VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1797292
Sex: F
Age:
State: CA

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 10/19/2021
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: 20210929; Test Name: D Dimer; Result Unstructured Data: Test Result:6337

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Guillen-Barre syndrome; weakness in her legs; Chills; little bit of a temperature; not felt good; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. She was taking another unspecified medication. She had her first dose on either 03Fed2021 or 04Fed2021, and instantly, within a few days, it started with the weakness and she had after the vaccine either. The next day and that night she had felt chills and a little bit of a temperature and then the next day that went away but she felt so weak. She felt like her legs were dragging, literally. She got the crutches from work and she was going to walk with the crutches to at least make sure that she would not fall. She went back to her doctor and asked if she should still get the second vaccine and her doctor said yes, she needed to get it and so the caller said okay and she got it. She then had the weakness again and then she ended up having pain in her legs that was so bad she had to go to the emergency room and they said that she was positive for her D dimer test, it has been more than 5000 since she had the vaccine. Her last D dimer was on 29Sep2021 and it was 6337. She was put on Xarelto for 22 days when she at first had the pain in her legs being so bad. Periodically it comes with weakness in her legs and the pain is so bad that she can't walk. Here she is now 4 days into this bout with it again and she is not able to walk without crutches because of the severe pain she has when she is walking. It is like nerve pain and it hurts so bad, it is like a 9 out of 10. This has been absolutely crazy and she is a practice manager at an orthopedic surgeon's office and she has been working from her bed because of how bad it is and she wanted to get a copy of what is in the COVID vaccine. She has been treated with a doctor in the beginning of this and they thought that maybe it could be Guillen-Barre syndrome and said that they were going to keep an eye on her and send her to a neurologist. Now she is with Scripts and she was sent another medication yesterday because of her D dimer and they said that her side effects are from the vaccine. They said it is an effect from the vaccine and that she needs to see a neurologist and she cannot get into one until Dec2021. She doesn't know what will happen to her before Dec2021. This has been destroying her lift and she is just working from her bed and it is absolutely crazy. The outcome of chills and little bit of a temperature was recovered in Feb2021, outcome of other events was not recovered. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101319916 same patient/drug, different dose

Other Meds:

Current Illness:

ID: 1797293
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: Maybe she had COVID; Maybe she had COVID; Tiredness; chills; arm hurts; headaches; feeling funky; It is almost like a light fever that she has; is not feeling too great after the booster; is not feeling too great after the booster; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, dose 1 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. The patient was receiving booster dose and began experiencing tiredness, chills and arm hurts. Patient was not feeling too well after the booster. She did fine after the other 2. Maybe she had COVID. She has been really tired, and was having chills, headaches, nothing serious, and was feeling funky. It was almost like a light fever that she had. Her arm still hurts. It had been since Friday. She would like to know if what she was feeling is typical and how long will it continue. She has heard from her pharmacist and she just sort of passed her off and said it could be 5 days, but she said that some people have had a sore arm for weeks. She did not have any specific information on anyone to report that had a sore arm for weeks. The outcomes of events were 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: 1797294
Sex: M
Age:
State: IL

Vax Date: 04/22/2021
Onset Date: 04/01/2021
Rec V Date: 10/19/2021
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: Test Date: 20210428; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Comments: EKG was normal, tachycardia; Test Date: 20210428; Test Name: D-Dimer; Result Unstructured Data: Test Result:elevated to 1.440; Test Date: 20210428; Test Name: x-ray; Result Unstructured Data: Test Result:Normal, no evidence of pulmonary embolism

Allergies:

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

Symptoms: tachycardia; Left sided chest pain and arm pit pain; Left sided chest pain and arm pit pain; aches and soreness on the left side; Non ST segment elevation myocardial infarction; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Support. A 56-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Apr2021 (at the age of 56-year-old; lot number: EW0175; expiry date: 31Aug2021) as DOSE 1, 0.3 ML, SINGLE for COVID-19 immunisation. Medical history included coronary artery disease, myocarditis, obesity, hyperlipidemia, smoker, depression, GERD. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Prior Vaccinations (within 4 weeks) was unknown. Events following prior vaccinations and family medical history relevant to events were none. There were no concomitant medications. Patient received the first dose on 22Apr2021, has not received the second dose yet. In Apr2021, the patient experienced non-ST segment elevation myocardial infarction. The clinical course was reported as follows: the reporting nurse noted from patient's chart stating that patient had non-ST segment elevation with myocardial infarction, which cardiology said may have been from the vaccine, and patient was referred to his physician to decide whether or not to get the 2nd dose. The reporting nurse went to speak with the patient to clarify what happened. Clarified that 4 days after receiving the 1st dose of the vaccine (on 26Apr2021), the patient started having left sided chest pain and left sided arm pit pain, as well as aches and soreness on the left side. He went to the ER on 28Apr2021, and had multiple tests done. He then went to the cardiologist and asked if this occurred from the vaccine. Clarified that the cardiologist put him on medication for his heart and said that he didn't think it was directly related to the vaccine, but suggested that the patient wait more than 6 weeks to get the 2nd dose. Events required a visit to emergency room and physician office. Lab data included testing done in the ER on 28Apr2021: EKG was normal, tachycardia; x-ray was normal, no evidence of pulmonary embolism; D-Dimer was elevated to 1.440. Treatment received for events. Outcome of events was unknown.; Sender's Comments: Based on the available information in the case, the causal association between the events, acute myocardial infarction, chest pain, axillary pain, pain and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1797295
Sex: U
Age:
State: KY

Vax Date:
Onset Date: 10/04/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Antibody test; Result Unstructured Data: Test Result:800s; Test Date: 2021; Test Name: echos; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211004; Test Name: COVID-19; Result Unstructured Data: Test Result:Confirmed

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Confirmed COVID-19 diagnosis; Confirmed COVID-19 diagnosis; Erectile dysfunction; heart palpitations; flu-like symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers and expiry dates not reported), via unspecified routes of administration, in the arm on unspecified dates, as dose 1, single and dose 2, single both for COVID-19 immunization. Medical history included autoimmune issues. The patient's concomitant medications were not reported. The patient experienced confirmed COVID-19 diagnosis on 04Oct2021. Also, patient experienced heart palpitations leading to ED and echos following the vaccinations on unspecified dates. Patient also experienced flu-like symptoms for weeks after vaccination. Antibody tests following the vaccinations were in the 800s. Patient also experienced magnetism at the shot site on the first arm and the entire length of the arm for the second shot arm. The magnetism persisted. Patient was about to receive REGENERON (at the time of report). The outcome of the events was unknown. Information on lot/batch number will be requested during follow up.

Other Meds:

Current Illness:

ID: 1797296
Sex: U
Age:
State: KY

Vax Date:
Onset Date: 10/04/2021
Rec V Date: 10/19/2021
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: 20211004; Test Name: Covid-19; Test Result: Positive

Allergies:

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

Symptoms: magnetism at the shot site; Confirmed diagnosis of COVID-19; Confirmed diagnosis of COVID-19; flu-like symptoms; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Patient had no underlying medical conditions. The patient's concomitant medications were not reported. The patient was vaccinated as of early summer. Patient experienced flu-like symptoms for 3 days following the vaccination. Patient experienced magnetism at the shot site. Patient had confirmed diagnosis of COVID-19 on 04Oct2021. 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: 1797297
Sex: F
Age:
State: FL

Vax Date: 07/19/2021
Onset Date: 08/02/2021
Rec V Date: 10/19/2021
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: Stocking-glove neuropathy, all 4 extremities; This is a spontaneous report from a contactable physician. A 46-years-old female patient (non-pregnant at time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 19Jul2021 (at the age of 46-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included asthma, COVID 19 pneumonia from Jan2021, CVA during COVID hospitalization, hypertension, covid prior vaccination, ophth (disorder). No covid tested post vaccination, no known allergies. No other vaccine in four weeks. Concomitant medications in two weeks included amlodipine; umeclidinium bromide, vilanterol trifenatate (ANORO); atorvastatin; aspirin [acetylsalicylic acid]; brimonidine tartrate (BRIMONIDINE) for ophth; carvedilol; latanoprost for ophth; hydrochlorothiazide; losartan; salbutamol sulfate (ALBUTEROL); montelukast. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on Jun2021 (at the age of 46-years-old) as single dose for COVID-19 immunization. Two weeks after administration of 2nd vaccine dose, on 02Aug2021, the patient reported stocking-glove neuropathy, all 4 extremities. Event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for event including gabapentin 300 mg TID (thrice a day). Outcome of the event was recovering. 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 event Neuropathy peripheral and BNT162B2. 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: AMLODIPINE; ANORO; ATORVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; BRIMONIDINE [BRIMONIDINE TARTRATE]; CARVEDILOL; LATANOPROST; HYDROCHLOROTHIAZIDE; LOSARTAN; ALBUTEROL [SALBUTAMOL SULFATE]; MONTELUKAST

Current Illness:

ID: 1797298
Sex: F
Age:
State: SC

Vax Date: 09/02/2021
Onset Date: 09/01/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: lupus; significant increase in hair loss; increased fatigue; joint pain; the feeling of swelling in joints and in particular hands and feet; the feeling of swelling in joints and in particular hands and feet; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 02Sep2021 (Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included COVID-19, lupus, joint pain. Patient was not pregnant. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); omeprazole; famotidine; vitamin d nos; curcuma longa (TURMERIC [CURCUMA LONGA]) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient previously took antibiotics and experienced neurological reactions, and experienced allergies. The patient experienced lupus, significant increase in hair loss, increased fatigue, joint pain, the feeling of swelling in joints and in particular hands and feet in Sep2021. Clinical course reported as: In addition to the normal side effects that were fairly strong and lasted for several days for me, I also had significant increase in hair loss that began in the days after the vaccine and has continued to the present day (almost 5 weeks post injection); increased fatigue; joint pain and the feeling of swelling in joints and in particular hands and feet. Everything has gradually improved (although still present) except the hair loss. The joint pain was a problem in the past with lupus but has not been an issue for many years and it just started again after the vaccine. I have not received the second injection yet due to these lingering symptoms. No treatment received for the events. Outcome of events was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit. Follow-up attempts are completed. No further information is expected.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; OMEPRAZOLE; FAMOTIDINE; VITAMIN D NOS; TURMERIC [CURCUMA LONGA]

Current Illness:

ID: 1797299
Sex: M
Age:
State: HI

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: Suicidal ideation; This is a spontaneous report from a contactable physician. 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 2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced suicidal ideation 10 days after vaccination in 2021. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of suicidal ideation included referral to behavioral treatment. The outcome of the event was recovered in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case a possible causal association between the reported event Suicidal ideation and the suspect drug BNT162B2 cannot be excluded. case can be reassess once additional information becomes 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: 1797300
Sex: M
Age:
State: WI

Vax Date: 02/12/2021
Onset Date: 02/26/2021
Rec V Date: 10/19/2021
Hospital: Y

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

Lab Data: Test Name: Nasal swab; Test Result: Negative ; Comments: Nasal swab

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Heart Attack; This is a spontaneous report from a contactable consumer reported for himself. This 59-year-old male patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) via an unspecified route of administration in the left arm on 12Feb2021 at age of 58 years old as single dose for COVID-19 immunization. Medical history included having risk factors for heart disease, Covid prior vaccination, known allergies: penicillin. Concomitant medications included other medications in two weeks. The patient had no other vaccine in four weeks. The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in the left arm on 22Jan2021 at age of 58 years old for COVID-19 immunization. The patient suffered from a heart attack on 26Feb2021 at 02:30 AM. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 2 days. AE treatment was received including cardiac catherization. The patient had Covid test post vaccination with negative result via nasal swab. Outcome of the event was recovered with sequel. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1797301
Sex: M
Age:
State: IL

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Name: Weight; Result Unstructured Data: Test Result:18 lbs; Comments: 18 lb weight loss

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: took 2 doses of Moderna shot Mar and Apr and Pfizer Booster shot in Sep; took 2 doses of Moderna shot Mar and Apr and Pfizer Booster shot in Sep; 18 lb weight loss; voice changed to soft and horse; inflammation flare up in lower back; extreme fatigue; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 78-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Sep2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included heart disease, Kidney disease, and arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of moderna (MODERNA COVID-19 VACCINE, lot number and expiry date were not reported) via an unspecified route of administration, on an unspecified date in Mar2021, as dose 1, single and second dose of moderna (MODERNA COVID-19 VACCINE, lot number and expiry date were not reported) via an unspecified route of administration, on an unspecified date in Apr2021, as dose 2, single for covid-19 immunisation. The patient took 2 doses of moderna shot in Mar and Apr and Pfizer booster shot in Sep2021. On an unspecified date, on 2021, the patient experienced 18 lb weight loss, voice changed to soft and horse, inflammation flare up in lower back and extreme fatigue. On an unspecified date, the patient underwent lab tests and procedures which included weight which was 18 lbs (weight loss). 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: 1797302
Sex: M
Age:
State: OK

Vax Date: 08/05/2021
Onset Date: 08/06/2021
Rec V Date: 10/19/2021
Hospital: Y

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

Lab Data: Test Date: 20210807; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Acute Appendicitis; This is a spontaneous report from a contactable consumer (patient). A 38-years-old male patient received bnt162b2 (BNT162B2) at the age of 38-years-old, dose 1 via an unspecified route of administration, administered in arm left on 05Aug2021 15:00 (Batch/Lot Number: FA7485) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included penicillin allergy. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks, no other medications in two weeks. There were no concomitant medications. No Covid prior vaccination. The patient previously took cephalex [cefalexin] and experienced drug allergy. The patient experienced acute appendicitis on 06Aug2021 01:00. Adverse event: Acute Appendicitis was observed within 24 hours and intensified to go to the emergency room where it was officially diagnosed resulting in an Appendectomy. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for acute appendicitis for 1 days. Covid tested post vaccination included Nasal swab: negative on 07Aug2021 Nasal Swab. The event outcome was recovering.

Other Meds:

Current Illness:

ID: 1797303
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: neuropathy symptoms; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), 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 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced neuropathy symptoms on an unspecified date with outcome of unknown. The patient had seen the neurologist and they can find no causes. The patient was notifying Pfizer as he/she felt it could be connected to the vaccine. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1797304
Sex: F
Age:
State:

Vax Date: 09/01/2021
Onset Date:
Rec V Date: 10/19/2021
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: limbs paralyzed (arms and legs); leg swelling; extreme tiredness; extreme joint pain in elbows and knees; could hardly walk; muscle pain; she couldn't sleep; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 75-years-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on Sep2021 as single dose for COVID-19 immunization. The patient's medical history included hypertension (She does not have illness except high blood pressure) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient got the tetanus shot on an unspecified date in 2001 and had no reaction to it. On an unspecified date, after first dose patient experienced limbs paralyzed, leg swelling, extreme tiredness, extreme joint pain in elbows and knees, could hardly walk, muscle pain and she couldn't sleep. she still has symptoms and with the aspirin they are not as bad, her friend told her to take some, she hadn't thought to. Patient had it for 2 weeks and she is hoping it goes away. Patient states she was a little afraid and she doesn't take aspirin and her friend told her to take some so last night she took some and it helped a little but the joint pain and muscle pain was still there. Caller relays that the swelling of her leg went down but it still feels uncomfortable. States the swelling is scary they felt like phone poles, big and heavy. Patient felt like she should go to the hospital and it's not supposed to kill you, it was bad severe pain in her muscles and joints and she felt like her limbs were kind of paralyzed. Patient didn't have arm pain or swelling at the injection site or other symptoms like nausea, vomiting or diarrhea but the paralysis, tiredness, muscle and joint pain was overwhelming. Patient states when she went to get a tetanus and something else and her whole life she hasn't needed any and doesn't get sick a lot. Patient asking should she get the 2nd shot. Patients doctor moved out of state and the new doctor she was supposed to meet was out on administrative leave and she got a new physician and sees them 02Nov2021. Therapeutic measures were taken as a result of extreme tiredness, extreme joint pain in elbows and knees and muscle pain. The outcome of the events sleep difficult, could hardly walk, limbs paralyzed (arms and legs) was unknown; muscle pain, extreme joint pain in elbows and knees, leg swelling was not recovered; extreme tiredness was recovered on an unspecified date.

Other Meds:

Current Illness:

ID: 1797305
Sex: F
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 10/19/2021
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: blood pressure; Result Unstructured Data: Test Result:Fluctuating blood pressure- high/low; Test Name: stress test; Result Unstructured Data: Test Result:Results Unknown; Test Name: EKG; Result Unstructured Data: Test Result:Results Unknown; Test Name: Holter monitoring; Result Unstructured Data: Test Result:Results Unknown

Allergies:

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

Symptoms: This is a spontaneous report from a contactable Other-HCP. This Other-HCP reported for a 35-year-old female patient in response to HCP follow-up letter sent in cross reference case that included A 35-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular, administered in Arm Left on 11Jan2021 11:32 (age at vaccination: 35years-old) (Batch/Lot Number: EL1284) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included fluxotine taken for approx. 4years unknown if ongoing and zolpidem as needed (takes occasionally), stop and start date was unknown. Patient previously took first dose of BNT162B2 (age at vaccination: 35years-old) (lot number: EH 9899, vaccine location: Left arm intramuscularly) on 21Dec2020 11:23 for covid-19 immunisation and Most recent non-covid vaccine was influenza administered in Oct/Nov 2020. Patient had no known allergies. The patient had events described as "my fingers in my left arm (here i got my vaccine) started going numb", "losing my breath", "my body went limp and i fell out of the bed", "my eyes rolling in the back of my head", "unable to sit up", "unable to swallow", "lost feeling in my fingers and legs", "l was shaking profusely", "my heartbeat felt really irregular", "fluctuating blood pressure", "difficulty speaking" and "drooling" on 11Jan2021. Patient also experienced prolonged panic attack, short of breath, tingling and trembling on 11Jan2021. Where the patient received 2nd dose of Pfizer vaccine at approximately 11:30 am on 11Jan2021. Remained at vaccination location for approximately 15 minutes without any symptoms, left the vaccination site and drove home. The patient is employed by the health-care system where she received the vaccine. After arriving home, approximately 45 minutes after administration of the second dose of vaccine she developed the symptoms that her fingers in her left arm (where she got her vaccine) started going numb, Losing her breath, her body went limp and she fell out of the bed, Prolonged panic attack, her eyes rolling in the back of my head, Unable to sit up, Unable to swallow, Lost feeling in her fingers and legs, she was shaking profusely and her heartbeat felt really irregular. Her husband drove her to the closest Emergency Department; a different hospital than where she received the vaccine. The patient states that she received IV fluids and Ativan (lorazepam) for her symptoms. She states that she did not receive epinephrine, corticosteroids, antihistamines, oxygen, bronchodilators, or other medications. Her symptoms resolved and she was discharged home after approximately 3-3.5 hours with instruction to follow up with a cardiologist. She did not state anything related to cardiac inflammation, etc. She denies cardiac/respiratory symptoms prior to the event but continues to have arrhythmias and unstable blood pressure since the time of the event. Since the event on 11Jan2021 the patient has had an extensive cardiac workup including EKG, stress test, Holter monitoring and is scheduled for an MRI of her heart on 23Sep2021. She noted that multiple, frequent, recurring PVCs were noted during Holter monitoring the patient received a third dose of vaccine on 01Sep2021 without recurrence of the symptoms associated with administration of the second dose. She reported feeling tired and sluggish and had some mild redness at the injection site and her arm was sore. but no cardiac, respiratory, or histamine-mediated allergic symptoms were noted following the third dose. Patient visited emergency room and received treatment for the events. Upper airway swelling, Increased use of accessory respiratory muscles: Recession, Cyanosis, Grunting, Dry cough, Hoarse voice, Difficulty breathing (without wheeze or stridor), Sensation of throat closure, Sneezing, Rhinorrhea Shock, Loss of consciousness: No. Outcome of all the events was recovered on 11Jan2021. No follow-up attempts are possible. No further information is expected.

Other Meds: FLUOXETINE; ZOLPIDEM

Current Illness:

ID: 1797306
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 10/19/2021
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: Epilepsy; This is a spontaneous report from a Pfizer sponsored Program from a non-contactable consumer reported for patient (consumer's husband). A 71-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, and first dose via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the first and second dose of Pfizer Covid-19 vaccine last April 2021 and wanted to get an appointment to get the booster dose. He had epilepsy as mentioned. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1797307
Sex: M
Age:
State: TX

Vax Date: 09/20/2021
Onset Date: 09/21/2021
Rec V Date: 10/19/2021
Hospital: Y

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

Lab Data: Test Name: Lab work; Result Unstructured Data: Test Result:Unknown Rueults

Allergies:

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

Symptoms: huge inflammation around heart, lungs and ribs; lot of water around the lungs; it has developed some bacterial pneumonia; there was a tremendous pain on my heart, lungs and ribs; there was a tremendous pain on my heart, lungs and ribs; there was a tremendous pain on my heart, lungs and ribs; the reaction was so tough that I could not even move at all; could not even sleep; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received third dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Sep2021 (Batch/Lot number was not reported) (vaccinated at 60-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Relevant medical history included diabetes and hypertension. Patient received first and second dose of bnt162b2 on an unspecified date. Patient's concomitant medications included unspecified diabetes medications and hypertension medications. Patient was talking about third dose of Covid-19 vaccine. He took the vaccine on 20th of last month and on 21st he was going to while on a reaction have to hospitalized from 21Sep2021 to 28Sep2021 for 8 days because of a huge inflammation around heart, lungs and ribs. And subsequently found lot of water also around the lungs. There was reaction of the vaccine on 21st last month. The reaction was so tough that could not even move at all and there was a tremendous pain on heart, lungs and ribs and then hospitalized in emergency and for first four days even with the Morphine injection (captured as suspect) and there was an opioid injection like Hydrocodone, pain could not be in control eventually and was grieving day and night that could not even sleep but later on they found that water has risen up around lungs so they drilled back and remove some water and then was feeling comfortable. They also found that it has developed some bacterial pneumonia. Patient was hospitalized for 8 days and now on antibiotics (treatment) at home, taking rest for two months. Lab work on an unspecified date with unknown results. 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: 1797308
Sex: M
Age:
State: IL

Vax Date: 10/07/2021
Onset Date: 10/08/2021
Rec V Date: 10/19/2021
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: At about 1:15-1:30am woke up with extremely itchy, swollen, and burning feet/toes.; At about 1:15-1:30am woke up with extremely itchy, swollen, and burning feet/toes.; At about 1:15-1:30am woke up with extremely itchy, swollen, and burning feet/toes.; This is a spontaneous report from a contactable consumer or other non hcp (Patient reported for self). A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FC3184), dose 3 via an unspecified route of administration, administered in Left arm on 07Oct2021 18:00 as dose 3 (booster), single for COVID-19 immunisation. Medical history included High blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s)/ Other medications in two weeks included escitalopram; bupropion hcl; amlodipine besylate all taken for unspecified indication(s), start and stop date(s) were not reported. The patient had earlier received second dose of BNT162B2 (lot number EN6199) via unspecified route of administration, administered in the Left arm on 24Mar2021 at 17:00 as dose 2, single and the first dose of BNT162B2 (lot number EN6201) via unspecified route of administration, administered in Left arm on 03Mar2021 at 18:00 both at the age of 34-Years old as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. On 08Oct2021 at 1:15-1:30am the patient woke up with extremely itchy, swollen, and burning feet/toes (reported as, At about 1:15-1:30am woke up with extremely itchy, swollen, and burning feet/toes). Adverse event did not result in emergency room or physician office visit. Patient was not tested for COVID post vaccination The patient did not received treatment for the adverse event. The events were non-serious. The outcome of the events was recovering.

Other Meds: ESCITALOPRAM; BUPROPION HCL; AMLODIPINE BESYLATE

Current Illness:

ID: 1797309
Sex: F
Age:
State: OR

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Date: 20210929; Test Name: COVID test: Diagnostic PCR; Test Result: Positive ; Comments: Post vaccination: Nasal Swab

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: COVID test result Positive; Within minutes, joint pain inflamed my wrist/hand of the arm I received the shot./ within the hour, it had spread to the rest of my body back, knees, ankles/feet every joint inflamed with pain; Within minutes, joint pain inflamed my wrist/hand of the arm I received the shot./ within the hour, it had spread to the rest of my body back, knees, ankles/feet every joint inflamed with pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3183), via an unspecified route of administration in left arm on 27Aug2021 at 16:30 (at the age of 27 years old, not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications the patient received within 2 weeks of vaccination included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 27Aug2021, 16:45 within minutes, joint pain inflamed wrist/hand of the arm she received the shot. It quickly spread to the rest of the joints in her arm, then to her shoulders/neck and down the other arm, including the wrist/hand. And within the hour, it had spread to the rest of her body back, knees, ankles/feet every joint inflamed with pain. It has not gone away, despite using ibuprofen to get the inflammation down. She have also experimented with anti-inflammatory diets and supplements and on her 2nd doctor trying to find treatment that will work. She was dealing with chronic joint pain constantly that was not there before. The patient underwent lab tests and procedures which included sars-cov-2 test (Diagnostic PCR): positive on 29Sep2021, Post vaccination: Nasal Swab. Therapeutic measures were taken as a result of within minutes, joint pain inflamed my wrist/hand of the arm i received the shot./ within the hour, it had spread to the rest of my body back, knees, ankles/feet every joint inflamed with pain with Ibuprofen, anti-inflammatory supplements. The events arthralgia and arthritis resulted in doctor or other healthcare professional office/clinic visit. No hospitalization required. Reporter considered events as non-serious. The outcome of the covid-19 was unknown, while with other events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1797310
Sex: F
Age:
State: NC

Vax Date: 09/08/2021
Onset Date: 10/05/2021
Rec V Date: 10/19/2021
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: Doctor had confirmed patient had shingles; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EW0217) via an unspecified route of administration, administered in arm left on 08Sep2021 12:00 (Age at vaccination 35 years-old) as DOSE 2, SINGLE for covid-19 immunization. Facility type Vaccine was workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had not known allergies. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number EW0186) via an unspecified route of administration, administered in arm left on 18Aug2021 12:00 (age at vaccination 34-years-old) as DOSE 1, SINGLE for covid-19 immunization. There was no COVID prior vaccination. There was no COVID tested post vaccination. On 05Oct2021 after second dose of vaccination, the patient experienced doctor had confirmed patient had shingles. This event was considered as medically significant. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment of valacyclovir for adverse event. The outcome of event was unknown.

Other Meds:

Current Illness:

ID: 1797311
Sex: F
Age:
State: CA

Vax Date: 07/15/2021
Onset Date:
Rec V Date: 10/19/2021
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: shingles; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187, NDC number and Expiry date are unknown), via an unspecified route of administration, administered in Left arm on 15Jul2021 at the age of 65-years-old as dose 1, single for covid-19 immunisation. Relevant medical history and concurrent conditions included A-fib, Arrhythmia, Pulmonary issues, eye and sinus infection, reflex sympathetic dystrophy in left foot and ankle, Hypothyroidism, which she has had practically forever and High cholesterol from unspecified date and unknown if ongoing. She has had an eye and sinus infection almost since her surgery because they cut a hole in one of her sinuses which exacerbated the problem. she has diagnosed allergies, a compromised immune status, and respiratory illness, and unfortunately, she may fall under the category of obese from unspecified date. With the last hospitalization she spoke of previously, she was referring to an eye and sinus infection. The best the doctors could figure out was that they happened simultaneously and ultimately it required emergency surgery. She had an abscess in her eye, but at first nobody believed her when she said she had something really wrong in her eye. She confirms this hospitalization was in Dec2018. She has autoimmune issues from unspecified date. She confirms all of these conditions happened prior to receiving the Pfizer COVID vaccine. There were no concomitant medications. Additional vaccines administered on same date of the pfizer suspect if applicable, list all vaccines administered on same date with the pfizer vaccine considered as suspect were none. She states they mentioned the booster and she was like no. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were none. AE(s) following prior vaccinations included the only issue she has had is feeling like crap for a few days on an unspecified date. Family medical history relevant to AE(s) was not provided. There was no investigation assessment. The Reporter was calling in regards to the COVID vaccine. She wanted to let Pfizer know and talked to several doctors and her pharmacist and they are just like totally blown away. With the first shot she got, she ended up with shingles on an unspecified date in 2021. The reporter stated that she was supposed to go to emergency Room but couldn't because she had a very bad experience at her last hospital visit. She stated that she talked to a couple doctors. She was seeing her cardiologist today. Everyone that she has spoken to has never heard of this before. The caller asked, how is it she is the only person on the planet this has happened to? She knows she is the trifecta between her age and underlying medical problems, but like really? No one else has experienced this? Reporter seriousness for shingles was unspecified. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1797312
Sex: F
Age:
State: NH

Vax Date: 10/05/2021
Onset Date: 10/01/2021
Rec V Date: 10/19/2021
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: Test Date: 202110; Test Name: Body Temperature; Result Unstructured Data: Test Result:she thinks it had to be 100 or 101; Comments: 97.6 is the caller's usual temperature, she thinks it had to be 100 or 101.

Allergies:

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

Symptoms: Dose 3 administered; Stomach pain; Headache/pain in her head that her whole head felt like it was going to come off; extreme body aches; fever; Chills; still sick, she got very sick; so cold and chilled; she was very scared; tired; couldn't sleep; felt like she had covid; migraines; gastroenteritis; she is weak; sense of taste was way off; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 75 year old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in Arm Right on 05Oct2021 11:00 (Batch/Lot Number: FF4481) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; The patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered on 05Mar2021 (Batch/Lot Number: not available) as DOSE 2 SINGLE for covid-19 immunisation and The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered on 15Feb2021 (Batch/Lot Number: not available) as DOSE 1 SINGLE for COVID-19 immunisation influenza vaccine (INFLUENZA VACCINE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for an unspecified indication. Medical history included epilepsy from an unknown date and unknown if ongoing, brain injury from an unknown date and unknown if ongoing, 3 brain injuries , respiratory disorder from an unknown date and unknown if ongoing , dust allergy from an unknown date and unknown if ongoing The caller is highly allergic to dust, cats, and dogs, and to mold , allergy to animal from an unknown date and unknown if ongoing, influenza from an unknown date and unknown if ongoing she was this sick she was in her 20s and got some sort weird flu. The patient's concomitant medications were not reported. The patient experienced chills on 05Oct2021 04:00 with outcome of recovered, headache/pain in her head that her whole head felt like it was going to come off on 07Oct2021 with outcome of recovered , extreme body aches on 07Oct2021 with outcome of recovered , stomach pain causing abdominal pain upper on 10Oct2021 with outcome of unknown, sense of taste was way off causing ageusia on Oct2021 with outcome of unknown , fever on 07Oct2021 with outcome of unknown, tired on Oct2021 with outcome of unknown, couldn't sleep causing insomnia on Oct2021 with outcome of unknown , felt like she had covid suspected covid-19 on Oct2021 with outcome of unknown , migraine, gastroenteritis on Oct2021 with outcome of unknown , she is weak causing asthenia on Oct2021 with outcome of unknown, still sick, she got very sick on 05Oct2021 with outcome of not recovered, cold and chilled causing nasopharyngitis on Oct2021 with outcome of unknown, she was very scared causing fear on Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: she thinks it had to be 100 or 101 on Oct2021 97.6 is the caller's usual temperature, she thinks it had to be 100 or 101, Therapeutic measures were taken as a result of headache/pain in her head that her whole head felt like it was going to come off and migraine. The patient usually takes Butobarbital/ acetaminophen/ caffeine- it has 325 mg of Bitibarbitol and 40 mg of caffeine. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1797313
Sex: F
Age:
State: NC

Vax Date: 01/27/2021
Onset Date: 06/28/2021
Rec V Date: 10/19/2021
Hospital: Y

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

Lab Data: Test Date: 202108; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Unevaluable event

Symptoms: Pulmonary Embolism; Covid Test Result-Positive Date Aug2021; Covid Test Result-Positive Date Aug2021; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 06Jan2021 (lot number: E13246), then second dose on 27Jan2021 (lot number: E19262), both via unspecified route of administration administered in the right arm as single dose for covid-19 immunisation. Medical history included known allergy to Sulfa. The patient has no covid prior to vaccination and no other vaccine in four weeks. Concomitant medication included an unspecified oral contraceptive. The patient previously took thiomersal and experienced allergy. The patient experienced pulmonary embolism on 28Jun2021. The patient was hospitalized for four days due to the event and was given heparin and Xarelto after hospital stay. The patient had a nasal swab/PCR test on Aug2021 and the result was positive. The patient was recovering from pulmonary embolism at the time of the report while outcome of covid-19 positive was unknown.

Other Meds:

Current Illness:

Date Died: 10/11/2021

ID: 1797314
Sex: F
Age:
State: MA

Vax Date: 10/08/2021
Onset Date: 10/11/2021
Rec V Date: 10/19/2021
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: 20211011; Test Name: oxygen; Result Unstructured Data: Test Result:loss of oxygen

Allergies:

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

Symptoms: Death Cause-Loss of Oxygen; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration on 08Oct2021 (at the age of 74 years old) as dose 3 (booster), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose and second dose of BNT162B2 (lot numbers were not reported), via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunisation. The patient did not receive any other vaccines in 4 weeks and it was unknown if the patient had other medications was received in 2 weeks. The patient experienced loss of oxygen as death cause on 11Oct2021. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Event resulted in life threatening illness (immediate risk of death from the event). The patient died on 11Oct2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death Cause-Loss of Oxygen

Other Meds:

Current Illness:

ID: 1797315
Sex: F
Age:
State:

Vax Date: 08/26/2021
Onset Date:
Rec V Date: 10/19/2021
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: First dose: had a rash on lower torso; First dose: had a rash on... legs; First dose: Had perfuse sweating; First dose: body odor; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Reported, Expiry Date: Not Reported), dose 1 via an unspecified route of administration, administered in Arm Left on 26Aug2021 (at the age of 59-year-old) as dose 1, single for covid-19 immunisation. The patient medical history included knee replacement in both knees (the caller states she had knee replacement in both knees.), and hysterectomy (did not even have perfuse sweating and body odor after a complete hysterectomy prior to Pfizer Covid Vaccine). There were no concomitant medications. No other products. No patient history. No investigation assessment. The caller stated that she was sorry, her allergies. she had some reactions after receiving the Pfizer Covid Vaccine and wanted to have the information documented. The caller was not planning to receive the booster dose Pfizer Covid Vaccine. The patient does not wish to provide mailing address or email also does not wish to provide name, address, telephone number or email of HCP. The caller states she had knee replacement in both knees: The patient clarifies both knee replacements occurred prior to receiving any dose Pfizer Covid Vaccine. The patient stated after the first dose had perfuse sweating and body odor. The patient stated she has never had perfuse sweating a body odor. The caller did not even haver perfuse sweating and body odor after a complete hysterectomy prior to Pfizer Covid Vaccine. The patient stated had perfuse sweating and body odor began after receiving the first dose Pfizer Covid Vaccine. The perfuse sweating and body odor has lessened. The patient stated had a rash on lower torso and legs. DSU Agent asked patient when this began, and patient replies after receiving first dose Pfizer Covid Vaccine. DSU Agent asks if ongoing and the caller replies no, she went to her family doctor and was given a steroid cream. Indication: The patient has a daughter in medical field. The patient helps with grandkids and the caller's daughter advised the caller to receive the Pfizer Covid Vaccine. History: No, the patient went to the family doctor before receiving the second dose Pfizer Covid Vaccine with the symptoms the patient was having. The doctor advised the patient that getting the vaccine and having the side effects is better than getting Covid. The patient asked how long the additional questionnaire will take? The patient stated she would rather not answer the additional questionnaire. The patient stated she does not know if this was relevant, the patient kids did not attribute this to the Pfizer Covid Vaccine. The patient never gets sick, never has flu like symptoms or anything like that. On an unspecified date, after the first dose, the patient experienced first dose: had a rash on lower torso, first dose: had a rash on legs, first dose: had perfuse sweating, first dose: body odor. The patient received steroid cream as a treatment for the event rash on lower torso and legs. Outcome of event First dose: had a rash on lower torso and First dose: had a rash on... legs was unknown. Outcome of the event was First dose: Had perfuse sweating and First dose: body odor was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1797316
Sex: M
Age:
State:

Vax Date: 01/10/2021
Onset Date: 01/30/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Date: 20210130; Test Name: Blood pressure; Result Unstructured Data: Test Result:173/110; Comments: his blood pressure went up, with maximum BP of 173/110.

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: blood pressure went up, with maximum BP of 173/110; hyperthyroid symptoms; had a bad thyroid reaction; Thinks it may be related to vestibular neuritis; he got bad vertigo, especially on bridges, which he now avoids; This is a spontaneous report from a contactable consumer (Patient). A 36-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, on 30Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: unknown) via an unspecified route of administration on an unspecified date for covid-19immunisation. On 30Jan2021 the patient experienced blood pressure went up, bad thyroid reaction, hyperthyroid symptoms, vestibular neuritis, bad vertigo. The reporter reported that he had a bad thyroid reaction after that second dose. Patient reported that the reaction did not occur until about 3 weeks after the second dose and that he had issues in the past to get the right dose for his thyroid medication. The patient went on to say that sometimes in the spring, it (thyroid) produces more, patient had hyperthyroid symptoms. The patient had to go to the ER for his reaction and blood pressure went up, with maximum BP of 173/110. The patient said he had never had an issue with blood pressure before. That all took place on 30Jan2021. reporter reported that the thyroid was almost cured, and that the patient no longer takes medication for that. The patient went to the VAERS website and found reports of thyroid issues, blood pressure increase, as well as vertigo. E-transmitted to DSU for possible duplicate or additional AE information. No Information section of the attached VR and referred to HCP for guidance on whether or not to get the booster dose.The patient received beta blocker and Lisinopril as treatment for the events. The patient underwent lab tests and procedures on 30Jan2021 blood pressure was 173/110. The outcome of the event of hypertension is not recovered while for thyroid disorder, hyperthyroidism was recovering. The outcome of the event of vestibular neuritis and vertigo was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1797317
Sex: F
Age:
State: FL

Vax Date: 08/23/2021
Onset Date:
Rec V Date: 10/19/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: COVID-19; Test Result: Positive

Allergies:

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

Symptoms: Contracted COVID-19 infection; Contracted COVID-19 infection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 23Aug2021 (at the age of 64 years old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient was contracted COVID-19 infection and received Regeneron. She was told that could not get any vaccination for 90 days. Caller has not received her second dose of the Pfizer COVID-19 vaccine yet. Caller would like to know if she receives the second dose of the Pfizer COVID-19 vaccine 90 days or more after the first dose, does she have to start over the vaccination series.Therapeutic measures were taken as a result of contracted covid-19 infection (suspected covid-19). The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1797318
Sex: F
Age:
State: CA

Vax Date: 04/02/2021
Onset Date: 04/01/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: After getting the vaccine, within about 5 hours, the nerves in my left leg from the peripheral nerve damage started firing and my back was in so much pain.; After getting the vaccine, within about 5 hours, the nerves in my left leg from the peripheral nerve damage started firing and my back was in so much pain/ bad reaction in her back; weakness in my ankle; The pad of my foot was swelling, all on the left side is pretty much where I have that issue.; my blood pressure was elevated; got a wave of nausea; pain in her peripheral nerve on the left side; could not sleep on her back and had to sleep on her stomach; ruptured disc; her temperature was running high from the heat; This is a spontaneous report from a contactable consumer. This 50-years-old female patient (consumer) reported via medical information team. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: ER8732, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 02Apr2021 15:00 (50-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. Medical history included back injury and ruptured disc from 2013, back pain and peripheral nerve damage (I had a ruptured disc in 2013 that caused back pain and peripheral nerve damage) to an unknown date. The patient's concomitant medications were not reported. Patient did not administer additional vaccines on Same sate of the Pfizer Suspect. On 02Apr2021, After getting the vaccine, within about 5 hours, the nerves in my left leg from the peripheral nerve damage started firing and my back was in so much pain, weakness in my ankle, The pad of my foot was swelling, all on the left side is pretty much where I have that issue, my blood pressure was elevated, got a wave of nausea, pain in her peripheral nerve on the left side, could not sleep on her back and had to sleep on her stomach, her temperature was running high from the heat, ruptured disc. " I had a ruptured disc in 2013 that caused back pain and peripheral nerve damage but I don't have daily back problems. After getting the vaccine, within about 5 hours, the nerves in my left leg from the peripheral nerve damage started firing and my back was in so much pain. I couldn't lay on my back and I had to lay on my stomach. I was getting close to having weakness in my ankle. The pad of my foot was swelling, all on the left side is pretty much where I have that issue. I went to the urgent care and I went to the doctor. I was sent back to physical therapy but I am still having back issues. I was doing well and was as recovered as I could be prior to getting the vaccine. The problems were more or less resolved before the vaccine. After I had the vaccine my blood pressure was elevated and my lab work was off for a month and then they went back to regular. The reporter stated that she got the 1st dose of the Pfizer COVID vaccine back in April and states she had a bad reaction in her back and has a ruptured disc there and after she got the vaccine she got a wave of nausea, pain in her peripheral nerve on the left side and could not sleep on her back and had to sleep on her stomach; states she did go to urgent care and also her doctor's office. The reporter stated her symptoms began about 5 hours after she got the shot and states her back pain is ongoing and she guesses better but it is ongoing and she had no back problem anymore until she got the shot; states the nausea was pretty brief and is not ongoing and states you know if you have morphine or something like that a wave kind of hits you and that is what it felt like during that wave. States she then started feeling her nerve firing in her leg and she did not know what to do with herself and knew it was a bad sign; states the nausea resolved that night of the vaccine but the leg nerve firing is ongoing and she has peripheral nerve damage and as long as her back is not aggravated she manages and if her back is bad the nerve damage is ongoing every day. States she does not know if this may affect this but she lives in the desert and it was really hot the day she went and got the vaccine and they did the test of taking her temperature for covid before you enter the facility and her temperature was running high from the heat and not from being ill and she was not ill but the heat was making her temperature high and maybe the lady did not administer her vaccine properly. States she has the back injury that occurred in 2013 and this just reignited the back injury. states the nausea resolved that night of the vaccine but the leg nerve firing is ongoing and she has peripheral nerve damage and as long as her back is not aggravated she manages and if her back is bad the nerve damage is ongoing every day. States her question is that she only got the first dose in April and not the 2nd dose so if she chooses or needs to get the 2nd dose she just wants to find out the protocol since she got the first dose and it was 6-7 months ago. There was a man in physical therapy at the same time I was who the same thing happened. He had gotten his second Pfizer shot and he had had back surgery 20 years ago and he could barely walk because it had caused so much pain and swelling after he received the shot. The same thing happened with my moms neighbour and they both had to get epidurals." The reporter stated that she received the first dose of the Pfizer COVID 19 vaccine on 02Apr2021and had a bad reaction. She did not receive the second dose and would like to know if she should. She states the following regarding her reaction. The events resulted in physician office visit. The patient received treatment for events After getting the vaccine, within about 5 hours, the nerves in my left leg from the peripheral nerve damage started firing and my back was in so much pain, weakness in my ankle, The pad of my foot was swelling, all on the left side is pretty much where I have that issue, pain in her peripheral nerve on the left side, could not sleep on her back and had to sleep on her stomach, ruptured disc. This was the first dose of the Pfizer COVID Vaccine and states this was her first vaccine she had in 7 years. The outcome of got a wave of nausea was recovered on 02Apr2021, ruptured disc, pain in her peripheral nerve on the left side, After getting the vaccine, within about 5 hours, the nerves in my left leg from the peripheral nerve damage started firing and my back was in so much pain/ bad reaction in her back were not recovered and other events were unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1797319
Sex: M
Age:
State: CO

Vax Date: 03/24/2021
Onset Date: 10/05/2021
Rec V Date: 10/19/2021
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: 20211005; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Breakthrough Covid Infection; Breakthrough Covid Infection; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE; Lot Number: EP6955), intramuscular, in left arm on 24Mar2021 as dose 2, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE; Lot Number: EL3248), intramuscular, in left arm on 03Mar2021 as dose 1, single, both at the age of 55-years-old, for COVID-19 immunization. The patient had no medical history or no known, allergies. Concomitant medications included citalopram, omeprazole and levothyroxine. Prior to vaccination, the patient was not diagnosed with COVID-19. No other vaccine was given in four weeks. The patient experienced breakthrough covid infection on 05Oct2021. The patient underwent lab tests and procedures which included nasal swab test: positive on 05Oct2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received Regeneron Antibody Infusion as treatment for the events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: CITALOPRAM; OMEPRAZOLE; LEVOTHYROXINE

Current Illness:

ID: 1797320
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: muscle spams...about 80 to 100 times per day; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), intramuscular on an unspecified date in 2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received his first injection of the Pfizer COVID-19 vaccine 4 to 6 weeks ago (2021) and he experienced muscle spams in the muscle where he was administered the shot, for about 80 to 100 times per day for 3 weeks after he received his first shot. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1797321
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: body aches; extreme fatigue; upset stomach; diarrhea; extreme headaches; muscles aches/every muscle in her body hurts; knee pain/ joint pain/ can''t even touch her elbow where she got the shot because of the pain; muscle pain at the site; This is a spontaneous report from a non-contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 10Oct2021 at 15:30 (Batch/Lot number was not reported) at the age of 53 years old as single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included botulinum toxin type a (BOTOX) taken for an unspecified indication, start and stop date were not reported. The patient stated that this vaccine, there's no words for it. The patient was reporting to complain but she feels like she is wasting her energy, nobody is going to care, Pfizer doesn't care. The patient stated she is not yelling, agent is on speaker phone because she can't hold it up to her. The patient stated that it was her first dose, the first and last, she will never get it again. On 10Oct2021, the patient stated she was having body aches, extreme fatigue, upset stomach, diarrhea, extreme headaches, she is just fatigued to the point she can't even go to work, muscle aches, body ache, knee pain, joint pain, the elbow she had it put in she can't even touch that elbow because of the pain. The patient was missing work now for 48 hours. The patient stated the symptoms began 10 minutes after the vaccine and that it happened almost instaneously and confirmed all symptoms began 10Oct2021, are ongoing, have worsened, they are not getting any better, its actually scaring her. The patient got sent home from work because she's going to the bathroom and she's tired, having headaches. She states every muscle everything in her body hurts, she can hardly move, headache, fatigue, diarrhea, muscle pain at the site, muscle pain at every joint in her body. The patient stated that when she got the Pfizer vaccine, she was so sick, Pfizer should be sued, Pfizer is horrible, its like somebody injected her with poison. She has every side effect known to man, it's literally poison. She can't go to work, she's really upset. She states she would be happy to tell. This should not be on the market, the Pfizer Vaccine. The patient had not recovered from the other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: BOTOX

Current Illness:

ID: 1797322
Sex: F
Age:
State: NY

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/19/2021
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: began to experience adrenal stress; fatigue; teeth chattering; confusion; nausea; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: 30155BA), dose 2 via an unspecified route of administration, administered in arm left on 29Sep2021 13:30 (at the age of 65-year-old) as dose 2, single for COVID-19 immunization. Medical history included Congenital Adrenal Hyperplasia and known allergies. Concomitant medication included dexamethasone 0.5 mg. The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot number: FD0809) administered in arm left on 01Sep2021 13:45 as single dose for COVID-19 immunization. No Covid prior vaccination nor Covid tested post vaccination. The patient has a congenital Adrenal Hyperplasia and 4 hours after injection on 29Sep2021 at 17:30 began to experience adrenal stress including fatigue, teeth chattering, confusion, nausea. Initiated stress protocol of increased dexamethasone (1.0 mg) in addition to normal dose. Symptoms abated within the hour. The adverse events resulted in Life threatening illness (immediate risk of death from the event). The patient received treatment for the events which included dexamethasone 1.0 mg. The patient recovered from the events 29Sep2021.

Other Meds: DEXAMETHASONE

Current Illness:

ID: 1797323
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: Shingles; This is a spontaneous report from a contactable consumer (Husband). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry date were not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/lot no and expiry date were not reported), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. The patient developed shingles two (2) weeks after receiving her second dose of the COVID-19 vaccine. Please send him a summary of how many other patients had developed shingles after taking the vaccine. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1797324
Sex: M
Age:
State: CA

Vax Date: 08/10/2021
Onset Date: 10/02/2021
Rec V Date: 10/19/2021
Hospital: Y

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: 20211002; Test Name: Nasal Swab; Result Unstructured Data: Test Result:result unknown

Allergies:

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

Symptoms: right side coronary artery blockage; Heart attack; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FC3180), via an unspecified route of administration, administered in left arm on 10Aug2021 (at the age of 56 years old) as dose 2, single for COVID-19 immunisation. Medical history included Diabetes. The patient has not had COVID prior to vaccination. Concomitant medications included metformin, lisinopril, insulin glargine (LANTUS), colecalciferol (VIT D), and simvastatin. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: FA7485) via an unspecified route of administration, administered in the left arm on 17Jul2021 15:00 (at the age of 56 years old) for Covid-19 immunization. No other vaccines were given in four weeks. On 02Oct2021 09:00, the patient suffered a right side coronary artery blockage (heart attack) requiring stent placement. The events resulted in Emergency room/department or urgent care, Hospitalization for 2 days on an unspecified date, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Therapeutic measures were taken as a result of the events which included coronary artery stent placement. The patient underwent nasal swab post vaccination with test result unknown on 02Oct2021. The outcome of the events was recovering.

Other Meds: METFORMIN; LISINOPRIL; LANTUS; VIT D [COLECALCIFEROL]; SIMVASTATIN

Current Illness:

ID: 1797325
Sex: M
Age:
State: CA

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/19/2021
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: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:120/65; Test Date: 20210928; Test Name: blood pressure; Result Unstructured Data: Test Result:105/55; Test Date: 2021; Test Name: body temperature; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: pulse rate; Result Unstructured Data: Test Result:55; Test Date: 20210928; Test Name: pulse rate; Result Unstructured Data: Test Result:132; Test Date: 2021; Test Name: laboratory test; Result Unstructured Data: Test Result:negative; Test Date: 20211005; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Tremor

Symptoms: severe diarrhea; woke up feeling bad; blood pressure was 105/55 with a PR of 132; blood pressure was 105/55 with a PR of 132; the patient also received FLUZONE on the same day as the vaccination date; the patient also received FLUZONE on the same day as the vaccination date; This is a spontaneous report from a contactable healthcare professional (patient). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FF8841), via an unspecified route of administration, administered in the left arm on 27Sep2021 15:00 (at the age of 82 years old) as dose 3 (booster), single for COVID-19 immunization; and influenza vaccine (FLUZONE; manufacturer: Sanofi Pasteur, lot number: UJ716AA), via an unspecified route of administration at the left arm on 27Sep2021, at dose 1, single for immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. There were no known allergies. Concomitant medications included finasteride, levothyroxine sodium (LEVOTHYROXIN), sertraline and simvastatin, all taken for unspecified indications, start and stop dates were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 29Jan2021 12:00 (at the age of 81 years old; lot number: EN5318) as dose 1, single and via an unspecified route of administration, administered in the left arm on 19Feb2021 12:00 (at the age of 81 years old; lot number: LN5518) as dose 2, single for COVID-19 immunization. The patient experienced severe diarrhea, woke up feeling bad, blood pressure was 105/55 with a PR of 132 on 28Sep2021. It was reported that the next day, on 28Sep2021, the patient began to have severe diarrhea and he woke up feeling bad. He checked his blood pressure and it was 105/55 with a PR of 132. He went to the emergency room at a cardiovascular center. They gave him one unit of saline drip and his BP returned to normal. They kept him for observation overnight. They tested him for all kinds of infections, and they were all negative. He went home and began using loperamide to try to control his diarrhea. The diarrhea continued and last Friday, he switched to Peptobismal and the BRAT diet. It has not controlled his diarrhea. He has no fever, aches, pains, nor any signs of other disease. His temperature was normal, and his BP and HR are normal. Consistently about 120/65 and PR 55. All events resulted in emergency room/department or urgent care. The reporter assessed all events as serious [life threatening illness (immediate risk of death from the event)]. It was also reported that the patient also received Fluzone on the same day as the vaccination date on 27Sep2021. The patient underwent lab tests and procedures which included blood pressure: 120/65 on an unspecified date in 2021 and 105/55 on 28Sep2021, laboratory test: negative on an unspecified date in 2021, body temperature: normal on an unspecified date in 2021, pulse rate: 55 on an unspecified date in 2021 and 132 on 28Sep2021, and COVID-19 virus test: negative on 05Oct2021. The outcome of the events severe diarrhea, woke up feeling bad was not recovered while the outcome of all other events was recovering.; Sender's Comments: Based on the available information in the case the causal association between the events diarrhoea, feeling abnormal, blood pressure diastolic decreased, heart rate increased and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: FINASTERIDE; LEVOTHYROXIN; SERTRALINE; SIMVASTATIN; FLUZONE [INFLUENZA VACCINE]

Current Illness:

ID: 1797328
Sex: F
Age:
State: KS

Vax Date: 10/03/2021
Onset Date: 10/04/2021
Rec V Date: 10/19/2021
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: 20211006; Test Name: COVID-19 test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20211004; Test Name: chest X-ray; Result Unstructured Data: Test Result:it was Atelectasis or a partially collapsed lung.

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Partially collapsed lung; pain in my abdomine; shortness of breath; Atelectasis; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine at Pharmacy or Drug Store, administered via an unspecified route, in left arm on 03Oct2021 13:30, at 26 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included autoimmune haemolytic anaemia (AIHA) from an unknown date; splenectomy, appendicectomy, tumor removal of the colon, tubal removal, gallbladder removal and intracranial brain anyerisum surgery on unknown dates and allergy to morphine and penicillin from an unknown date. The patient's concomitant medications were not reported. The patient didn't receive any other vaccine in the 4 weeks prior BNT162B2 vaccination. The patient was not diagnosed with COVID-19 prior vaccination. On 04Oct2021 the patient started to have pain in her abdomen and shortness of breath, therefore she went to the ER and got a chest X-ray and was told it was atelectasis or a partially collapsed lung. She received treatment with pain managment and oxygen. The event "partially collapsed lung" was assessed as medically significant. On 06Oct2021 the patient underwent SARS-CoV2 test via nasal swab, which resulted negative. At the time of the report the events were resolving. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1797329
Sex: M
Age:
State: MO

Vax Date: 03/03/2021
Onset Date: 03/01/2021
Rec V Date: 10/19/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: 6 fractures in his back that broke; sick; Heart attack; stroke in the back of his eye; could not see out of his right eye/ blind; This is a spontaneous report from a contactable consumer (patient's wife). A 69-year-old male patient received BNT162B2 (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021; NDC number: 59267-1000-1), via an unspecified route of administration, administered in arm on 03Mar2021 (time the vaccination was given: between 1330-1400) at the age of 69 years old, as dose 1, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) - had it for years. No family medical history relevant to events. There were no concomitant medications. In Mar2021, they had the first Pfizer shot and within a week, the patient had a heart attack. It was almost like he was dead and does not expect him to live much longer; he crashed a week after the vaccine. The patient has been in the hospital and had a heart attack (Mar2021) and has 6 fractures in his back that broke (unknown date). He has been in and out of hospital since March and was in the hospital 'now'. It caused him to have a heart attack. When querying the details of heart attack, stated that he drove himself and was going to the store. He was honking his car for ambulance, he laid on the horn since he could not breathe and was weak. Also reported that the patient must have had a stroke since he woke up one day and could not see out of his right eye, went to eye doctor and said it was a stroke in the back of his eye and he cannot see out of that eye, he is blind. This occurred about 2.5 to 3 months ago (in 2021). He has seen so many doctors. Doctor said his sight in his right eye will never come back. Saw two specialists and they tried everything they could to save his eyesight but could not. The patient always gets the flu shot but he was sick in the hospital and they do not want to give it to him. The patient was hospitalized from Mar2021 to an unknown date. The reporter talked to all of the patient's doctors and asked if the shot did this to him and they say they don't know. He was fine before the shot. The patient did not get a second dose and neither did the reporter. Outcome of events stroke in the back of his eye and could not see out of his right eye/ blind were not recovered, while other events were unknown. Follow-Up (18Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1797331
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 10/19/2021
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: got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; This is a spontaneous report from a contactable consumer and a physician. This consumer reported similar events for 5 patients. This report is the fifth of 5 reports. A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patients got covid within a few days of getting the immunization. Also, the reporter assumes that they got it at the testing site because she knows of five other patients of her own doctor who had that same experience in the same week. Outcome of the events was unknown. Information about Lot/batch number is requested. Follow-up (21Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. Follow-up (27Apr2021): New information reported from a contactable consumer includes: patient details, relevant medical history, concomitant medications, suspect vaccine details, and reaction data (onset, seriousness, outcome of COVID; new event shortness of breath). Follow-up (13Jul2021): The is a follow-up spontaneous report received from product quality complaints group. New information received included: investigation results were received from Product Quality Complaint group. Follow up attempts are completed. No further information is expected. Follow-up (22Jul2021): Further information was received from a Product Quality Complaint Group. This report included that: Investigation findings- Summary of Investigation for Lot number EN6200 were added in the narrative. Follow-up (07Oct2021): New information received from a contactable consumer: reporter details updated. This is also a follow-up report being submitted to amend previously reported information: the reported information from date 27Apr2021 to 22Jul2021 were not belong to this patient, the information will be reported in another report. Follow-up (18Oct2021): This is a follow-up report to notify that the case 2021317618 and case 202101389497 are duplicates. All subsequent follow-up information will be reported under Manufacturer report number case 202101389497.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021317500 same reporter, product and event; different patient.

Other Meds:

Current Illness:

ID: 1797332
Sex: F
Age:
State: MA

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 10/19/2021
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: hips were hurting; having hard time getting up and down; Her arm is a little sore now; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6201, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 22Feb2021 11:00 (at the age of 78-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included heart condition, AFib (atrial fibrillation) had in last Jan2020 (on a blood thinner for that now), breast cancer, blood pressure, and sensitivity to medication (some medications do not agree with her). The other conditions were started about 8-9 years ago. In the left breast no investigation assessment was performed. Concomitant medications included apixaban (ELIQUIS) taken for AFib (atrial fibrillation) and ongoing, diltiazem hcl (DILTIAZEM HCL) taken to regulate her heart and ongoing, lisinopril (LISINOPRIL) taken for blood pressure and ongoing and hydralazine (HYDRALAZINE) taken for blood pressure and ongoing. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), via an unspecified route of administration on 01Feb2021 (at the age of 78-year-old) as dose 1, single for COVID-19 immunization and she said that her arm was sore for like a day and a half, but she had no other reactions with the first vaccine. It was reported that, the patient had the second shot yesterday around 11:00 on 22Feb2021 and stated that around 14:00- 15:00 (3) her hips started hurting (hips were hurting) and got progressively worse. Then they hurt all night and have hurt ever since. She was "having hard time getting up and down". She said that she kept a hot water bottle on it. She said that it was hard to get up and down, especially off of the toilet. She took a Tylenol at 09:00 on 23Feb2021. She said that she has had no problem with her hip prior to this. The patient said that she last saw her physician last Thursday. She said that she felt her age today, but she usually did not. The pain in her hips had improved since she took a Tylenol. "She said that she does have a sensitivity to medication. She said that some medications do not agree with her". The patient said, on an unspecified date in 2021 "her arm is a little sore now", but it was her hip that was bothering her now. She said that she did not have any artificial hips or anything. "She said that she has all of her body parts". The outcome of event hips were hurting was reported as resolving. The outcome of the event "having hard time getting up and down" was reported as not recovered. The outcome of event "her arm is a little sore now" was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225296 Same patient, different AE, different dose

Other Meds: ELIQUIS; DILTIAZEM HCL; LISINOPRIL; HYDRALAZINE

Current Illness: AFib (on a blood thinner for that now.); Blood pressure abnormal; Drug allergy

ID: 1797333
Sex: F
Age:
State: NY

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Loose stools; Arm pain lasted 7 days; chills two days; generalized malaise aches 3 days; cramping; This is a spontaneous report from a contactable nurse (patient, self-reported). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EL9266 and expiry date was not reported), via intramuscular route of administration at right arm, on 11Feb2021 at 08:30 AM (age at vaccination 53 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes scallops and menieres disease. The patient concomitant medications were not reported. The patient received other medications in two weeks. Reportedly the patient did not have other vaccine in four weeks. Reportedly the patient did not have COVID prior vaccination and was not COVID tested post vaccination. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EL8982 and expiry date was not reported), via intramuscular route of administration, on 21Jan2021 at 09:00 AM, as a dose 1, single for COVID-19 immunization. On 11Feb2021 at 09:00 PM one week after second vaccine was given the patient experience loose stools continue. Arm pain lasted 7 days, chills two days, generalized malaise aches 3 days. But the loose stools and cramping started right after vaccine and still continue. The patient did not received treatment for the adverse event. Outcome of the events was not recovered for the event loose stools and cramping. Outcome of the event was recovered for other events on an unspecified date in Feb2021. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1797334
Sex: F
Age:
State: CT

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 10/19/2021
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: Headache; Mild nausea; Muscle ache; This is a spontaneous report from a contactable consumer. A 45-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route, administered on 22Feb2021 (age at vaccination 45 years) as dose 2, single for COVID-19 immunization. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route, administered on 01Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 23Feb2021 the patient experienced headache, nausea, muscle ache. It was unknown that patient was received any treatment for events. The events accessed as a non serious. The outcome of all events was reported as not recovered. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1797335
Sex: F
Age:
State: OK

Vax Date: 01/28/2021
Onset Date: 02/05/2021
Rec V Date: 10/19/2021
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: 8 days after my vaccine, the injection site started itching; swelled up; became red; hot to the touch; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EL3262), dose 1 via an unspecified route of administration, administered in left arm on 28Jan2021 09:15 as dose 1, single for COVID-19 immunization (at the age of 39-year-old). Medical history included known allergies: Compazine, Reglan, and Phenergan. Concomitant medications included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), zinc and elderberry [sambucus nigra]. No other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. On 05Feb2021 15:00, 8 days after his vaccine, the injection site started itching, swelled up, became red and hot to the touch. The patient was treated with Benadryl as a therapeutic measure of all the events. On an unspecified date, the patient recovered from all the events. Follow-up attempts completed. No further information expected.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ZINC; ELDERBERRY [SAMBUCUS NIGRA]

Current Illness:

ID: 1797336
Sex: F
Age:
State: FL

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 10/19/2021
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: This is a spontaneous report from a contactable consumer reported for herself. A 71-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL9262), at the age of 71, via unknown route, in left arm, on Feb 19, 2021, at 08:15, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications reported as none. Prior vaccinations (within 4 weeks): Patient did not receive other vaccines. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL3246), at the age of 71, via unknown route, in left arm, on Jan 29, 2021, single dose, for COVID-19 immunisation. On Feb 19, 2021, patient experienced soreness in arm. On Feb 20, 2021, patient had chills, body aches and headache (which was gone now). On Feb 21, 2021, patient had dizziness, still having body aches and soreness in arm. The patient did not visit the emergency room or physician office due to the events and not hospitalized. No relevant test was performed. The patient received treatment for the events with Tylenol. The outcome of soreness in arm and headache resolved on Feb 21, 2021; and of the other events: not recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1797337
Sex: F
Age:
State: MI

Vax Date: 02/20/2021
Onset Date: 02/21/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Lymph node swelling / slight pain to touch.; Lymph node swelling / slight pain to touch.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 20Feb2021 at 12:45 (at the age of 34-year-old) as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient's medical history was not reported. The patient's concomitant medications were reported as none. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Jan2021 at 12:00 PM (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. Patient did not receive other vaccine in four weeks and no medications in two weeks. Patient had no COVID prior vaccination. Not tested for COVID post vaccination. On 21Feb2021 at 14:00, the patient experienced lymph node swelling and slight pain to touch. No treatment was received for events. Outcome of the events was recovering at the time of reporting. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1797338
Sex: F
Age:
State: CT

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 10/19/2021
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: 20210221; Test Name: PCR test; Test Result: Negative; Comments: nasal swab.

Allergies:

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

Symptoms: First dose on 06Feb2021 and Second dose on 20Feb2021; no appetite; I had body aches; Chills; Headache; This is a spontaneous report from a contactable 60-year-old Female consumer (patient). A 60-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer COVID-19 vaccine, solution for injection, Lot number: Not available), via an unspecified route in the right arm on 06Feb2021 at 15:00 and second dose of bnt162b2 (Pfizer COVID-19 vaccine, solution for injection, Lot number: Not available), via an unspecified route in the right arm on 20Feb2021 (age at vaccination: 60-year-old), both as a single dose for COVID-19 immunization. Medical history included covid-19. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was diagnosed with COVID-19. After both shots patient had body aches, chills, headache, and no appetite. Event onset date for body aches, chills, headache and no appetite were 07Feb2021 at 15:00. First dose of bnt162b2 was administered on 06Feb2021 and second dose on 20Feb2021. Patient did not receive any treatment for the events. The patient underwent lab test and procedure post vaccination which included on 21Feb2021 COVID PCR test, nasal swab negative. The clinical outcome of the events was recovering at the time of this report and of first dose of bnt162b2 was administered on 06Feb2021 and second dose on 20Feb2021 was unknown. Follow-up attempts completed. No further information expected. Reporter's Comments: Reporter assessed the events as non-serious.

Other Meds:

Current Illness:

ID: 1797339
Sex: M
Age:
State: CT

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 10/19/2021
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: injection site pain; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 22Feb2021 14:30 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. No known allergies, no allergies to medications, food, or other products. On 23Feb2021, the patient experienced injection site pain next day. The patient did not receive any treatment for the event. The seriousness of the event was non-serious. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1797340
Sex: F
Age:
State: NC

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: tired; sore from the tension; migraine; extreme discomfort; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot: EN6201, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 08:30 (at the age of 71 years old) as dose 2, single for covid-19 immunisation. Also, patient has previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EL9262, Expiry date was not reported) via an unspecified route of administration, administered in Right arm on29Jan2021 at 08:45 AM as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes, Metastatic melanoma, post-menopausal migraine, known allergies were reported as Sulfa and Penicillin from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID), desvenlafaxine succinate (PRISTIQ), latanoprost (LATANOPROST), vitamins. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient has received other medications in two weeks which includes, synthroid, pristiq, latanoprost, vitamins. The reporter reported that, after he was administered with second Covid vaccine in the morning he was fine. At 3 am (on 20Feb2021) he woke with a migraine, one of the worst that he has had in eight years. Was in extreme discomfort and in bed the rest of the day. Next day, besides being somewhat tired and sore from the tension of the prior day, he was fine. he has been under the care of a neurologist for many years for postmenopausal migraine, complex. Just wanted others to know that this might occur and be prepared for it. It was not just a headache. Patient received no treatment for the event. The outcome for the event migraine, extreme discomfort and tired was recovered and for the event sore from the tension was recovering. Follow-up attempts completed. No further information expected.

Other Meds: SYNTHROID; PRISTIQ; LATANOPROST

Current Illness:

ID: 1797341
Sex: M
Age:
State: MO

Vax Date: 02/20/2021
Onset Date: 02/21/2021
Rec V Date: 10/19/2021
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: got his first dose gave him the shot/his arm might get sore and it did/it little puffed up/redness and circle around the injection site/throbbing pain in circle around injection site; got his first dose gave him the shot/his arm might get sore and it did/it little puffed up/redness and circle around the injection site/throbbing pain in circle around injection site; got his first dose gave him the shot/his arm might get sore and it did/it little puffed up/redness and circle around the injection site/throbbing pain in circle around injection site; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6203) via an unspecified route of administration, administered in right arm on 20Feb2021 09:15 as dose 1, single (age at vaccination 79-year-old) for covid-19 immunisation. Medical history included ongoing blood pressure high (diagnosed at 40 years old) it was controlled and ongoing diabetes from 2000 (controlled). The patient's concomitant medications were not reported. The patient reported that he got his Pfizer Covid 19 first dose 20Feb2021 and was told by the nurse that his arm might get sore and swollen. The following day there was redness and circle around the injection site that was 1-2 inches and also experienced throbbing pain. Asking if that was one of the reported side effects. The patient reported that the lady that gave him the shot said that his arm might get sore, and it did and it puffed up. He reported that it was just sore and a little puffed up, then the day before it started aching every once in a while, and then there was a red circle around it about 1.5 inches. He was not in deep pain, but it throbs. Throbbing pain in circle around injection site was reported as worsened. He wanted to know whether that was a side effect and should he have worried about it. The patient did not remember when his arm started getting sore and puffed up, it was either Saturday night or Sunday morning. The throbbing pain started the day before and even woke him up last night. The redness around the injection site was about the same as when he noticed it the previous day, but he did not know when it started. He was scheduled to get his 2nd dose on 10Mar2021. Outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Blood pressure high (Verbatim: Blood pressure high diagnosed when he was 40 years old. states it's controlled.); Diabetes (Verbatim: Diabetes States it's controlled.)

ID: 1797342
Sex: F
Age:
State:

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: caller states she and her husband both had a sore arm for 2 days; This is a spontaneous report from a contactable other hcp. A 71-years-old female 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 26Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on un specified date (at the age of: 71-years-old) as dose 1, single for covid-19 immunisation. It was reported that the reporter states that she and her husband both had a sore arm for 2 days after the vaccine was administered. She states that she also had a sore arm after her flu shot. She takes B12 injections every 30 days and is wondering if it would be safe for her to take the B12 injections before the vaccine or should she wait. she wanted to know if it's ok to take pain/fever reducing medication after receiving the Pfizer vaccine. Outcome of the events was unknown. Follow-up (11May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223134 same drug/reporter/event, different patient

Other Meds:

Current Illness:

ID: 1797343
Sex: F
Age:
State: FL

Vax Date: 02/19/2021
Onset Date:
Rec V Date: 10/19/2021
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: headaches; dizziness; loose stomach feeling/ loose stools; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 19Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headaches for several days and today he woke with a horrible headache it so happens that when they gave her the vaccine it started to hurt again, it was hurting the side of her forehead, probably had to do with the ear, dizziness, loose stomach feeling on an unspecified date. Therapeutic measures were taken as a result of headaches. She took Meclinizine and antivert for headache and dizziness. The outcome of the events was unknown. Information of lot/batch number is requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1797344
Sex: F
Age:
State:

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 10/19/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: feeling unwell; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (wife) that: A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown), via an unspecified route of administration as dose 2, single on 23Feb2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller reported that his wife received the second dose of the vaccine today and was feeling unwell on 23Feb2021. Caller wanted to know if she ever starts to feel any joint or muscle pain can she take Tylenol. At the time of this report, the outcome of event was unknown. Information about lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am