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**
PLEASE CHECK BACK SOON
Download the files above while you wait.







Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1817400
Sex: M
Age:
State:

Vax Date: 06/09/2021
Onset Date: 10/15/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 20211015; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Covid Diagnosis 15Oct2021; Covid Diagnosis 15Oct2021; This is a spontaneous report from a contactable other hcp. A 14-Year-old male patient received bnt162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 09Jun2021 16:00 (Batch/Lot Number: EW0185) (age at vaccination 13 years) as dose 2, single and via an unspecified route of administration on 19May2021 (Batch/Lot Number: EW0187) (age at vaccination 13 years) as dose 1, single both doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior vaccination, the patient has not been diagnosed with COVID-19 and Since the vaccination, patient has been tested for COVID-19. On 15Oct2021, patient experienced Covid Diagnosis 15Oct2021. Seriousness of the event was medically significant. Adverse event resulted in physician office visit. The patient underwent lab tests and procedures which included PCR: positive on 15Oct2021 (Nasal Swab). The patient did not receive any treatment for the adverse event. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1817401
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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 Name: IgG antibodies; Test Result: Negative ; Test Name: IgM antibodies; Test Result: Negative ; Test Name: Chest x-ray; Result Unstructured Data: Test Result:revealed bilateral pleural effusions with; Comments: bibasilar opacities.; Test Name: Computed Tomography (CT) Chest; Result Unstructured Data: Test Result:showed progressive worsening of COVID-19 Pneumonia; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Diagnosed with COVID-19 two months after completing the Pfizer vaccination course; Diagnosed with COVID-19 two months after completing the Pfizer vaccination course; INTRODUCTION: Vaccinations against Novel Coronavirus 2019 (COVID-19) for immunocompromised individuals have been increasingly prioritized to avoid severe infection. Here is a case of severe COVID-19 infection in a patient with malignant lymphoma who completed the vaccination course.CASE PRESENTATION: A 79-year-old male with malignant lymphoma on active Rituximab was diagnosed with COVID-19 two months after completing the Pfizer vaccination course. He presented with a worsening cough despite receiving monoclonal antibodies outpatient. On evaluation, his vitals were stable. Chest x-ray revealed bilateral pleural effusions with bibasilar opacities. During his hospitalization, he received a full course of dexamethasone, ivermectin, remdesivir and baricitinib. However, his cough and oxygenation progressively worsened, with eventual intubation and vasopressor support. Computed Tomography (CT) Chest showed progressive worsening of COVID-19 Pneumonia. Originally on admission he had tested negative for the IgM and IgG antibodies against the Nucleocapsid (N) Protein which raised the suspicion that he had not mounted an immune response to the vaccine. On further evaluation, he was found to have positive antibody titers against Spike (S) proteins which confirmed that he had mounted a response to the vaccine despite his imnmunocompromised status. DISCUSSION: Anti-CD20 therapy is one of the primary therapies for hematological malignancies. Despite T cell function being the primary role against COVID-19, there is increasing evidence that B-cell depletion may inhibit protective immunity following infection and vaccination. A two-dose regimen of BNT162b2 (Pfizer) conferred 95% protection against COVID-19 in persons 16 years of age or older, and decreased the rate of severe infection. However, only 4% of the vaccinated patients suffered from any malignancy; 0.2% of them had metastatic solid tumors, leukemia, lymphoma and none were on chemotherapy. The efficacy of the vaccine was extrapolated to include the subset of individuals on active chemotherapy. Interestingly, despite having an active immunological response to the vaccine and normal T-cell function, the patient suffered from severe COVID pneumonia. CONCLUSIONS: Though widespread immunization against COVID-19 is underway, patients with hematological malignancies still remain a vulnerable population. The decision to halt immunomodulatory therapy to improve efficacy of the vaccine needs further investigation.; Sender's Comments: Efficacy of the vaccine varies from patient to patient. However, a contributory role of the usage of the vaccine BNT162B2 to the reported events vaccination failure and COVID-19 (two months after completing the Pfizer vaccination course) 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: Malignant lymphoma (on active Rituximab)

ID: 1817402
Sex: F
Age:
State: NJ

Vax Date: 04/12/2021
Onset Date: 10/15/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 20211015; Test Name: PCR; Test Result: Positive ; Test Date: 20211015; Test Name: Covid test; Test Result: Positive ; Comments: Nasal Swab

Allergies:

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

Symptoms: Tested positive for COVID after fully vaccinated; Tested positive for COVID after fully vaccinated; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old (non-pregnant) female patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: EP6955, expiration date: not reported), via intramuscular route, administered in right arm on 12Apr2021 as dose 2, single and patient had earlier received dose 1 of bnt162b2 (COMIRNATY, formulation: intramuscular, lot number was EP6955 expiration date was not reported), via intramuscular route administered in right arm on 22Mar2021 as dose 1, single for COVID-19 immunisation. Age at vaccination was 47 years. Medical history included dry eye, Chronic pain in hands from an unknown date and unknown if ongoing. Known allergies were none. Patient was not pregnant at time of Vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within 2 weeks of vaccination) included pregabalin (LYRICA) 25mg (2 per day), probiotics, colecalciferol (VITAMIN D [COLECALCIFEROL]), omega 3 (OMEGA 3 [FISH OIL]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. On 15Oct2021 at 20:00 the patient was tested positive for covid after fully vaccinated. The most recent COVID-19 vaccine was administered in workplace clinic. On 15Oct2021 the patient underwent lab tests and procedures which included PCR (polymerase chain reaction) with result positive and Covid test (SARS-CoV-2 test) with result positive (nasal Swab). No hospitalization. Therapeutic measures were not taken. The outcome of events was recovering. Follow-up attempts completed. No further information is expected.

Other Meds: LYRICA; PROBIOTICS; VITAMIN D [COLECALCIFEROL]; OMEGA 3 [FISH OIL]

Current Illness:

ID: 1817404
Sex: F
Age:
State:

Vax Date: 02/13/2021
Onset Date: 09/14/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Developed Blood clot in right leg; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself. This is the 1st case out of 2 cases. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 13Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was previously took historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. On 14Sep2021, the patient developed blood clot in right leg. The outcome of the event was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101383187 same reporter/drug/AE, different patient

Other Meds:

Current Illness:

ID: 1817405
Sex: M
Age:
State:

Vax Date: 10/13/2021
Onset Date: 10/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: his legs were weak; his arms felt like they were floating; seemed to move like he was drunk and uncoordinated; seemed to move like he was drunk and uncoordinated; got his second dose of the covid vaccine 2 weeks after his first dose; It is like a spinal cord myelitis; numbness in his hands and feet; This is a spontaneous report from a contactable consumer. This consumer (parent) reported for a 46-year-old male patient (reporter's son) that: A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 2, single on 13Oct2021 (at the age of 46-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccina included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on unspecified date in Sep2021 for covid-19 immunisation and experienced sore arm. Patient got his second dose of the Covid vaccine (on 13Oct2021) 2 weeks after his first dose (inappropriate schedule of product administration). He had nothing but a sore arm after the first dose but within 8 hours after the second shot he began to experience numbness in his hands and feet on unspecified date in Oct2021 and the next day his legs were weak, and his arms felt like they were floating on 14Oct2021. Patient had to work very hard when walk to keep from falling he seemed to move like he was drunk and uncoordinated on 14Oct2021. This is the second day after his shot and his condition was unchanged. Has anyone reported any reactions similar to this. It was like a spinal cord myletitus on unspecified date in Oct2021. If he was no better by tomorrow 48 hours after the shot, we will get medical attention. Reporter's hope that others have had a reaction like this and that it was just a temporary condition. At the time of this report, the outcome of events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1817406
Sex: M
Age:
State: MA

Vax Date: 03/26/2021
Onset Date: 10/16/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 20211015; Test Name: Nasal Swab; Test Result: Positive

Allergies:

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

Symptoms: tested positive for Covid-19; Covid-19; This is a spontaneous report from a contactable consumer. A 24-year-old male patient received bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EP6955), dose 1 intramuscular, administered in left arm on 26Mar2021 09:00 (at age of 24-year-old) as dose 1, single and then second dose of bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EP6955), intramuscular, administered in left arm on 17Apr2021 10:30 (at age of 24-year-old) as dose 2, single for covid-19 immunization at clinic. The patient medical history was not reported. Concomitant medications included Vita Fusion multivitamin gummies within 2 weeks 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, the patient has been tested for COVID-19. Patient TL tested positive for Covid-19 on Saturday 16Oct2021 at 08:30 AM (PCR test via nasal swab administered on Friday 15Oct2021). Patient was experiencing minor fever, cough, and nasal congestion. Patient had no known exposure prior to testing positive. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab): positive on 15Oct2021. The outcome of event covid-19 was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1817407
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: scan; Result Unstructured Data: Test Result:large heart; Comments: had a large heart

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: She had colon cancer and they took out half her colon; Chest pain; She had a large heart; This is a spontaneous report from a contactable consumer or other non hcp. A 72-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot/NDC number and Expiry date was not reported) via an unspecified route and date in Jan2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, she had colon cancer and they took out half her colon (medically significant), chest pain and she had a large heart. On an unspecified date in 2021, the patient underwent lab tests and procedures which included a scan and found that she had a large heart. Other information included, patient received the vaccine in Jan2021 and 3 weeks later she was having chest pains. She went to her doctor who did a scan which showed she had a large heart. She had to get a stent placed and while they were in there they found out she had colon cancer and they took out half her colon. Now she has stage 4 colon cancer and she isn't going to make it. Reporter does not know the date of her procedure, but thinks it was probably sometime in Feb2021. Healthcare Professional postal address was reported. The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

Date Died:

ID: 1817408
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: his best friend died; This is a spontaneous report from a contactable consumer or other non-HCP. A 56-years-old patient of an unspecified gender received unknown dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that his best friend died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: his best friend died

Other Meds:

Current Illness:

ID: 1817409
Sex: F
Age:
State: CA

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/26/2021
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: My mouth was little numbness -upper level and tongue; dizziness; hot; My face was red and itchy; My face was red and itchy; This is a spontaneous report from a contactable consumer, the patient. A 50-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration, in arm left on 18Oct2021 at 15:15 as dose 1, single (age at vaccination 50 years) for covid-19 immunisation. Medical history included allergy to penicillin since an unknown date. The patient was allergic to pneumonia 23 vaccine. The patient's concomitant medications were not reported. The patient after 5 minutes of vaccination got dizziness and hot, her face was red and itchy and her mouth had little numbness -upper level and tongue an 18Oct2021 at 15:30. Therapeutic measures were taken as a result of the events that included taking twice loratadine at same day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for covid post vaccination. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1817410
Sex: M
Age:
State:

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

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: Septicemia; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program (Patient's wife reported). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single; patient also received dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The Patient's wife reported that her husband was in the hospital with septicemia on an unspecified date before the booster. Patient was over it now. Two weeks after he recovered on antibiotics and fluids. He was fine, the reporter stated. Seriousness was reported as hospitalization and medically significant. Outcome of event was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101400475 Same patient and drug, different event separated in time

Other Meds:

Current Illness:

ID: 1817411
Sex: F
Age:
State: SC

Vax Date: 09/26/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:182/115

Allergies:

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

Symptoms: Blood pressure, it was 182/115, in her doctor's office, after second vaccine.; Pain from her injection site shooting down her arm in a single line for a day/ Severe pain in both of her forearms and then it went away; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided, after second vaccine; Wheezing and coughing and then it stopped, after second vaccine.; Wheezing and coughing and then it stopped, after second vaccine.; She had intense pain in the left side of her abdomen, and by the next day it was gone.; pain from her injection site; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) (at the age of 64 year-old), via an unspecified route of administration on 26Sep2021 as Dose 2, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination included the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on on an unspecified date for covid-19 immunization. The patient reported, after taking second shot, she had been having side effects. The patient had pain from her injection site shooting down her arm in a single line for a day. She had kidney pain, and dropped to her knees, causing her to throw up water and then it subsided. She had wheezing and coughing and then it stopped. The patient had intense pain in the left side of her abdomen, and by the next morning it was gone. She had severe pain in both of her forearms and had to take two Tylenol, and the pain went away. The patient went to her doctor and when they took her blood pressure, it was 182/115. She has never had any previous problems and this is not normal. The patient underwent lab tests and procedures which included blood pressure measurement: 182/115 on an unspecified date. The outcome of events was resolved on an unspecified date while the outcome of the events blood pressure, it was 182/115, in her doctor's office; kidney pain, and dropped to her knees, causing her to throw up water and then it subsided was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1817412
Sex: M
Age:
State:

Vax Date: 03/10/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Name: COVID-19 test; Test Result: Positive ; Comments: Patient tested positive for COVID following completion of the 2 dose series.

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Patient tested positive for COVID following completion of the 2 dose series.; Patient tested positive for COVID following completion of the 2 dose series.; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN5318) via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN5318) via an unspecified route of administration on 19Feb2021 as dose 1, single for COVID-19 immunization administered at Workplace clinic. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID following completion of the 2 dose series. The patient had vaccination failure. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on an unspecified date. The outcome of the events was unknown. No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1817413
Sex: M
Age:
State: MO

Vax Date: 02/18/2021
Onset Date: 10/17/2021
Rec V Date: 10/26/2021
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: 20211018; Test Name: Covid test; Test Result: Positive ; Comments: Nasal swab

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: patient experienced headaches, cough and fever and tested positive for COVID on 18Oct2021; patient experienced headaches, cough and fever and tested positive for COVID; This is a spontaneous report from a contactable Other Health Professional. A 34-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318, Expiry Date was not provided), via an intramuscular route of administration, on 28Jan2021 (age at vaccination was 34 Years) as DOSE 1, SIN-GLE, second dose via an intramuscular route of administration on 18Feb2021 (Batch/Lot Number: EN5318) as DOSE 2, SINGLE for COVID-19 immunization. Relevant medical history and Concomitant medication(s) were not reported. It was unknown if patient received any other vaccines in four weeks prior to the COVID vaccine and diagnosed with COVID-19 prior vaccination. Patient has been tested positive for COVID-19 since the vaccination on 18Oct2021. On 17Oct2021, patient experienced headaches, cough and fever and on 18Oct2021, patient experienced tested positive for event COVID on 10/18/2021. The patient underwent lab test and procedure included COVID test (nasal swab) with positive result on 18Oct2021. Patient did not receive treatment for events. The outcome of events was not recovered for Headaches, fever and Cough while for tested positive for event COVID on 10/18/2021 under PT 'Vaccination failure' was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Covid-19.

Other Meds:

Current Illness:

ID: 1817414
Sex: F
Age:
State: OH

Vax Date: 10/15/2021
Onset Date: 10/16/2021
Rec V Date: 10/26/2021
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: dizzy; felt like her throat was closing; rash on her neck; slight headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (COMIRNATY), (at the age of 61years old) via an unspecified route of administration, administered in Arm Left on 15Oct2021 (probably around 10:00 O'clock in the morning, 10:30) (Batch/Lot Number: FE3590) as dose 3 (booster), single for covid-19 immunisation. Medical history included allergic to shrimp. The patient stated, "sometimes I am sensitive to take properly you know I wanna knew antibiotics and some I might be sensitive but that I not know". There were no concomitant medications. The patient has no prior vaccination within 4 weeks. The patient had BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 09Jan2021 (at the age of 60 years old) (Batch/Lot Number: EK5730) and dose 2 on 30Jan2021 (at the age of 60 years old) (Batch/Lot Number: EN5318) for COVID-19 immunization, both were administered at a pharmacy. The patient called and stated that she had the booster vaccine on Friday at work and on Saturday (16Oct2021) had a slight headache, on Sunday (17Oct2021) woke up with a rash on her neck and on Monday (18Oct2021) felt like her throat was closing and went to the doctor on Monday. The patient stated that It felt like her throat was closing and she had a headache and dizzy and they gave her a shot of cortisone in her arm and she was put on a steroid pack. The patient wanted to know how long it takes to get better. She does feel better since having cortisone and being on the steroid, but she gets lightheaded and dizzy and wanted to know how long that would last. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1817415
Sex: U
Age:
State: NY

Vax Date: 01/17/2021
Onset Date: 01/28/2021
Rec V Date: 10/26/2021
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: blood tests; Result Unstructured Data: Test Result:unknown results

Allergies:

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

Symptoms: Atrial flutter; arm 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, Lot Number: EL9262), intramuscular, administered in arm right on 17Jan2021 16:00 as dose 1, single for covid-19 immunisation. The patient medical history included hypothyroidism from 05Jan1976 and ongoing, occasional atrial flutter from 02Jul2020 and ongoing 0x or 1x or 2x/ month and none on Apr2021, endometriosis from 1963 to 1990, caesarean section from 06Jan1976 to 06Jan1976, hip fracture from 02Jul2018 to 03Jul2018, and had surgery - 3 titanium screws inserted. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 1976 and ongoing; metoprolol taken for atrial flutter from Jul2020 and ongoing; apixaban (ELIQUIS) taken for atrial flutter from Jul2020 and ongoing. The patient previously took DANAZOL for endometriosis from 1975 to 1990. On 28Jan2021, the patient experienced atrial flutter and arm pain. The patient underwent lab tests and procedures which included too many blood test: unknown results on an unspecified date. No covid-19 testing. The events were considered as important medical event by the reporter. No treatment was received for the events. The outcome of the events was recovered on 28Jan2021.

Other Meds: SYNTHROID; METOPROLOL; ELIQUIS

Current Illness: Atrial flutter (0x or 1x or 2x/ month, and none on Apr2021); Hypothyroidism (discovered 05Jan1976)

ID: 1817416
Sex: F
Age:
State: NJ

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sore left arm, felt heavy, and when she lifted it, "super sore; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Left Arm on 24Feb2021 13:45 (Batch/Lot Number: EL9262, expiry date: unknown) (at 41-years age) as dose 1, single for COVID-19 immunisation at the hospital. Medical history included thyroid cancer, and covid-19. Concomitant medication(s) that within 2 weeks prior to the vaccination includes included levothyroxine sodium (SYNTHROID); topiramate (TOPAMAX); rizatriptan (RIZATRIPTAN) taken for migraine. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 24Feb2021 09:00PM the patient experienced sore left arm, felt heavy, and when she lifted it, super sore. Sore left arm started around 9pm (after 1:40pm vaccination that day) felt heavy, and when she lifted it, super sore. She said milder as of following morning. The patient had not received treatment for all the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving. No follow-up attempts are needed. No further information is expected

Other Meds: SYNTHROID; TOPAMAX; RIZATRIPTAN

Current Illness:

ID: 1817417
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: Sore arm/soreness and swelling for a day; Sore arm/soreness and swelling for a day; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team. A female patient of unspecified age (Age: 66; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm/soreness and swelling for a day on an unspecified date. The Caller says had that before with a shot. Soreness and swelling for a day. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1817418
Sex: F
Age:
State:

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

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

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:unknown result

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Experienced chills and a temperature; Experienced chills and a temperature; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unknown date as DOSE 2, 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, Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that on an unspecified date, she took the second dose of the Pfizer BioNTech COVID-19 vaccine yesterday and last night experienced chills and a temperature. She inquired and would like to know if there are any other people who took the second dose of the Pfizer BioNTech COVID-19 vaccine and reported a fever afterwards. Therapeutic measures were taken as a result of events and patient already took two Tylenol. The outcome of events was unknown. Information about lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1817419
Sex: F
Age:
State: FL

Vax Date: 02/21/2021
Onset Date: 02/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 20210203; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Comments: she recently had an MRI on 03Feb2021.

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Headache; Tiredness; sharp excruciating pain in her lower back when she stood up and walked; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN(6)200), via an unspecified route of administration, administered in left arm on 21Feb2021 as single dose and first dose via an unspecified route of administration, administered in left arm on 31Jan2021 (Lot Number: EN5318) (at the age of 78-year-old) as single dose for COVID-19 immunization. The patient's medical history included pleurisy and bacterial pneumonia, had abdominal surgery and liver hemangioma (maybe 8-10 years ago). The patient's concomitant medication included vitamins NOS. No prior vaccinations within 4 weeks. The patient previously took morphine and experienced severe facial itch, codeine and experienced rapid heart beat and legs very weak. On an unspecified date in Feb2021, the patient experienced sharp excruciating pain in her lower back when she stood up and walked. The patient stated that the patient had the exact same pain when she was treated for bacterial pneumonia a year ago. She suspects it has something to do with the nerve. She wanted to know if this adverse event was reported as an adverse event associated with the vaccine. On 22Feb2021, The patient experienced headache and tiredness. No visits of emergency room and physician office. On 03Feb2021, the patient underwent lab tests and procedures which included MRI: unknown results. On 22Feb2021, the patient recovered from all the events. No follow-up attempts are possible. No further information is expected.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1817420
Sex: F
Age:
State: NC

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Tingle and numb in left arm where I got shot.; Tingle and numb in left arm where I got shot.; This is a spontaneous case received from a contactable consumer (patient). A 37-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 at 14:30 (age at vaccination 37-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Prior vaccinations within 4 weeks were reported as none. On 25Feb2021, the patient experienced tingle and numb in left arm. The patient did not receive any treatment for the event. The patient did not had any vaccination prior to COVID vaccination and had not tested positive after vaccination. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1817421
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: temp chills; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported similar event for 2 patients. This is 1st of 2 reports. This consumer reported for himself. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Lot number and expiration date not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced temp chills on an unspecified. Patient stated that, yesterday (name) and got shot number 2 of the Pfizer COVID-19 injection. We have had a temp chills etc. Not getting COVID-19 is worth it. The outcome of the event unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225707 same drug/reporter/AE, different patient

Other Meds:

Current Illness:

ID: 1817422
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Hurt to raise his arm the day after getting vaccine; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the day after getting vaccine, patient hurt to raise his arm. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1817423
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 02/22/2021
Rec V Date: 10/26/2021
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: flu; This is a spontaneous report from a Support, from a contactable consumer (Patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Feb2021, the patient experienced flu. Caller asked if it is still okay to get the vaccine tomorrow as scheduled appointment for a second dose. The outcome of the event was unknown. Information of batch/lot number has been requested. Follow-up (13May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1817424
Sex: F
Age:
State: FL

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Sore arm; slightly lightheaded; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 66-year-old non-pregnant female patient received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: En6199), via an unspecified route of administration on 03Mar2021 at 13:00 (at the age of 66-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation administered in facility. Medical history included known allergies from an unknown date and unknown if ongoing. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) inhaler taken for an unspecified indication, start and stop date were not reported, ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C) taken for an unspecified indication, start and stop date were not reported. It was reported that patient was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 at 17:30 patient experienced sore arm, slightly lightheaded. No treatment was received for events. The outcome events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: EMERGEN C; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1817425
Sex: F
Age:
State: NC

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: node on the back side of her shoulder; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Mar2021, 4 hours ago, the patient experienced node on the back side of her shoulder. caller wants to know if it is normal. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1817426
Sex: F
Age:
State: CA

Vax Date: 02/06/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Injection site minimally effective; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL3302, Expire date: Unknown) via an unspecified route of administration on 06Feb2021 at 15:00 (at the age of 78 years-old) as dose 2, single for COVID-19 immunization. Patient medical history included ongoing asthma and chronic obstructive pulmonary disease (COPD) from approx. 2000 to an unknown date and underwent thoracostomy 2014 - Dx book, ongoing hypogammaglobulinaemia from 2016 to an unknown date, ongoing sjogren's syndrome from approx.2000 to an unknown date, ongoing Paroxysmal sympathetic hyperactivity (Nonspecific paroxysmal spell) from 2000 to an unknown date controlled with RX, not controlled after vaccine, atrial fibrillation was ongoing from 2016 to an unknown date (ongoing). Patient was never smoked. The concomitant medications included ongoing metoprolol tartrate, ongoing hydroxychloroquine sulfate, Apixaban from 2020 still ongoing, ongoing propafenone, ongoing Topiramate (TOPAMAX), ongoing ciclosporin (RESTASIS), ongoing tiotropium bromide (SPIRIVA), ongoing amlodipine, ongoing fluticasone propionate, salmeterol (WIXELA INHUB), ongoing montelukast, ongoing methenamine, ongoing buspirone hydrochloride (BUSPAR), ongoing omeprazole, ongoing cevimeline all taken for an unspecified indication, start and stop date were not reported. The patient had shortness of breath (SOB) with lidocaine + methylparaben, leg pain with ciprofloxacin (CIPRO) and SOB with Rocephin (ROCEPHIN). Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 16Jan2021 (at the age of 78 years-old) as dose 1, single for COVID-19 immunization and experienced nauseous (time of onset: 15:01), lightheaded (time of onset: 15:20, Fine now), unbalanced (time of onset: 15:20), difficulty in walking and talking (Gait and speech disturbances, time of onset: 15:25), Intermittent shortness of breath (time of onset: 15:30), headache (Fine now), Dizziness (Fine now), Tired (Fine now) Brain fog (Fine now). No treatment received and not admitted in hospital for the events. This symptom Lasted the longest 2 weeks. The others were gone within 24 hours of administrating the vaccine. Patient previously taken Prevnar (PREVNAR PNEUMONIA Vaccine, Batch/Lot number: Unknown), via an unspecified route of administration from an unspecified date to an unspecified date (at the age of 70 years-old), for pneumonia vaccine. It was reported that adverse events relating to prior vaccination was none. The patient experienced injection site minimally effective on an unspecified date in 2021. None of these medicines (SOB with Lidocaine + Methylparaben, Cipro-ceg pain, Rocephin- SOB) were taken. No illness ware noted at time of vaccines. No tests or labs performed. The patient was not visited to physician and emergency room. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: METOPROLOL TARTRATE; HYDROXYCHLOROQUINE SULFATE; APIXABAN; PROPAFENONE; TOPAMAX; RESTASIS; SPIRIVA; AMLODIPINE; WIXELA INHUB; MONTELUKAST; METHENAMINE; BUSPAR; OMEPRAZOLE; CEVIMELINE

Current Illness: Asthma (Thoracostomy 2014 - Dx book); Atrial fibrillation; COPD (Thoracostomy 2014 - Dx book); Hypogammaglobulinemia; Paroxysmal sympathetic hyperactivity (controlled with RX, not controlled after vaccine); Sjogren's syndrome

ID: 1817427
Sex: M
Age:
State: NJ

Vax Date: 01/11/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Name: oxygen levels; Result Unstructured Data: Test Result:oxygen levels were usually good; Comments: oxygen levels were usually good and he never had to be intubated; Test Name: COVID test; Test Result: Negative ; Comments: tested negative three times before rehab.; Test Name: COVID test; Test Result: Negative ; Comments: tested him again and he was negative.

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: : Since it was less than 60 days is there any danger since the vaccine was administered.; Caller states her dad cannot even walk at this point; This is a spontaneous report from a contactable consumer or other non-health care professional (patient daughter). An 84-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 2 via an unspecified route of administration on 11Jan2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation and also received remdesivir (REMDESIVIR), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, for an unspecified indication. Medical history included tested positive for COVID from 14Nov2020 to an unknown date and he had double pneumonia from an unknown date and unknown if ongoing. The concomitant medication was not reported. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, on 28Dec2021 (Batch/Lot Number: unknown) for covid-19 immunization. The reporter stated the patient had tested positive for COVID on 14Nov2020. He progressively got worse and had to be hospitalized a few days before thanksgiving. He had double pneumonia. The reporter was not sure, but reporter thought it was not bad COVID pneumonia. A day or two after thanksgiving they administered Remdesivir with a COVID Cocktail. Reporter was not sure what else was in it. The patient was transferred into a nursing home for rehab for a month. As a protocol in the nursing home his first dose of Pfizer vaccine was 28Dec2020 and he got second dose on 11Jan2021. They said the patient should not get the vaccine if you got a monoclonal. Reporter was not sure if that is what the patient got. The patient was given the vaccine. Reporter enquired as is it a danger to the patient and they knew the patient tested negative three times before rehab. Reporter stated her father cannot even walk at this point. He was not your typical 84-year-old. He was driving and running up and down stairs. He lives in (State) and they would not accept him without two consecutive negative COVID test. Then they kept him in isolation for 10 days and tested him again and he was negative. When the patient was in the hospital he was on two different IV antibiotics. He kept getting worse. His oxygen levels were usually good and he never had to be intubated. They called her brother and told him they were going to start her dad on the COVID cocktail. That is how they described it. Reporter brother remembered that one of the medications was Remdesivir. Reporter was not sure if a steroid was in the cocktail. It had to be administered over a couple of days. Reporter has been on hold for close to two hours. Yesterday reporter was on hold for two and a half hours and she tried emailing but has not received an answer. Reporter clarified her question. Since it was less than 60 days is there any danger since the vaccine was administered. Reporter enquired does it affect the efficacy of the vaccine and was the patient going to have to have it again. Now the patient has 24-hour assistance at home. They were happy that he got the vaccine until they started to read that he should have waited 90 days. Reporter does not have exact information with reporter at the time of the call. It was two months and hard to get information without contact. Reporter does not have all the paperwork. He was on different things. Reporter declined to do a report at this time. There is a product complaint reported. Description of Product Complaint: Caller is calling about her father. He had tested positive for COVID on 14Nov2020. He progressively got worse and had to be hospitalized a few days before Thanksgiving. He had double pneumonia. When he was in the hospital he was on two different IV antibiotics. He kept getting worse. His oxygen levels were usually good and he never had to be intubated. A day or two after Thanksgiving they administered Remdesivir with a COVID Cocktail. She is not sure what else was in it. She is not sure if a steroid was in the cocktail. It had to be administered over a couple of days. They say you should not get the vaccine if you got a monoclonal. She is not sure if that is what he got. He was given the vaccine. Is it a danger to him? Caller clarified vaccine as COVID19 Vaccine. Caller clarified her question. Since it was less than 60 days is there any danger since the vaccine was administered. Does it affect the efficacy of the vaccine? Is he going to have to have it again? Caller declined to proceed with a report. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1817428
Sex: F
Age:
State: NC

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 10/26/2021
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: I got place in my arm like a 'kicked' placed; lumps under my arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EN6208, Expiry date was not reported) via an unspecified route of administration, administered on 12Mar2021 (at the age of 66-year-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date the reporter reported that, I got my shot Pfizer shot next day I got place in my arm like a 'kicked' placed, lumps under my arm. Patient received no treatment for the event. The outcome for the event was reported as unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1817429
Sex: F
Age:
State: OH

Vax Date: 03/13/2021
Onset Date: 03/14/2021
Rec V Date: 10/26/2021
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: Headache; fever; Chills; inflamed nerve 2-3 days; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6203) via an unspecified route of administration in the left arm on 13Mar2021(at the age of 68-years-old) at 12:00 as a single dose for COVID-19 immunisation. Medical history included high cholesterol. The patient had a history of allergy to sulfa, lanolin, latex, thimerosal and nickel. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), Fluvastatin (MANUFACTURER UNKNOWN) and vitamins B, C and D (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN); all for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 14Mar2021 at 02:00, the patient experienced headache for 1 day, fever/chills for 2 days, fatigue for 3 days and had inflamed nerve for 2 to 3 days. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache was resolved on 15Mar2021, fever and chills was resolved on 16Mar2021, however the outcome of the event fatigue was resolved on 17Mar2021, and inflamed nerve was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Updated Relevant Med History verbatim (from 'Sulfonamide allergy' to 'known_allergies: sulfa', 'Nickel sensitivity' to 'known_allergies: Nickel') and added 'known_allergies: Latex'. Updated concomitant medications VITAMIN C and VITAMIN D.

Other Meds: LEVOTHYROXINE; FLUVASTATIN; VITAMIN B; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; ZINC

Current Illness:

ID: 1817430
Sex: F
Age:
State:

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 10/26/2021
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: Injection site pain; Swollen injection site; chills; Slight fever; Muscle ache all over the body; This is a spontaneous report received from a non-contactable pharmacist, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248) via the unspecified route of administration on 23Mar2021 at 10:45 hours (at the age of 33-years-old) as a single dose, for COVID-19 immunisation. Medical history included seasonal allergy from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. On 23Mar2021 at 23:00, about 12 hours after the vaccination the patient experienced injection site pain, swollen injection site, chills, slight fever, and muscle ache all over the body. The symptoms lasted for about a day and resolved. The event did not result in a doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care visits. The patient did not receive any treatment for the events. The clinical outcome of the events injection site pain, swollen injection site, chills, slight fever, and muscle ache all over the body was recovered on 24Mar2021. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: updated lead sentence to reflect "non-contactable pharmacist"; narrative verbatim updated as "Since the vaccination, the patient had not been tested for COVID-19".

Other Meds:

Current Illness:

ID: 1817431
Sex: F
Age:
State:

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: dulled taste buds; dizziness; thirst; pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 at 9:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Patient was allergic to sulfa. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 14:00, the patient experienced dulled taste buds, dizziness, thirst, and pain at injection site. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dulled taste buds, dizziness, thirst and pain at injection site was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: updated Relevant medical history verbatim to known_allergies sulfa. Vaccine Facility Information updated.

Other Meds:

Current Illness:

ID: 1817432
Sex: M
Age:
State:

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fever; chills; sweating; Light-headed; Unwell for 24 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Er8737) via an unspecified route of administration in the left arm on 31Mar2021 at 18:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208) via an unspecified route of administration in the left arm on 12Mar2021 at 02:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 01Apr2021, the patient experienced fever, chills, sweating, light-headed, and unwell for 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the event fever, chills, sweating, and light-headedness was recovering. The clinical outcome of the event unwell for 24 hours was recovered on 02Apr2021. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: updated Patient Country, updated administration time of first dose of BNT162b2 from 12Mar2021 at 14:45 to 12Mar2021 at 02:45 in narrative.

Other Meds:

Current Illness:

ID: 1817489
Sex: F
Age:
State: TN

Vax Date: 10/06/2021
Onset Date: 10/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Mild chest pain; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 308444, expiry date 25th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 6th October 2021, the patient received the 1st dose of Fluarix Quadrivalent 2021-2022 season (intramuscular) .5 ml and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, less than a week after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced chest pain. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the chest pain was not recovered/not resolved. It was unknown if the reporter considered the chest pain to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows; This case was reported by the patient for herself. The age at vaccination was not reported. The provided lot number and expiry date, but SF shows no result for the lot number given. The patient received FLUARIX QUAD and experienced mild chest pain, for which, she went to emergency room. She had been discharged from the emergency room and had been prescribed steroid medication. The reporter was in rush, therefore, was unable to gather the date of birth, email address, and if the vaccine administered in left/right arm. The patient did not consented to follow-up. Therefore, Health care professional contact information was not collected.

Other Meds:

Current Illness:

Date Died: 08/30/2021

ID: 1817491
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 10/26/2021
Hospital: Y

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: 20210813; Test Name: COVID-19 PCR test; Result Unstructured Data: positive

Allergies:

Symptom List: Tremor

Symptoms: DEATH; ACUTE RESPIRATORY FAILURE; PULMONARY EMBOLISM; SEPTIC SHOCK; VENA CAVA THROMBOSIS; ACUTE KIDNEY INJURY; COVID-19 PNEUMONIA; COVID-19; DIZZINESS; COUGH; ENDOTRACHEAL INTUBATION; RENAL REPLACEMENT THERAPY; SARS-COV-2 TEST POSITIVE; CONFIRMED CLINICAL VACCINATION FAILURE; DYSPNOEA; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System)(VAERS ID 1655956),concerned a 68 year old male. Initial information was processed with additional information received on 13-SEP-2021. The patient's height, and weight were not reported. The patient's past medical history included: Sorin Perceval S (S/P) aortic valve replacement, and concurrent conditions included: hypertension, congestive heart failure, and hyperlipidemia. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A and expiry: Unknown) dose was not reported, 1 in total, administered on 27-APR-2021 for prophylactic vaccination. Concomitant medications included lorazepam, atorvastatin, and carvedilol. On 13-AUG-2021, the patient arrived at the emergency room (ER) due to shortness of breath (dyspnoea) which he had since 1 week ago. Associated symptoms include dry cough and dizziness. The patient was intubated (endotracheal intubation) in the emergency room(ER). On the same day, Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) positive. Finally, the patient was diagnosed with acute hypoxic respiratory failure, covid-19 (confirmed clinical vaccination failure), covid-19 pneumonia, septic shock, oliguric acute kidney injury (AKI) which required continuous renal replacement therapy (CRRT). The patient was also diagnosed with partial proximal inferior vena cava (IVC) thrombosis and emboli in the lingual (pulmonary embolism) and due to these events the patient was hospitalized (dates unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the event confirmed clinical vaccination failure was not reported. On 30-AUG-2021, the patient died from acute kidney injury, acute respiratory failure, covid-19, covid-19 pneumonia, cough, dizziness, dyspnoea, pulmonary embolism, septic shock, vena cava thrombosis, renal replacement therapy, endotracheal intubation, death, sars-cov-2 test positive. It was unspecified if an autopsy was performed. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000193188. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Additional information received from Central Complaint Vigilance department on 22-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1:This follow up adds- Product quality complaint investigation result. This new information does not alter prior causality assessment. 20210920491-covid-19 vaccine ad26.cov2.s- Death, acute kidney injury, acute respiratory failure, covid-19, covid-19 pneumonia, cough, dizziness, dyspnoea, pulmonary embolism, septic shock, vena cava thrombosis, renal replacement therapy, endotracheal intubation, sars-cov-2 test positive. This event is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210920491-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure.This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: ACUTE KIDNEY INJURY; ACUTE RESPIRATORY FAILURE; COVID-19; COVID-19 PNEUMONIA; COUGH; DIZZINESS; DYSPNOEA; PULMONARY EMBOLISM; SEPTIC SHOCK; VENA CAVA THROMBOSIS; RENAL REPLACEMENT THERAPY; ENDOTRACHEAL INTUBATION; DEATH

Other Meds: ATORVASTATIN; CARVEDILOL; LORAZEPAM

Current Illness: Congestive heart failure; Hyperlipidemia; Hypertension

ID: 1817492
Sex: M
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: FELT SICK; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211048011.

Other Meds:

Current Illness:

ID: 1817493
Sex: M
Age:
State: WV

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 10/26/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: BLOOD CLOTS IN LEFT LUNG; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height and weight were not reported. The patient had no known allergies and had COPD(chronic obstructive pulmonary disease)for which the patient used an inhaler. The patient had also previous occasions of blood clots before due to surgery but that he had seen his pulmonologist about a year ago and nothing was there. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A and expiry: UNKNOWN) dose was not reported, 1 total administered to the left arm on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. The patient's wife reported that about a week after getting the vaccine on SEP-2021, her husband started feeling chest pains in and around the underarms and back area. They thought it was indigestion and received treatment for it. On 18-Oct-2021(monday), the patient went to see his PCP(primary care physician) who told him to go to ER(emergency room) and the patient was diagnosed with 3 blood clots, 1 clot in his lower left lobe of his lung and 2 in the upper left lobe of his lung(blood clots in left lung). The patient was admitted to hospital on 18-OCT-2021 and was discharged on 18-OCT-2021(hospitalized for 1 day). The patient was given lovenox and started on a prescription of xarelto which the patient's wife stated that the patient will be on for the rest of his life and that this episode could have killed him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in left lung was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint 90000198851.; Sender's Comments: V0: 20211046226-COVID-19 VACCINE AD26.COV2.S- blood clots in left lung. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Chronic obstructive pulmonary disease (used an inhaler for COPD(Chronic obstructive pulmonary disease).)

ID: 1817494
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: DIARRHEA; FEVER; This spontaneous report received from a consumer concerned a 6 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced diarrhea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea and fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944337, 20210627859 and 20210651237.

Other Meds:

Current Illness:

ID: 1817495
Sex: U
Age:
State: AZ

Vax Date:
Onset Date: 10/21/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: USE OF EXPIRED PRODUCT (VACCINE OPENED ON 19-OCT-2021 AND ADMINISTERED TO PATIENT ON 21-OCT-2021); This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 21-OCT-2021, the patient experienced use of expired product (vaccine opened on 19-oct-2021 and administered to patient on 21-oct-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of use of expired product (vaccine opened on 19-oct-2021 and administered to patient on 21-oct-2021) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817496
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: tested positive for covid-19; A spontaneous report was received from a Reporter concerning about a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) The patient's medical history was not provided. No relevant concomitant medications were reported. Consumer received the first dose of the Moderna Covid-19 vaccine and tested positive for covid. She is a student and wants to know how this will affect anything. No treatment details were provided Action taken with mRNA-1273 in response to the events was not reported.

Other Meds:

Current Illness:

ID: 1817497
Sex: F
Age: 66
State: OK

Vax Date: 07/28/2021
Onset Date: 07/28/2021
Rec V Date: 10/26/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Covid arm/Redness area raised and enlarged through August 10, 2021, and eventually included neck and back; Redness at site of injection on left arm appeared; Itching at site of injection on left arm; Red blotchy patches lower down on chest appeared; Rash on her neck, back, chest and part of her arms; Hypersensitivity reaction; Redness on her neck, back, chest and part of her arms; Shortness of breath; Itching on neck and chest; Red/itchy eyes; Hives/urticaria local; Chest tightness; Red/itchy eyes; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on her neck, back, chest and part of her arms), DYSPNOEA (Shortness of breath), PRURITUS (Itching on neck and chest), OCULAR HYPERAEMIA (Red/itchy eyes) and URTICARIA (Hives/urticaria local) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Flu. Past adverse reactions to the above products included Hives with Flu. Concurrent medical conditions included Asthma since 01-Jan-1958, Diabetes since 06-Jan-2019, Blood pressure, Osteoporosis, Anaphylaxis, Hypersensitivity reaction, Hay fever, Hives, Food allergy (Reaction included hives, diverticulitis), Food allergy (Reaction included hives, diverticulitis), Food allergy (Reaction included hives, diverticulitis), Food allergy (Reaction included hives, diverticulitis), Allergic reaction to bee sting (Reaction included hives, asthma), Pollen allergy (Reaction included asthma, sinusitis), Shellfish allergy (Reaction included asthma, hives) and Iodine allergy (Reaction included asthma, hives). Concomitant products included LISINOPRIL for Blood pressure, CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]) for Osteoporosis, FISH OIL (OMEGA 3 [FISH OIL]), GARLIC [ALLIUM SATIVUM] and BIOTIN for an unknown indication. On 28-Jul-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021 at 2:30 PM, the patient experienced ERYTHEMA (Redness on her neck, back, chest and part of her arms), DYSPNOEA (Shortness of breath), PRURITUS (Itching on neck and chest), OCULAR HYPERAEMIA (Red/itchy eyes), URTICARIA (Hives/urticaria local), CHEST DISCOMFORT (Chest tightness), EYE PRURITUS (Red/itchy eyes), RASH (Rash on her neck, back, chest and part of her arms) and HYPERSENSITIVITY (Hypersensitivity reaction). On 28-Jul-2021 at 8:30 PM, the patient experienced RASH MACULAR (Red blotchy patches lower down on chest appeared). On 05-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at site of injection on left arm appeared) and VACCINATION SITE PRURITUS (Itching at site of injection on left arm). On 10-Aug-2021, the patient experienced VACCINATION SITE REACTION (Covid arm/Redness area raised and enlarged through August 10, 2021, and eventually included neck and back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 28-Jul-2021 for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. On 28-Jul-2021 at 8:30 PM, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. On 29-Jul-2021, PRURITUS (Itching on neck and chest), OCULAR HYPERAEMIA (Red/itchy eyes), URTICARIA (Hives/urticaria local), CHEST DISCOMFORT (Chest tightness), EYE PRURITUS (Red/itchy eyes) and RASH (Rash on her neck, back, chest and part of her arms) had resolved. At the time of the report, ERYTHEMA (Redness on her neck, back, chest and part of her arms) and VACCINATION SITE REACTION (Covid arm/Redness area raised and enlarged through August 10, 2021, and eventually included neck and back) had not resolved and DYSPNOEA (Shortness of breath), RASH MACULAR (Red blotchy patches lower down on chest appeared), VACCINATION SITE ERYTHEMA (Redness at site of injection on left arm appeared) and VACCINATION SITE PRURITUS (Itching at site of injection on left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ERYTHEMA (Redness on her neck, back, chest and part of her arms), DYSPNOEA (Shortness of breath), PRURITUS (Itching on neck and chest), OCULAR HYPERAEMIA (Red/itchy eyes), URTICARIA (Hives/urticaria local), CHEST DISCOMFORT (Chest tightness), EYE PRURITUS (Red/itchy eyes), VACCINATION SITE REACTION (Covid arm/Redness area raised and enlarged through August 10, 2021, and eventually included neck and back), RASH MACULAR (Red blotchy patches lower down on chest appeared), RASH (Rash on her neck, back, chest and part of her arms), VACCINATION SITE ERYTHEMA (Redness at site of injection on left arm appeared), VACCINATION SITE PRURITUS (Itching at site of injection on left arm) and HYPERSENSITIVITY (Hypersensitivity reaction) to be possibly related. Other concomitant medication include Symbicort inhalers. The vaccination facility gave breathing treatment. Treatment information include patient took Benadryl and steroids orally for redness and itching on neck and chest and the reaction got controlled by 03:45 pm. At approximately 8:30 pm, redness of neck and chest and red blotchy patches lower down on chest appeared. Took liquid Benadryl and reaction controlled. Patient reported to have recovered with residual effect such as covid arm on 10-AUG-2021. Additional information reported include that the redness did not resolve until later in August. Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Additional informations include Physician details, Patient demographics, Medical history, Concomitant drugs, treatment medications and new events.

Other Meds: LISINOPRIL; CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]; OMEGA 3 [FISH OIL]; GARLIC [ALLIUM SATIVUM]; BIOTIN

Current Illness: Allergic reaction to bee sting (Reaction included hives, asthma); Anaphylaxis; Asthma; Blood pressure; Diabetes; Food allergy (Reaction included hives, diverticulitis); Hay fever; Hives; Hypersensitivity reaction; Iodine allergy (Reaction included asthma, hives); Osteoporosis; Pollen allergy (Reaction included asthma, sinusitis); Shellfish allergy (Reaction included asthma, hives)

ID: 1817498
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
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: Sore arm after each dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm after each dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Cancer. Concurrent medical conditions included RA. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after each dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after each dose) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. On an unknown date, patient took second dose and received third dose on 25Sep2021. Treatment medication was not provided by the reporter. This case was linked to MOD-2021-350754, MOD-2021-350755 (Patient Link).

Other Meds:

Current Illness: RA

ID: 1817499
Sex: M
Age: 63
State:

Vax Date: 03/10/2021
Onset Date: 04/09/2021
Rec V Date: 10/26/2021
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: Sick; Body Aches; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), MYALGIA (Body Aches) and PAIN IN EXTREMITY (Sore Arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02FB21A and 040A21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced ILLNESS (Sick), MYALGIA (Body Aches) and PAIN IN EXTREMITY (Sore Arm). On 10-Apr-2021, ILLNESS (Sick), MYALGIA (Body Aches) and PAIN IN EXTREMITY (Sore Arm) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was unknown Treatment information was unknown

Other Meds:

Current Illness: Diabetes.

ID: 1817500
Sex: F
Age: 71
State: TX

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: swelling on the injection site/swollen/a whole 5 inches below the injection site/slight swelling; Red; feels slightly warm to the touch compared to the other arm/slightly warm to touch; kind of tender to the touch/Tender; the feeling of wanting to go back into bed and sleep; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling on the injection site/swollen/a whole 5 inches below the injection site/slight swelling), ERYTHEMA (Red), VACCINATION SITE WARMTH (feels slightly warm to the touch compared to the other arm/slightly warm to touch), VACCINATION SITE PAIN (kind of tender to the touch/Tender) and SOMNOLENCE (the feeling of wanting to go back into bed and sleep ) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A, 013M20A and 035C21A) for COVID-19 vaccination. Previously administered products included for an unreported indication: FLU on 15-Oct-2021. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling on the injection site/swollen/a whole 5 inches below the injection site/slight swelling), ERYTHEMA (Red), VACCINATION SITE WARMTH (feels slightly warm to the touch compared to the other arm/slightly warm to touch), VACCINATION SITE PAIN (kind of tender to the touch/Tender) and SOMNOLENCE (the feeling of wanting to go back into bed and sleep ). At the time of the report, VACCINATION SITE SWELLING (swelling on the injection site/swollen/a whole 5 inches below the injection site/slight swelling), ERYTHEMA (Red), VACCINATION SITE WARMTH (feels slightly warm to the touch compared to the other arm/slightly warm to touch), VACCINATION SITE PAIN (kind of tender to the touch/Tender) and SOMNOLENCE (the feeling of wanting to go back into bed and sleep ) outcome was unknown. No concomitant and treatment drugs were provided. This case was linked to MOD-2021-356400. Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Significant follow-up : AE added On 18-Oct-2021: Significant Follow Up Appended; Mailbox Contains Pictures to describe the event

Other Meds:

Current Illness:

ID: 1817501
Sex: M
Age: 78
State: FL

Vax Date: 06/18/2021
Onset Date: 07/19/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Joint pains in both the shoulders and progressing to the hips; Pain at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Joint pains in both the shoulders and progressing to the hips) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 037B21A) for COVID-19 vaccination. The patient's past medical history included Radical prostatectomy on 04-Oct-2004. Concurrent medical conditions included Bee sting, Drug allergy (Meloxicam and carry a epipen) and Prostate cancer since 14-Aug-2004. On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 02-Aug-2021, the patient experienced ARTHRALGIA (Joint pains in both the shoulders and progressing to the hips). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Joint pains in both the shoulders and progressing to the hips) had not resolved. No relevant concomitant medications were reported.. The patient had unbearable pain. He applied rubs which do not help and packs occasionally Patient had an appointment on 1st of July and he has been using salonpas on shoulders which lessens the soreness and also bio freeze on the hip areas to relieve the stiffness . This case was linked to MOD-2021-359083 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: FU received on 20 Oct 2021 . Added patients demographics , past medical conditions, information regarding suspect product and outcome of events.

Other Meds:

Current Illness: Bee sting; Drug allergy (Meloxicam and carry a epipen); Prostate cancer

ID: 1817502
Sex: F
Age: 74
State: KY

Vax Date: 01/13/2021
Onset Date: 08/30/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: she didn't realize they were given the booster before it was "approved".; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (she didn't realize they were given the booster before it was "approved".) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Heart attack. Concurrent medical conditions included Sepsis. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced OFF LABEL USE (she didn't realize they were given the booster before it was "approved".). On 30-Aug-2021, OFF LABEL USE (she didn't realize they were given the booster before it was "approved".) had resolved. No Concomitant medications were reported. No Treatment medications were reported. reoporter said she took the flu shot and so far so good. This case was linked to MOD-2021-355780 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: FU received on 20 oct 2021,mentioning patient has taken flu shot

Other Meds:

Current Illness: Sepsis

ID: 1817503
Sex: M
Age: 74
State: KY

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 10/26/2021
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: second vaccine felt cold when it was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE COLDNESS (second vaccine felt cold when it was given) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Blood pressure high since an unknown date. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE COLDNESS (second vaccine felt cold when it was given). At the time of the report, VACCINATION SITE COLDNESS (second vaccine felt cold when it was given) outcome was unknown. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. The patient toll the flu vaccine. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received on 20 oct 2021 relevant information updated in the I narrative.

Other Meds:

Current Illness: Blood pressure high

ID: 1817504
Sex: U
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: other people had situations that required treatment; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (other people had situations that required treatment) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (other people had situations that required treatment). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (other people had situations that required treatment) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to MOD-2021-355659.

Other Meds:

Current Illness:

ID: 1817505
Sex: F
Age: 67
State: MI

Vax Date: 09/13/2021
Onset Date: 10/11/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Received expired second dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant follow up received- Patient, product and reporter HP details added,

Other Meds:

Current Illness:

ID: 1817506
Sex: F
Age: 66
State: CA

Vax Date: 09/10/2021
Onset Date:
Rec V Date: 10/26/2021
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: Patients received a dose past 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received a dose past 30-day use by date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received a dose past 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received a dose past 30-day use by date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication was reported. No treatment medications were reported. This case was linked to MOD-2021-355943, MOD-2021-355908 (Patient Link).

Other Meds:

Current Illness:

ID: 1817507
Sex: F
Age:
State: CA

Vax Date: 09/23/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Name: blood pressure measurement; Result Unstructured Data: Elevated; Test Name: heart rate; Result Unstructured Data: Elevated

Allergies:

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

Symptoms: Back pain; This spontaneous case was reported by an other health care professional and describes the occurrence of BACK PAIN (Back pain) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated (High) Elevated. On an unknown date, Heart rate: elevated (High) Elevated. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medical information were reported. No Treatment informations were reported.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am