VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1774390
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: rash; This is a spontaneous report from non-contactable consumer (patient). A female patient of an unspecified age BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date: Not reported), via an unspecified route of administration, administered in Arm, on an unknown date in Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Mar2021, after first vaccination (on Saturday) patient experienced a rash on her forearm and wanted to know what to do and how to treat the rash. The clinical outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774391
Sex: F
Age:
State:

Vax Date: 04/10/2021
Onset Date:
Rec V Date: 10/09/2021
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: her whole left side where her arm all the way to her elbow and around her back its hurting; headaches; her whole left side where her arm all the way to her elbow and around her back its hurting; her whole left side where her arm all the way to her elbow and around her back its hurting; her whole left side where her arm all the way to her elbow and around her back its hurting /Verified that she was referring to injection site; up to her neck it hurts; maybe that's part of the body aches; it's like some weight is on me; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 10Apr2021(Saturday) (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, patient experienced headache and this morning when she woke up her whole left side where her arm all the way to her elbow and around her back its hurting this has been since Saturday and verified that she was referring to injection site, up to her neck it hurts, it was like some weight is on her and maybe that's part of the body aches. Patient wants to know how long side effects will last and stated people say it couple of days, but it has been almost 5 days. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774392
Sex: F
Age:
State: CT

Vax Date: 04/08/2021
Onset Date: 04/09/2021
Rec V Date: 10/09/2021
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: Pain at the injection site; Numbness in left arm (location of the immunization); Fatigue; Headache; Full body aches; Intermittent chills; Hot flashes; Possible fever; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 08Apr2021 12:45 (at the age of: 48-years-old) as dose 2, single for covid-19 immunisation. Medical history included depression, insomnia and blood cholesterol increased from an unknown date . The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 18Mar2021 12:15 for covid-19 immunisation. The patient was non pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient received other medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Apr2021 08:00 the patient experienced pain at the injection site, numbness in left arm, fatigue, headache, full body aches, intermittent chills, hot flashes and possible fever. Therapeutic measures were taken as a result events with tylenol extra strength. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774393
Sex: F
Age:
State:

Vax Date: 04/08/2021
Onset Date: 04/13/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: my arm was really itchy; lump; This is a spontaneous report from a consumer (patient) reported for herself that. A 67-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Apr2021, the patient noticed her arm was really itchy and a lump there, not at the injection site, it's 2 inches over from the injection site. It was reported that, she laid on her left side all the time. Not sure if side effect or something else. Outcome of events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1774394
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: developed hives within an hour; This is a spontaneous case received from a contactable consumer from a Pfizer-Sponsored Program. A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unknown date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. According to the reporter, the patient received second dose of vaccine and developed hives within an hour and has not gone away. The outcome of the event was not recovered. No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1774395
Sex: F
Age:
State: MI

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Right arm is swollen and tingling/Right hand is numb and swollen; Right hand is numb and swollen; Right shoulder hurts; Arm is tingling; Fell on right arm; Hurst to move her right arm, hand, and shoulder; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 12:15 (at the age of 16-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no medical history and family history. The patient's concomitant medications were not reported. The patient had no other products. The patient had no history of previous immunizations. No additional vaccines administered on same date. The patient had no prior vaccinations within 4 weeks. The patient received first shot yesterday on 14Apr2021. On the same day, at night, she fell on her right arm when she was playing with her dog. On 15Apr2021, symptoms developed about 22 hours later in the morning. Her arm was experiencing pain, numbness and swelling, her right shoulder also hurts, but the dog jumped on her, so she was not sure if it was from the vaccine or not. She asked are these normal side effects. Her right arm was swollen, right hand was numb and swollen, asked if this could be from the shot. Right Arm was tingling. Hurst to move her right arm, hand, and shoulder. Caller was looking on her paperwork and didn't know if this was a side effect. Was it different in children. The patient did not visit any not yet. The patient had no relevant tests. The outcome of the event Fell on right arm was unknown and outcome of all other events was not recovered. Information on lot/Batch number has been requested. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774396
Sex: U
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: I have a rash that has appeared on my extremities (arms and legs); This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced i have a rash that has appeared on my extremities (arms and legs) on an unspecified date. Reported as, patient have a rash that has appeared on his extremities (arms and legs) since my first Covid shot. Patient was concerned about receiving the second shot. Patient was concerned about the rash spreading. Outcome of the event was unknown. No Follow-up attempts are needed. information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774397
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: Sore arm; Got chest pains; Headache; Chronic migrains; Pain in my neck; This is a spontaneous report from a contactable consumer or other non-HCP (patient) received via sponsored program. A 68-years-old patient of an unspecified gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single and received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization at Baylor Dallas downtown. Patient medical history included immune system disorder and heart problems. The concomitant medication included rizatriptan benzoate (MAXALT) taken as a 10 mg for unspecified indication start and stop date were not reported. The patient experienced sore arm until the next day it went away, got chest pains, headache, pain in my neck, pain in my left arm and chronic migrains on an unspecified date. The clinical outcome of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: MAXALT

Current Illness:

ID: 1774398
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: had pelvic pain; spotting; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, exactly 10 days after vaccine administration, the patient experienced pelvic pain and spotting. She stated this was not normal for her and she wants to speak to someone about side effects. Case assessed as non-serious by reporter. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774399
Sex: F
Age:
State: TX

Vax Date: 04/06/2021
Onset Date: 04/07/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: She slept 14 hours, but she is an insomniac; High pulse; Chills; Low grade fever; Really tired; Arm hurt a little; This is a spontaneous report received from a contactable female consumer. This 63- year- old consumer reported for herself that who received bnt162b2 (BNT162B2) solution for injection, dose 2 (Lot number and expiry date was not reported) via an unspecified route of administration. administered at arm left on 06Apr2021 (at the age of 63-years-old) as a single dose for covid-19 immunisation. Medical history included asthma, diagnosed about 15 years ago, hypertension from an unknown date and unknown if ongoing Diagnosed around 20 years ago, a couple years give or take. Concomitant medication(s) included hydrochlorothiazide, losartan potassium (LOSARTAN HCT) taken for blood pressure measurement, start and stop date were not reported; salbutamol (ALBUTEROL HFA) taken for asthma, start and stop date were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Time the Vaccination Was Given:(24-hour clock) First vaccine 1300, second vaccine 1400. Historical Vaccine BNT162B2 solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration. administered at arm left on 16Mar2021 as a single dose for covid-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available)- No never had issues with vaccine. Reporter was 60 years old, she received both doses of Pfizer-BioNTech COVID-19 Vaccine, first dose on 16Mar2021, second dose on 06Apr2021, after second dose she experienced: "she virtually had no immediate side effects at all, stated she used to say she's 5'7". Reporter does not have e-mail address and declined to provide HCP information at this time. States her doctor does not believe in the vaccine. The doctor would have said, "just wait until March and it'll all be over. She feels really tired, she arms was a little sore (From: 7Apr2021 to: 9Apr2021), no big deal no problem and hard to say if she started feeling this on 12Apr2021 or 13 APR 2021. She slept for 14 hours the night of the 12Apr2021 going in to the 13Apr2021. Last night she slept 12 hours, which doesn't usually happen, but she is still tired. She had a low-grade fever yesterday, but not today. She also monitors her blood pressure and heart rate every day and everything is normal. States her low-grade fever resolved sometime during the night. It didn't last longer than 24 hours. She said it is improving as long as it doesn't come back. Captured as provided by caller. Her fever was 100.3 Fahrenheit. She also had a slight chill around the time of the fever. Her pulse was up just teeny bit today. She doesn't know if this resolved until she checks it again. It wasn't high enough to raise any eyebrows. Her doctor would have shrugged because he didn't think she should get the vaccine. Symptoms were not treated in any way. Stated she received the vaccine because she doesn't want to die. She's not sceptical of the vaccine, and states she wanted to protect herself. Her son also told her to get the vaccine. No expiration date or NDC number for first or second vaccine on the card. Provides second vaccine lot number as ER8 (I believe its 7) 3, and (I hope this is an O and not a C). She didn't take anything new 2 weeks before. Takes Ibuprofen, but not every day for back problems. She did not take Ibuprofen the 2 days prior or at least 3 days after the vaccine. She read it could interfere with the vaccine. She occasionally takes Xanax but doesn't know what days she took it. She doesn't take it every day, but she took one the day of both vaccines. Since having the vaccine she took Tramadol twice, but it didn't have to do with the vaccine. It was for her bad back. She has a steroid inhaler but suspended its use during the vaccine process. Most recent blood work she had was couple months before the vaccine and it was normal. Reporter asked do she need to be concerned about it being something else or is this normal so far out from the vaccine?. PSCC Communication: Unable to warm transfer to Pfizer Medical Information as no agents are currently available. Placed in the queue as agreed by caller. Provided caller with phone number. Provided hours of operation. Refused website information. Outcome of the events was arm hurt a little, low-grade fever, chills, was recovered, really tired and somnolence was unknown. follow-up attempts are needed. No further information is expected.

Other Meds: LOSARTAN HCT; ALBUTEROL HFA

Current Illness:

ID: 1774400
Sex: F
Age:
State: TX

Vax Date: 04/10/2021
Onset Date:
Rec V Date: 10/09/2021
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: Got a ball like a golf ball as diameter at injection site/ I have got ball in my arm? I have got a ball about the size of a tennis ball; Rash near elbow but not injection site; Fever; Feeling down kind of not feeling well; Fatigue, tiredness; Dizziness; Nausea; Aching for few days all over the body; Very achy; arm is sore; Aching for few days all over the body but still feeling it at the injection site; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer- sponsored program. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 10Apr2021 as dose 2, single for COVID-19 immunization. Historical vaccine included 1st dose of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on 20Mar2021 for COVID-19 immunization. Medical history included diabetes mellitus and obesity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced got a ball like a golf ball as diameter at injection site/ i have got ball in my arm i have got a ball about the size of a tennis ball, rash near elbow but not injection site, fever, feeling down kind of not feeling well, fatigue, tiredness, dizziness, nausea, aching for few days all over the body, very achy, arm is sore, aching for few days all over the body but still feeling it at the injection site on an unspecified date. It was reported that, after received the 2nd dose she experienced injection site swelling about the size of a tennis ball, nausea, fatigue, fever and pain on the arm. Patient took it on Saturday and had got ball in her arm, got a ball like a golf ball as diameter at injection site and rash near elbow but not injection site. She was feeling still tired. After 4 days she had got a ball about the size of a tennis ball. It has not gone down. It was hot. Her arm was sore and she was still very achy and very fatigue. She asked if that was normal for this shot and could she have this reaction for this long. Also had fever for 1 day then it was ok also was feeling down kind of not feeling well. Added symptoms as fatigue, tiredness, dizziness, nausea, aching for few days all over the body but still felt it at the injection site. She enquired if rash, the ball on her injection site, the fatigue and not feeling well was normal. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774401
Sex: M
Age:
State: IL

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
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: body aches, joints/shooting pain; body aches, joints/joint, neck and shoulder pain after the first dose; fatigue; dozing on and off cause he's had no sleep; spasms; fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 14Apr2021 08:00 as dose 1, single for COVID-19 immunization. The patient medical history included two surgeries in his spine. Concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced body aches, joints, fatigue, neck and shoulder pain. Patient states that he dozing on and off cause he's had no sleep because it started getting to him at 02:00-03:00. He had spasms and shooting pain from his fusion, and his bad bones, the patient had got a lot of broken bones (inaudible side effects). Patient later mentioned fever, back of his skull, the fusion in his spine was standard but it's kicking more. Patient was wondering if he can take aspirin or tramadol. The outcome of all events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774402
Sex: M
Age:
State: TX

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 10/09/2021
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: A bruise on the left side of her mouth; Pain when swallowing and drinking water; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 23Mar2021 (at the age of 48-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced joint pain on 24Mar2021 with outcome of recovered, on an unspecified date he had a bruise on the left side of her mouth and pain when swallowing and drinking water. Reporter mentioned that he got the first dose of the Pfizer covid vaccine on 23Mar2021. The next two days he suffered from joint pain that went away on the third day. But one week after getting the vaccine, while he was eating, he felt that something under her tongue burst up and after a while that he checked this up, he said a bruise on the left side of her mouth. This got him pain when swallowing and drinking water. This has disappeared also. He mentioned that he should have received the second dose but when he went to the vaccination post and described his experienced, they changed his appointment and sent him to his doctor. He just wanted to know if he should get the second dose or not. He reported that, he read that there might be swelling on the lymph nodes after the vaccine, and he thinks that this is what happened to him. Case was reported as non-serious. PQC was not present. Outcome of the joint pain was resolved on 26Mar2021 whereas, rest of the events were resolved on an unspecified date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774403
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: face was swollen; tongue felt fat; This is a spontaneous report from a contactable consumer. A female patient with unknown age received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: unknown) through an unspecified route on an unspecified date as Dose 1 SINGLE for covid-19 immunization. The patient medical history included she had shellfish allergy. Concomitant medications were not reported. Reporter stated that she went last Saturday to get her first dose of the Covid vaccine at 4:15 in the afternoon and at 3 am her face was swollen, and tongue felt fat, She was afraid to go to the walk-in because she did not want to come in contact with someone who has Covid. She took Benadryl but that did not work. The patient was asked to take prednisone. The outcome of the event was unknown. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1774404
Sex: F
Age:
State: TX

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: allergic reaction; swelling of her eyes and face; swelling of her eyes and face; headaches; nausea; fever; body aches; This is a spontaneous report received from a contactable consumer (patient). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number-unknown, Expiry date-unknown) via an unspecified route of administration, on unspecified date of Apr2021 as Dose 1, Single for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. Patient experienced headaches, nausea, fever, bodyaches after first dose of the vaccine. On 14Apr2021 patient experienced allergic reaction that was manifested in swelling of her eyes and face. The patient received treatment with taken Tylenol, Ibuprofen and Aspirin it was reported that the medication had helped with 60% of the symptoms but have not eliminated them completely. The outcome of all events were recovering. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774405
Sex: M
Age:
State: IN

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: Blood Pressure; Result Unstructured Data: Test Result:121/72; Test Name: temperature; Result Unstructured Data: Test Result:98.2; Test Name: temperature; Result Unstructured Data: Test Result:98.5; Test Name: Pulse rate; Result Unstructured Data: Test Result:80; Comments: low; Test Name: Oxygen levels; Result Unstructured Data: Test Result:97-98

Allergies:

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

Symptoms: He only had 3 hours of sleep and was tired on Sunday.; diarrhea; slight headache; His face, neck and chest looked red; stomach ache; hot flashes; sweat; He only had 3 hours of sleep and was tired on Sunday.; got dizzy. Caller clarified not dizzy, but lightheaded.; He had a pain that came into his upper right chest lasting a few minutes and went away; can move his right arm well. It was swelled after both shots; sore arm with second dose; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration, administered in Arm Right on 07Apr2021 (on this past Wednesday) 10:20 (at the age of 47-year-old) as dose 2, single for COVID-19 immunisation. There were no prior vaccinations within 4 weeks. Medical history included ongoing high blood pressure, fibroneuropathy in his feet, tremors both arms and hands, mainly left (started in high school when he was drinking chocolate milk. His arms shook and it spilled all over), high cholesterol from early 2000s and ongoing, surgery from an unknown date and unknown if ongoing started after low back surgery 30 years ago, L5 fractured, had 2 rods and 4 screws into low back. He has it in his feet, heart disease runs on both sides of his family from an unknown date and unknown if ongoing. The patient has been on social security disability since 2014. He was 47 and feels like he is falling apart.The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration, administered in arm right on 17Mar2021 10:15 as dose 1, single for COVID-19 immunisation. He recovered completely from both episodes. He received both his doses in his right arm because he was right-handed, and it made it less sore and it did work. The patient stated that he did not know if his symptoms were side effects or not. On 07Apr2021, the patient got dizzy, Caller clarified not dizzy, but lightheaded, he had a pain that came into his upper right chest lasting a few minutes and went away, only had 3 hours of sleep and was tired on Sunday, can move his right arm well. It was swelled after both shots, sore arm with second dose. On 08Apr2021 (Thursday), the patient experienced hot flashes, that started the next day during the day, it made him sweat. The patient was fine on Friday and Saturday and he got them again Saturday night and only got three hours of sleep and was tired on Sunday. The patient had none on Sunday but was really tired due to no sleep. He did not have hot flashes on Monday, Tuesday or Wednesday of this week. The patient does not know what caused it was related to the Covid Vaccine or was it something he ate. On 14Apr2021, the patient had stomach-ache last night when he went to bed. He went to sleep at 10: 30. The patient added he was not young, and he cannot eat what he wants anymore. On 15Apr2021 13:30, the patient had diarrhea. The patient stated that last night at 1:30 he woke up with diarrhoea and ended at 4:00- 5:00. He had hot flashes at 12:30 and 2:30 last night. On 15Apr2021, the patient had slight headache, his face, neck and chest looked red. The patient stated it lasted a few minutes then goes away. He gets a slight headache when it happens. He took his temperature twice last night and it was 98.5 and 98.2. The patient asked what does Pfizer consider a fever. The patient stated that most of his side effects on the list had disappeared. He wanted to know how long the side effects can last after the second dose. He had his head laying on the couch and he woke up and his head was wet and sweaty. After the second hot flash today, he looked at himself in the bathroom in mirror. His face, neck and chest looked red. It lasted a few minutes. He took his temperature it was 98.2 degrees. Sometimes he gets a hot flash and has a slight headache, like right now. He was fine up to the 2nd shot and got dizzy. The patient clarified not dizzy, but lightheaded. Then he was fine. He got the other symptoms of hot flashes and diarrhea, but that might have come from something he ate. The patient was happy he got the shots, but not happy about how they are making him feel. He never had this until he got the shot. On an unspecified date, the patient checked his blood pressure, temperature and oxygen levels and they were all fine. The patient underwent lab tests and procedures which included blood pressure measurement: 121/72, body temperature: 98.2, Pulse rate: 80 (low), Oxygen levels: 97-98. On an unspecified date, outcome for hot flashes, slight headache, sweat, was not recovered and sleep disorder was unknown. On 07Apr2021, the patient was recovered from lightheaded and chest pain. On 09Apr2021, the patient had recovered from tiredness and can move his right arm well. It was swelled after both shots (lasted 2 days) and sore arm with second dose. On 15Apr2021, the patient was recovered from diarrhea, stomach-ache and his face, neck and chest looked red. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Blood pressure high (Patient Medical continuing: Yes Start date: In early 2000s); High cholesterol (Patient Medical continuing: Yes In early 2000s); Neuropathy peripheral (Patient Medical continuing:Yes); Tremor of hands (Patient Medical continuing:Yes)

ID: 1774406
Sex: F
Age:
State: IL

Vax Date: 04/14/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:101.4 Fahrenheit

Allergies:

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

Symptoms: my arm started hurting where shot was, then whole arm started hurting, then I could not lift it; muscle pain; could not sleep at all last night; I have the chills; itch; I am in pain, ache all over; nausea; dizziness; weakness; tiredness; headache; feeling unwell; sore throat; 101.4 F temperature; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0153), dose 1 via an unspecified route of administration on 14Apr2021 as DOSE 1 SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 14Apr2021, the patient stated that I got the first dose of the Pfizer Covid 19 vaccine yesterday,. Later one in the day, my arm started hurting where shot was, then whole arm started hurting, then I could not lift it, could not sleep at all last night, very excruciating. I have the chills, I itch, I am in pain, ache all over, nausea, dizziness, weakness, tiredness, headache, muscle pain, chills, fever, feeling unwell, and sore throat. No additional details provided. She declined transfer to Safety but consented to further follow-up from Safety. The patient underwent lab tests and procedures which included 101.4 F temperature on an unknown date. The outcome of all events was an unknown

Other Meds:

Current Illness:

ID: 1774407
Sex: U
Age:
State: FL

Vax Date: 03/27/2021
Onset Date: 03/30/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: PCR test; Test Result: Negative

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: burning and pain in my eyes; Burning and pain in my eyes; felt very bad; pain throughout my body; sensitivity; sweating at night; joint pain; muscle and joint pain; felt very bad, with a headache; very strong tiredness and exhaustion; depression; loss of sleep; This is a spontaneous report from a Pfizer sponsored program (stimulated report) via a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on 27Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reported were the effects of the covid 19 vaccine Pfizer, the patient took the vaccine on 27Mar2021 and on 30Mar2021 (after three days) the patient "felt very bad, with a headache, pain throughout my body, muscle and joint pain, very strong tiredness, and exhaustion, sweating at night, sensitivity, burning and pain in my eyes, this lasted me three weeks". The patient had had depression and loss of sleep on unspecified date in 2021. On 13Apr2021 (today) the patient still had the same symptoms. The patient already did the PCR test, and it came out negative on unspecified date, and reportedly the patient must take patient's second vaccine on 17Apr2021. The outcome of events felt very bad, with a headache, pain throughout my body, muscle and joint pain, very strong tiredness, and exhaustion, sweating at night, sensitivity, burning and pain in my eyes, all were recovered in 2021; and for depression and loss of sleep was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774408
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: when she peeled off the band-aid she had on the injection site, she noticed blood on it.; This is a spontaneous case received from a non-contactable (patient). A female patient of unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient stated that she received the second dose of the Pfizer COVID vaccine and hours later when she peeled off the band-aid she had on the injection site, she noticed blood on it. The seriousness was reported as non-serious. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774409
Sex: F
Age:
State: ND

Vax Date: 03/20/2021
Onset Date:
Rec V Date: 10/09/2021
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: itching on the shot side and then spread to the other side and upper body; itching on the shot side and then spread to the other side and upper body/her whole body started itching; swollen; tingling in her fingers; skin broke open; orange under her skin for a day .where the vaccine shot was given; tired; five lumps came up on her arm at that same time; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 20Mar2021 (age at vaccination: 62 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included allergy to chemicals. She was allergic to all generic Zoloft, Lexapro, Quetiapine, and Moban. The Moban makes her run in place. It has been like 5 years or more since she took one of those and had reactions. One was even 20 years ago and one of the others was probably 15 years ago. She stays away from generic antidepressants because they all caused a great deal of pain. She tried 14 to be exact. She cannot sit still. She was also allergic to canned crab meat she thinks it was the Formaldehyde. She didn't take anything old. She was on psych meds. She had bad reactions to the generic antidepressants. She has no problems on the medications she was on now. On an unknown date, reported as next day, the patient experienced itching on the shot side and then spread to the other side and upper body/her whole body started, itchy and swollen for 2 weeks after the shot, tingling in her fingers, the itching was so bad at her injection site, she scratched it and when the skin broke open, she noticed it was orange under her skin for a day where the vaccine shot was given, tired and five lumps came up on her arm at that same time. They were itchy, but not real big. They were itching like crazy . She couldn't take it. She was given her second injection on the side of her arm and not in the middle of her arm like everyone else; states she believes it definitely went into a muscle. The itching went away. After the vaccination she was very tired and came home and didn't think about it. The next day, she took the band aid off. She noticed the shot was on the side of her arm instead of the middle of her upper arm. She thought it was weird. She got the shot in her left arm. She saw other people get it right in the middle of their arm on TV and stuff. Hers was to the side. The shot swelled up about the second day, and by the third day, it was more swollen. It stayed that way 2 weeks. The swelling finally went down after 2 weeks. Then, five lumps came up on her arm at that same time. They were itchy, but not real big. They were itching like crazy . She couldn't take it. She had to scratch them, and she broke the skin a little. She tried not to itch them at all. She noticed that the broken skin was orange where it was broken. It was really weird. Then, she noticed another cut on her arm which had nothing to do with the shot. It was there before the shot. It was weird because that normal scratch was reddish pinkish like expected. The one where she got the shot was orange. It was really weird. She thought something had to be wrong. The orange had to be from the COVID shot. The breaking of the skin made the itchiness gradually subsided. The bumps and the swelling started to go down. They were firm, but not real large. They were small, but not real small. That was when they were starting to go down. All of this was on her left side. Then, her left hand started itching like crazy especially on her middle and ring finger. Then the ankle on her right side started itching like crazy. It was itching so bad. It was worse than anything. The skin broke open as well. That seemed to help some of the itchiness. It subsided as a couple of days went by. It was relieved some. She cleaned the areas and put some Vaseline on it. She couldn't find her neomycin or antibiotic ointment. The Vaseline did seem to soothe it. It was still a little itchy, but it was getting better. Then, the next day, her other hand started itching too. It was driving her crazy. Her elbow was itching on the right side . Then, the next day, her left arm was itching. Then, her whole body started itching. Her whole upper body was itching. Her legs seemed okay. She decided to take a bath to calm down. She did take a warm one. Her body started itching like crazy. So she used her scrub brush to scrub her skin top to bottom. She got out of the tub, and for an hour and a half there was no itching. She even scrubbed her hands and everything. She had a tingling feeling and a slight burning but it was very mild. She has scrubbed herself before . She has done this scrubbing on a regular basis. But this itching was severe she did it to herself 2-3 times over and over. She thought something was wrong. She wanted to see the doctor but couldn't get her sleep schedule turned around. Then, the itching started up again. She had no idea what was happening. She tried not to scratch, and she tried to stay calm. She tried to zone out of it. She distracted herself, but then broke the skin on her finger from itching. The next day, she only had itching on her hand and her right hand was a little less. The itching was still on her elbow, but now today she was completely itch free. Yesterday, her elbow and hand were itching. Today she was fine. She doesn't have a prescribing doctor. The end of yesterday night she started to feel better. Today she only has a little tingling in her fingers. They are barely tingling though. She thinks it was getting better. The outcome of the event pruritus was recovering; mass was recovered on an unknown date and all the other events were unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Allergy

ID: 1774410
Sex: F
Age:
State: CT

Vax Date: 04/05/2021
Onset Date:
Rec V Date: 10/09/2021
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: "bronchospasm, had a bad cough, and a lot of mucus".; "bronchospasm, had a bad cough, and a lot of mucus".; "bronchospasm, had a bad cough, and a lot of mucus".; This is a spontaneous report received from a contactable Nurse. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 05Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history included Auto immune disease. The patient Concomitant medications were not reported. On an unspecified date, the patient experienced "bronchospasm, had a bad cough, and a lot of mucus". It was reported that patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 05Apr2021 and the second dose is scheduled for 26Apr2021. She mentioned she has an auto-immune disease and is on a "couple things", including Stelara. She explained the morning following the injection she experienced "bronchospasm, had a bad cough, and a lot of mucus". She tested for COVID-19 twice, once on the following Wednesday and the other on the Friday, because she "wasn't any better". She explained she was prescribed an inhaler and Z-pack. She added she improved over the weekend but wasn't better on Monday. She asked if there is data on auto-immune vaccine recipient or those on Stelara showing that prolonged symptoms to the vaccine could correlated with either. She has auto immune disease and is on immunosuppressant medication and after the vaccine she developed coup and is on antibiotics and inhalers now. The outcome of events was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774411
Sex: F
Age:
State: WI

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

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

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:between 96-98

Allergies:

Symptom List: Unevaluable event

Symptoms: has also been checking her temperature and it has been between 96-98 and earlier she was feeling warm but she was in class and couldn't check; a slight cough/had a cough and it wasn't long just a couple of times, a little more than normal; nausea/feels the nausea in her throat; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0158, NDC number: not reported, Expiration Date: Jul2021) via an unspecified route of administration, administered in upper right arm on 08Apr2021 09:45 (age at vaccination 21-year-old) as dose 1, single for covid-19 immunisation. The patient's medical history included COVID-19 from an unspecified date in Dec2020 to an unknown date. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) (200mg and took 2 for a total of 400mg) for unknown indication from an unknown date. Patient stated she took ibuprofen one time around the beginning of the 2 weeks before the vaccine. There were no additional vaccines administered on same date of the pfizer suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, patient stated she got the Pfizer vaccine last thursday and she feels fine, none of it was very drastic. Caller stated that her side effects started on 09Apr2021. Stated she was feeling some side effects where the 1st day she had a cough and it wasn't long just a couple of times, a little more than normal. Stated she was nauseous but was not throwing up and that has been off and it will come at random times throughout the day and on since then. Patient stated she was concerned if this was normal or if she should see a doctor. Patient stated she had also been checking her temperature and it had been between 96-98 and earlier she was feeling warm, but she was in class and couldn't check. Patient stated this was her 1st shot and she was skeptical and knows it can last a couple days but not this long. stated she only had slight nausea and she can feel it in her throat, that it's not like she was going to throw up, but she was cautious about what she eats. Stated the cough was for the first 2 days. Caller wanted to know if she was fine or was there something else, she should do. Caller was concerned because her side effects have lasted seven days. The events did not result in emergency room or physician office. The outcome of event was resolved for cough on 10Apr2021 and unknown for other events. No follow-up attempts are needed. No further information is expected.

Other Meds: IBUPROFEN

Current Illness:

ID: 1774412
Sex: F
Age:
State: VA

Vax Date: 04/10/2021
Onset Date: 04/10/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: tightness of chest; asthma; Today she felt weird/she does not feel right; she has a sore throat; she also doesn't feel appetite; she felt dizzy; weird taste in her mouth; headache; This is a spontaneous report received from a contactable consumer (patient, reported for self). A female patient of an unspecified age (40-units not mentioned) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history included, Rheumatoid arthritis, asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took metotrexate for 15 years for rheumatoid arthritis. On 10Apr2021, the patient experienced, immediately after receiving the injection she felt dizzy, and weird taste in her mouth only the first day along with headache. On 15Apr2021, she started experiencing tightness of chest, she has asthma and used her inhalator but it did not help, she also experienced felt weird, sore throat, headache, does not feel appetite (she also doesn't feel appetite) and she did not feel right. She has been only working from home in her computer. She would like to know if this was a regular side-effect even if it happened 5 days after she received the vaccine. The patient stated she has taken Methotrexate for 15 years for rheumatoid arthritis, she did not take it 2 weeks before the shot and has not taken it this week because she was told that it is not recommended to receive immunosuppressants a week before or a week after the vaccine. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774413
Sex: F
Age:
State: NJ

Vax Date: 04/05/2021
Onset Date: 04/14/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Eyelids were swollen; Mild itching near anus; Full body rash and hives; Full body rash and hives; Itching began in armpits; This is a spontaneous report from a contactable consumer or other non-HCP. A 49-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0151) via an unspecified route of administration in right arm on 05Apr2021 10:45 as dose 2, single (at the age of 49 years-old) for COVID-19 immunization. Patient medical history included blood cholesterol diagnosis, lumpectomy for a non-cancerous papiloma 2014, spinal fusion surgery 2011 and sulfa drugs allergy (drug hypersensitivity). The concomitant medications included montelukast sodium taken as 10mg 1 QD, loratadine taken as 10mg 1 QD, fluticasone propionate taken as 1 spray per nostril QD, atorvastatin taken as 10mg 1 QD all for an unspecified indication, start and stop date were not reported. The patient was not a pregnant at the time of vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6208) via an unspecified route of administration in right arm on 14Mar2021 02:45 PM as dose 1, single for COVID-19 immunization. Vaccination facility type reported as Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient experienced on 14Apr2021 morning itching began in armpits, full body rash and hives, the evening mild itching near anus that lasted a few days, and eyelids were swollen on 15Apr2021. Patient took three 12.5 mg Benadryl dose tablets and by morning of April 15 rash had spread to neck and eyelids were swollen. Took 2 more 12.5 mg Benadryl. Then patient went to Urgent Care facility to seek more medical attention. Therapeutic measures were taken as prescription issued for 6-day treatment course of 4mg methyl prednisone dose pack a result of eyelids was swollen (swelling of eyelid), mild itching near anus (anal pruritus), full body rash and hives (rash), full body rash and hives (urticaria), itching began in armpits (pruritus). The outcome of all events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: MONTELUKAST SODIUM; LORATADINE; FLUTICASONE PROPIONATE; ATORVASTATIN

Current Illness:

ID: 1774414
Sex: F
Age:
State: FL

Vax Date: 04/07/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: stiffness when lifting arm; Left sided neck pain; Lightheadedness; Chills; Tiredness; Left sided chest discomfort; chest pain; Left arm hurt; Her muscle would tighten up when it does that; throat pain on the left side from the cheek all theway down her neck; This is a spontaneous report from a contactable consumer (patient herself). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 09:15-09:30, (Batch/Lot Number: ER8737) as dose 1, single (age at vaccination was 57 years old) for covid-19 immunisation. Medical history included she had a fall and her back hurts (states she sees a chiropractor for her back), she passed out and miscarried while she was pregnant, ongoing blood pressure and ongoing diabetes mellitus. Concomitant medication(s) included hydrochlorothiazide taken for pressure (has been taking for years. It is a water pill) and empagliflozin, metformin hydrochloride (JARDIANCE DUO) taken for diabetes mellitus from Oct2020 and ongoing. Patient clarified that on 07Apr2021, she had not eaten before she got the shot because it was early in the morning. She felt a little lightheaded. She thinks it was because she didn't eat. She went out and ate and then she felt fine for a minute or two. When she was coming home, she started to feel like her arm was hurting. Then it started hurting all the way up to her shoulder area. by the time she got home and got ready for bed she could feel it coming up to her back and more on left side. It was hurting because of the vaccine. That was the first day she took the shot. Patient reported, the first day (07Apr2021) she had lightheadedness, and her arm hurt. By the time she got home, she had some stiffness when lifting her arm up (08Apr2021 in the morning). She also had left side chest discomfort, which travelled to her neck. It is in left neck on left side (on 08Apr2021). It really hurts. Every time it does that, she takes Ibuprofen. She breaks it in half and takes half the dose and the minute the medicine wears off it comes back and hurts. Her muscles on the left side will tighten up when it does that (unspecified date in Apr2021). When it hurts, she takes Ibuprofen. The pain stops and once it wears off, the pain would come back. Her muscle would tighten up when it does that. She has been putting a warm towel on it. She's worried because she has to take the second one. Her doctor said she should maybe have to take a booster or something before she takes the shot because she might have an allergic reaction or something. The doctor told her to call Pfizer, and she asks what should she do. Reporting about her weight, she at first stated that she was 264 at the time she guesses or 265. She thinks she is 264 or she was the last time she was at the doctor 2 weeks ago. Then she said that she is 265. She is self employed. The reason she took the shot is because she has not been out there working because she is not good in the morning. She has pressure and takes pressure medication and sugar medication. she was not going out of her house to work at all. She went to her doctor's office today and she wasn't in. They are off on Thursday in that location. She left a message for them to call her. At first patient thought she could handle it, but the pain is there. She doesn't want to wait and it gets worse and she doesn't want to take the second shot until she knows she is not allergic to something. She doesn't want to go there and pass out. She wants to know if others have the same symptoms. Patient received first dose of Pfizer BioNTech Covid 19 vaccine last wednesday 07Apr2021. She's been experiencing throat pain on the left side from the cheek all the way down her neck (unspecified date in Apr2021). Its only on the left side which is the same side as where she received the vaccine. She said there is no lymph node swelling and it feels more like a pulled muscle. She states it's been over a week, and questions how long does this side effect usually occur. She was questioning if there is any Phenergan in the vaccine. She took it while pregnant and she passed out and miscarried. The events were described by the patient as for lightheadedness, she didn't recover completely. She still felt strange of course. For stiffness, when lifting the arm, patient clarified that it started on 08Apr2021 in the morning. It is ongoing more towards her neck. It is to her shoulder and neck. For left sided neck pain, she will take the medicine and the pain will go away. She is concerned because the pain comes back and it has been six of seven days now. Left sided chest discomfort started the night of the vaccine when she went to lay down. It only happened when she laid down. It stopped on 10Apr2021. For the chest pain she drank some tea. The Tylenol wasn't helping the neck pain and changed to Ibuprofen. The chills were from the first day (07Apr2021) through the third day, 10Apr2021. It would come and go. Now, the only time the chills will come is if her daughter comes in and puts the air down. If she notices the air conditioner gets high she will put it down to low and it won't bother her as much for the past few days. She would say the chills are ongoing. it is not as severe as before. At first when she had the cold, it would come with tiredness. The first three days were cold, neck starting to hurting, and then chest thing went away. For the first three days, she experienced tiredness and she thought it was just the vaccine doing its thing. Stop date for the tiredness 10Apr2021. She described Tylenol saying it has a red top and white bottle. She doesn't normally take Tylenol. Provided Tylenol expiration date of Apr2021. This is a 325 mg pill (Quantity dispensed: 20). She took two Tylenol per day for two days twice a day. Provided lot number as 1639370. Indication was high risk. She has sugar and pressure. She didn't want to get infected. She has kids and her husband teaches. She is also a substitute teacher, but hasn't been doing that since COVID. History: States she sees a chiropractor for her back. She had a fall and her back hurts. No further details provided. She went to physician because of the neck pain, but was not able to see the doctor and that is why she called Pfizer's hotline. Patient states while on the phone the pain is starting to come back. She will take some medicine while she holds for Medical Information agent. She's been taking with tylenol but that didn't work and so she's been taking ibuprofen. It helps with the pain, but is still feeling bad once medicine wears off. Therapeutic measures were taken as a result of left arm hurt, stiffness when lifting arm, left sided neck pain, Left sided chest discomfort, chest pain and muscle stiffness. The outcome of lightheadedness was recovered/resolved with sequel on 07Apr2021 and left arm hurt was recovered/resolved with sequel on 08Apr2021. Events stiffness when lifting arm and chills were recovering, left sided neck pain was not recovered, and outcome for all the other events was unknown. No follow up attempts are needed.No further information is expected.

Other Meds: HYDROCHLOROTHIAZIDE; JARDIANCE DUO

Current Illness: Blood pressure; Diabetes

ID: 1774415
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: she reports a lot of swelling and redness of her arm; she reports a lot of swelling and redness of her arm; This is a spontaneous report from contactable consumer (patient) via medical information team. A 55-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the Pfizer Covid 19 vaccine a week and one day ago. After it was administered, she said the provider massaged her arm. A day and a half later she reported a lot of swelling and redness of her arm that lasted for a day. The outcome of events was recovered on unspecified date. Follow-up attempts were completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1774416
Sex: M
Age:
State: GA

Vax Date: 04/06/2021
Onset Date: 04/07/2021
Rec V Date: 10/09/2021
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: congestion; Sore throat; extreme tiredness, extreme fatigue; Low grade fever; This is a spontaneous report from a contactable consumer (Patient). A 32-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0158; Expiration Date: 31Jul2021, patient was 32-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 06Apr2021 at 05:00 PM as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included ongoing borderline high blood pressure. Concomitant medication(s) included ongoing hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for to regulate his blood pressure from an unspecified start date, taking this for maybe 6 months; ongoing lepidium meyenii root (MACA 2H) taken for supplementation therapy from an unspecified start date, he started taking this 3 weeks ago. He said it was just a good supplement. No previous immunization with the Pfizer vaccine considered as suspect, no additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior vaccinations within 4 weeks, no AE(s) following prior vaccinations. No illnesses at time of vaccinations. No family medical history relevant to AE(s). It was reported that patient had symptoms for the last 7 days now. He asked that if it was normal or should he go into urgent care. Not really sure what to do. On 07Apr2021, the patient experienced extreme tiredness, extreme fatigue, low grade fever, sore throat on 09Apr2021, congestion on 10Apr2021. Reported that low grade fever which was 70 to 80% improved at the time of report, a little every morning when he wakes up its sore. The outcomes of events were recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: HYDROCHLOROTHIAZIDE; MACA 2H

Current Illness: Blood pressure high (Verbatim: borderline high blood pressure)

ID: 1774417
Sex: F
Age:
State: SC

Vax Date: 04/07/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:fever, temperature 102

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: fever, temperature 102; cough with bright green phlegm; Sore throat; lost voice; cold chills and achy all over; cold chills and achy all over; Headache; felt like a train hit her; breaks out in sweats; Her arm was still sore; This is a spontaneous report from a contactable consumer (patient, reported for self). A 56-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0151, Expiry date: not reported), via an unspecified route of administration in left arm on 07Apr2021 08:00 (at age of 56-years-old) as dose 1, single for covid-19 immunisation in the clinic. Medical history included ongoing asthma (she has asthma and has had it for most of her life), ongoing rheumatoid arthritis (she has autoimmune deficiency and Rheumatoid Arthritis that was diagnosed in her mid-20s), Diverticulosis (she was diagnosed with diverticulosis in the last year). Medical history of patient (including any illness at time of vaccination): her uncle, brother of her Dad, had the same thing she was doing, but he had Agent and he had his second shot and it did not bother him. The patient's concomitant medications were not reported. History of all previous immunization with the bnt162b2 vaccine considered as suspect was none. No additional vaccines administered on same date of the bnt162b2 suspect. The patient had not received any other vaccine within 4 weeks. On 09Apr2021, the patient experienced lost voice, cold chills and achy all over, headache and sore throat. On 10Apr2021, the patient experienced fever, temperature 102, cough with bright green phlegm. On an unspecified date in Apr2021, her arm was still sore. Reporter called to report side effect she had been sick since Friday (unspecified date). She received her first shot on Wednesday, 07Apr2021. It was weird because she heard the second shot is worse than the first. She was fine the first day and the next day she had a few symptoms. On Friday (09Apr2021), she went into work and felt like a train hit her. She lost her voice had cold chills and was achy all over. The next day, her temperature was 102degrees. She had a cough with bright green phlegm. She thought it was weird. She had cold chills, headache, and was sore all over. She didn't expect this. She had a fever the last 2 days and it broke early that morning between 2 and 3am. She knew that because she was soaked and now had no fever. She took her temperature before she called and it was right at normal. She did not have one right now, but is not sure if it will go up later or what. Her arm was still sore today, but she figured that it would be gone. Treatment: She had been taking cold medicine and trying to relax. She had a hard time because she can't do too much or over exert herself. Indication: She has asthma and was one of the second ones in line to get the vaccine because of that. Reporter added she also breaks out in sweats. This was something new she forgot about that and was not sure when started. The patient confirmed on Friday night. She worked 12 hour shifts from 1900 to 0700 and was breaking out in sweats then cold as she was working on Friday night. She was scared to take the second shot. She thought about getting Covid tested to see what that was. She kept thinking it was going to go away, but she had been in bed and it's terrible. The patient asked if she should be tested for Covid or what should she do. The patient added she had a sore throat started on Friday. The adverse events did not result in emergency room or physician office visit. No relevant tests were performed. The event fever, temperature 102 recovered on 13Apr2021; outcome of the events felt like a train hit her, breaks out in sweats were unknown; while outcome of rest of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Asthma (She has asthma and has had it for most of her life.); Rheumatoid arthritis (She has autoimmune deficiency and Rheumatoid Arthritis that was diagnosed in her mid-20s)

ID: 1774418
Sex: F
Age:
State:

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 10/09/2021
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: hives; itches so bad; body rash; Her feet hurt so bad; joint pain; This is a spontaneous report from a contactable consumer (patient, reported for herself). A female patient of unspecified age received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via unspecified route of administration on 18Mar2021 as a dose 2, single for covid-19 immunization. The patient stated she was allergic to the Pfizer covid vaccine. The patient's medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: not reported), via unspecified route of administration on unspecified date as a dose 1, single for covid-19 immunization and experienced Few hives, swollen lip, Allergic to the Pfizer covid vaccine. On an unspecified date in 2021 she broke out in hives, with the second dose. Her doctor prescribed her steroids and the hives/rash comes back once she finishes the steroids treatment. The patient stated that it itches so bad, she has body rash, have joint pain, her feet hurt so bad. Patient queried for what she can do about her symptoms. Therapeutic measures were taken as a result of hives, itches so bad, body rash. Outcome of hives, itches so bad and body rash was not recovered and for feet hurt so bad and joint pain was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774419
Sex: F
Age:
State: KY

Vax Date: 04/12/2021
Onset Date: 04/12/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210413; Test Name: body temperature; Result Unstructured Data: Test Result:100.6

Allergies:

Symptom List: Nausea

Symptoms: Temperature, 100.6; Aching all over; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 72-years-old (73-year-old as reported) female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0158, Expiration date not reported), via an unspecified route of administration, administered in left arm on 12Apr2021 at 11:30 (at the age of 72 years) as dose 1 single for covid-19 immunization. Medical history included Covid positive (sars-cov-2 test positive on 04Jan2021) and she went to the emergency room, patient stated that she had to wait 90 days to get her vaccine. The patient's concomitant medications were not reported. Family Medical History Relevant to events reported as no. No history of all previous immunization with the pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and no additional vaccines administered on same date of the pfizer suspect no. Patient did not receive any vaccine within 4 weeks, prior vaccinations. On 12Apr2021, the patient experienced severe headache at 5 PM (5 hrs 30 min after the vaccination) and aching all over at 10 PM (10 hrs 30 min after the vaccination). On 13Apr2021 (1 day after vaccination), patient had temperature 100.6. The patient underwent lab test included body temperature: 100.6 on13Apr2021. The outcome of all the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774420
Sex: F
Age:
State:

Vax Date: 04/08/2021
Onset Date: 04/09/2021
Rec V Date: 10/09/2021
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: she noticed her hand trembling a little bit/shaky; she had pain on the right side of her chest on Friday; Caller states she was also jittery and shaky; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch Number: not reported), via an unspecified route of administration in left arm on 08Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 09Apr2021 she noticed her hand trembling a little bit and she had pain on the right side of her chest on Friday. She also experienced jittery and shaky. The patient was not received any treatment for events. Outcome of events was recovered on 10Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774421
Sex: F
Age:
State:

Vax Date: 04/07/2021
Onset Date: 04/08/2021
Rec V Date: 10/09/2021
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 had Bronchitis like symptoms; Chest was full; Coughing, a lot; Back hurt, not like muscle pain, like her lung hurt; Felt under the weather; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient states that she called her family doctor today. patient states that she got the shot last Wednesday on 07Apr2021, and on Thursday 08Apr2021, she felt under the weather. She states that on Friday, she sort of felt alright. She states on Saturday 10Apr2021, she had bronchitis like symptoms, her chest was full, she was coughing alot and her back hurt. Caller describes her back hurting as not like muscle pain, reclarified, like her lung hurt. Caller states she was not having trouble breathing. The patient wants to know, what steps should she take. Reclarified, the patient states that should she take a COVID test, or does she have COVID. Reclarified, patient would like to know how to treat her symptoms. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774422
Sex: F
Age:
State: HI

Vax Date: 03/24/2021
Onset Date: 04/10/2021
Rec V Date: 10/09/2021
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: Rashes developing on her core/rashes developing around her armpit area/She says the rashes are both sides, left and right; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration, administered in Left Arm on 24Mar2021 12:30 (at the age of 24 years) as DOSE 1, SINGLE for covid-19 immunization. Family medical history relevant adverse event included high blood pressure (mom and dad both have high blood pressure), diabetes (mom has diabetes), and breast cancer (grandmother had breast cancer).No medical history (including any illness at time of vaccination) was reported. No Prior vaccinations (within 4 weeks). Relevant tests were none. No AE following prior vaccinations. The patient other concomitant medications was not reported. No additional vaccines administered on same date of the pfizer suspect was reported. On 10Apr2021, the patient experienced rashes developing on her core, developing around her armpit area and the rashes are both sides, left and right. On 12Apr2021, the patient experienced rashes developing on her core was reported as worsened. The caller was calling about the shot. She says she has a quick question. She asked was it safe for her to get the second shot since she has rashes developing around her core and around her armpit area. No adverse event resulted in emergency room/physician office visit. The outcome of the event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1774423
Sex: F
Age:
State: MO

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: First dose: arm of course hurt and itched; First dose: arm of course hurt and itched; This is a spontaneous report from a contactable consumer. This consumer Female (patient) reported. A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK2176), via an unspecified route of administration on 14Jan2021 (at the age of 63-years-old) as dose, 1 single for covid-19 immunisation. The patient medical history included Alzheimer's from an unknown date and unknown if ongoing, cognitive issues from an unknown date and unknown if ongoing, Stroke (she had a stroke last year and Part of her throat is half paralyzed and even her voice dropped) from an unknown date and unknown if ongoing and COPD (chronic obstructive pulmonary disease) from an unknown date and unknown if ongoing, she also has COPD, so she had a problem breathing. The patient concomitant medications were not reported. On an unspecified date on 2021, the patient experienced first dose: arm of course hurt and itched. The outcome of event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774424
Sex: U
Age:
State:

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 10/09/2021
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: I am feeling weak; I had a severe back; muscle pain; joint pain; headache; tiredness; chills; nausea; I had difficulty breathing; Arm sore; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A patient of unspecified age and gender received bnt162b2 ,( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 23Mar2021 as DOSE 2, SINGLE for Covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced i am feeling weak , i had a severe back, muscle pain, joint pain, headache, tiredness, chills, nausea, i had difficulty breathing , arm sore. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774425
Sex: F
Age:
State: NC

Vax Date: 03/24/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: Really bad cough; Makes her so tired; Makes her chest hurt; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient has never had a Covid test. On 26Mar2021, 2 days later, the patient experienced really bad cough. On an unspecified date in Mar2021, the patient experienced makes her so tired and makes her chest hurt. The patient has been coughing ever since and was still coughing. The patient went to the doctor 7 days after the cough started and she started taking a cough medicine at night. The patient was still taking the cough medicine at night. The patient does not know what it was. It makes the patient so tired and makes her chest hurt. The patient called to check if this was a symptom of the vaccine. Therapeutic measures were taken as a result of really bad cough using Mucinex. The outcome of the event really bad cough was not resolved while other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774426
Sex: F
Age:
State: VA

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 10/09/2021
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: Rash on arm; This is a spontaneous report received from a contactable pharmacist. A 37-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208, Expiration date: 30Jun2021), via an unspecified route on 15Mar2021 (at the age of 37-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021, the patient experienced rash on arm. Reporter stated that the patient came in for the second dose of the Covid-19 vaccine and that the patient still had a red rash on her arm. Reporter reported that because the rash was still present on the patient's arm, the second dose of the Covid-19 vaccine was not administered and that he did not see the patient's rash but that he was told that the rash was still present. Reporter reported that he did not know if the rash had improved, persisted, or worsened. It was unknown that patient visited to Emergency Room or Physician Office. Reporter stated that the pharmacy on duty on 12Apr2021 instructed the patient to go see her primary care doctor and ask about the rash and see what the physician though. Reporter reported that he didn't think that the patient followed up with her physician but just called to complain. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774427
Sex: M
Age:
State: NY

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 10/09/2021
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: severe calf pain; pain and discomfort in joints; migraines; unprovoked chills; pain in the opposite left arm,; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203; Expiration Date: Jun2021), via an unspecified route of administration, administered in Arm Right on 02Mar2021 as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7534; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Right on 23Mar2021 (at the age of 68-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Verbatim: Vestibular impairment, ongoing nystagmus Verbatim: Nystagmus, ongoing vertigo Verbatim: Vertigo, gets 300 minutes a day of sleep from an unknown date and unknown if ongoing, temporal pain in the eyes from an unknown date and unknown if ongoing, vision really kind of blurry from an unknown date and unknown if ongoing, spinal surgery from an unknown date and unknown if ongoing, esophagus was taking a beating from an unknown date and unknown if ongoing. Family medical history and Relevant tests was reported as no. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication(s) included lisinopril taken for blood pressure systolic increased from an unspecified start date and ongoing; ubiquinol taken for an unspecified indication from an unspecified start date to 28Mar2021; (B-2) taken for an unspecified indication from an unspecified start date and ongoing; ascorbic acid, biotin, calcium pantothenate, choline bitartrate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol, inulin, magnesium citrate, nicotinamide, pyridoxine hydrochloride, retinol palmitate, zinc citrate (ADULT MULTIVITAMIN) taken for vitamin supplementation from an unspecified start date and ongoing; magnesium oxide (MAGNESIUM OXIDE) taken for an unspecified indication, start and stop date were not reported; pyridoxine hydrochloride (VITAMIN B 6) taken for an unspecified indication, start and stop date were not reported; vitamin b12 no's (VITAMIN B 12 [VITAMIN B12 NOS]) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D3) taken for an unspecified indication from an unspecified start date and ongoing; magnesium (MAGNESIUM) taken for an unspecified indication from an unspecified start date and ongoing; paracetamol (TYLENOL) taken for an unspecified indication from an unspecified start date and ongoing; curcuma longa root (TURMERIC CURCUMIN) taken for an unspecified indication, start and stop date were not reported; botulinum toxin type a (BOTOX) taken for an unspecified indication, start and stop date were not reported. Patient was calling regarding the recent Covid vaccines he had back on 2Mar2021 and follow up second dose on 23Mar2021. Is 68 years old, was drafted way back in conflict and has had a lot of vaccines. Used to work for the health department. Is concerned because he felt like a stoned sphynx when he gets up in the morning. All of his joints are screaming at him. Any place where he has had broken bones seems to be exacerbating and ridiculously painful. Tries to do strengthening exercises to get limbered up and still has trouble with that. Became very pronounced on 26Mar2021. Pretty much stopped him in his tracks. Had been putting it off because of all the migraines and stuff that he had been having, it has been getting more painful, usually it was more visual. Has been seeing neurologist downstate. Came down on 26Mar2021 to resume Botox injections but haven't been to him since last October because he was concerned about riding the subway transit with social distancing and all. With all of the variants of Covid being brought to the public, thought he probably shouldn't go when he was scheduled. Ended up going on 26Mar2021 and ended up staying in the city. By the time he got to the hotel, was so wiped out, he had no energy. Was very strange. Even with the first dose. He couldn't' explain it. Had so much pain in the opposite left arm, which he didn't receive the vaccine in. Had it in the right arm from the start. Had first inoculation on 2Mar2021, more in the bicep and triceps area of the left arm. Left it up to them with the second dose on 22Mar2021 It was given in the right arms again. Restated that the second injection was 23Mar not 22Mar. Is really not any better. At points when he is sitting, it will all of a sudden just rear its ugly head and is really bizarre. Has not really done any treatment, just the Botox injections, about 7 rounds. Takes Tylenol, about 4 a day. Has gotten so bad, he has stopped taking Tylenol but has been getting so uncomfortable, that he went and bought a bottle of a newer version of Tylenol. Is 500mg tablets. Usually takes one in the morning, one in the afternoon and one at night. If it is really bad, takes a fourth one. Before taking Tylenol, was taking Turmeric extract 450mg that is a 95% extract of Curcumin. Is like the herb powders used for cooking but this is more designed for inflammation and pain. Migraines are more painful than they used to be, were usually just visual. Tries not to sit for long periods of time. When getting up, it is really painful in both knees. Notices when stretching, sometimes has severe calf pain, almost like a muscle knot. Want to scream, it is just so brutal. Just expressed concerns over these symptoms. After the first shot, experienced symptoms and talked to the physician. Gets unprovoked chills, not cold or anything. Just started noticing it frequently within the last 6 or 8 weeks. Haven't really gotten any worse but kind of annoying. not like a draft in the room, but all of a sudden getting goosebumps. Patient did not visit to Emergency Room or Physician's office. The clinical outcome of events severe calf pain and pain in the opposite left arm was unknown, while all other events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: LISINOPRIL; UBIQUINOL; ADULT MULTIVITAMIN; MAGNESIUM OXIDE; VITAMIN B 6; VITAMIN B 12 [VITAMIN B12 NOS]; VITAMIN D3; MAGNESIUM; TYLENOL; TURMERIC CURCUMIN; BOTOX

Current Illness: Nystagmus (Verbatim: Nystagmus); Vertigo (Verbatim: Vertigo)

ID: 1774428
Sex: F
Age:
State: SC

Vax Date: 04/07/2021
Onset Date: 04/09/2021
Rec V Date: 10/09/2021
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 Date: 20210410; Test Name: Body temperature; Result Unstructured Data: Test Result:102

Allergies:

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

Symptoms: breaks out in sweats.; arm is still sore today; fever, temperature 102; Cough; Sore throat; lost voice; cold chills and achy all over; cold chills and achy all over; Headache; This is a spontaneous report from a non-contactable consumer. A 56-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: EW0151), dose 1 intramuscular on 07Apr 2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccoination: 56-Year-old) The patient medical included she has asthma and has had it for most of her life. She has autoimmune deficiency and Rheumatoid Arthritis that was diagnosed in her mid-20s and she was diagnosed with diverticulosis in the last year. Concomitant medications were not reported. On 09Apr2021 the patient had lost voice, cold chills, achy all over, headache and sore throat. On 10Apr2021 the patient had fever (temperature 102) and cough. She was weird because she heard the 2nd shot is worse than the 1st. She was fine the first day and the next day she had a few symptoms. On Friday, she went into work and felt like a train hit her. She lost her voice had cold chills and was achy all over. The next day, her temperature was 102degrees. She had a cough with bright green phlegm. She thought it was weird. She had cold chills, headache, and was sore all over. She did not expect this. She had a fever the last 2 days, and it broke early this morning between 2 and 3am. She knows this because she was soaked and now has no fever. She took her temperature before she called, and it was right at normal. She doesn't have one right now but is not sure if it will go up later or what. Her arm was still sore today, but she figured that it would be gone. The outcome of the event lost voice, cold chills and achy all over, headache, cough and sore throat was not recovered. The outcome of the event fever and temperature 102 was recovered on 13Apr2021. The outcome of the event break out in sweats and arm is still sore today was reported as unknown. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Asthma (Verbatim: Asthma She has asthma and has had it for most of her life); Rheumatoid arthritis (Verbatim: Rheumatoid arthritis diagnosed in her mid 20s)

ID: 1774429
Sex: F
Age:
State: AL

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 10/09/2021
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: 02/10/2021; Test Name: COVID-19 Test; Test Result: Negative.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient) reported in response to non-HCP follow-up letter sent in cross reference case. A 79-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EL9809, expiration date: Jun 2021), at the age of 79, intramuscularly, in right arm, on Feb 17, 2021, at 15:00, single dose, for COVID-19 immunization, at a hospital. Historical vaccine included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EL8982, expiration date: May 2021), intramuscularly, in right arm, on Jan 27, 2021, at 15:00, single dose, for COVID-19 immunization and experienced projectile vomit, projectile diarrhea, high temperature, muscle fatigue and extreme tiredness. The patient's medical history and concomitant medications not reported. Prior vaccination within 4 weeks was none. The patient experienced high fever, headache, chills and arm pain on Feb 17, 2021, at 01:00. Reported serious (important medical event). The patient underwent lab tests and procedures, which included SARS-CoV-2 test: negative on Feb 10, 2021, with all the symptoms of COVID-19 except lost of taste and smell. Patient wanted to make sure she did not have COVID-19 for the sake of her husband. The patient did not received treatment for the events. The outcome of the events was recovered on an unspecified date. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1774430
Sex: M
Age:
State: SC

Vax Date: 03/18/2021
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
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: little rash on my arm/rash on left arm; unable to sleep because of the itching; unable to sleep because of the itching; This is a spontaneous report from a Pfizer sponsored program support from a contactable consumer (patient). An 89-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported), via an unspecified route of administration, administered in left arm on 18Mar2021 (at the age of 89-year-old) as DOSE 2, SINGLE, for COVID-19 immunisation. The patient medical history was reported as none. Concomitant medication(s) included atenolol (MANUFACTURER UNKNOWN) taken 50 mg daily and hydrochlorothiazide (MANUFACTURER UNKNOWN) 25 mg daily; both taking for 10-15 years and taken for unsure water or blood pressure from an unspecified start date and ongoing. Patient previously 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 in left arm on 24Feb2021 (at the age of 89-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer Suspect. On an unspecified date in Mar2021, patient developed a rash after a week of getting it and it has returned. Patient was trying to find out what was happening. He was unable to figure out why or what it was. It didn't do any damage. He was unable to sleep because of the itching. The events did not result in emergency room or physician office. The seriousness of the events was reported as non-serious. The outcome of all events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: ATENOLOL; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1774431
Sex: M
Age:
State: WI

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 10/09/2021
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: gout flare up and pain; Was in so much pain; Toes are all swelled up on the right side; had to help to stand up and put leg on couch, so he could lay down; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (at the age of 65 year) as dose 2, single for COVID-19 immunisation. Medical history included gout. The patient had not been taking any medicine 2 weeks prior to the Covid 19 vaccine. No prior vaccinations within 4 weeks. Concomitant medication(s) included ongoing metformin (METFORMIN); ongoing atenolol (ATENOLOL) taken for blood pressure abnormal; ongoing lisinopril (LISINOPRIL) taken for blood pressure abnormal; ongoing atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal, all has been taking for years. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206), dose 1 via an unspecified route of administration on 03Mar2021 for COVID-19 immunisation. On 25Mar2021, Patient gout picked up tremendously right after the shot. Patient gout flare up, originally in one knee, the left, then went to the right and then to foot. Toes were all swelled up on the right side. Started the day after the second shot. Patient was in so much pain, had to help to stand up and put leg on couch, so he could lay down. Pain get better, but then worse. This week he has felt in his big toe but has now spread to other toes. Patient took gout medicine only after the flare up. Medication was Indomethacin and the dose was 50mg three times a day. Patient took on an as needed basis. Patient did not receive Emergency Room and Physician's office. The outcome of events Pain and Gout flare was not recovered while for rest events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: METFORMIN; ATENOLOL; LISINOPRIL; ATORVASTATIN

Current Illness:

ID: 1774432
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: Itching; Joint pain; One left eye is watery/eyes is still watery; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: EN6204), as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Blood pressure high. Concomitant medication(s) included Amlodipine taken for an unspecified indication, start and stop date were not reported and Lisinopril taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced Itching, Joint pain and one left eye is watery/eyes is still watery. Consumer stated Since she got the shot on an unspecified date Wednesday night, but she thought it was going to go away by maybe Thursday or Friday. She was talking to you, and she was still getting itchy its very itchy and eyes is still watery. Consumer asked what could do, just leave it or just, do you have anything to put on it, you say anything or what and not want itching, she meant she did not know about her eyes, they were watery. She stated she was still getting itchy. Consumer stated, she just dropped alcohol on the top of her hand. For her eye she did not put anything she just rubbed the alcohol and put it last night. The consumer stated that the events were still consistent. Consumer stated, she was caregiver. She take care of disability people. (Further not clarified, hence captured as consumer or non-health professional). (Not alpha spelled, hence not captured in tab). There was no Investigation Assessment provided. 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 are needed. No further information is expected.

Other Meds: AMLODIPINE; LISINOPRIL

Current Illness:

ID: 1774433
Sex: M
Age:
State: SC

Vax Date: 04/12/2021
Onset Date: 04/13/2021
Rec V Date: 10/09/2021
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: 20210413; Test Name: body temperature; Result Unstructured Data: Test Result:100.5; Comments: 100.5

Allergies:

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

Symptoms: Feeling unwell; throwing up; slight fever of 100.5 degrees Fahrenheit; feels very tired; is fully dressed and feels cold; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old male patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Batch/Lot number was not reported) an unspecified route of administration, administered in Arm Right on 12Apr2021 13:00 (at the age of 61 years) as dose 2 single for COVID-19 immunization. Medical history included ongoing diabetes mellitus Verbatim: Diabetes, renal disorder from 2020 and ongoing Verbatim: kidney disease from 2020 To Ongoing. The patient's concomitant medications were not reported. Historical vaccination included the patient received first dose 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 Left on an unspecified date in Mar2021 as single for COVID-19 immunization and experienced soreness at injection site, had a big knot on his arm and indigestion No prior vaccination within 4 weeks. No investigation assessment was done. After receiving the second dose of COVID-19 vaccine on 12Apr2021, one day after (13Apr2021) the patient experienced feeling unwell, throwing up, he ate some saltines and ginger ale and has had no further episodes of throwing up. He doesn't feel like he needs to throw up at the moment, slight fever of 100.5-degree Fahrenheit, feels very tired, is fully dressed with a sweater, wind breaker fully and feels cold. The patient underwent lab tests and procedures which included body temperature: 100.5-degree Fahrenheit on 13Apr2021. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Diabetes (Verbatim: Diabetes); Kidney disorder (Verbatim: kidney disease From: 2020 To: Ongoing)

ID: 1774434
Sex: M
Age:
State: CT

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 10/09/2021
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: Dizzy; hard to chew and talk; hard to chew and talk; Pain; Tiredness; difficult to breathe; Weakness; throat closing up; This is a spontaneous report received from contactable consumer (patient himself). A 34-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 13Apr2021 (age at vaccination: 34-years), as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route, in left arm, on 08Mar2021 (age at vaccination: 34-years) as dose 1, single for covid-19 immunisation. Patients medical history included HIV since 2015, unknown if ongoing. Concomitant medications were not reported. Patient took the vaccine on Tuesday morning, 13Apr2021, and he felt sick after it. He felt pain, was weak, and tiredness yesterday 14Apr2021. Today the caller was feeling dizzy, his throat was kind of closing up, it was hard to chew and talk, he felt he needs more air, and was very tired. Patient was at work today and when stands up he feels tired, weak and it was difficult to breathe. The outcome of events for difficult to breathe, weakness and throat closing up was not recovered, and rest was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1774435
Sex: F
Age:
State: NJ

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/09/2021
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: Hives arms legs & torso/ I had a reaction of hives on my arms and legs; Received the first vaccine and broke out in hives within two hours of the shot; This is a spontaneous report from a contactable consumer. This 56-year-old non-pregnant female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7533) via an unspecified route of administration on 01Apr2021 at 05:30 PM (at 56-year-old) on left arm, as dose 1, single for COVID-19 immunization. The patient had history of allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for covid-19 since the vaccination. No other vaccines were received within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. On 01Apr2021, within two hours of the shot the patient experienced hives arms legs & torso/ had a reaction of hives on my arms and legs. The patient received treatment with Benadryl. The patient was recovering. No follow-up attempts were needed. No further information was expected.

Other Meds:

Current Illness:

ID: 1774436
Sex: F
Age:
State: FL

Vax Date: 04/11/2021
Onset Date: 04/12/2021
Rec V Date: 10/09/2021
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: weakness; burning sensation in face and lymph nodes; burning sensation in her eyes; intense headache; pain in ears; body aches; Chills; Fever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in arm left on 11Apr2021 (at the age of 40-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included endometriosis, hysterectomy, ovaries removed, surgeries (clarifies she actually had 4 total surgeries), severe allergies (had her epi pen with her at the time of the vaccination but everything was fine). The patient concomitant medication included estradiol (ESTROGEL) cream (applies cream every 2 days, intravaginally) via vaginal route taken for oestrogen replacement therapy (had endometriosis and had ovaries removed last year) from on an unspecified date in Feb2020 and ongoing. On 12Apr2021, the patient experienced body aches, chills, fever. On 14Apr2021, the patient experienced burning sensation in her eyes, intense headache, pain in ears, burning sensation in face and lymph nodes. On 15Apr2021, the patient experienced weakness. Calling because she got vaccine on Sunday, 11Apr2021, stated she has been having some reactions, wants to know how long will they last. The next day after the vaccine, she had body aches, chills, and fever. Stated the next day she started out feeling the same and then got a little better, states yesterday 14Apr2021 she had burning sensation in her eyes and lymph nodes and intense headache, stated it's not like a normal headache but it is hard to explain, stated she had pain in her ears, then felt a little better, in the evening yesterday felt the same. Cannot work due to symptoms. Product information: NDC, expiration date and dosage were unknown. Patient stated she does have severe allergies and had her epi pen with her at the time of the vaccination, but everything was fine. No further information provided. Stated previously she did have endometriosis and had ovaries removed, clarifies she actually had 4 total surgeries, had hysterectomy as well, everything prior to vaccine. The patient received acetaminophen and ibuprofen as treatment medication for all the events. Outcome of the event weakness was not recovered, and outcome of remaining events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: ESTROGEL

Current Illness:

ID: 1774437
Sex: M
Age:
State: AZ

Vax Date: 04/13/2021
Onset Date: 04/14/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: plantar fasciitis in his right foot and ankle area; joint pain is very isolated to his right foot and ankle area; right foot and ankle are very tender; having to walk with a limp; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch number EW0162) via an unspecified route of administration, administered in arm left on 13Apr2021 10:45 AM (age at the time of vaccination was 64 years) as dose 1, single for COVID-19 immunisation. The patients medical history included arthritis in all his joints. He received a flu vaccine in Sep2020 or Oct2020. He had a hernia surgery on 29Jan2021, and he was looking at his medical history and the doctor told him he was a healthy guy. He had a family history of cancer and heart disease. The patients concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) and Vitamin B12.The patient experienced no side effects for the first 24 hours. The patient reported about 30 hours afterwards maybe around 4:00-5:00PM the next day on 14Apr2021, tenderness in his right foot and ankle. He had been dealing with a case of plantar fasciitis in his right foot and ankle area that he thought he was over. He experienced the joint pain was very isolated to his right foot and ankle area. It was over a month ago that he had the plantar fasciitis. His doctor had prescribed an anti-inflammatory medicine and he had not been taking that medicine. He reported he and his wife were walking 4-5 miles a day and now he was back up to walking 1-3 miles a day. He was having to walk with a limp because it was so tender. There was none history of all previous immunization with the Pfizer vaccine considered as suspect and no additional administered vaccines, no any vaccine administered on same date with the pfizer vaccine considered as suspect. There was no any vaccine administered prior vaccinations (within 4 weeks) and no adverse event following prior vaccinations. There was no relevant test. The outcome of plantar fasciitis was unknown and other events was not recovered. No follow-up attempts were needed, information about lot/batch number could not be obtained.

Other Meds: ADVIL [IBUPROFEN]; VITAMIN B12 NOS

Current Illness:

ID: 1774438
Sex: F
Age:
State: FL

Vax Date: 04/06/2021
Onset Date: 04/12/2021
Rec V Date: 10/09/2021
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: red spots and very itchy on her left arm where she got the vaccine and, on her leg/left arm and then leg and then backside and right arm and mostly in her legs/all over her body; red spots and very itchy on her left arm where she got the vaccine and, on her leg/left arm and then leg and then backside and right arm and mostly in her legs; feels like it was an allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0150, Expiration Date: 30Jul2021 and NDC number was unknown) via an unspecified route of administration, administered in left arm on 06Apr2021 as dose 1, single (at the age of 31-years-old) for COVID-19 immunization. The patient had no medical history and did not receive any concomitant medications. On 12Apr2021 (something strange a week after receiving the vaccine, Monday), patient started a weird reaction, patient had red spots and very itchy on her left arm where she got the vaccine and, on her leg/left arm and then leg and then backside and right arm and mostly in her legs. On 15Apr2021, the red spots bursted out all over her body and patient feels like it was an allergic reaction to the vaccine. Patient wanted to know what to do with her second dose and was she going to get something in the mail saying she should not get it. The outcome of feels like it was an allergic reaction to the vaccine was unknown and recovering for rest both the events. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1774439
Sex: F
Age:
State: MI

Vax Date: 04/10/2021
Onset Date: 04/10/2021
Rec V Date: 10/09/2021
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: Elbow pain 20 min after injection.; Pain traveled to neck and shoulders; Injection site pain lasted 2 days; Fatigue for 3 days; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). An adult unknown pregnant female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown, Expiry date: not reported) via an unspecified route of administration on 10Apr2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown If the patient was diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, has the patient been tested for COVID-19. On 10Apr2021, the patient experienced elbow pain 20 min after injection, pain travelled to neck and shoulders and then to the site of injection, injection site pain lasted 2 days. Fatigue for 3 days. The reporter assessed the events as non-serious. It was unknown if patient received the treatment for events.: The outcome of the elbow pain 20 min after injection, pain travelled to neck and shoulders was recovered in 2021, for injection site pain lasted 2 days and fatigue for 3 days was recovered in Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am