VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1681766
Sex: F
Age:
State:

Vax Date: 07/01/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Swollen lymph node; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 27-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration on an unknown date in Jul2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced swollen lymph node. The clinical outcome of the event swollen lymph node was unknown at the time of report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1681767
Sex: F
Age:
State: IN

Vax Date: 02/11/2021
Onset Date: 02/01/2021
Rec V Date: 09/08/2021
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: The left arm side has been painful/left arm pain shooting down; Shooting nerve pain; Shooting nerve pain; This is a spontaneous report from a contactable consumer. A female patient of 77-years old received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 11Feb2021(at the age of 76 Years) as single dose for COVID-19 immunisation. Medical history included , injury to brachial plexus due to birth trauma, bladder cancer, type 2 diabetes mellitus, hypertension, bursitis, arthritis from an unknown date and unknown if ongoing Verbatim: Arthritis in the hip , surgery, allergy to animal: Allergies: Dust all 3 types, dogs, cats, and feathers. Concomitant medication included ethanol (LINIMENT AQUOS SR) taken for an unspecified indication, start and stop date were not reported. The patient experienced shooting nerve pain on Feb2021, shooting nerve pain on Feb2021, the left arm side has been painful/left arm pain shooting down on 11Feb2021. Clinical course reported as She is calling because she had the vaccines withheld in hospital in Febuary and March, because she thought she was going to go on a trip to withheld, but she had both vaccines in the left arm, however she has had Erbs Palsy in the left arm. Her left arm has never hurt her in the past, but now she cant even lift the arm to even put deodorant on. She had the vaccine in left arm because she didnt want the right good arm to be messed up. She even has this thing that is on her sewing desk and the desk to use the computer, and she cant even rest the left arm on it because its so painful. Caller asks does she need to get a booster vaccine. Her First Dose was on 19Jan2021 with Lot EL8982. When trying to read the card caller states that her vision is . its so little. Administered in the Left Arm. The Second Dose was on 11Feb2021 Lot EN5318, there is No Expiry written also administered in the Left arm. After getting the shot, the left arm side has been painful since the first day, she doesn't know if they hit a nerve or what. She was tempted to call the hospital after being on the phone for 30 or 20 minutes she gave up, they did give her a 211 number which she called. Caller explains that she has had Erbs Palsy in the left arm prior to the vaccine, she already had that, when she weighed 11lbs 14 oz her head wasn't delivering to her arm and it damaged the nerve trunks. The reason she has the thing on desk and sewing machine, is because the left arm is shorter than the right arm, and when she uses the left arm she can only lift it so high. She wore a brace on it as a baby, she is okay, she can lift it up to the chest, but she cant lift higher, the thing that her arm rests on, it rotates the arm to be able to manipulate the arm, now it hurts with her arm in there, it lifts the arm up, and its so painful. She can lift her arm the same amount, but she feels like it shoots pain down the arm to the elbow to the thumb. Outcome: it has stayed the same, it brings tears to her eyes. Treatment information included that she tried Liniment heat rub that is over the counter, hot compresses. She also explains that her right arm is the good arm, shes had 4 kids and she used to lay them on the floor with her arm manipulated. In the good arm she has had shoulder, arm, and wrist surgery. The outcome of the events limb discomfort, Neuralgia was unknown and pain in extremity was not recovered.

Other Meds: LINIMENT AQUOS SR

Current Illness:

ID: 1681768
Sex: F
Age:
State: OK

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she did not react to both doses of the Pfizer COVID-19 Vaccine, except having sore arm.; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received first dose of bnt162b2 (BNT162B2; Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 as single dose, Second dose via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included immunodeficiency from an unknown date and unknown if ongoing Caller stated that she is immunocompromised and is concerned about getting sick , illness from an unknown date and unknown if ongoing verbatim: Caller stated that she is immunocompromised and is concerned about getting sick. The patient's concomitant medications were not reported. The patient experienced she did not react to both doses of the pfizer covid-19 vaccine, except having sore arm. Clinical course reported as has received both doses of the Pfizer BioNTech COVID-19 vaccine. She received her first dose in Jan2021 and her second dose 3 weeks later in early Feb2021. Caller is concerned about getting the booster dose and she would like to know when to get and if she is eligible. Caller stated that she is immunocompromised and is concerned about getting sick. She heard that an Infectious disease doctor at the national health department said that the efficacy of the Pfizer COVID-19 vaccine decreases to 84% after 6 months. Caller stated that she did not react to both doses of the Pfizer COVID-19 Vaccine, except having sore arm. 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: 1681769
Sex: F
Age:
State: VA

Vax Date: 04/17/2021
Onset Date: 04/26/2021
Rec V Date: 09/08/2021
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: Ultrasound; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Soft lumps appeared on the top/sides of scalp (both sides); Enlarged lymph node in left neck; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 11:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to pain medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), imipramine (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC) and ibuprofen (ADVIL); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7553) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunization. The patient previously received hydrocodone bitartrate/paracetamol (VICODIN), paracetamol/oxycodone hydrochloride (PERCOCET) and hydromorphone hydrochloride (DILAUDID); all on unknown dates for unknown indications and experienced drug allergy. On 26Apr2021, within a week of the final vaccine, soft lumps appeared on the top/sides of the scalp (both sides) and the patient also had an enlarged lymph node in the left neck area that was currently being checked through an ultrasound. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events soft lumps appeared on the top/sides of scalp (both sides) and enlarged lymph node in left neck were not recovered at the time of this report.

Other Meds: LEXAPRO; IMIPRAMINE; BYSTOLIC; ADVIL [IBUPROFEN]

Current Illness:

ID: 1681770
Sex: M
Age:
State: ME

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

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

Lab Data:

Allergies:

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

Symptoms: unable to curl the finger down; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; it is red and swollen and inflamed and painful; This is a spontaneous report from a contactable consumer (patient himself). A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0271; Expiration Date: Sep2021) intramuscular, administered in Arm Left on 10Aug2021 11:50 (at age of 58-years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Patient had not any history or other products. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, her husband (patient) got COVID shot yesterday. On his left hand, index finger, it was red, swollen, inflamed and painful on 10Aug2021. On an unspecified date he was unable to curl the finger down because of the inflammation. He got the shot before lunch at 11:50 AM yesterday. The index finger being red, swollen, inflamed, and painful started a couple of hours after the shot. He mentioned it started to bother him in the afternoon. When he woke up this morning it was much worse on an unspecified date. They were not sure where it would progress from here. He never had an issue with his hand before. Adverse event did not require to visit emergency room or physician office; but caller told him to that she recommended that he follow up with his doctor. She was calling because she was required to report it within 24 hours. The outcome of events unable to curl the finger down and it is red and swollen and inflamed and painful (Condition aggravated) was unknown while it was not recovered for all other events. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1681771
Sex: U
Age:
State: TN

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 05/13/2021; Test Name: SARS-CoV-2; Test Result: Negative.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 70-year-old patient, of unspecified gender, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EM9809), at the age of 70, intramuscularly, left arm, on Feb 22, 2021, single dose, for COVID-19 immunisation. The patient's medical history included polymyalgia (Oct 2020); she was treated for a few months with prednisone 5mg; and rheumatic from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On unspecified date in Feb 2021, patient experienced a sore arm. Patient received treatment for event. The patient underwent lab tests and procedures, which included SARS-CoV-2 RNA test: negative on May 13, 2020. The event assessed non-serious, with outcome of unknown. Follow-Up (Aug 18, 2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness: Polymyalgia

ID: 1681772
Sex: M
Age:
State:

Vax Date: 08/10/2021
Onset Date:
Rec V Date: 09/08/2021
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: pins and needles; skin feels wormed; sore arm; felt numbness in his fingertips; This isThis is a spontaneous report from a contactable consumer or other non-healthcare professional. A 32-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on 10Aug2021 (Batch/Lot number and Expiry date was not reported) (at the age of 32-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pins and needles, skin feels wormed, sore arm and felt numbness in his fingertips. The reporter stated that he did not want to report a side effect as it did not do him any good to just report it. He declined to complete report. He was calling in regard to the Pfizer COVID vaccine and wanted some information about a side effect. The reporter stated that his side effect was not the same day and it was the day after. He further stated that he received the vaccine on Tuesday 10Aug2021 and starting yesterday and today he felt pins and needles throughout his body as if he took pre-workout. His skin feels wormed like pins and needles or as if he took beta alanine or been in the sun too long, it varies in intensity. The reporter would like to know if this side effect has been reported and is it something that goes away. It was reported that on 10Aug2021 the day he received the vaccine he did not have many side effects and he did not really have a sore arm until the next day and he felt numbness in his fingertips on the same side he got the shot but that went away. Also stated that three hours prior to the receiving the shot he took a medication called meloxicam and he told the pharmacist initially and they did not think it would be an issue. After delivering response to question caller stated that was true and he knew that they have to cover themselves and this was a waste of time. Caller then disconnected call. Unable to offer survey as the call was disconnected. Unable to attempt to transfer again as the reporter disconnected call. He is 32-years-old male. Unable to ask for consent to contact as caller disconnected call. The clinical outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up

Other Meds:

Current Illness:

ID: 1681773
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: This is a spontaneous report from a contactable consumer. A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced "memory issues" and can't remember if she ever had a vaccine card on an unspecified date. Patient stated, she went to get a 2nd dose of Pfizer COVID-19 vaccine and was turned away because she did not have a vaccination card. She wanted to know what can she do about the card. Received the 1st Pfizer COVID-19 vaccine 4 months ago. She went to the hospital shortly after the 1st dose for "side effects from the vaccine." After discharge from the hospital, she never received a 2nd vaccine dose. Has it been too long now to get the second dose? Wanted to know if she needed both doses again. The outcome of event: unknown. The lot number for the vaccine (BNT162B2), was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1681774
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/08/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: ringing in my ear/humming in my ears; This is a spontaneous report from a contactable consumer. This 54-year-old female consumer (patient) reported for herself. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0151), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for COVID-19 immunization. Medical history included tuberculosis from 1974 to an unknown date (I had tuberculosis as a child. i had tuberculosis in nineteen seventy-four and I was medically treated for that). The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced some adverse reactions. It was reported that the patient had ringing in her ear, the ring like a humming like tinnitus since her second dose on 08Apr2021. Outcome of the event was reported as not recovered at this time of the report. No follow up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681775
Sex: F
Age:
State: PA

Vax Date: 02/19/2021
Onset Date: 03/01/2021
Rec V Date: 09/08/2021
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 Date: 202105; Test Name: Stress test; Result Unstructured Data: Test Result:3 blockages between 30-40%; Test Name: covid test; Test Result: Negative ; Test Date: 202012; Test Name: covid test; Test Result: Negative

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: awful cough/Horrendous cough; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:15 (at the age of 53-years-old) (Batch/Lot Number: EN1201) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes, hypothyroidism (from 2000) and blood pressure. Concomitant medication included metoprolol tartrate taken for blood pressure from 2003 and ongoing. Patient previously took first dose of bnt162b2 (Batch/Lot Number: (F or E) L3248, No Expiry or NDC) administered in left arm on 29Jan2021 at 02:30pm (at the age of 53-years-old) for covid-19 immunisation. The patient experienced awful cough/horrendous cough and shortness of breath on unspecified date in 1st week in Mar2021. It was reported that She received her second dose in the middle of Feb2021 and 2 weeks after experienced an awful cough and shortness of breath. The shortness of breath has resolved, but she still has a cough. She is a diabetic for the past 50 years. Her doctor follows her closely and she had an insulin pump, the Dexcom System. Callers husband and she thinks it was coincidental that a few weeks after the second dose, she developed a cough. She contacted her doctor and her primary care provider advised her to stay home. She went to a Cardiologist and had a chemical stress test done on 18-19May2021, and he found that she had 3 blockages between 30-40%. But the doctor felt that was not the cause of the shortness of breath. States that no one has been able to tell her why she had shortness of breath. Previous to finding the blockages she didn't had any problems. She knows with having the diabetes for so long that it was just a matter of time, but it was a little to coincidental in her opinion. She doesn't remember exactly when, but the shortness of breath resolved in either Apr2021 or May2021. The patient underwent lab tests and procedures which included cardiac stress test showed 3 blockages between 30-40% on unspecified date in May2021, sars-cov-2 test was negative on an unknown date and on unspecified date in Dec2020. Outcome of the event shortness of breath was recovered on unspecified date in 2021 and outcome of event cough was recovering.

Other Meds: METOPROLOL TARTRATE

Current Illness: Blood pressure abnormal; Diabetes; Hypothyroidism

ID: 1681776
Sex: F
Age:
State: MI

Vax Date: 05/04/2021
Onset Date: 05/06/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: After the second dose I had pain not only at the injection site, but also in a circle around the arm to the underarm/armpit area. This lasted a few days, went away and has come back intermittently.; After the second dose I had pain not only at the injection site, but also in a circle around the arm to the underarm/armpit area. This lasted a few days, went away and has come back intermittently.; This is a spontaneous report from a contactable consumer(patient). A 60-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04May2021 14:45, at 60-year-old, as single dose (Lot Number: EW0162) for covid-19 immunisation. Medical history included arthritis in jaw. The patient had known allergies to erythromycin. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 13Apr2021 02:45 PM, at 60-year-old, as single dose(Lot Number: EW0150)for covid-19 immunisation. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced vaccination site pain and pain in arm on 06May2021 at 02:00. The patient stated: after the second dose I had pain not only at the injection site, but also in a circle around the arm to the underarm and armpit area. This lasted a few days, went away and has come back intermittently. Also sometimes happens in the other arm but not as painful. The outcome of events was not recovered. The patient received no treatment and no hospitalization prolonged. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681777
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Dizzy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on 2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient just took the vaccine that day (yesterday) and the patient was wondering what the different side effects were and do they have a 'black box label' (Clarification unknown) and what should the patient do if something was like 'talking about the' nausea it did or something because the patient experienced felt dizzy earlier on an unspecified date in 2021. The patient concern was about the different 'black box label'. The patient had already asked the questions, and this was concerning self then and the patient took the vaccine, questioned whether she would get the COVID or not. The patient was unclear about that question. The patient just did not want to die on that medicine. The patient questioned the side effect of catching COVID while taking it. The patient questioned if the vaccine caused hearing loss. Outcome of the event dizzy was reported as Unknown at this time of the report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681778
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 09/08/2021
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: Felt ill for 24 hours after second dose; light sensitivity; similar to hangove; loss of appetite; This is a spontaneous report from a contactable consumer or other non-healthcare professional. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on an unspecified date in Apr2021, as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on an unspecified date in Apr2021, as a single for COVID-19 immunisation. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On an unspecified date in 2021, the patient felt ill for 24 hours after second dose, light sensitivity, similar to hangover, loss of appetite. No treatment was received for the events. The outcome of the event was reported as resolved on an unspecified date. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681779
Sex: F
Age:
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: get these purple bumps all over your body; itching; pain; she was dealing with it through tears; This is a spontaneous report received from a contactable consumer. This consumer reported for a Female patient (Daughter in Law). This is the second case out of 3 split cases. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Provided) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, My daughter in law has an auto immune condition, and after she took the shot, the vaccine (Pfizer COVID 19 Vaccine) she has met the worst case ever as I complaint this which was that where you get these purple bumps all over your body. So, I just wanted to report that, she was dealing with it through tears and pain and itching. But I really would recommend that something needs to be said prior to getting that shot. If you have an auto-immune condition that really needs to be truly discussed with their doctor because anyone with the auto-immune condition is sounds like to me they are having some trouble. It is just breaking in my heart (general sentence) So, I just wanted to report that, it is horrible. Reporter further stated, What strange was, I have met two other people that have developed the same condition So, anyway I really think a warning or just say you know kind of deal. You know, something that the person administrating the vaccine could share. But anyway, you know just like they should not take the Flu Vaccine So, it is the way that the body responding to some kind of, chemical in the vaccine (not appropriately clarified hence not captured as event). But anyway, I just wanted to report that. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101050810 same report/drug/AE, different patients;US-PFIZER INC-202101050518 same report/drug/AE, different patients

Other Meds:

Current Illness:

ID: 1681780
Sex: U
Age:
State:

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

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

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:100.3

Allergies:

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

Symptoms: Patient had 100.3 temp 16 hours after vaccine administration; This is a spontaneous report from a contactable consumer or other non hcp. A 12-year-old patient of an unspecified gender received bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration on 2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On2021, The patient experienced patient had 100.3 temp 16 hours after vaccine administration. The patient underwent lab tests and procedures which included body temperature: 100.3. 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: 1681781
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: my face is like swelled up; hives on my face; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient reported for self). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), first dose via an unspecified route of administration on an unspecified date, as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Report not related to a study or programme. On an unspecified date, the patient experienced face was like swelled up, hives on face. It was reported that, yesterday "I got my first dose with Pfizer vaccine and I don't know if I am having allergic reactions to it because my face is like swelled up". When asked to specify the reaction, consumer stated, Like hives on my face. Further probing could not be done as consumer was unwilling to further answer the questions. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call. The outcome of the events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681782
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: she experiences a severe allergic reaction with the Pfizer BioNTech COVID-19 vaccine; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable 68-year-old female consumer (patient) reported that: A 68-year-old female patient received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, single dose for covid-19 immunisation. Medical history included, animal bite, panic attack, agoraphobia from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took penicillin b and experienced drug hypersensitivity, tetanus vaccines. On an unspecified date, she experiences a severe allergic reaction with the Pfizer BioNTech covid-19 vaccine. Patient has Agoraphobia and panic disorder for 30 years and is taking MAO Inhibitor which is Phenelzine and wanted to know if this and other medications she is on has an interaction or contraindication with the Pfizer BioNTech COVID-19 vaccine. She wanted to know if Penicillin is in the Pfizer BioNTech COVID-19 vaccine because she mentioned that when she was 6 years old, she had a shot of Penicillin and died on the kitchen table and her father got a doctor who gave her a shot, took her to the hospital and she lived. Patient mentioned that she had a lethal allergic reaction to Penicillin. She mentioned that she had severe reactions with other medications before. She mentioned that when she got bitten by her cat, they had to give her medicines in half doses, the medication was Tetnus perhaps. She wanted to know if there is an interaction with Tetnus and the Pfizer BioNTech COVID-19 vaccine. She mentioned that Phenelzine is a tricky medicine, but it works and that she tried different medicines that didn't work. She mentioned that she had horrible panic attacks and couldn't leave the house and with the medicine, she got better, she got her master's in fine arts and she became a full professor. She mentioned that she is on MAO Inhibitor Phenelzine and is not sure if she can be given an Epi pen or Epinephrine since she can't have any decongestants in case, she experiences a severe allergic reaction with the Pfizer BioNTech COVID-19 vaccine. She decided to call Pfizer because Pfizer makes the MAO Inhibitor. AE. 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: 1681783
Sex: F
Age:
State: NY

Vax Date: 07/28/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Pain she is having in her Achilles that started getting swollen and hard 2 days ago; Pain she is having in her Achilles that started getting swollen and hard 2 days ago; Saturday the pain in the caller's Achilles got worse; Flip flips caused tendonitis or something or fasciitis; Flip flips caused tendonitis or something or fasciitis; Limping; This is a spontaneous report received from a contactable consumer (patient). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0217; Expiration Date: 30Sep2021), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jul2021 at 1:30 (at the age of 73-years-old) as a DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient Medical history included osteoporosis from an unknown date and unknown if ongoing and family Medical History Relevant to the event was none. Concomitant medications included ibuprofen (ADVIL) 2 every morning taken for osteoarthritis, start and stop date were not reported and colecalciferol (VITAMIN D) 1,000 every other day taken for an unspecified indication, start and stop date were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Prior Vaccinations (within 4 weeks) and event following prior vaccinations were none. On Aug2021, the patient experienced pain she was having in her achilles that started getting swollen and hard 2 days ago, on an unspecified date in 2021 flip flips caused tendonitis or something or fasciitis, limping and saturday the pain in the reporter's achilles got worse on Aug2021. Reporter was asking with a question about the Covid vaccine. Reporter reported that she received her first vaccine dose on 28Jul, Lot number ew0217 and was due for her second dose on Wednesday but she has been needing to take Advil for pain she was having in her Achilles that started getting swollen and hard 2 days ago. Now it's completely swollen and hard. Reporter reported that she has her family there and has been doing work in the garage, lifting things and running around in flip flops. Reporter states "it looks like I had a trauma, but there was no trauma I have been running around in flip flops and began having weird pains and limping the whole week now I'm worried it might rupture". Reporter reported that yesterday she took 4 Advil, today she took 2, and while she normally takes 2 Advil ad day she now asked if that would interfere with the vaccine she was planning to get on Wednesday? Reporter reported that she was planning on going to the doctor because she doesn't usually have this and its weird and unusual, she doesn't normally have this much swelling. Reporter did also report having a history of a bone spur in her heel, but she doesn't remember which heel. Reporter asked, "When am I fully protected after getting the vaccine?" weird pain in her Achilles was reported as worsened. It was reported that, other Conditions was in her hips. Diagnosed many years ago, when she was 50 years old (unspecified). It was reported that, the reporter received her first dose on 28Jul2021, lot EW0217. The reporter is due for her second dose this coming Wednesday but is worried. The reporter had family around and was running around in flip flops. The reporter started getting a weird pain in her Achilles. 2 days ago, it started looking swollen and hard and looks like there is trauma but has no trauma. The reporter took 4 Advil yesterday and 2 today. Normally the reporter takes 2 Advil a day. Can the reporter take that? Will it interfere with vaccine? The withheld agent provided the reporter with this information prior to transfer. The reporter also has a history of bone spurs in one of her heels. The reporter saw the Achilles 2 days ago or yesterday and immediately took 4 Advil, 2 around 3:00 am and then 2 more at 9:00. The reporter got really scared because it was sticking out and hard and she thought if she couldn't get the swelling down it may rupture. The reporter applied a bandage and relaxed. The reporter walked around but had a bandage on yesterday and walked around in sneakers, her flip flops may have caused this. The reporter wears flip flops every summer and has never had this. The reporter had been limping for a week or a week and half because she felt something hurt. The reporter's kids thought the flip flips caused tendonitis or something or fasciitis. The reporter was worried it is going to get worse and wanted to get the second dose. The reporter feels it is getting better with rest and the bandage. It was reported that, a week ago the reporter couldn't walk naturally and thought it was plantar fasciitis. The reporter was running around a lot and didn't stop using her flip flops. The reporter thinks she has allergies to heat and doesn't have air conditioning and it has been almost 100 degrees where she lives. Saturday the pain in the reporter's Achilles got worse, at 6:00 am she noticed the swelling on her Achilles. The limping has been going on for about a week, maybe since last Monday. The reporter was taking a book off a shelf and lifting a box and thought this could have caused this issue. The swelling has gone down, but the reporter's Achilles is wider and still swollen. The pain has gone down but the reporter has adjusted by walking on the other leg, so it doesn't get worse. If this gets work the reporter was afraid, she will have to go to the doctor and delay her second dose and she doesn't want that. The reporter slipped in the bathroom 2 weeks ago and hurt her back because she took her bathmats out. Could this have caused this? The reporter feels like she may have tendonitis in her back. The reporter stopped taking Oscal because she didn't want kidney stones so now, she just drinks milk. The reporter takes 1,000 of vitamin D every other day and sits in the sun. Reporter asked whether she could continue taking Advil? Event did not require a visit to, Emergency Room or Physician Office. Family Medical History Relevant to the evet were none. Relevant Tests were none. Reporter seriousness for the events were unspecified. Outcome of the pain she was having in her achilles that started getting swollen and hard 2 days ago and saturday the pain in the reporter's achilles got worse were not recovered, flip flips caused tendonitis or something or fasciitis was unknown whereas, limping was recovered in 2021. Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: ADVIL; VITAMIN D

Current Illness:

ID: 1681784
Sex: F
Age:
State: NJ

Vax Date: 03/16/2021
Onset Date: 07/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: cholesterol; Result Unstructured Data: Test Result:Unknown results; Test Name: Blood Work; Result Unstructured Data: Test Result:Unknown results; Test Name: gout; Result Unstructured Data: Test Result:Negative; Comments: It's not gout she has no uric acid; Test Name: Heart; Result Unstructured Data: Test Result:good; Test Name: Liver Function; Result Unstructured Data: Test Result:Good; Test Name: Lyme's; Result Unstructured Data: Test Result:showing negative; Test Name: Cancer; Result Unstructured Data: Test Result:No; Test Name: Kidney Function; Result Unstructured Data: Test Result:Good

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: started having complaints of body aches, chills, and fever/achiness, joint pain in neck and shoulders that shifted down the body; Caller received the first dose of the Pfizer Covid-19 vaccine on 16MAR2021 and started having complaints of body aches, chills, and fever.; Caller received the first dose of the Pfizer Covid-19 vaccine on 16MAR2021 and started having complaints of body aches, chills, and fever.; her eye balls swelled; ears shooting in pain; sinus infection; joint pain in neck and shoulders that shifted down the body; her neck on the right side was swelling; This is a spontaneous report from a Pfizer Sponsored Marketing Program COVAX US Support contactable consumer (patient). A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6206; Expiration Date: not reported), via an unspecified route of administration, administered in Arm Right on 16Mar2021 (at age of 58-years-old )as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Lyme disease (Lyme's disease was diagnosed 8 years ago. She had Lyme's for over 5 years before it was diagnosed and caught, she was misdiagnosed), breast cancer (She got rid of breast cancer in the left breast last May )and menopause. Concomitant medication(s) included tamoxifen (TAMOXIFEN) taken for an unspecified indication from 2021 and ongoing; anastrozole (ANASTROZOLE) (Batch/Lot 110796, Expiry DEC2022) taken for an unspecified indication from Jul2021 and ongoing. The patient received the first dose of the pfizer covid-19 vaccine on 16mar2021 and started having complaints of body aches, chills, and fever. Achiness, joint pain in neck and shoulders that shifted down the body, sinus infection, eye balls swelled, ears shooting in pain on unknown date and her neck on the right side was swelling on Jul2021. . Caller has taken both doses of the Pfizer Covid vaccine, she has experienced joint pain, sinus infection, and severe swollen feet. She wants to know what to do and see if there is more information on the side effects. The patient had an infectious disease doctor and with her Lyme's disease he was the first to crack it, he got to the end result. She was 58 and has been through menopause, other doctors would tell her what she was experiencing was menopause, but she knew that there was something serious going on. She did not get covid. She recalls getting the second dose in a 3 weeks span. She was due on the 7Apr2021 but went on the 8Apr2021 at 8AM. She has always had joint pain because of Lyme's Disease, but this was more out of ordinary last month. Inclusively with the first vaccine she had achiness, joint pain in neck and shoulders that shifted down the body, mild fever, and sinus infection. Her symptoms occurred for the 3-4 days after the first dose. She thought she didn't have a reaction, but after the first 4 days, which was a breeze she thought, on the 4th or 5th days she had the sinus infection come out the blue, with her eye balls swelled, ears shooting in pain and even her neck on the right side was swelling. She discontinued the Arimidex generic called Anastrozole 1mg once a day at night. She discontinued Anastrozole at the end of Jul2021. When queried for the Lot number, caller states that she needs to get the bottle, during this she states that it be easier to walk on her butt right now than her feet, maybe that would help her abs, she wanted to be swimming like she does seasonally and that she was not doing. Anastrozole was dispensed in a manufacture bottle, 1mg tablet, Lot 110796 Expiry DEC2022 NDC... caller states that she needs to focus on it, her eyes are screwing up it is 0093-7536-56 Manufacture in by Teva. She did 4 vials of Blood work on Wednesday and got results on Saturday, they checked Liver and kidney function, cholesterol and gout. It's not gout she has no uric acid. The Lyme's was showing negative, it was low levels not big enough to be put as a red flag. The kidney and liver was good, heart was good, no cancer. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533; Expiration Date: 31JUL2021), via an unspecified route of administration, administered on 08Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient underwent lab tests and procedures which included blood cholesterol with result as unknown on unknown date , blood work with result as unknown on unknown date , gout with result as negative on unknown date, It's not gout, patient has no uric acid , The heart rate of the patient was good on unknown date, liver function test with result: good on unknown date , Lyme disease showing negative on unknown date, neoplasm malignant with result as no on unknown date , renal impairment: good on unknown date. The outcome for the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: TAMOXIFEN; ANASTROZOLE

Current Illness:

ID: 1681785
Sex: U
Age:
State:

Vax Date: 08/12/2021
Onset Date: 08/13/2021
Rec V Date: 09/08/2021
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: Little rash on my ankle; Have a rash on both ankles and on my legs and on my back; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot number: FC318O, expiration date not provided) via an unknown route of administration, administered on 12Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medication was not provided. On 13Aug2021, the patient experienced a little rash on ankle and then had a rash on both ankles, legs and on back. The patient wanted to know what could take to reduce it. The patient did not receive any treatment for the events. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681786
Sex: F
Age:
State: TX

Vax Date: 07/15/2021
Onset Date: 08/09/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dizzy; her left side of her body was uncontrollable like she couldn't reach up to her mouth or head she would miss it; she couldn't walk because her foot was dragging; neurological attack; This is a spontaneous report from a contactable consumer or other non hcp. A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178), via an unspecified route of administration in left upper arm on 05Aug2021 at 14:00 (at the age of 74-year-old) as dose 2, single for covid-19 immunisation at pharmacy. Medical history included high cholesterol from 30 years and unknown if ongoing, blood pressure high from about six months; doctors are aware of it and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid from an unspecified start date and ongoing (taking all her life, switched from armour thyroid to Synthroid when it came out); rosuvastatin (ROSUVASTATIN) taken for heart and cholesterol from an unspecified start date and ongoing (they just increased it to 40mg; it pulled her cholesterol and triglycerides into good range; she has not seen that in years; it was good medicine); ezetimibe (ZETIA) taken for cholesterol and triglycerides from an unspecified start date and ongoing (goes with ROSUVASTATIN); oxybutynin (OXYBUTYNIN) taken for bladder control from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for heartburn from an unspecified start date and ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0170), via an unspecified route of administration in left upper arm on 15Jul2021 at 14:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Caller reported that "after she received the second dose of the vaccine on 05Aug2021, the following 09Aug2021 she started having an episode, like a neurological attack, she was dizzy; her left side of her body was uncontrollable like she could not reach up to her mouth or head she would miss it; and she could not walk because her foot was dragging. The first episode lasted about five minutes. Mentions she was in the shower when it happened. This continues all that week, with daily episodes; Thursday she had two; and then one each day on the weekend. Now she has been 24 hours without any of that neurological stuff. Adds she had no pain or anything. Each time the dizziness was less and less until the dizziness went away on 12Aug2021 or 13Aug2021. She did send a note to her PCP. The doctor advised to go to the ER if it got worse. She received no treatment. Mentions the levothyroxine has no effect on her. When ask to provide product information caller has no product to provide NDC, lot or expiration date for Levothyroxine". The adverse events were not resulted in emergency room and physician office.The outcome of dizzy was reported as resolved on 12Aug2021, her left side of her body was uncontrollable like she could not reach up to her mouth or head she would miss it, she could not walk because her foot was dragging was resolved on 16Aug2021; neurological attack was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: SYNTHROID; ROSUVASTATIN; ZETIA; OXYBUTYNIN; OMEPRAZOLE

Current Illness:

ID: 1681787
Sex: F
Age:
State:

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: dizzy and really light headed; Tired; dizzy and really light headed; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). A 13-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Aug2021 (at the age of 13-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17Aug2021, the patient experienced dizzy and really lightheaded, tired. Reporter stated, my 13-year-old got her first shot today (Confirmed Pfizer COVID 19 vaccine) and she is like really dizzy and really lightheaded, Is that normal. Reporter stated, tired she said. 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: 1681788
Sex: F
Age:
State: OH

Vax Date: 08/17/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: 101F temperature; Result Unstructured Data: Test Result:101 Fahrenheit; Test Name: 101F temperature; Result Unstructured Data: Test Result:101.5 Fahrenheit

Allergies:

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

Symptoms: sick; 101F temperature/temperature of 101.5; aching; she's really flu-like; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 17Aug2021 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 bnt162b2 on an unspecified date for covid-19 immunisation. Caller is a consumer reporting adverse event symptom for his wife after receiving her second dose of the Pfizer-Biontech Covid19 vaccine yesterday (17Aug2021). He reports my wife has a 101F temperature, she got her second shot yesterday. She's aching, she's really flu-like, she's very very sick. Caller reports that he has been trying to get in touch with someone at Pfizer since midnight last night and that he's so concerned about his wife, I want to take her to the hospital, but they don't want us to bring her, that's how sick she is. Reporter stated, It was too ridiculous. Pfizer should be ashamed of itself when someone is sick and they must fill out all of that stuff, that is baloney. How dare them. So, my wife is very sick right now. She said she feels beyond the flu. Last night when this developed at about 12 o'clock, she was at a 10 and now she is at a 9. We just took the temperature, and she is a 101.5. The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on an unspecified date, body temperature: 101.5 fahrenheit on an unspecified date. The outcome of the events was unknown. The action taken in response to the events for bnt162b2 was not applicable.

Other Meds:

Current Illness:

ID: 1681789
Sex: F
Age:
State: FL

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:elevated; Test Date: 20210802; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: difficulty swallowing; elevated blood pressure; feeling of going to jump out of skin; severe stomach issues; Severe neurological reaction including face; Severe neurological reaction including face, arms; legs tingling and numbness.; Severe neurological reaction including face, arms, legs tingling and numbness.; Heart racing; difficulty speaking; double vision; This is a spontaneous report from a contactable consumer (parents). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, and patient was 47-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 30Jul2021 at 03:30 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune issues. There were no concomitant medications. No other vaccine received in four weeks; no other medications received in two weeks, no covid prior vaccination, no known allergies were reported. On 30Jul2021 at 08:30 PM, the patient experienced Severe neurological reaction including face, arms, legs tingling and numbness. Heart racing, difficulty speaking and swallowing, double vision, elevated blood pressure, feeling of going to jump out of skin, severe stomach issues. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021, blood pressure: elevated on 30Jul2021. Therapeutic measures were taken as a result for all reported events with Methyl PrednisoSolone. The outcomes of events were recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1681790
Sex: F
Age:
State: CA

Vax Date: 08/15/2021
Onset Date: 08/15/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210817; Test Name: fever/today her temperature is normal; Result Unstructured Data: Test Result:fever of 101; Comments: yesterday; had a fever of 101; Test Date: 20210818; Test Name: fever/today her temperature is normal; Result Unstructured Data: Test Result:normal; Comments: today her temperature is normal

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: woke up with sweats; couldn't sleep; even her earlobe felt like it was pinching; Fatigue; feeling sick; headache; fever of 101/ Fever; aching like her nerves are high pitched; injection site redness, swelling, and itching; injection site redness, swelling, and itching; injection site redness, swelling, and itching; aching burning sensation; Injection site lump; her third, or booster dose; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 15Aug2021 at 15:00 (Batch/Lot Number: FC3180) as dose 3, single for covid-19 immunization (at the age of 66-years-old). Medical history included allergic to Sulfa and gastrooesophageal reflux disease (GERD) from an unknown date and unknown if ongoing and ongoing arrhythmia from an unknown date and had family history of cholesterol from an unknown date. Concomitant medication(s) included atenolol taken for arrhythmia; olmesartan medoxomil (BENICAR) taken for prophylaxis; omeprazole taken for gastrooesophageal reflux disease; atorvastatin calcium (LIPITOR) taken for blood cholesterol and flecainide (FLECAINIDE) taken for arrhythmia, start and stop date were not reported for all. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249) on 30Jan2021 early morning in the left arm and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9265) on 20Feb2021 at 09:00 as single dose for COVID-19 immunization and had no side effects. The patient previously also received flu shot last year for immunization and experienced frozen shoulder from the flu shot (mentions she got frozen shoulder from the flu shot last year; but she has no product information, no NDC, lot or expiration for that flu shot). Patient had not received any other vaccine within 4 weeks of vaccination. It was reported that patient received her third, or booster dose of vaccine on 15Aug2021 and stated that the next day on 16Aug2021 she was feeling sick, had headache, fever of 101/ fever, aching like her nerves are high pitched, injection site redness, swelling, and itching, aching burning sensation and injection site lump. On 17Aug2021 she couldn't sleep, even her earlobe felt like it was pinching and had fatigue. On 18Aug2021 she woke up with sweats. The patient stated that "After the booster on 15Aug2021, the next day she reports she got a headache, felt really sick the next day and yesterday; had a fever of 101 and felt an aching burning sensation, even her earlobe felt like it was pinching then at the site of the injection she has a four inch by two inches red red area and it had a lump that may have gone down some; and it is itchy. Adds she also felt fatigue. Adds the ache she would guess it was some kind of vagal response, anytime she felt pain she could feel it projecting to another part of her body, like ants running in her body and her nerves were so high pitched she couldn't sleep. Today her arm maybe is a little less lumpy; and she doesn't feel nearly as bad as Sunday; and today her temperature is normal. Mentions there is no sign of blood so the lump on her arm is not like a hematoma. Adds the worst was on Sunday; she woke up with sweats like menopause. Today she reports all of her symptoms have gone away, except the lump on her arm and it is improved. Adds she would not have called except for the arm. She is asking is this normal or is it something she should be concerned about?. Treatment: Mentions she would have gone to the emergency room if it had not gotten better. Caller confirmed she did not contact her doctor and did not report any treatment". Patient had not visited emergency room or physician office for the events. The patient underwent lab tests and procedures which included body temperature which showed fever of 101 on 17Aug2021 (yesterday) and was normal on 18Aug2021. The outcome of the event vaccination site lump was recovering at the time of report and patient had recovered from the event feeling sick and headache on 17Aug2021 and from event fever on 18Aug2021and was recovered from rest of the other events on an unspecified date in 2021.The outcome was unknown for the event extra dose administered. The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow-up.

Other Meds: ATENOLOL; BENICAR; OMEPRAZOLE; LIPITOR; FLECAINIDE

Current Illness: Arrhythmia

ID: 1681791
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/16/2021
Rec V Date: 09/08/2021
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 Name: Covid test; Result Unstructured Data: Test Result:COVID-19 diagnosis

Allergies:

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

Symptoms: Covid diagnosis; Covid diagnosis; This is a spontaneous report from a contactable consumer (parent). A 27-year-old male patient received an unknown dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization at workplace clinic. Medical history and concomitant medications were not reported. Patient previously received Psyllins on an unspecified date and experienced allergy. Patient did not receive any other vaccine within four weeks of COVID-19 vaccine. Patient was not tested for COVID prior vaccination. On 16Aug2021, patient was diagnosed with COVID-19. Patient was tested for COVID-19 post vaccination on an unspecified date [test type: unknown] and had diagnosis of COVID-19. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment in response to the event. Outcome of the event was resolving. That information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1681792
Sex: F
Age:
State:

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/08/2021
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: extreme dizziness; weakness; heart was racing; had trouble walking; This is a spontaneous report from a contactable consumer. This 59-year-old female consumer (patient) reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 16Aug2021 as dose 1, single (age at vaccination: 59 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Aug2021, she experienced extreme dizziness and weakness, my heart was racing immediately after receiving the shot. It was pretty bad for one hour, had trouble walking and with 2-3 hours it was completely gone and queried that she had a side effect after first dose and if she should get the 2nd Pfizer covid vaccine dose. The clinical outcome of the events was resolved. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681793
Sex: F
Age:
State:

Vax Date: 08/14/2021
Onset Date: 08/16/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: swollen lymph nodes in the groin area; she had bumps all over her body, painful to the touch, in her groin, collar bone, and arm; she had bumps all over her body, painful to the touch, in her groin, collar bone, and arm; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 14Aug2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. On 16Aug2021, two days after receiving the dose, the patient experienced swollen lymph nodes in the groin area, she had bumps all over her body, painful to the touch, in her groin, collar bone, and arm. The bumps are on the side of the body where she received the vaccine, the left side. The patient reports feeling the same today, according to the caller. Outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1681794
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Since having the vaccine though, the patient is reporting that she sleeps all through the day, wakes up and then goes back to sleep; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of ad-ministration on an unspecified date in 2021 as dose 1, single for covid-19 immunisation. Patient medical history included insomnia from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Caller reported after having the Pfizer COVID-19 Vaccine she was having a harder time with her sleep schedule. She stated she previously, after the first dose had insomnia on an unspecified date in 2021 and took sleeping medications. The outcome of the events was not recovered. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681795
Sex: F
Age:
State: HI

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 09/08/2021
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: Started to feel a little weird; extreme thirst; nausea/started feeling nauseous again; After she ate, she started to get a weight on her chest; pressure; Difficulty Breathing; Couldn't Breathe; allergic reaction; hyperventilated, she couldn't catch her breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration, administered in arm left on 03Apr2021 14:00 (at the age of 58-year-old) at dose 1, single for covid-19 immunisation. Medical history included Flu shot she only had a sore arm; NDC, Lot, Expiration Unknown. Reporter states during the measles outbreak a few years ago, she took the MMR and was totally fine. Reporter stated she is highly sensitive to everything, food, medications, she is a very sensitive individual. Prior Vaccinations (within 4 weeks) were none. Concomitant medications were not reported. On an unspecified date 2021 the patient experienced hyperventilated, she couldn't catch her breath, allergic reaction on 03Apr2021 patient experienced difficulty breathing; couldn't breathe, started to feel a little weird, extreme thirst, nausea/started feeling nauseous again, after she ate, she started to get a weight on her chest; pressure. Reporter stated she received the first dose of the Pfizer-BioNtech Covid-19 vaccine in April, and she experienced difficulty breathing, she states that she's highly sensitive to the vaccine and the standard dose is high for her but she needs to be protected. She would like to know if and where she can receive a lower dose of the vaccine similar to the dose for children. Stated the reporter had her first dose in Apr, she didn't give the specific date. Reporter reported after that she encountered difficulty breathing but provided no other information. Reporter stated the caller called to see if she could get a lower dose of the vaccine like they are giving to children, because she is sensitive and the regular dose is too high for her. Reporter stated she knows that the 10mcg dose, she read, is being given to the 5-11 yr old group and the babies are being given a 3mcg dose. Reporter stated she knows the 5-11 year old dose is getting approved in September. Reporter stated the caller states he is very, very upset that she was told she had an allergic reaction, because she doesn't think she had an allergic reaction and she is very frustrated. Reporter stated she contacted the , and she believes her PCP reported it already but she can not be certain because she has no report number. Reporter stated she went and saw someone at her doctor's office and she asked for it to be reported, but she is not sure if she really did report it. Reporter stated the first time she went to the doctor, she took the first available appointment, so she saw a new physician and she asked for it to be recorded, but the doctor probably blew her off because she said just go get your second shot. Reporter stated she had been looking online and it said don't do it. Reporter stated she went back again to follow up with her doctor, said she said she wanted it reported and she stressed that to her so she probably did. Reporter stated her doctor is one of the head administrators and she actually had to beg to get her as her doctor, usually they just assign patients to a rotating doctor, but she got a higher up administer that also sees patients. Reporter stated after the 15 minutes they came around and asked if she is okay. Reporter stated she started to feel a little weird but she thought she was okay. Reporter stated by the time she got to her vehicle, she had extreme thirst and nausea, this was about 25 minutes after her vaccine. Reporter stated she chugged and chugged water and then it kind of went away for a good hour or 2 and then she started feeling nauseous again and drinking water and decided she needed to eat something, so she ate and then it was like after she ate, she started to get a weight on her chest so she laid down and tried to relax. Reporter stated the pressure lasted 4 hours and then all of a sudden that pressure released. Caller states her initial reaction from the shot was from 2:00pm until 9:00pm. Reporter stated and then she still had difficulty breathing through 07Apr2021. Reporter stated Sunday was the next day, and she thought this is not a normal reaction. Reporter stated she was expecting fever, headache, aches and pains. Reporter stated she was looking at the side effects and said oh no, this is considered an allergic reaction. Reporter stated she was on the phone Monday morning to her doctor's office. Reporter stated she probably should've gone to the hospital but she was too afraid to move, she thought she needs to lay down and keep relaxed and hydrated and concentrate on breathing. Reporter stated on Monday when they called her back, she kind of had to run a bit for her phone and she almost hyperventilated, she couldn't catch her breath. Reporter stated she would not go get the second shot, she can't get the full dose. Caller states she is willing to try a lower dose. Treatment: None, Reporter stated when she talked to the doctor's office, she talked to the nurse, and she said she is not the only one calling with those same symptoms, and they should dissipate in 3-5 days. Caller states the nurse said she should have gone to the ER or the fire station to have her vitals checked. Caller states she lives near the fire station but she didn't think about it. Reporter stated she guesses everyone will make her wait until the lower dose comes out. Reporter stated the previous agent basically said the lower dose is not approved and it has never been studied in her age group. Reporter stated she is going to have to do something because she is anticipating this is not even going to go away and we'll probably be in the pandemic probably for 3 years because people won't get their shots. Caller states she can't be a prisoner for the rest of her life, she has to try something. Adverse events required a visit to Physician Office. Description of Product Complaint: Description of complaint: Covid Vaccine; called to see if she could get a lower dose of the vaccine like they are giving to children, because she is sensitive and the regular dose is too high for her. Pfizer Covid 19 vaccine- caller is a 58-year-old female who received the first dose in Apr and had difficulty breathing after the dose. She is asking if she can get a lower dose of the vaccine, such as what is being given to children, as her second dose and where she can receive it. She is very sensitive. The regular dose is too high for her due to her side effect from the first dose. Caller states: Its too strong for me. It overwhelmed my body and then I had difficulty breathing. Reporter stated this has happened before and too much of anything and this happens. I need to find a dose I can tolerate. She stated she does not think she is allergic to the vaccine. She states she has read the 5-11 year old study is giving a 10mcg dose and there is a 3mcg for the baby dose. She knows the 5-11 year old are supposed to be approved in September. "I need to be protected. I want to be protected. I need someone to help. Its ridiculous. If I can't tolerate that what am I supposed to do? She called CDC and told her doctor she wanted it reported. She didn't follow up with the office to ensure it was reported and does not have a report number. She stated she does not think she is allergic to the vaccine. Question: I need to be protected. I want to be protected. I need someone to help. Its ridiculous. If I can't tolerate that what am I supposed to do. Outcome of the events hyperventilated, she couldn't catch her breath, allergic reaction was unknown, Difficulty Breathing; Couldn't Breathe was resolved on 07Apr2021, remaining other events was resolved on 03Apr2021.

Other Meds:

Current Illness:

ID: 1681796
Sex: M
Age:
State:

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/08/2021
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: received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021; received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021; achiness; metallic taste in his mouth; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 16Aug2021 as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) on an unspecified date for COVID-19 immunization. It was reported that a 48 year male "received his third dose/booster dose of the Pfizer COVID 19 vaccine on 16Aug2021" and since then had "achiness, which has gone away", but "still has a metallic taste in his mouth". The patient had not seen this listed as a common side effect. He was wondering if this had been reported. "Because it is not getting any better". The outcome of the event achiness was reported as resolved on an unspecified date in 2021. The outcome of the event "metallic taste in his mouth" was reported as not resolved. Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.

Other Meds:

Current Illness:

ID: 1681797
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: she could "barely walk after the 2nd dose/had to help her walk around for a couple days; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's wife) that: A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and was fine after first dose. On an unspecified date after receiving second dose of vaccination, patient could barely walk. Patient couldn't walk, her husband (reporter) had to help her walk around for a couple days. Reported also mentioned that patient had loss of both his mother and grandmother, although they did not pass due to COVID related illnesses. When probing for information regarding the caller's wife he reports she was ok now, he was concerned for her when it happened. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681798
Sex: F
Age:
State:

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: her arm hurt more and she could feel a lump/nodule and the muscle feels hard; her arm hurt more and she could feel a lump/nodule and the muscle feels hard; low grade fever of 100.5 degrees Fahrenheit; red rash; flu like symptoms; Extra dose administered; the injection site became tender; malaise; injection site soreness in right arm; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old female patient received third dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Aug2021 08:30 (age at vaccination:50 Years) as DOSE 3, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination. Medical history included renal transplant from 1998 to an unknown date. The patient's concomitant medications were not reported. Patient previously received first dose bnt162b2(BNT162B2, solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2(BNT162B2, solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on 30Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced the injection site became tender on 17Aug2021, malaise on 17Aug2021, her arm hurt more and she could feel a lump/nodule and the muscle feels hard on 18Aug2021, her arm hurt more and she could feel a lump/nodule and the muscle feels hard on 18Aug2021, low grade fever of 100.5 degrees fahrenheit on 18Aug2021, red rash on 18Aug2021, flu like symptoms on 18Aug2021, injection site soreness in right arm on 17Aug2021 , extra dose administered on 17Aug2021 08:30. No relevant tests were reported. The outcome of the events vaccination site pain recovering, the outcome of the event malaise was recovered, the outcome of the events vaccination site pain, pain in extremity, nodule, pyrexia, rash erythematous, Influenza like illness, Extra dose administered was unknown. PSCC Communication: She declined report number and phone number prior to attempted transfer to USMI. Caller agreed to be placed in the queue to hold for next available agent. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681799
Sex: M
Age:
State: CA

Vax Date: 04/12/2021
Onset Date: 07/01/2021
Rec V Date: 09/08/2021
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: 202103; Test Name: Resting Heart Rate (RHR); Result Unstructured Data: Test Result:63 beats per minute (bpm); Comments: utilizing Blood Pressure Monitors, Finger Pulse Oximeter, and Fitbit wrist monitor; Test Date: 202105; Test Name: Resting Heart Rate (RHR); Result Unstructured Data: Test Result:63 beats per minute (bpm); Comments: utilizing Blood Pressure Monitors, Finger Pulse Oximeter, and Fitbit wrist monitor; Test Date: 202107; Test Name: Resting Heart Rate (RHR); Result Unstructured Data: Test Result:52 bpm; Test Date: 202108; Test Name: Resting Heart Rate (RHR); Result Unstructured Data: Test Result:47-48 bpm; Test Date: 202108; Test Name: Resting Heart Rate (RHR); Result Unstructured Data: Test Result:42-40 bpm

Allergies:

Symptom List: Tremor

Symptoms: Adverse Event is an Acute and continuous drop in my Resting Heart Rate (RHR). As recorded and filed, utilizing Blood Pressure Monitors, Finger Pulse Oximeter, and Fitbit wrist monitor; my RHR was rec; Adverse Event is an Acute and continuous drop in my Resting Heart Rate (RHR). As recorded and filed, utilizing Blood Pressure Monitors, Finger Pulse Oximeter, and Fitbit wrist monitor; my RHR was rec; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 13:30 (at the age of 62-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient had no covid prior vaccination. The patient had no known allergies. Concomitant medication(s) included Losartan potassium taken for an unspecified indication, start and stop date were not reported. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 13:30 (at the age of 62-year-old), as single for covid-19 immunisation. No other vaccine in four weeks. The patient had not been covid tested post vaccination. On an unspecified date in Jul2021, the patient experienced an acute and continuous drop in his resting heart rate (RHR). The clinical details of the events as follows: An Acute and continuous drop in his Resting Heart Rate (RHR). As recorded and filed, utilizing Blood Pressure Monitors, Finger Pulse Oximeter, and Fitbit wrist monitor; patient RHR was recorded at 63 beats per minute (bpm) in March and May, no monitoring in June 21, and between 7/1 - 7/14/21 RHR was dropped to 52 bpm, and from 7/15-8/18 dropped to 47-48 bpm. Further nightly sleeping RHR via Fitbit devices reflects lows of 42-40 bpm. The events were resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received to treat the events. The patient outcome of the events was not resolved at the time of this report. No follow-up attempts possible. No further information expected. Information on lot number already obtained.

Other Meds: LOSARTAN POTASSIUM

Current Illness:

ID: 1681800
Sex: F
Age:
State:

Vax Date: 08/16/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: headaches; she felt weak; having a little bit of a temperature; had to ice arm because it felt swollen and painful; had to ice arm because it felt swollen and painful; sweating; felt hot; This is a spontaneous report from a contactable consumer reported for herself. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 16Aug2021 (at the age 42-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. On 16Aug2021 (Monday), having headaches after injection of Pfizer covid-19 vaccine. On Monday, when patient got it, patient felt weak. Patient read the paper they gave her that said it was normal and little bit of a temperature, but that was fine. Yesterday, patient felt really weak, had headaches, and had to ice arm because it felt swollen and painful. The headaches come and go. This morning, patient could not even get out of bed; felt really weak. Describes headache as the top portion of it (her head) was pulsating, hurting. States this was too much. Patient was tearful. States that patient knows it was part of the side effects, but thought it was more with the second dose. Patient works in front of computer, but can't with this. Patient was trying to clean up a little bit, but was sweating like crazy. Patient told her son it felt hot, he said its not hot. Patient was supposed to go back to work yesterday and today, but could not. Asked what patient should do, keep taking Tylenol. The outcome of the event pyrexia was unknown while other events were not recovered. The lot number was not provided. Information on lot number has been requested during follow up.

Other Meds:

Current Illness:

ID: 1681801
Sex: F
Age:
State: CA

Vax Date: 02/20/2021
Onset Date: 07/26/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: a rough UTI; This is a spontaneous report from a contactable consumer (patient herself). This consumer reporter similar events for three patients. This is First of three report. A 66-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6200; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 20Feb2021 (at age of 66-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included, ongoing sjogren's syndrome; compromised immune system. There were no concomitant medications. Family Medical History Relevant to AE(s); caller stated 2 other family members also had UTIs after the Pfizer Vaccine. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9261; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 30Jan2021 (at age of 65-years-old) as DOSE 1, SINGLE for COVID-19 immunization. AE(s) following prior vaccinations: Caller stated two years ago, she got a combo of 4 shots, the pneumonia, flu, tetanus and another one all at the same time and she would not say it was an adverse reaction but she was down for several days because of it. Caller stated she will never do that again. NDC, Lot, Expiration: Unknown. Additional Vaccines Administered on same date of the Pfizer suspect was reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Caller stated that she received both doses of the Pfizer COVID-19 vaccine, her second one being administered on 20Feb2021 and had recently experienced a rough UTI on 26Jul2021. Caller stated that she was not prone to getting them and was wondering if they were connected to the vaccine. She stated that two of her family members have also had UTIs around the same time, within a month or so. She stated that she just recently went through a UTI, and she was not prone to them and it was a tough one. She stated she has to be on three different types of medications before it knocked it out and it lasted about two weeks. Caller stated that one family member was in the hospital and the reason was originally for a UTI, and her sister-in-law had to go to the emergency room for a UTI. She was looking for any connection to the vaccine and UTIs in the 55 year and older population. Caller stated she was curious about whether or not there was any data on possible UTIs several months after taking the vaccine. Adverse event resulted in physician office visit. Patient had received treatment for AEs. Treatment: Caller stated she had to get a second round of different antibiotics because the first one was not correct. Caller stated the first medication was Amoxicillin and she was given that because didn't want to go in to the doctor. NDC, Lot, Expiration: Unknown Pharmacy Bottle. Caller stated when she got to the urgent care they gave her a combination of Phenazopyridine 200mg and Nitrofurantoin Mono-MCR 100mg after they did the culture, but it did not work. NDC, Lot, Expiration: Unknown. Pharmacy Bottle. Caller stated the expiration is Feb2023. Caller stated she waited until the 6th day of the UTI to go to the Urgent Care. Caller stated then they gave her another one that was a 5 day Steroid that knocked it out. Relevant tests were none. The outcome of event was recovered on 08Aug2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101070859 same reporter/drug/AE with different patient;US-PFIZER INC-202101070858 same reporter/drug/AE with different patient

Other Meds:

Current Illness: Sjogren's syndrome (compromised immune system)

ID: 1681802
Sex: F
Age:
State:

Vax Date: 08/16/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
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: shortness of breath/ she is gasping for air.; This is a spontaneous report from contactable Physician. A 69-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 16Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date of Aug2021, the patient experienced shortness of breath. Reporter stated that patient had been having shortness of breath when talking. She had been fine when going up and down stairs and when walking. But when talking it's like she is gasping for air. The event was assessed as non-serious. 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: 1681803
Sex: M
Age:
State:

Vax Date: 08/16/2021
Onset Date: 08/18/2021
Rec V Date: 09/08/2021
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: Developed a rash today 18Aug2021 on his left arm that has spread to the back of his neck; Swollen lymph nodes; This is a spontaneous report received from a contactable pharmacist. A 15-years-old male patient received unknow dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 16Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter called about a patient who received the Pfizer Covid-19 vaccine on 16Aug2021 and developed a rash today 18Aug2021 on his left arm that has spread to the back of his neck and has developed swollen lymph nodes as well. Health care professional was asking how long will it be before the above rash will disappear and if there are treatment recommendations for the rash. The outcome of the events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681804
Sex: M
Age:
State: RI

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: Temperature; Result Unstructured Data: Test Result:Up; Comments: his temperature is up; Test Name: Breathing test; Result Unstructured Data: Test Result:Lower than 300; Comments: breathing meter goes lower than 300

Allergies:

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

Symptoms: Fever; Pain; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program COVAX US Support. A 78-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number: EL9267, Expiry date: was not reported) via an unspecified route of administration on 23Feb2021(at the age of 77-year-old) as dose 1, single and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number: EN6208, Expiry date: was not reported) via an unspecified route of administration on 16Mar2021 11:00 as dose 2, single for covid-19 immunization. Medical history included Lung problems from an unknown date and unknown if ongoing Verbatim: Lung problems, Blood pressure high from an unknown date and unknown if ongoing Verbatim: Blood pressure high, Diabetes from an unknown date and unknown if ongoing Verbatim: Diabetes , asthma from an unknown date and unknown if ongoing Verbatim: Asthma , severe bronchitis from 2000 to an unknown date he was getting severe bronchitis twice a year , pneumonia from an unknown date and unknown if ongoing He was in Oregon and he went to his Pulmonologist's office twice within 6 months with Pneumonia , immunocompromised from an unknown date and unknown if ongoing He states because he is immunocompromised, Temperature is up, Wheezing, Cough, breathing meter goes lower than 300. The patient's concomitant medications were not reported. The patient previously took flu, Pneumonia shot, cortisone inhalant for asthma, prednisone for cough, Azithromycin for Temperature is up, Prednisone for wheezing. Additional Vaccines Administered on Same Date of the Pfizer Suspect and AE(s) following prior vaccinations was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. Reporter stated that he already got the first and second dose of the Pfizer Covid Vaccine back in February and March. Reporter stated he was immunocompromised and has low immunity in any viruses. Reporter was advised to get the booster shot or the third dose of the Pfizer vaccine. After he got the second dose the vaccine or in between the doses, he experienced fever and pain. He also mentioned her lung problems and that he had blood pressure and diabetes. Basically, the reporter wanted to know was it good to take the third dose or the booster shot or was it better to get the Moderna Vaccine for the the third shot. Reporter also clarified the fever and pain (on 2021) occurred after the first dose and after the second dose for a couple of days and then it was all gone. On an unspecified date the patient underwent lab tests and procedures which included body temperature: up as his temperature is up, investigation: lower than 300 as breathing meter goes lower than 300. The patient did not visit to Emergency Room or Physician Office. The clinical outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681805
Sex: F
Age:
State: AR

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 09/08/2021
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: Test Date: 20210805; Test Name: Covid test; Test Result: Positive ; Comments: she tested positive for Covid on 05Aug2021, and quarantined until 14Aug2021

Allergies:

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

Symptoms: after her first Covid vaccine, she felt a little tired and fatigued; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on Feb2021 at the age of 43-years-old as DOSE 1, SINGLE for covid-19 immunization. Medical history included immune thrombocytopenia from 2004 and ongoing Caller believes she was diagnosed in 2004 , splenectomy from an unknown date and unknown if ongoing she does not have a spleen, so she tends to get sicker and stay sicker longer than most people. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was diagnosed with Covid 19 and has been tested for Covid-19 Since the vaccination. On Feb2021 the patient experienced after her first covid vaccine, 4-6 hours after the vaccine ,she felt a little tired and fatigued .The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 05Aug2021 she tested positive for Covid on 05Aug2021 and quarantined until 14Aug2021. On an unspecified date in Feb2021, the patient had recovered from the events. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness: Immune thrombocytopenia (Caller believes she was diagnosed in 2004.)

ID: 1681806
Sex: U
Age:
State:

Vax Date: 03/17/2021
Onset Date: 03/01/2021
Rec V Date: 09/08/2021
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: lymph nodes in my neck at very swollen; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 2 via an unspecified route of administration on 17Mar2021 (Batch/Lot number and Expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced lymph nodes in my neck at very swollen. It was reported that the patient had a reaction with the lymph nodes in my neck at very swollen and the doctor sent me for two needle biopsy's and one surgical biopsy and was wondering if the patient was allergic to 'penicillin' (Further not clarified) but actually wanted to know what was there in the shot that the patient took. Further probing could not be done as consumer was unwilling to complete the report and wanted to transfer the call to the Pfizer Medical Information Department. Hence limited information was available over the call. The clinical outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681807
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: He knows someone who now has tinnitus (ringing in the ears) right after second of covid vaccine; This is a spontaneous report received from a contactable consumer via Pfizer sponsored Program. A patient of unspecified age and gender received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported),via an unspecified route of administration on an unspecified date as Dose 2,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The reporter stated that he knows someone who now has tinnitus right after second of covid vaccine on an unspecified date.Medical inquiry forwarded or referred to MI.The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101069074 same reporter, same drug/event, different patient

Other Meds:

Current Illness:

ID: 1681808
Sex: M
Age:
State: FL

Vax Date: 05/03/2021
Onset Date: 07/23/2021
Rec V Date: 09/08/2021
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: My entire body had hives; stomach as incredibly painful; manageable swelling (edema) and hives on my face, scalp, hands, arms, back, and feet.; manageable swelling (edema) and hives on my face, scalp, hands, arms, back, and feet.; manageable swelling (edema) and hives on my face, scalp, hands, arms, back, and feet.; experience some stomach discomfort; allergic to wheat or gluten intolerant; This is a spontaneous report from a contactable consumer (reported for himself). A 24-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0171), via an unspecified route of administration, administered in arm left on 03May2021 (age at vaccination was 24-year-old) as dose 2, single for covid-19 immunisation in school or student health clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8729), via an unspecified route of administration, administered in arm left on 09Apr2021 (age at vaccination was 24-year-old) as single for COVID-19 immunisation. The patient was not diagnosed with COVID prior vaccination. Roughly two months (23Jul2021) after the second dose, the patient experienced random minor and manageable swelling (edema) and hives on my face, scalp, hands, arms, back, and feet and also experienced some stomach discomfort at times. This continued to occur for roughly two weeks, taking place hours after eating gluten/wheat without me realizing the connection because it was not severe enough for me to be worried. The patient had a severe outbreak in (23Jul2021) mid-July2021 hours after eating and drinking a large amount of gluten/wheat paired with many beers. Patient stated that "my entire body had hives, my face, hands, and feet were swollen, and my stomach as incredibly painful". Since this outbreak the patient had cut out gluten, wheat, and alcohol and had not experienced any symptoms since. On an unknown date 2021, the patient believes the vaccine made the patient allergic to wheat or gluten intolerant, as the patient was not previously allergic to these ingredients. As a result, the patient had to visit an urgent care site to receive a prednisone shot and antihistamine shot to subside the symptoms. Since the vaccination, the patient was not tested with COVID-19. The outcome of the other events was resolved with sequel on an unknown date 2021. The outcome of the event allergic to wheat or gluten intolerant was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681809
Sex: U
Age:
State: IA

Vax Date: 03/20/2021
Onset Date:
Rec V Date: 09/08/2021
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: 2021; Test Name: Biopsy; Result Unstructured Data: Test Result:skin cancer

Allergies:

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

Symptoms: skin cancer; site has never healed. It scabs over, then the scabs fall off and it bleeds again; site has never healed. It scabs over, then the scabs fall off and it bleeds again; This is a spontaneous report from a contactable consumer (patient) reported for self that forwarded as an adverse event by the epsilon escalation team on 18Aug2021. A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection, Lot number was not reported), via an unspecified route of administration on 20Mar2021 as dose 2, single for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), on unspecified date as dose 1, for covid-19 immunisation with no reaction. The patient got the 2nd covid shot on 20Mar2021. The site has never healed. It scabs over, then the scabs fall off and it bleeds again. This has happened multiple times. The patient had a punch biopsy and it came back as skin cancer in 2021. The patient never had any sign of skin cancer before got the second shot. Patient was never one of those people who had crazy ideas about the vaccine but what has happened to patient was too strange to ignore. The patient underwent laboratory data and procedures which included biopsy showing skin cancer in 2021. 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: 1681810
Sex: M
Age:
State:

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 09/08/2021
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: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. The patient experienced feeling bad, unspecified, after second vaccine. Caller states he is calling about the Covid 19 shot, reclarified as Pfizer. Caller states he took the second shot on Tuesday. Caller states ever since, he is feeling bad. Caller states he takes no medicine. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1681811
Sex: F
Age:
State: NC

Vax Date: 05/13/2021
Onset Date:
Rec V Date: 09/08/2021
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: pain in her shoulder in the exact place she got the shot/ pain at the injection site; This is a spontaneous report from a contactable nurse (patient) received from a Pfizer Sponsored Program. This is report one of three. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0167, Expiration date: not reported), via an unspecified route of administration in arm left on 13May2021 at 11:22 AM (at the age of 38-year-old) as a dose 2, single for COVID-19 immunization. The family medical history included shoulder pain, the patient (mother) did have shoulder pain before getting the vaccinations. The patient's medical history included epilepsy from an unspecified date in 2016 and unknown if ongoing, secondary to domestic violence, anaemia, from all her life, fracture of her shoulder, from 17 years old and refractured in 2016, ongoing seizures, she has seizures and she doesn't know what she was doing, she gets beat up with the seizures so she did have shoulder pain before getting the vaccinations, ongoing sleep disorder and ongoing post-traumatic stress disorder. The patient's concomitant medications included ongoing acamprosate calcium (CAMPRAL), 500 mg, 2x/day, oral, taken for seizure, ongoing trazodone, 50 mg, 1x/day (at night), taken for sleep, ongoing prazosin, 1 mg, 1x/day (at night), taken for PTSD. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8735, Expiration date: not reported), via an unspecified route of administration in arm left on 22Apr2021 at 10:22 AM (at the age of 38-year-old) as a dose 1, single for COVID-19 immunization and experienced pain in her shoulder in the exact place she got the shot. It was reported that, the history of all previous immunization with the Pfizer vaccine considered as suspect: Vaccine name: Pfizer COVID-19 vaccine. Prior vaccinations (within 4 weeks) were reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. The AE(s) following prior vaccinations reported as she usually has pain in the place she gets the shot for all vaccines, no product information to provide NDC, lot or expiration date. On an unspecified date, the patient experienced pain in her shoulder in the exact place she got the shot/ pain at the injection site. The caller clarified that, she was called regarding the Pfizer COVID-19 vaccination and the date of the second dose was supposed to be 24Jun2021 and she was a registered nurse. Added that, she doesn't know whether they would get the second dose or have to start over. The caller stated that, she was seen at the hospital but not for her neuro problems. No specific provider was provided. Stated that, no NDC, expiration date or dose seen on her vaccination card, she added that, she received them at the (name withheld). Added that, since she got hers, since she got both shots she has had pain in her shoulder in the exact place she got the shot. Stated that, the patient experienced mild shoulder pain. Added that, she does have history of an old shoulder fracture because she plays sports and she has seizures and she doesn't know what she was doing, she gets beat up with the seizures so she did have shoulder pain before getting the vaccinations. When asked for seriousness, she rated it as non-serious and when asked for causality she stated as no, not related to the product. Added she thinks that, she just has a pulled muscle or she slept on it wrong. Stated that, she didn't get any treatment. Stated that, it only bothers her occasionally like when she picks up groceries. Stated that, it was always like, pain at the injection site, even when she got shots as a teenager, too. Stated that, she doesn't have any information about those vaccinations, they were just regular vaccinations. No NDC, lot or expiration date provided for any other vaccinations with injection site pain. The AE(s) did not require a visit to emergency room and physician office. Treatment was not received for the event. The relevant tests were reported as none. The outcome of the event was recovering.

Other Meds: CAMPRAL; TRAZODONE; PRAZOSIN

Current Illness: Post-traumatic stress disorder; Seizures (she gets beat up with the seizures so she did have shoulder pain before getting the vaccinations.); Sleep disorder

ID: 1681812
Sex: F
Age:
State:

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 09/08/2021
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: armpit is aching; She had her 3rd dose yesterday; She had her 3rd dose yesterday; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on 18Aug2021 as dose 3, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient historical vaccine included first dose of BNT162B2 as dose 1, single and second dose of BNT162B2 as dose 2, single for COVID-19 immunization. On 18Aug2021, the patient experienced armpit is aching, she had her 3rd dose yesterday. It was further stated that, caller stated that she was calling about the Covid Vaccine, specifically the 3rd vaccine. She has a question about a concern. She has had no real problems with the first and 2nd dose. She had her 3rd dose yesterday and with her armpit, on the side where she got the shot, the armpit is aching. Caller wants to know if this is a normal side effect. Caller consents to safety report, but when this call handler attempts to start the safety report caller said before she answered questions she wanted to just know is this a normal side effect. The clinical outcome for all the events was reported as unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1681813
Sex: F
Age:
State:

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

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

Lab Data: Test Name: WBCS; Result Unstructured Data: Test Result:Low

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: she received her 1st and 2nd Pfizer vaccine doses she was "a little headachy.; This is a spontaneous report from a contactable consumer (Patient). 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date single for covid-19 immunisation. Medical history included neoplasm malignant, white blood cell count decreased. The patient's concomitant medications were not reported. The patient previously took chemotherapy nos. She received Pfizer covid vaccine both 1st and 2nd doses with no problem. She stated when she received her 1st and 2nd Pfizer vaccine doses she was "a little headachy. The reason she received her 3rd dose was she had "cancer last year and she had chemo and she still have low WBCs." Is this a normal side effect? and will it go away? The patient underwent lab tests and procedures which included white blood cell count: low. The outcome of event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681814
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: This is a spontaneous report from a noncontactable consumer or other non-HCP. The consumer (patient's mother) reported for a 17-year-old female patient (daughter) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient experienced a fast heart rate and breathing problems on an unspecified date. The outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1681815
Sex: F
Age:
State:

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 09/08/2021
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: extreme pain to the Right hip and leg; extreme pain to the Right hip and leg; muscle pain; This is a spontaneous report form a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 11Feb2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. The patient who received the second dose of the Pfizer Covid vaccine on 11Feb2021 and 2 weeks after began to extreme pain to the Right hip and leg. "she was able to walk, but it was extremely painful, it took 5 months for her to be able to put full weight on her foot." Reporter asking has anyone else reported muscle pain as a side effect of the Pfizer Covid vaccine? What was a few people or a lot that reported this side effect? 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:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am