021 as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration on 09Jan2021 at 13:00 as a dose 1, single in the left arm and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC2181) via an unspecified route of administration on 09Jan2021 at 15:00 as a dose 1, single in the left arm for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 23Sep2021, the patient experienced rash at the injection site that showed up 2 weeks after the shot and was likely Covid arm and on unspecified date of 2021 patient received third shot of Covid vaccine. Patient did not received treatment for events. The patient underwent lab tests and procedures which included Covid test Unknown- saliva test was negative on 16Sep2021. The outcome of the events rash at the injection site that showed up 2 weeks after the shot and was likely Covid arm was resolving, and other events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790807
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: bilateral T; This is a spontaneous report from a non-contactable consumer and a non-contactable other HCP. This report was received via a sales representative. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a bilateral T and she was on Eliquis after her vaccination. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1790808
Sex: U
Age:
State: NY

Vax Date: 05/04/2021
Onset Date: 05/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Many Test; Result Unstructured Data: Test Result:CSF leak

Allergies:

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

Symptoms: but a slight headache started/headaches got extremely strong and unbearable; I had two days of muscular and joint pain.; I had two days of muscular and joint pain.; Around May 7th the body pain was mostly gone; it was determined I had a CSF leak.; This is a spontaneous report from two contactable consumer. A 43-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 04May2021 (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: not reported), on 13Apr2021 (at the age of 43-year-old) as DOSE 1, SINGLE for covid-19 immunization. On May2021, After the 2nd dose of Pfizer vaccine patient had two days of muscular and joint pain. Around May 7th the body pain was mostly gone but a slight headache started. During the week of May 10th to 14th the headaches got extremely strong and unbearable, and patient went to the emergency room on the 15th of May. After coming back to the Emergency room again a couple days later, many tests and seeing a few neurologists, it was determined patient had a CSF leak. The patient was initially treated with steroids, the headaches subsisted, one blood patch at lower back that solved 50% of the issue. Finally, a second blood patch at upper back by July 29th, that solved the problem. The outcome of the event CSF leakage was recovered, while the events Muscular pain and Joint pain was unknown, body pain was recovering, and Headache was not recovered at time of report. The lot number for BNT162B2, was not provided and will be requested during follow up

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am