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

Date Died:

ID: 1320290
Sex: M
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
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: Lungs filled up with fluid; could not breath after the second dose; This a spontaneous report from a contactable consumer via a Pfizer sales representative. An 89-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient's concomitant medications were not reported. On an unspecified date, the patient died due to lungs filled with fluid and could not breath after the second dose. It was not reported if an autopsy was performed. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: Lung filled up with fluid; could not breath after the second dose

Other Meds:

Current Illness:

ID: 1320291
Sex: M
Age:
State:

Vax Date: 03/13/2021
Onset Date: 03/20/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data: Test Date: 20210320; Test Name: Covid; Result Unstructured Data: Test Result:positive

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: patient contracted COVID and went to the hospital and got monoclonal antibodies; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on 13 Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Mar2021, patient contracted COVID and went to the hospital and got monoclonal antibodies. Lab test included SARS-CoV-2 antibody test positive on 20 Mar 2021. Outcome of the event was unknown. Follow up #2(07May2021) This is a spontaneous report from a contactable consumer (patients wife) in response to trail mail sent included: the correct name for the wife provided over the call is withheld and the name for the husband (withheld) mentioned in the document was not spelled nor clarified. Follow-up needed. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1320292
Sex: F
Age:
State: CA

Vax Date: 04/09/2021
Onset Date: 04/13/2021
Rec V Date: 05/15/2021
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: bloody stool; Yeast infection; swollen upper eyelid; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 17:00 at the age of 31 years old (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The patient experienced yeast infection, bloody stool, swollen upper eyelid on 13Apr2021. The patient did not receive treatment for the events. The outcome of the events was not recovered. Information about Lot/Batch number is obtained. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1320293
Sex: U
Age:
State:

Vax Date: 03/22/2021
Onset Date:
Rec V Date: 05/15/2021
Hospital: Y

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: They actually did admitted me to the hospital (further clarification unknown), did all cardiac stuff; Fatigue; Headache; Ringing in my ear; Flashed face; Fluctuation with my blood pressure and heart rate; Fluctuation with my blood pressure and heart rate; I have chest pressure; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient had the typical fatigue, headache, ear ringing and flashed face that lasted a couple days. And about few days after (unspecified date), the patient had fluctuation with blood pressure and heart rate and chest pain. It was reported that the patent was actually admitted to the hospital (further clarification unknown), did all cardiac stuff and everything was okay. 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: 1320294
Sex: M
Age:
State:

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Myocarditis; Pleuritic Chest Pain; Difficulty breathing; Myalgia; Headache; Flu-like symptoms; This is a spontaneous report from a contactable physician. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 01May2021 as second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2, on an unknown date, for COVID-19 immunization. The patient experienced myocarditis on 05May2021, and in May2021 (reported as started 2 and a half days after receiving the second dose) experienced pleuritic chest pain, difficulty breathing, myalgia, headache, and flu-like symptoms. The patient was hospitalized for the events from 05May2021 to an unknown date. The reporter assessed the events as life-threatening. The adverse events required a visit to Emergency Room. The reporter assessed that the patient's events were caused by the vaccine. The outcome of the events was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported events cannot be excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1320295
Sex: U
Age:
State:

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 05/15/2021
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: Tunnel vision; Dizziness; Nausea; ringing in ears; Flushed face; chest pressure; my blood pressure up; fatigue; headache; fluctuation with blood pressure and heart rate; fluctuation with blood pressure and heart rate; chest pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient also received first dose of BNT162B2 on 22Mar2021 for COVID-19 immunization and experienced fatigue, headache, ear ringing, and flushed face that lasted a couple days; and fluctuation with blood pressure and heart rate and chest pain which resulted to hospital admission. The patient mentioned that with the second dose, the patient had just typical reaction with the first one (such as fatigue, headache, fluctuation with blood pressure and heart rate, and chest pain) on unspecified dates in 2021. The patient also mentioned that immediately like within 20 minutes following second dose on 21Apr2021, the patient had like tunnel vision, dizziness, nausea, ringing in ears, and flush face. The patient further stated, "Well here is my problem, I am having this, it will go away for a day and then it'll come back worst, and today is the worst it's been. I was fine this morning but for 10 hours now, my heart rate is up, it's just in the 90s, I have chest pressure, my blood pressure up. This morning when I got up and I didn't have any symptoms, my pressure was 107 over". Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320296
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
Hospital:

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

Lab Data: Test Name: Tested positive for Covid virus; Test Result: Positive

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Tested positive for Covid virus after first Covid vaccine; Tested positive for Covid virus after first Covid vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable reporter reported for a patient (reporter's father). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that the patient (reporter's father) tested positive for COVID virus after first of COVID vaccine on an unknown date. The patient's wife (reporter's mother) was also tested positive for COVID virus after the first dose of the COVID vaccine. The reporter asked that his father (patient) would like to make an appointment for his second COVID vaccine. The reporter notified that Pfizer did not participate in scheduling vaccinations. The reporter was referred back to healthcare provider, and/or local county and state resources that may possibly be of some assistance. The report was related to a study or programme. There was a Product Complaint and description of complaint was COVID 19 vaccine. Outcome of the events was unknown. Reporter seriousness for At risk: needs to schedule second Covid vaccine: Unspecified Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320297
Sex: F
Age:
State: CO

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data: Test Date: 20210428; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: fluttering in chest; Nauseous; Dizzy; extreme fatigue; cold like symptoms; sore throat; slept on and off for 2 days; sinus drainage; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in arm right on 21Apr2021 at 12:45 (at the age of 56-years-old) as 2nd dose, single for COVID-19 immunisation. Concomitant medication included omeprazole taken for an unspecified indication, start and stop date were not reported. The patient previously took minocycline and had allergies. The patient also previously received the first dose of BNT162B2, administered in right arm on 31Mar2021 at 12:45 PM (at the age of 56-years-old) for COVID-19 immunisation. The patient experienced nauseous, dizzy, extreme fatigue, cold like symtoms with sore throat - sinus drainage, fluttering in chest and slept on and off for 2 days on 22Apr2021 at 04:00. The patient went to the doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 28Apr2021. There was no treatment received for nauseous, dizzy, extreme fatigue, sore throat, fluttering in chest and slept on and off for 2 days. The outcome of the events was unknown.

Other Meds: OMEPRAZOLE

Current Illness:

ID: 1320298
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
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: Delirious; felt like she had COVID; body ache; fast heart rate; Sneezing; Joint pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included Crohn's disease and synovial cyst (Verbatim: Ganglion cyst). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced delirious, felt like she had COVID, body ache, fast heart rate, sneezing, and joint pain. It was further reported that for 7 days straight, her body ache and had joint pain for 12 days. The outcome of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1320299
Sex: F
Age:
State:

Vax Date: 04/26/2021
Onset Date: 04/27/2021
Rec V Date: 05/15/2021
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: Red hard hot itchy area around injection site; Extreme fatigue; body aches; joint pain; nausea; headache; Red hard hot itchy area around injection site; Red hard hot itchy area around injection site; This is a spontaneous report received from a non- contactable consumer (patient). A 52-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 12:45 (at 52 years old, not pregnant) (Batch/Lot Number: ER8736) as 2nd dose, single for covid-19 immunisation. Medical history included Hashimoto Thyroiditis from an unknown date. The patient had her first dose of bnt162b2 (lot number -EL9263) vaccine on 05Apr2021 11:00, on left arm for covid-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID); vitamin b complex (VITAMIN B); vitamin d [vitamin d nos]; magnesium. After dose 2, patient experienced on 27Apr2021 08:00, Extreme fatigue, body aches, joint pain, nausea, headache, no treatments for these events. Red hard hot itchy area around injection site that she took Benadryl for. Patient had no reaction to dose 1. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow up possible. Follow up information can not be obtained

Other Meds: SYNTHROID; VITAMIN B; VITAMIN D [VITAMIN D NOS]; MAGNESIUM

Current Illness:

ID: 1320300
Sex: M
Age:
State: CA

Vax Date: 02/02/2021
Onset Date: 02/10/2021
Rec V Date: 05/15/2021
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: Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; This is a spontaneous report from contactable consumer (patient). A 36-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown), via unknown route of administration on the left arm on 02Feb2021 at 11:30 AM, as a 1st single dose for covid-19 immunization. Medical history of the patient was none. Patient did not have any known allergies. Patient did not receive any other medications in two weeks after vaccination. Patient did not receive any vaccine within 4 weeks prior to the first dose of vaccine. Prior to vaccination, patient did not diagnose with Covid-19. On 10Feb2021 at 01:00 AM after receiving first dose of vaccine, patient experienced extreme pressure in brain, screaming tinnitus, muscle cramps and aches, which was resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment received for the events included medicine (unspecified). Since the vaccination, patient has not been tested for Covid-19. Outcome of the events were not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320301
Sex: M
Age:
State: FL

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data: Test Date: 20210428; Test Name: echocardiogram; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210428; Test Name: ST Elevation on EKG; Result Unstructured Data: Test Result:ST Elevation; Test Date: 20210428; Test Name: Cardiac enzymes increased; Result Unstructured Data: Test Result:increased; Test Date: 20210428; Test Name: Troponin increased; Result Unstructured Data: Test Result:increased

Allergies:

Symptom List: Rash, Urticaria

Symptoms: myocarditis; Strange weird bilateral wrist pain severe; Pericarditis/inflammation around the heart; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for two patients (twins). This is the first of two reports. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170), via an unspecified route of administration, administered in the left arm, on 26Apr2021 10:00, as 2nd dose, single, for COVID-19 immunization, at a pharmacy/drug store. Medical history included ongoing rare metabolic disorder. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735) received at age 22 years, on 05Apr2021, for COVID-19 immunisation. On 26Apr2021, the patient received the second dose of BNT162B2. In the evening of the same day, 26Apr2021, the patient experienced tiredness/fatigue, and headache. In the morning of 27Apr2021, the patient was feeling really crappy and they though it was like the flu and it would pass. In the evening of 27Apr2021, the patient didn't sleep at all and was uncomfortable all night and pain. On the same day, 27Apr2021, the patient had severe chest pain, chest tightness, and lightheadedness. On 28Apr2021, the pain didn't go away, and the twins had elevated ST evaluation on the EKG (electrocardiograph). ST evaluation was done by the reporter's husband who is a retired firefighter emergency medical technician. The reporter decided to take the patient to hospital and said that the other twin had the same symptoms but kept saying his wasn't as bad as his brother's because he did not want to go to the hospital. The doctor advised the reporter to bring the other twin. The twins had the same echo cardiogram on 28Apr2021 (unknown results). On 28Apr2021, their troponin levels were elevated, and their cardiac enzymes continued to go up. On the same day, 28Apr2021, the patient had a strange weird bilateral wrist pain severe. It was reported that the twins were hospitalized on 28Apr2021 with myocarditis/pericarditis and inflammation around the heart. Treatment for myocarditis/pericarditis included ibuprofen and colchicine; and Toradol for breakthrough pain. The reporter stated that the twins are two identical males with the same DNA, had the vaccine at the same time, had the reactions at the same length of time, have the same lifestyle and live at the same house. The reporter said it would go a long way if they help her understand the complication. The patient recovered "strange weird bilateral wrist pain severe" on 29Apr2021. The outcome of the event myocarditis and pericarditis/inflammation around the heart was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021487544 same reporter, suspect drugs and events; different patients

Other Meds:

Current Illness: Metabolic disorder

ID: 1320302
Sex: M
Age:
State: NY

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 05/15/2021
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: Went to bed around 9:00 to 9:30 PM and he woke up around 11:00 PM; Couldn't even move; Whole body is aching; Sweating; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0170), via an unspecified route of administration in left arm, on 29Apr2021 at 03:00 PM (15:00), as first dose, single, for COVID-19 immunization. The patient's medical history included blood pressure, atrial fibrillation, cholesterol, and heart problem. The patient's concomitant medications included metoprolol and acetylsalicylic acid (BABY ASPIRIN); both were ongoing. The patient takes acetylsalicylic acid because he can't take blood thinners because he works with sharp objects all day. The patient had no prior vaccinations within 4 weeks; and he didn't know adverse events following prior vaccinations as he received vaccines as a child. The patient received his first COVID-19 vaccine in his left arm (because he's right-handed) yesterday (29Apr2021) and his whole body is killing him, it's aching, and he's sweating. The patient was asking if his symptoms are normal. Last night (29Apr2021) when the patient was sleeping, he went to bed around 9:00 to 9:30 PM and he woke up around 11:00 PM and he couldn't even move. The patient got up this morning and took 2 paracetamol (TYLENOL) for the events. The patient was sweating like there's no tomorrow, but he thinks that paracetamol is working. The events did not require a visit to the emergency room and physician office. The patient's second COVID-19 vaccine is scheduled for 20May2021. The patient had not recovered from "Whole body is aching" and "Sweating". The outcome of the other events was unknown.

Other Meds: METOPROLOL; BABY ASPIRIN

Current Illness:

ID: 1320303
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
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: Shingles; This is a spontaneous report from a non-contactable nurse (patient). A 35-year-old female not pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Right on an unspecified date (Lot number was not reported) as single dose (at age of 35-year-old) for covid-19 immunisation. Medical history included Hereditary haemorrhagic telangiectasia (HHT) and allergies to sulfa. Concomitant medications were not reported. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on unknown date for Covid-19 immunisation. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On an unspecified date patient experienced shingles. Event resulted in Emergency room/department or urgent care, patient was treated with Antiviral,steroid, pain medication. Outcome of the event was unknown. Follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1320304
Sex: F
Age:
State: TX

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 05/15/2021
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: Dizziness; Hallucinations; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 30Apr2021 11:45 as unknown, single for COVID-19 immunization. Medical history included other medical history: asthma, known allergie: shell fish, thyroid, COVID prior vaccination: Yes, known allergie: bee stings, and known allergie: codine. Concomitant medications included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D), and fluticasone propionate (FLONASE). Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hallucinations on 30Apr2021, and dizziness on 30Apr2021 15:30. No treatment was received for the events. The outcome of the event hallucinations was recovered on 30Apr2021 and for dizziness was recovered on 01May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: ALLEGRA D; FLONASE [FLUTICASONE PROPIONATE]

Current Illness:

Date Died:

ID: 1320305
Sex: F
Age:
State:

Vax Date: 03/04/2021
Onset Date: 03/22/2021
Rec V Date: 05/15/2021
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: 20210323; Test Name: covid test; Test Result: Positive

Allergies:

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

Symptoms: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a non-contactable consumer. A 71-year-old female patient (reporter's mother) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 04Mar2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient contracted COVID a few days before her second dose (event onset date 22Mar2021). She felt symptoms about 3 days before she was scheduled to receive her second dose. Covid test on 23Mar2021 was positive. She was officially diagnosed with COVID on 25Mar2021, the day of her scheduled second dose, which she did not get. She died several days later. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the event. The patient died on an unknown date with death cause of COVID. It was unknown if autopsy performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test

Other Meds:

Current Illness:

ID: 1320306
Sex: F
Age:
State: PA

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Knocked out for 2 days, couldn't eat or drink, felt unconscious; Swollen Arm; Fever; Chills; Aches; Headache; Fatigue; Pain in legs so bad cannot handle it; Edema from face down to ankles; Lump on arm, left groin, underarm, back of neck; Weakness; Can't lift arm; Knocked out for 2 days, couldn't eat or drink, felt unconscious; Sense of smell funny at times; ; lymph nodes that were as big as golf balls and are still swollen and still sore; ; lymph nodes that were as big as golf balls and are still swollen and still sore; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 14:00 (lot number: EP7534; Expiration Date: 31Jul2021) at the age of 69 years old, as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included ongoing allergy to mold, mildew, dust, pollen, some trees, dander, ongoing lactose intolerant, ongoing bronchitis chronic (stated that she gets this from any sinus or allergy), ongoing bowel intussusception (was causing bowel blockages, every 2 days or so. Diagnosed about 2 years ago; monitored by Gastroenterologist), ongoing Nonpolyposis colon cancer (diagnosed about 35 years ago. Says polyps would grow to be cancerous if not monitored regularly). Concomitant medications included linaclotide (LINZESS) taken for intestinal obstruction, start and stop date were not reported; epinephrine (EPIPEN) taken for anaphylactic reaction, start and stop date were not reported. The patient previously received bnt162b2, first dose, on 12Mar2021 at the age of 69 years old for COVID-19 immunization and experienced sore arm (Lot Number: EN6202; Expiry Date: 30Jun2021). No other vaccines received 4 weeks prior to COVID vaccine. The patient has gone to her doctor already. She was kept 45 minutes after her second dose of the COVID vaccine. On 02Apr2021, her arm started to swell up, and she left. A couple of hours later (02Apr2021), she was in bed with a fever, chills, aches, a headache, and stated she was knocked out for 2 days. In those 2 days she couldn't eat or drink and felt like she was unconscious. Her husband had to wake her up and make her drink. Now, a month later, she still has fatigue. She still has pains, pains in her legs are so bad she cannot handle it. She keeps getting chills, headaches, fatigue, states she takes an aspirin for it every day. Says she never lost her sense of smell, but it is funny at times. States she could sleep all day she has so much fatigue. She asked what is going on with her. She asked why are her symptoms prolonged? Why are her legs hurting so bad? Why does she have edema from her face down to her ankles? Event Details: Stated that her arm swelled so bad that by the time she got home it looked like a little football. It was big and red hot. There was a lump there on her arm the size of a silver dollar. There was also a lump in her underarm, left groin, back of neck; lymph nodes that were as big as golf balls and are still swollen and still sore. Stated that all of her symptoms started the day of the second vaccine and are still persisting. She still has a fever and chills on and off, aches, headaches, edema, fatigue. Says she is not used to being so tired as normally she is very active. Still feels very weak. Mentions again that she can't lift her arm and has weakness and fatigue. The events required visit to Physician office. Outcome of knocked out for 2 days, couldn't eat or drink, felt unconscious was unknown. Outcome of sense of smell funny at times was recovered on Apr2021; while outcome of the remaining events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: LINZESS; EPIPEN

Current Illness: Allergy to animal dander; Allergy to plants; Bowel obstruction (causing bowel blockages, every 2 days or so. Diagnosed about 2 years ago.); Chronic bronchitis (States that she gets this from any sinus or allergy.); Colon cancer (diagnosed about 35 years ago.Said polyps would grow to be cancerous if not monitored regularly.); Dust allergy; Lactose intolerant; Mycotic allergy; Pollen allergy

ID: 1320307
Sex: F
Age:
State: CO

Vax Date: 04/09/2021
Onset Date: 04/23/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data: Test Date: 20210429; Test Name: Covid 19 Test; Result Unstructured Data: Test Result:Positive

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Missed appointment for second vaccine on 30Apr2021; Tested positive for Covid 19; Tested positive for Covid 19; Felt Sick; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0153, Expire Date: Unknown), dose 1 via an unspecified route of administration, administered in left arm on 09Apr2021 as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient states that she had her first vaccine a couple of weeks ago. She was supposed to have her second one on Friday. States her kids were sick. She went and got tested for Covid 19 and it was positive. She has conflicting information on when she can have the second dose of her vaccine. Was calling to see when she could get it. States that it is hard to say. On 23Apr2021, patient experienced felt sick, Tested positive for Covid 19 after first dose of Covid 19 vaccine, she was supposed to get her second dose on 30Apr2021 but missed The patient underwent lab tests and procedures which included COVID-19 (sars-cov-2) test: positive on 29Apr2021. Outcome of the events was unknown. follow-up attempts are possible. further information is expected.

Other Meds:

Current Illness:

ID: 1320308
Sex: F
Age:
State: CA

Vax Date: 04/06/2021
Onset Date: 04/11/2021
Rec V Date: 05/15/2021
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: Post menopausal vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: Lot Number: ER8737), via an unspecified route of administration, administered in the left arm on 06Apr2021 at 10:30 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:00, the patient experienced post menopausal vaginal bleeding. The patient did not receive treatment for the event. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1320309
Sex: F
Age:
State: ID

Vax Date: 03/16/2021
Onset Date: 03/22/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data: Test Date: 20210322; Test Name: Covid 19; Result Unstructured Data: Test Result:Positive

Allergies:

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

Symptoms: days later, on 21Mar2021, they both tested positive for Covid-19; days later, on 21Mar2021, they both tested positive for Covid-19; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6204), via an unspecified route of administration on 16Mar2021 (at an age of 83-years-old) as 2ND DOSE, SINGLE for covid-19 immunization. Caller stated wife takes medications for arthritis and high blood pressure, no other information provided. Stated they are pretty healthy for being in their 80s. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6203), via an unspecified route of administration on 23Feb2021 as 1ST DOSE, SINGLE for covid-19 immunization. Caller stated his wife and he both received the first dose of the Pfizer Covid 19 shot on 23Feb2021, stated they got second shot on 16Mar2021. Five days later, on 21Mar2021, they both tested positive for Covid-19. Caller clarified that they came down with symptoms on 21MAR2021, then tested positive on 22Mar2021. Caller stated his wife dealt with Covid symptoms for about 3 weeks and has pretty much recovered, her symptoms were somewhat more mild that callers. Product details : EN6204, Second dose, exact dosage was not recorded on the patient vaccine record card. On 22Mar2021, the patient underwent lab test which included covid-19 test: positive. The outcomes of events were unknown. No follow-up attempts are needed; No further information is expected.

Other Meds:

Current Illness: Arthritis; Blood pressure high

ID: 1320310
Sex: M
Age:
State: NC

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 05/15/2021
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: body aches; Fatigue; laying around; vaccine expired two hours before he got it; This is a spontaneous report from a contactable physician. A 18-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration, administered in arm on 01May2021 (at the age of 18 years) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization and meningococcal vaccine b (MENB) taken on Feb2021. The patient had no other vaccinations the dates he got his Pfizer COVID-19 vaccine or in the four weeks prior. On 01May2021, saturday patient received second dose of vaccine which was expired two hours before he got, which the patient should not had got and was called back in. On 02May2021 patient experienced side effects such as body aches, laying around, and fatigue. The reporter informed about seriousness that she felt it is significant, in that there was already hesitancy, so for them to mess up on this is significant. The outcome of event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Expired vaccine used, fatigue and the suspect drug BNT162B2. Also, there is limited information in the case provided, the causal association between the event pain, bedridden and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1320311
Sex: M
Age:
State: IN

Vax Date: 04/27/2021
Onset Date: 05/03/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data: Test Date: 20210503; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptom List: Unevaluable event

Symptoms: He was positive for COVID 19; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old male consumer received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration in left arm on 27Apr2021 at 14.00 as first single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any antipyretic drug around the date of vaccination. Product complaint was reported. The patient reported that he got first shot 27Apr2021 and he took a test on 03May2021 and he was positive for COVID 19. He only got the first dose, he goes for the second dose 14May2021, he says they did not give him a vaccine card. He did not know any lot number or expiration for the dose he received. The case was classified as serious. The outcome of event was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

Date Died: 04/09/2021

ID: 1320312
Sex: M
Age:
State: CT

Vax Date: 02/01/2021
Onset Date: 04/09/2021
Rec V Date: 05/15/2021
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: first dose on 21Jan2021 and second dose on 01Feb2021; passed away; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 01Feb2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation and experienced a terrible reaction. The patient passed away (death) on 09Apr2021. It was unknown if an autopsy was performed. The information on the lot/batch number has been requested.; Reported Cause(s) of Death: passed away

Other Meds:

Current Illness:

ID: 1320313
Sex: F
Age:
State: MD

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 05/15/2021
Hospital: Y

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: Unknown event; 1st dose received in Jan2021, the patient missed her second dose appointment because she was in the hospital; This is a spontaneous report from a Pfizer sponsored program COVAX Support. A pharmacist reported on behalf of the patient. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on Jan2021, as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient has been in and out of the hospital for an unknown event which was something unrelated to the COVID vaccine. The caller stated that the patient's hospitalization wasn't related. The patient missed her second dose appointment because she was in the hospital. The reporter wanted to know whether the patient could take their second dose or start all over again. The reporter was aware that the Pfizer shot has to be taken after 3 or 4 weeks at most apart but it had been 4 month or above for the patient. The case was assessed as serious (hospitalization). The outcome of the event was unknown. Information about lot/batch number has been requested. ; Sender's Comments: Based on current information available, the events was considered unrelated to Bnt162b2.

Other Meds:

Current Illness:

ID: 1320314
Sex: M
Age:
State: MA

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:102 Fahrenheit; Comments: fever

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Blood Clot in right leg; Severe pain in leg; cry; This is a spontaneous legal report (Marketing Program) from a contactable consumer (patient himself). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection) dose 2 (Batch/Lot Number: EW0770) via an unspecified route of administration, on 21Apr2021 11:30, as single dose for covid-19 immunization. Medical history included Asthma ongoing, Diabetes had been on and off since 2018, Covid-19 in an unspecified date in Jan2021. The patient received dose 1 (Batch no/Lot Number: ER8732) via an unspecified route of administration, on 29 Mar 2021, as single dose for covid-19 immunization. The patient's concomitant medications were not reported. On 21Apr2021 around 11:30-12:00 in the night the patient experienced Blood clot in his right leg, had a severe pain and cannot walk, feels like he's being stabbed in the leg every time he gets up. He had to keep his legs up all the time and not put them down. He stated that his life was going to be upside down for 6 months because of the Covid vaccination. Stated that was unacceptable. Reporter also said that if the blood clot breaks off it could be dangerous. Said it was substantial; it was all the way up to his groin, not its down almost to his knee and goes all the way down to his ankle. Patient went to the hospital last Saturday due to pain in the back of his leg. The pain started 12 hours after the second Covid vaccine. He wanted to cry he was in so much pain. He could not take anything for it. Patient stated that if the clot breaks off, he was dead. So, he had to put everything on hold because he did the right thing which ended up being the wrong thing. Patient stated that the pain in his leg was a 13 or 14 on a scale of 1-10. Patient took Tylenol and Pain patches did not work on a blood clot. Patient stated that when he was in the hospital, 4 different doctors, told him the event was at least 50 if not 100 percent caused by the Covid dose of vaccine. Patient stated that after the first dose of vaccine he was sick as a dog and he said that the clot may have started with the first dose of vaccine, stated that he had a 102 degree fever a few minutes after the vaccination, felt dizzy and thought he was going to fall over. Patient stated that he got the vaccination dose to get his life back and now he could not, that what about in 6 months if he had to get a booster vaccine and probably go through it all over again; or to be on quarantine. Patient stated that he went with his 84-year-old mother to get the vaccine. Patient said that the only reason she didn't get a blood clot was because she was already on blood thinners and said that he is the one who takes care of his mom and now he cannot walk barely, he had Covid in January and that people who had Covid shouldn't be taking these vaccinations because they have immunity, he talked to a doctor and a woman yesterday who still have their antibodies a year after having Covid. He said that the vaccine was injuring people. He was hospitalized related to his leg pain and diagnosed with the blood clot from 24 Apr 2021 to 27 Apr 2021. In the hospital he was told to him take Oxycontin or Morphine. He said that he did not want to take those and end up addicted. He said after a motor vehicle accident he had in 2002 he took Naprosyn and it helped, he said could not take that now because he was on a blood thinner. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had tested COVID-19 positive prior to vaccination. This is to notify that potential legal action from a reporter in the attached source document booked into AER 2021506757 and 2021506972. The outcome of the event Blood Clot in right leg and Severe pain in leg was not recovered, feels like he's being stabbed in the leg was recovered and cry was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness: Asthma (Verbatim: Asthma); Diabetes (Verbatim: Diabetes)

ID: 1320315
Sex: F
Age:
State:

Vax Date: 04/12/2021
Onset Date: 04/01/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data: Test Name: Cultures performed; Test Result: Positive ; Comments: They did two; Test Date: 20210421; Test Name: Unspecified COVID19 test; Test Result: Positive

Allergies:

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

Symptoms: SARS-CoV-2 test positive; Vomiting; She was still sick; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:00 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization.There patient's medical history included blood clot.The patient's concomitant medications were not reported. The patient experienced sars-cov-2 test positive and Vomiting on 21Apr2021, she was still sick on Apr2021. Caller was calling about the Pfizer Covid-19 Vaccine. She was having a problem. She was due to schedule her second COVID Pfizer Vaccine on 03May2021. Caller states that she was still sick, she is still sick with it. She was going to go on 03May2021 but she was vomiting and she could not make it for her second shot. Now, she was trying to contact the place she went to which was care center in (With held). She did not have a number to call to reschedule. he lost her registration card. She did not know how to go about getting the second vaccine. Caller clarifies that she received her first dose of the vaccine three weeks ago this past Monday on 12Mar2021. Call handler clarifies infor-mation and caller asks what she said and then states she meant she received the first vaccine 12Apr2021. On 12Apr2021, caller received her first vaccine. On 21Apr2021, caller got a test for COVID and was diagnosed with COVID. Caller states they went to use urgent care on 21Apr2021 and her and her husband tested positive. caller does not provide address. Caller states that her husband has an e-mail address because she does not know how to use the computer. Caller states that it was okay to use this e-mail address. caller provides name and facility name, does not provide address or any contact information. Caller states she is not fully sure if that is the spelling of the doctor's name. Caller adds she was afraid to go to get her second vaccine because she was vomiting. Caller adds that she had vomiting a couple of times during - caller interrupts sentence - and states she had it but she does not have it no more. Caller adds she had vomiting on Monday and two other times but that was all. The last ten day, but she can not remember what days it was. Caller clarifies that she received a COVID-19 test and they put a swab in her nose. That was very uncomfortable. caller states she does not know. She misplaced her card and she can not find it. Her husband and her looked all over for it.Caller does not have any additional details. caller adds that she just wanted to get the COVID vaccine. She adds just so that she does not get sick. She was anxious to get it like everyone else was. She ended up getting sick. Caller adds she has never been so sick in her life and would not wish this on her worst enemy.Caller clarifies that she means with the vomiting. caller states she does not have any medical concerns. caller was not sure which COVID-19 test she received. Caller adds that she did not go to the emergency room. She went to an urgent care and does not know the name or contact information. She only knows that, she states she was just vomiting, They performed two culture and She had to wait 20 minutes and then they sent another one out. Caller confirms both were positive.Caller adds she was just concerned about where and when she can get her second shot. She wanted to see where she should go. The paper she was given is how she got Pfizer's number and that is where they wrote 03Mar2021 for her sec-ond dose. They did not give her local numbers or anything like that where she could go. Caller was advised that Pfizer cannot schedule appointments for the vaccinations. Caller states she was just glad she got to talk to a person and that she knows where to call. Caller advised to contact her physician or local health authority and states she will do so.The patient underwent lab tests and procedures which included culture: positive (they did two) on unspecified date, unspecified COVID19 test: positive on 21Apr2021.Therapeutic measures were taken as a result of sars-cov-2 test positive,vomiting she was still sick.the doctor just told her to take Tylenol. he has taken Tylenol. It was 500 mg tablets.The doctor she saw there also told her to take vitamins. She is now taking Vitamin C 1000 mg, zinc 50 mg, and Vitamin D3. Caller adds the Vitamin D3 is 50 mcg, whatever that means. The doctor also put her on a baby aspirin in case she gets a blood clot or something - like a low dose aspirin. Caller adds there is also one more thing, it is a probiotic.The outcome of she was still ill was not recovered and outcome of rest of the events was unknown. No follow-up attempts are needed. information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1320316
Sex: U
Age:
State: NC

Vax Date: 01/29/2021
Onset Date: 02/01/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data: Test Date: 202102; Test Name: got the COVID; Result Unstructured Data: Test Result:positive; Comments: I got the vaccination on 29Jan2021, 3 days later I got the COVID.

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: patient got the COVID, patient was tested positive; This is a spontaneous report from a contactable consumer(patient). A 67-year-old patient of an unspecified gender received first dose of BNT162B2 (Pfizer COVID-19 vaccine, solution for injection, lot# EL9262) via an unspecified route of administration on 29Jan2021 (at the time of 67-year-old) at single dose for COVID-19 immunization. The patient medical history included blood pressure, arthritis, depression and cholesterol. Concomitant medication included rosuvastatin at 10 mg for blood cholesterol, losartan potassium via oral at 25 mg once daily, venlafaxine at 75 mg twice daily, meloxicam via oral at 5 mg once daily, colecalciferol (D3) at 2000 daily, fish oil at 1000 mg, ascorbic acid (VITAMIN C), magnesium at 500 mg, ubidecarenone (COQ-10) once daily and hydrochlorothiazide at half of 25 mg. On an unspecified date it was reported that patient got the vaccination on 29Jan2021, 3 days later patient got the COVID, patient was tested positive. Patient went to the hospital last day at the vaccination centre and had diffusion that caused help with vial. Patient has to wait 9 days before got another shot. Didn't know whether it would be affective and patient might have to start all over again. Because it might not helped because it's been so long. Confirmed the date of getting positive as 29Jan2021, patient got the first shot on 29Jan2021 and then patient went next week and the COVID test and it tested positive. Patient tested positive probably around the 03Feb2021. Then patient went to have the diffusion on the 5Feb2021. Patient need to do diffusion because of high blood pressure at the hospital. So, patient had diffusion. Patient need to take another shot and patient might have to start back again with another first shot. Indications of the medications reported that for cholesterol, blood pressure, arthritis and depression. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Other Meds: ROSUVASTATIN; LOSARTAN POTASSIUM; VENLAFAXINE; MELOXICAM; D3; FISH OIL; VITAMIN C; MAGNESIUM; COQ-10; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1320317
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Bells Palsy; This is a spontaneous report from a contactable consumer. This consumer reported same event for three patients. This is the first of three reports. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced Bell's palsy. The outcome of Bell's palsy was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Follow-up (06May2021): This is a follow-up report to notify that the case 2021345756 and case 2021507291 are duplicates. All subsequent follow-up information will be reported under Manufacturer report number 2021507291. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345757 same reporter, product, and event; different patient.;US-PFIZER INC-2021345758 same reporter, product, and event; different patient.

Other Meds:

Current Illness:

ID: 1320318
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
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: Hashimoto's Thyroiditis; had a sore in my mouth after the 2nd outbreak; lips were really dry; rash; chills; low grade fever; This is a spontaneous report from a contactable consumer (reported on herself). The female patient of an unspecified age received second dose of BNT162B2 (solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a first dose, single for COVID-19 immunization. After the first dose on the third day, she had patchy redness on her cheek. Then she had a rash on her face from earlobe to the other earlobe. It started out as red spots that it was so bad that it welts together. It went down her neck and she had one spot that stayed on face and one spot on chest and a rash on face. After the first, she went to a dermatologist and he put her on a topical steroid cream and steroid tablet for 5 days. After she had the second vaccine, she did not have an outbreak until 2 weeks after because she still had that steroid in her system, as she believed. She had a sore in mouth after the second outbreak. It was also on her lips during my second one. Her lips were really dry, so it was possibly her body just being run down. About 5-6 days ago, she had a rash, but it had appeared only on lips. Each time she got this outbreak, she got chills (4 hours of chills) and a low grade fever. Now it was on lips and on the outer rim of lips. It was stated that she would be going to the dermatologist on the day of this report. On an unknown date, the patient had Hashimoto's Thyroiditis, which reduced her immune system. The patient had been to urgent care, to HCP, and was on third trip to the dermatologist. The outcome of the events of Hashimoto's Thyroiditis, had a sore in mouth after the second outbreak, lips were really dry, rash, chills, low grade fever was unknown. information on about lot/batch number has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1320319
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Girl's family who got vaccinated died along with their dog due to have been being exposed to the members who got vaccinated; 11 year old, pre-period, girls family who got vaccinated; This is a spontaneous report from a contactable consumer. A 11-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter reported that 11 year old, pre-period, girls family who got vaccinated died along with their dog due to have been being exposed to the members who got vaccinated. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot/batch number has been requested; Reported Cause(s) of Death: Girl's family who got vaccinated died along with their dog due to have been being exposed to the members who got vaccinated

Other Meds:

Current Illness:

ID: 1320320
Sex: F
Age:
State: DE

Vax Date: 04/16/2021
Onset Date: 04/01/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data: Test Name: COVID test; Test Result: Positive

Allergies:

Symptom List: Injection site pain

Symptoms: She tested positive with Covid-19 after taking the 1st dose; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified gender started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 16Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she got the first dose of the vaccine on 16Apr2021. She tested positive with Covid-19 after taking the first dose and it's already been 2 weeks. She's scheduled to get the second dose on 07May2021 and she wants to know if she should take the second dose on the scheduled date or if she needs to be tested as negative with Covid-19 first before taking the second dose. The 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: 1320321
Sex: M
Age:
State: MO

Vax Date: 01/19/2021
Onset Date: 04/30/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data: Test Date: 20210501; Test Name: Rapid Test; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab

Allergies:

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

Symptoms: I awoke with distorted vision in my Left eye.; a stroke; visual impairment; This is a spontaneous report from a contactable Other Health Professional (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), via an unspecified route of administration, administered in arm left on 19 Jan 2021 at 19:00 (Batch/Lot Number: EL3302) as 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included omeprazole (PRILOSEC [OMEPRAZOLE]), rosuvastatin, metoprolol, and ezetimibe (ZETIA), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (lot number: EL1284) in the left arm on 29Dec2020 07:00 PM for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to COVID-19 vaccine. He was not diagnosed with COVID-19 prior vaccination. It was reported that the patient awoke with distorted vision in his left eye. He went to the emergency room and was diagnosed with a stroke. He was subsequently transferred to the (hospital name) Level 1 Stroke Center. He continued to have visual impairment. The events started on 30Apr2021 07:00 AM. The patient was hospitalized for 5 days. The events was reported serious life-threatening, hospitalization and disabling/incapacitating. Therapeutic measures were taken as a result of the events with TPA. He had been tested for COVID-19 since the vaccination through rapid test (nasal swab) on 01May2021 with negative result. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: PRILOSEC [OMEPRAZOLE]; ROSUVASTATIN; METOPROLOL; ZETIA

Current Illness:

ID: 1320322
Sex: M
Age:
State: KY

Vax Date: 02/17/2021
Onset Date: 04/22/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data: Test Date: 20210424; Test Name: COVID Test; Test Result: Positive ; Comments: Nasal swab

Allergies:

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

Symptoms: Tested positive for COVID on 4/24/2021 and hospitalized for 6 days; Tested positive for COVID on 4/24/2021 and hospitalized for 6 days; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration administered in left arm on 17Feb2021 (Lot Number: EN6201) (Lot number also reported as EL9262) (vaccination age was 63-year-old) as single dose for covid-19 immunisation. Medical history included ocular myasthenia gravis. There were no known allergies and no Covid prior vaccination. Concomitant medication in two weeks included prednisone. There was no other vaccine in four weeks. The patient had tested positive (Nasal swab) for COVID on 24Apr2021 and hospitalized for 6 days in 2021. The adverse event occurred on 22Apr2021. The event was considered as serious as results in emergency room/department or urgent care, hospitalization for 6 days. The patient had 5 days treatment of remdesivir for the event. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: PREDNISONE

Current Illness:

ID: 1320323
Sex: F
Age:
State:

Vax Date: 04/25/2021
Onset Date: 04/27/2021
Rec V Date: 05/15/2021
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: not able to move her shoulder/neck; experience pain in her neck and shoulder; experience pain in her neck and shoulder; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Apr2021 as 2ND DOSE, SINGLE, received 1ST DOSE on an unspecified date for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On Tuesday 27Apr2021, patient began to experience pain in her neck and shoulder. On Wednesday 28Apr2021, patient was not able to move her shoulder/neck. patient has been to the MD 3 times and also one time to the Emergency Department for treatment. patient states it is on-going extreme pain and patient has had to take time off of work and go to physical therapy to treat it. Patient was worried about taking time off of work and wants to know if there is anything that can be done to help (compensate) her. Outcome of the events was not recovered. Information about batch/lot number has been requested. Further information is expected.

Other Meds:

Current Illness:

ID: 1320324
Sex: F
Age:
State: FL

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/15/2021
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: Immunocompromised; patient is skinny/underweight; having a multiple sclerosis relapse/Multiple Sclerosis flared up after she got the vaccine; double vision that is intermittent and unilateral; had a funny feeling around the lips, tongue, and on the left side of her face; This is a spontaneous combined report from a contactable consumer (patient) via Pfizer. A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6199) (51 year at the time of vaccination) via an unspecified route of administration in arm left on 15Apr2021 at 10:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Medical history included multiple sclerosis from 2000 and ongoing. The patient's concomitant medications were not reported. On 15Apr2021, after the first dose the patient started experiencing double vision and had funny feeling in her lip, tongue and left side of the face (started prior taking the vaccine). The patient said she might be relapsing from multiple sclerosis. The patient was confused whether she should take the second dose of the vaccine. The patient also received IV methylprednisolone (3gm) (to be administered over 2 hours for three days) and taking prednisone for her double vision which comes and goes. Patient stated she had been immunosuppressed due to being on prednisone for 7days. The patient went to the health care professional and the health care professional gave her a steroid and patient stated the steroid was not responding to the double vision. The patient reported that she does not remember having any issues with her eyes subsequent to taking the vaccine which could be coincidental or nothing to do with the vaccine, but she then developed double vision which was getting worse. The patient also reported that she was skinny and underweight. The patient took 3 grams of Solumedrol IV and it did not help her. Therapeutic measures were taken in response to the events and the patient also had to visit emergency room. The outcome of the event's multiple sclerosis relapse, double vision, immunocompromised and skinny/underweight was unknown while for the event funny feeling around the lips, tongue, and on the left side of her face it was reported as not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness: Multiple sclerosis

ID: 1320325
Sex: F
Age:
State: NY

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 05/15/2021
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: faint; Fever; chills; body ache; diahhrhea; nausea; light headed ness; unable to move cause in so much pain- arms felt like lead weights; unable to move cause in so much pain- arms felt like lead weights; ring in ears; lethargic; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 29Apr2021 13:00 (at the age of 17-year-old) (Batch/Lot Number: EW0172) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Medical history included seasonal allergies and known allergies to non-steroidal inflammatory drugs (NSAIDs), tree nuts, and pitted fruit. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and mometasone furoate (ASMANEX). Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, batch/lot number: EW0150), administered in left arm on 08Apr2021 at 01:00 PM for COVID-19 immunization and experienced foggy head and sore arm which was treated with Tylenol. On 29Apr2021 at 23:30, the patient experienced fever, chills, body ache, diarrhea, nausea, light headedness/faint, unable to move cause in so much pain- arms felt like lead weights, ring in ears, and lethargic. Therapeutic measures were taken as a result of all events. On an unspecified date, the patient recovered from all events.

Other Meds: ZYRTEC ALLERGY; ASMANEX

Current Illness:

ID: 1320326
Sex: M
Age:
State: IL

Vax Date: 03/17/2021
Onset Date: 03/19/2021
Rec V Date: 05/15/2021
Hospital: Y

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: STROKE IN PONS AREA OF BRAIN MEASURING 8.5MM; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er2613), via an unspecified route of administration, administered in the left arm, on 17Mar2021 12:00, as 1st dose, single, for COVID-19 immunisation, at a public health department. Medical history included bipolar 2, control hypertension, and control diabetes type 2. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since vaccination. Concomitant medications included lamotrigine; trazodone; verapamil, all taken for unspecified indications, start and stop dates were not reported. The patient previously took metformin and simvastatin and experienced allergies to both. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 19Mar2021 00:00, the patient experienced stroke in pons area of brain measuring 8.5 mm. This event resulted to emergency room visit and hospitalization for 2 days (from 19Mar2021 to 21Mar2021). Unspecified treatment was given by the neurologist, physical and occupational therapy. The event was assessed as serious (life-threatening, disability and hospitalization). The outcome of the event was not resolved. Follow up needed, further information has been requested.

Other Meds: LAMOTRIGINE; TRAZODONE; VERAPAMIL

Current Illness:

ID: 1320327
Sex: F
Age:
State: CA

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data: Test Date: 20210423; Test Name: Bloop pressure; Result Unstructured Data: Test Result:Jumped extremely; Comments: Jumped extremely; Test Date: 20210424; Test Name: BPM; Result Unstructured Data: Test Result:extremely high and resting was about 99

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: heart start hurting on Monday with almost each breath; BPM was also extremely high and resting was about 99; blood pressure jumped extremely; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 22Apr2021 at 18:00 (batch/lot number and expiration date were not reported) as the 2nd dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as the pharmacy or drug store. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733) on 31Mar2021 at 04:00 PM (at the age of 37 years old) in the left arm and experienced terrible pain in her arm. Relevant medical history included ongoing hypertension/high blood pressure (BP), which was controlled; ongoing Hashimoto; ongoing chronic herpes; and known allergies to Penicillin. The patient's concomitant medications were not reported. The patient previously took celecoxib (CELEBREX), from which the patient had known allergies. The patient was 37 years old and was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. After the second vaccine on 23Apr2021 at 05:00, the patient's blood pressure (bp) jumped extremely and lasted for at least five days. The patient had to monitor and had taken a lot of medication to keep it stable and not to pass the low blood bp of 110. It almost did one day. The patient's heart started hurting on Monday (26Apr2021) with almost each breath. The patient's beats per minute (bpm) was also extremely high and resting was about 99 on 24Apr2021. The patient stated that she was "not chainring" the regular symptoms of the flu such as fever, chills, sweating, exhaustion, and headache; her heart suffered the most. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of blood pressure jumped extremely, which included series of BP medicine and "different hours" (as reported). The patient recovered from the event "blood pressure jumped extremely" on 28Apr2021, while she was recovering from the rest of the events. Information on the batch/lot number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event angina pectoris and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE0 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness: Hashimoto's disease; Herpes virus infection; Hypertension (Controlled)

ID: 1320328
Sex: F
Age:
State: SC

Vax Date: 03/22/2021
Onset Date: 04/10/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Suffered mini stoke approximately 20 days after vaccine and a stroke 21 days after vaccine.; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Mar2021 09:30 (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunisation. Medical history included Covid-19 from Jul2020 (prior Covid 19 in July of 2020 with longhaul issues) and allergy to compazine and meperghan. Concomitant medications included gabapentin, rosuvastatin, colecalciferol and ubidecarenone (CO-Q10+VITAMIN D3). On 10Apr2021, the patient suffered mini stoke approximately 20 days after vaccine and a stroke 21 days after vaccine. The patient was released from urgent care on 10Apr2021 and went back 11Apr2021 after apparently having the stroke during morning hours of 11Apr2021. Transported around midnight of the 11th to hospital. The patient was hospitalized for four days and received Plavix and aspirin. The outcome of the event was recovering. Information on the lot/batch number has been requested.

Other Meds: GABAPENTIN; ROSUVASTATIN; CO-Q10+VITAMIN D3

Current Illness:

ID: 1320329
Sex: M
Age:
State:

Vax Date: 05/03/2021
Onset Date: 05/04/2021
Rec V Date: 05/15/2021
Hospital: Y

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 Name: systolic blood pressure; Result Unstructured Data: Test Result:220; Test Name: platelets; Result Unstructured Data: Test Result:46

Allergies:

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

Symptoms: Left intracerebral brain hemorrhage; Right hemiparesis; His platelets were 46; Systolic blood pressure 220; only responsive to touch and pain; Unresponsive; This is a spontaneous report from a non-contactable healthcare professional. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) as 2nd dose, single for Covid-19 immunisation. Medical history included hypertension. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for COVID-19 immunization. On 04May2021, the patient was found unresponsive by family, taken to Emergency department where left intracerebral brain hemorrhage was diagnosed. His platelets were 46 and systolic blood pressure 220. He has right hemiparesis and is only responsive to touch and pain. He is currently on hospice. The patient was hospitalized for 3 days and received platelet transfusion. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information and known drug profile it is unlikely that the reported events were causally related to bnt162b2 . The patient's history of hypertension is a risk factor for the reported left intracerebral brain hemorrhage and. blood pressure systolic increased. Case will be reassessed if additional information is received

Other Meds:

Current Illness:

ID: 1320330
Sex: M
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
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: 13 minutes after dose patient passed out.; This is a spontaneous report from a contactable consumer. A male patient of an unknown age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, batch/lot number unknown) via an unspecified route of administration on an unknown date at unknown dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received vaccine, 13 minutes after dose he passed out. The outcome of event was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1320331
Sex: F
Age:
State: LA

Vax Date: 04/05/2021
Onset Date:
Rec V Date: 05/15/2021
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: 3rd time CMV has reactivated; This is a spontaneous report from a contactable consumer (patient) reported that a 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729), via an unspecified route of administration, administered in arm left on 05Apr2021 14:45 (02:45 PM) (at the age of 36-years-old) as 1st dose, single for covid-19 immunization. The vaccine was administered at the hospital. The patient was not pregnant at the time of vaccination. The patient medical history included that she had preeclampsia, HELLP syndrome and CMV when she delivered her son 3 weeks early on 28Jan2021. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ferrous sulfate; and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) both taken for an unspecified indication, start and stop date were not reported. On an unspecified date in 2021, for the 3rd time CMV has reactivated. It was unknown if the patient received treatment for the event. The outcome of the event was unknown. She also added that she also have a colicky 3-month-old at home that her husband dealt with.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509886 baby case

Other Meds: FERROUS SULFATE; ADDERALL

Current Illness:

ID: 1320332
Sex: F
Age:
State: NY

Vax Date: 04/15/2021
Onset Date: 05/03/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data: Test Date: 20210503; Test Name: Strep test; Test Result: Positive ; Comments: she tested positive with her Strep test yesterday (03May2021)

Allergies:

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

Symptoms: however she tested positive with her Strep test yesterday (03May2021) and she also started to take Azithromycin yesterday.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (mother) reported for a 16-year-old female patient reported that patient received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Batch/Lot number and expiration date were not reported), via unspecified route on 15Apr2021 at single dose for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient was scheduled to get the 2nd dose of the vaccine on 06May2021, however she tested positive with her Strep test yesterday (03May2021) and she also started to took Azithromycin yesterday. (name) wanted to know if her daughter could still take the 2nd dose on the scheduled date. The outcome of the events was unknown Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320333
Sex: M
Age:
State: KY

Vax Date: 04/08/2021
Onset Date: 05/03/2021
Rec V Date: 05/15/2021
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: 20210504; Test Name: Covid test; Test Result: Negative

Allergies:

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

Symptoms: Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, in arm left, on 08Apr2021 16:00 (at the age of 36-year-old), at single dose, for COVID-19 immunization. Medical history included cholesterol, anxiety, depression, and Barrera esophagus. No known allergies. Concomitant medications included unspecified medication (patient received other medications within 2 weeks of vaccination). The patient previously received 1st dose of BNT162B2 for Covid-19 immunization, in left arm. The patient experienced Bell's palsy a month after 2nd shot on 03May2021, and received Steroids and antivirus medicine as treatment. The event caused Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have Covid prior vaccination. On 04May2021, patient had negative Covid test post vaccination with Nasal swab. The outcome of the event was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320334
Sex: F
Age:
State: WY

Vax Date: 04/01/2021
Onset Date: 04/09/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data: Test Date: 20210311; Test Name: Weekly spit test--work; Result Unstructured Data: Test Result:Negative; Test Date: 20210318; Test Name: Weekly spit test--work; Result Unstructured Data: Test Result:Negative; Test Date: 20210325; Test Name: Weekly spit test--work; Result Unstructured Data: Test Result:Negative; Test Date: 20210408; Test Name: Weekly spit test--work; Result Unstructured Data: Test Result:Negative; Test Date: 20210419; Test Name: Weekly spit test--work; Result Unstructured Data: Test Result:Negative; Test Date: 20210428; Test Name: Weekly spit test--work; Result Unstructured Data: Test Result:Pending

Allergies:

Symptom List: Vomiting

Symptoms: Perhaps this is a very mild case of thrombocytopenia?; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; severe muscle and joint pain; severe muscle and joint pain; low electrical shock in limbs; hives all over my body which would welt up like measles if I scratched them; This is a spontaneous report from a contactable Consumer (patient). A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 12:45 (at 51 years old, not pregnant) (Batch/Lot Number: EP7533) as 2nd dose, single for covid-19 immunisation. Medical history included cholesteatoma from an unknown date (Cholesteatoma as a teen--resolved with modified canal-wall down tympanomastoidectomy. No problems since 1989-1990), Allergy to cephalosporins, Sulfa drugs, strawberries, all from an unknown date. The patient had no concomitant medications. The patient had her first dose of bnt162b2 (Lot numberEN6204) vaccine on Mar2021 12:45 at 51 years old on left arm for COVID-19 Immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second dose, after about 12 hours (reported also as 09Apr2021 22:00), as expected, patient had moderate to severe muscle and joint pain and a sensation of low electrical shock in limbs. No other symptoms and this resolved in 24 hrs. Eight days after dose 2 (reported also as 09Apr2021 22:00), patient developed hives all over the body which would welt up like measles if patient scratched them. Patient tolerated them for 19 days before patient finally sought help from a doctor, who prescribed a short 20mg/2X/day course of prednisone and hives are improving significantly. However, wherever she scratches these hives on her legs,especially right, she developed bruises and petechiae, which "travel" up and down her thigh corresponding to where she scratches. She was in good health, active, and don't bruise easily. Bruising has not resolved over about 23 days, but has not gotten worse. Patient has no other symptoms. Perhaps this is a very mild case of thrombocytopenia. The adverse events resulted in visit to Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was Prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. All the events start date was reported as 09Apr2021 22:00 (for clarification). The outcome of the vaccines was recovering. The patient underwent lab tests and procedures which included Weekly spit test--work: negative on 11Mar2021; negative on 18Mar2021; negative on 25Mar2021; negative on 08Apr2021; negative on 19Apr2021; pending on 28Apr2021. Device used Date : 02May2021 Information about Lot/batch number was available. Further information was expected.

Other Meds:

Current Illness:

ID: 1320335
Sex: M
Age:
State: WI

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 05/15/2021
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: Pneumonia; headaches; fever; fatigue; chills; This is a spontaneous report from a contactable consumer (reporting for himself). A 75-years-old male patient received bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 02Feb2021, the patient experienced headache, fever, fatigue and chills. On 20Feb2021, the patient experienced pneumonia. The patient was recommended to get the Bamlanivimab infusion, which the patient did. The patient was told to wait 90 days after the infusion before getting his second dose of the series. The patient stated his 90 days will be up in about a week or so. The outcome of the event headache was recovered on 17Feb2021; fever and chills was recovered on 18Feb2021; fatigue was recovered on 20Feb2021; and pneumonia was recovered on 10Mar2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320336
Sex: F
Age:
State: WA

Vax Date: 04/15/2021
Onset Date: 04/26/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data: Test Name: tests for factor 5; Result Unstructured Data: Test Result:Awaiting results; Test Name: tests for lupus; Result Unstructured Data: Test Result:Awaiting results; Test Name: tests for protein s deficiency; Result Unstructured Data: Test Result:Awaiting results; Test Date: 20210428; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative; Comments: Covid test Nasal swab; Test Date: 20210430; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative; Comments: Rapid covid test Nasal Swab; Test Date: 20210502; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Pending; Comments: Covid test Nasal swab

Allergies:

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

Symptoms: multiple bilateral pulmonary embolism; shortness of breath; elevated heart rate; elevated blood pressure; decreased oxygen saturation; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 15Apr2021 at 10:30 (at age of 47 years old, no pregnant, Lot Number: EW0151) as a single dose for covid-19 immunization. Medical history included hypertension, known allergies Amoxicillin, sulfa, Keflex. Concomitant medications included losartan and omeprazole. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Apr2021 at 09:00, reported at 11 days post vaccine experienced shortness of breath, elevated heart rate, elevated blood pressure, decreased oxygen saturation. Diagnosed with multiple bilateral pulmonary embolism. No typical risk factors. Awaiting results of tests for protein s deficiency/factor 5/lupus. No family history of any. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care/ Life Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized from 26Apr2021 to 29Apr2021. The treatment received with IV heparin, now oral warfarin and Lovenox shots. The patient underwent lab tests and procedures which included SARS-CoV-2 test (SARS-CoV-2 test): negative on 28Apr2021, negative on 30Apr2021 and pending result on 02May2021. The outcome of the events was not recovered.

Other Meds: LOSARTAN; OMEPRAZOLE

Current Illness:

ID: 1320337
Sex: F
Age:
State:

Vax Date: 01/04/2021
Onset Date: 01/18/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data: Test Date: 20210118; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Positive; Comments: Positive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: 1st Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021; 1st Pfizer vaccine on 04Jan2021/returning for her 2nd vaccine dose today 06May2021; 1st Pfizer vaccine on 04Jan2021/returning for her 2nd vaccine dose today 06May2021; 1st Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021; This is a spontaneous report from a contactable pharmacist via medical information team. A 41-year-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 04Jan2021 (at the age of 41-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 18Jan2021-positive. It was reported as the patient received her first Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021. She then received a "plasma transfusion on 28Jan2021. She is now returning for her second vaccine dose today 06May2021. The reporter asked if is this ok since it has been 90 days and does her first dose need to be repeated. Therapeutic measures were taken as a result of the event covid-19. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1320338
Sex: M
Age:
State: TX

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 05/15/2021
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: Severe cough and congestion and hacking up green stuff like infection; Severe cough and congestion and hacking up green stuff like infection; Pain in mouth; wheezing; Pain in face from that; in the roof of his mouth near his teeth and it was extremely painful; Excessive sleepiness; Pain in sinus cavity; Headache; Thrush; Cannot hardly breathe; Mouth blister; Laryngitis; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received first dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 22Apr2021 (Batch/Lot Number: EW0151; Expiration Date: 01Jul2021) as 1st dose single for COVID-19 immunization, prophylaxis. Medical history included diabetes mellitus and blood pressure measurement ongoing. The patient's concomitant medications were not reported. Today is the first day he has a voice since the injection on 23Apr2021. He later stated he received injection on 22Apr2021. Today he is able to speak. The patient experienced laryngitis on 23Apr2021, excessive sleepiness (sleeping until around 3pm every day for the last 3 days) and pain in sinus cavity on 03May2021, cannot hardly breathe on 24Apr2021, mouth blister on 23Apr2021, thrush on 26Apr2021, headache on 27Apr2021, severe cough and congestion and hacking up green stuff like infection (cough and nasal congestion). He is getting a little better and is on antibiotics and Mucinex and everything trying to get a control of it. It has been so bad he cannot breathe. He is still wheezing. Now it is like bronchitis and he is still coughing today. In the beginning, it was like pneumonia. It was so bad. Pain in mouth, pain in face from that and in the roof of his mouth near his teeth and it was extremely painful on an unspecified date. He did not realize they were there until he brushed teeth and popped them and had massive amounts of blood in his mouth. He did not experience anything like that before and that really scared him. They gave Nystatin to heal up his mouth. Blisters are fading and blood blisters have stopped bleeding. He still has pain in mouth and face from that. He was also given Albuterol to help him breathe. The antibiotic is a great big pink tablet. It is 800 some mg of Amoxicillin. All of these are in a pharmacy vial and he does not have a lot or expiration for any. He was also prescribed Bromphen cough syrup. It is in a pharmacy vial with no lot or expiration. All are in pharmacy vials except the Mucinex and it is over the counter. He started taking it after the vaccine to control the cough. No further details provided. He was going to see an infectious disease doctor. They were going to do a vaccine challenge test to find out if he needs IVIG. He will see if it is something inside of him that the vaccine triggered that he needs to fix and won't know until he sees the doctors. The doctor's are hoping the infectious disease doctor will be able to give him answer about second dose as well. Received call from consumer regarding the Pfizer COVID vaccine. He received it at pharmacy and nothing happened the day of. He wanted to report what happened after that. He also would like to know if he should attempt to get second dose. PSCC Communicated to the patient as due to extended hold time caller opted to be transferred to hold his place in the queue and Provided caller with websites and contact information. Treatment was received and Therapeutic measures were taken. The outcome of the events pain in mouth, wheezing, pain in face and gingival pain were unknown whereas the other events were recovering. Follow up attempts needed. Further information is expected.

Other Meds:

Current Illness: Blood pressure; Diabetes

ID: 1320339
Sex: F
Age:
State: TN

Vax Date: 04/04/2021
Onset Date: 05/04/2021
Rec V Date: 05/15/2021
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: Bell's Palsy; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm at the age of 34-year-old on 04Apr2021 15:00 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. Medical history included asthma, pernicious anaemia, Polycystic ovarian syndrome, Hashimots thyroiditis, Atopic dermatitis. The patient's concomitant medications were not reported. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 34-year-old on 07Mar2021 15:00 at left arm for COVID-19 Immunization. The most recent COVID-19 vaccine was administered at Hospital. No other vaccines within 4 weeks prior to the COVID vaccine received by patient, other medications the patient received within 2 weeks of vaccination confirmed yes but not specified and stated more than there was room for here. The patient experienced bell's palsy on 04May2021 12:00. The event resulted in Emergency room/department or urgent and Doctor or other healthcare professional office/clinic visit, no treatment received. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering. No follow-up attempts are possible. Information about batch/lot number can not be requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am