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: 1681665
Sex: F
Age: 35
State: CA

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Patient has a cold; Congestion; The injection site is magnetized, I can stick a magnet to the injection site; Injection site is the size of a dime; Injection site is red; Injection site is swollen; Headache; Patient is 31 weeks pregnant; Injection site left arm was sore.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Patient has a cold), NASAL CONGESTION (Congestion), VACCINATION SITE REACTION (The injection site is magnetized, I can stick a magnet to the injection site), VACCINATION SITE PAPULE (Injection site is the size of a dime) and EXPOSURE DURING PREGNANCY (Patient is 31 weeks pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Jan-2021 and the estimated date of delivery was 28-Oct-2021. On 18-Aug-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient is 31 weeks pregnant) and VACCINATION SITE PAIN (Injection site left arm was sore.). On 26-Aug-2021, the patient experienced NASOPHARYNGITIS (Patient has a cold), NASAL CONGESTION (Congestion), VACCINATION SITE REACTION (The injection site is magnetized, I can stick a magnet to the injection site), VACCINATION SITE PAPULE (Injection site is the size of a dime), VACCINATION SITE ERYTHEMA (Injection site is red), VACCINATION SITE SWELLING (Injection site is swollen) and HEADACHE (Headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-ninth week of the pregnancy. On 18-Aug-2021, EXPOSURE DURING PREGNANCY (Patient is 31 weeks pregnant) had resolved. At the time of the report, NASOPHARYNGITIS (Patient has a cold), NASAL CONGESTION (Congestion), VACCINATION SITE REACTION (The injection site is magnetized, I can stick a magnet to the injection site), VACCINATION SITE PAPULE (Injection site is the size of a dime), VACCINATION SITE PAIN (Injection site left arm was sore.), VACCINATION SITE ERYTHEMA (Injection site is red), VACCINATION SITE SWELLING (Injection site is swollen) and HEADACHE (Headache) 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 did not provide any causality assessments. The patient stated that she is 31 weeks pregnant currently, with a due date of 28 October 2021. No concomitant product use was provided by the reporter. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Significant follow-up. Pregnancy details updated. New event-vaccination exposure during pregnancy added.; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this 3 5-year old female. Patient will not be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1681666
Sex: M
Age: 76
State: MS

Vax Date: 01/12/2021
Onset Date: 08/26/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Extra dose administered; given an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given an expired dose) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A, 010M20A and 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (given an expired dose). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (given an expired dose) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Relevant concomitant medications were not reported by reporter Treatment information was not provided by reporter

Other Meds:

Current Illness:

ID: 1681667
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: first 24 hours he had itching at his injection site/first 24 hours he had scratching at his injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (first 24 hours he had itching at his injection site/first 24 hours he had scratching at his injection site) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (first 24 hours he had itching at his injection site/first 24 hours he had scratching at his injection site). At the time of the report, VACCINATION SITE PRURITUS (first 24 hours he had itching at his injection site/first 24 hours he had scratching at his injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication was provided. No Treatment medication was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1681668
Sex: F
Age: 22
State: CA

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Sore arm; A bit of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (A bit of fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The patient's past medical history included Digestion impaired, Depression, Irritable, Hair loss and Memory loss. Concurrent medical conditions included Oil allergy and Reaction to sulfites (Allergic to sulfite or histamine allergy.). On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (A bit of fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (A bit of fatigue) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Treatment medication was not reported. It was reported that patient is taking allergic injections.

Other Meds:

Current Illness: Oil allergy; Reaction to sulfites (Allergic to sulfite or histamine allergy.)

ID: 1681669
Sex: M
Age: 65
State: NY

Vax Date: 02/26/2021
Onset Date: 03/26/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: malaise; shaky feeling; I would fight to keep my eyes open; It felt like I was going to go blind in any second; very sore in the arm; substantial headache; nausea; very fatigued; symptoms got progressively worse; very ill; it felt like having a flu; The vision seemed to be affected; It felt like two fingers pressured the eyes; When I walked it seemed that things didn't move normally; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (symptoms got progressively worse), ILLNESS (very ill), PAIN IN EXTREMITY (very sore in the arm), INFLUENZA (it felt like having a flu) and VISUAL IMPAIRMENT (The vision seemed to be affected) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. Concomitant products included FISH OIL, VITAMINS NOS and PROBIOTICS NOS for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced CONDITION AGGRAVATED (symptoms got progressively worse), ILLNESS (very ill), PAIN IN EXTREMITY (very sore in the arm), INFLUENZA (it felt like having a flu), VISUAL IMPAIRMENT (The vision seemed to be affected), OCULAR DISCOMFORT (It felt like two fingers pressured the eyes), DYSKINESIA (When I walked it seemed that things didn't move normally), HEADACHE (substantial headache), NAUSEA (nausea) and FATIGUE (very fatigued). On an unknown date, the patient experienced MALAISE (malaise), NERVOUSNESS (shaky feeling), EYELID IRRITATION (I would fight to keep my eyes open) and VISION BLURRED (It felt like I was going to go blind in any second). At the time of the report, CONDITION AGGRAVATED (symptoms got progressively worse), ILLNESS (very ill), PAIN IN EXTREMITY (very sore in the arm), INFLUENZA (it felt like having a flu), VISUAL IMPAIRMENT (The vision seemed to be affected), OCULAR DISCOMFORT (It felt like two fingers pressured the eyes), DYSKINESIA (When I walked it seemed that things didn't move normally), MALAISE (malaise), NERVOUSNESS (shaky feeling), EYELID IRRITATION (I would fight to keep my eyes open), VISION BLURRED (It felt like I was going to go blind in any second), HEADACHE (substantial headache), NAUSEA (nausea) and FATIGUE (very fatigued) had not resolved. Patient also took concomitant medications of inhaler as needed for asthma. Patient saw a general practitioner and he suggested to take Ibuprofen. Mainly, patient tries not to take medicine. Patient tires to walk and exercise. Reporter said that 'post' second vaccination symptoms continue to exist as of 30-AUG-2021. This case was linked to MOD-2021-298103 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received and events outcome were updated to not recovered.

Other Meds: FISH OIL; VITAMINS NOS; PROBIOTICS NOS

Current Illness: Asthma

ID: 1681670
Sex: M
Age: 75
State: CT

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Was not a booster, but it was 3rd shot; Second dose on 17-FEB-2021 and third dose on 23-AUG-2021; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Was not a booster, but it was 3rd shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 17-FEB-2021 and third dose on 23-AUG-2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0PF2D21A, 023M20A and 032L2(Z)1A) for COVID-19 vaccination. Concurrent medical conditions included Prostate cancer (It became aggressive this last fall (2020) before receiving the Moderna vaccine.) since 2017. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Was not a booster, but it was 3rd shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 17-FEB-2021 and third dose on 23-AUG-2021). At the time of the report, OFF LABEL USE (Was not a booster, but it was 3rd shot) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 17-FEB-2021 and third dose on 23-AUG-2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient stated that he recently had a hormone shot to keep the cancer from growing. Treatment information was not provided.

Other Meds:

Current Illness: Prostate cancer (It became aggressive this last fall (2020) before receiving the Moderna vaccine.)

ID: 1681671
Sex: M
Age:
State: FL

Vax Date: 08/14/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: I think he had covid but did not get tested; He got sick like I did a week before me; He had a reaction to the vaccine really bad; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (He got sick like I did a week before me), VACCINATION COMPLICATION (He had a reaction to the vaccine really bad) and COVID-19 (I think he had covid but did not get tested) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ILLNESS (He got sick like I did a week before me) and VACCINATION COMPLICATION (He had a reaction to the vaccine really bad). On an unknown date, the patient experienced COVID-19 (I think he had covid but did not get tested). At the time of the report, ILLNESS (He got sick like I did a week before me), VACCINATION COMPLICATION (He had a reaction to the vaccine really bad) and COVID-19 (I think he had covid but did not get tested) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient had a reaction to the vaccine really bad. No concomitant medications were reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1681672
Sex: F
Age: 63
State: IL

Vax Date: 08/26/2021
Onset Date: 08/25/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Dose administered greater than 12 hours after initial vial puncture; Vial was not stored in refrigerator and administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) and PRODUCT STORAGE ERROR (Vial was not stored in refrigerator and administered to patient) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. Concurrent medical conditions included Hypercholesteremia, Osteoarthritis, Anxiety, Blood pressure and Insomnia. Concomitant products included SPIRONOLACTONE, CARVEDILOL and AMLODIPINE for Blood pressure, ROSUVASTATIN for Cholesterol high, ALPRAZOLAM for Insomnia. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Vial was not stored in refrigerator and administered to patient). On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) and PRODUCT STORAGE ERROR (Vial was not stored in refrigerator and administered to patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Updated reporter information, patient demographics, Added past relevant history, and updated vaccine dose details, and added concomitant medications.

Other Meds: SPIRONOLACTONE; ALPRAZOLAM; CARVEDILOL; AMLODIPINE; ROSUVASTATIN

Current Illness: Anxiety; Blood pressure; Hypercholesteremia; Insomnia; Osteoarthritis

ID: 1681673
Sex: F
Age: 31
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Has not received her 2nd dose; Was pregnant after she received the 1st dose/might have been pregnant when she received the 1st dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant after she received the 1st dose/might have been pregnant when she received the 1st dose) and PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In January 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant after she received the 1st dose/might have been pregnant when she received the 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose). In January 2021, MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant after she received the 1st dose/might have been pregnant when she received the 1st dose) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. The patient was still currently pregnant. She has 3 possible due dates were 11 Oct 2021, 18 Oct 2021 and 19 Oct 2021. The patient do not have information on her last period since she was on birth control, she did not have period. Treatment information was not provided. This is a case of product exposure during pregnancy and product dose omission issue with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy and product dose omission issue with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1681674
Sex: F
Age:
State: MI

Vax Date: 04/20/2021
Onset Date: 05/20/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Emergency dental surgery; caller received the 1st Moderna vaccine on 20Apr2021 and didn't receive 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL OPERATION (Emergency dental surgery) and PRODUCT DOSE OMISSION ISSUE (caller received the 1st Moderna vaccine on 20Apr2021 and didn't receive 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. Concurrent medical conditions included Leukemia and Immunocompromised. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (caller received the 1st Moderna vaccine on 20Apr2021 and didn't receive 2nd dose). On an unknown date, the patient experienced DENTAL OPERATION (Emergency dental surgery). The patient was treated with Surgery for Dental operation. On 20-May-2021, PRODUCT DOSE OMISSION ISSUE (caller received the 1st Moderna vaccine on 20Apr2021 and didn't receive 2nd dose) had resolved. At the time of the report, DENTAL OPERATION (Emergency dental surgery) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Treatment information was not provided by reporter. company comment:Very limited information regarding this event Dental Operation has been provided at this time. Further information has been requested. The event Product Dose Omission Issue was not accompanied by any adverse event. A causality assessment is not applicable.; Sender's Comments: Very limited information regarding this event Dental Operation has been provided at this time. Further information has been requested. The event Product Dose Omission Issue was not accompanied by any adverse event. A causality assessment is not applicable.

Other Meds:

Current Illness: Immunocompromised; Leukemia

ID: 1681675
Sex: F
Age:
State: UT

Vax Date: 03/02/2021
Onset Date: 08/27/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Lots of pain/Severe pain; She cold hardly walk; Back hurts; Collar bone hurts; Legs hurts; Eyes are burning (like where the socket is); Feels like something is wrong; Pain at the site of injection; Wrist hurts/Ankles hurts; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lots of pain/Severe pain), HYPOKINESIA (She cold hardly walk), BACK PAIN (Back hurts), BONE PAIN (Collar bone hurts) and PAIN IN EXTREMITY (Legs hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A, 003B21A and 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced PAIN (Lots of pain/Severe pain). 27-Aug-2021, the patient experienced HYPOKINESIA (She cold hardly walk), BACK PAIN (Back hurts), BONE PAIN (Collar bone hurts), PAIN IN EXTREMITY (Legs hurts), EYE IRRITATION (Eyes are burning (like where the socket is)), FEELING ABNORMAL (Feels like something is wrong), VACCINATION SITE PAIN (Pain at the site of injection), ARTHRALGIA (Wrist hurts/Ankles hurts) and MYALGIA (Muscle pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, PAIN (Lots of pain/Severe pain), HYPOKINESIA (She cold hardly walk), BACK PAIN (Back hurts), BONE PAIN (Collar bone hurts), PAIN IN EXTREMITY (Legs hurts), EYE IRRITATION (Eyes are burning (like where the socket is)), FEELING ABNORMAL (Feels like something is wrong), VACCINATION SITE PAIN (Pain at the site of injection), ARTHRALGIA (Wrist hurts/Ankles hurts) and MYALGIA (Muscle pain) had not resolved. No concomitant medication information was provided. Patient did not have this experience with the 1st two doses.

Other Meds:

Current Illness: Arthritis

ID: 1681676
Sex: F
Age: 90
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Maternal exposure during pregnancy; really bad headache/headache; arm is sore and hurting; feel exhausted; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is sore and hurting), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), FATIGUE (feel exhausted) and HEADACHE (really bad headache/headache) in a 91-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and HEADACHE (really bad headache/headache). In August 2021, the patient experienced VACCINATION SITE PAIN (arm is sore and hurting) and FATIGUE (feel exhausted). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Headache, at an unspecified dose and frequency. On 04-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and HEADACHE (really bad headache/headache) had resolved. At the time of the report, VACCINATION SITE PAIN (arm is sore and hurting) and FATIGUE (feel exhausted) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Patient was pregnant before she received her vaccination and currently, she was 32 weeks pregnant. Her second dose would be due on 30-Aug-2021. She had headache on the 1st day and went away. That evening, she got really bad headache and took some Tylenol, and she thinks it had gone now. On the second day and third day, she felt exhausted. Her arm was sore and hurting. She read about Moderna COVID 19 vaccine and that people can get blood clot. Although she didn't get blood clot with her first dose, she was worried that she can get it with the second dose. She asked if she could get blood clot with the second dose. Also, she wants information on blood clot like what types of people can get it and why. She was frustrated that agent didn't have information on this, and she didn't feel comfortable about providing further information about herself. She disconnected the call immediately after agent sated no information.; Sender's Comments: This is a case of product exposure during pregnancy with associated adverse events for this 91-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events headache, vaccination site pain and fatigue, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring during the pregnancy. Patient?s date of birth confirmation has been requested.

Other Meds:

Current Illness:

ID: 1681677
Sex: F
Age: 68
State: CA

Vax Date: 01/11/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: Low heart rate below 50; Result Unstructured Data: below 50

Allergies:

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

Symptoms: feeling of tightness in her chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (feeling of tightness in her chest) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (feeling of tightness in her chest). At the time of the report, CHEST DISCOMFORT (feeling of tightness in her chest) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 50 (Low) below 50. Treatment information was not provided by reporter. Patient went to the emergency room where she stayed overnight due to the feeling of tightness in her chest and low heart rate below 50. Patient stated that she has developed bradycardia with heart rate of 45 to 50 pulse per minute after the first dose and still having episodes of it ever since. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-299694 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: ASPIRIN 81

Current Illness: Atrial fibrillation

ID: 1681678
Sex: F
Age: 20
State: WA

Vax Date: 07/06/2021
Onset Date: 07/06/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information not provided. Treatment information not provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-300239 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1681679
Sex: F
Age: 54
State: FL

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Intoxication; Rash in all over her Body; This spontaneous case was reported by a consumer and describes the occurrence of POISONING (Intoxication) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by reporter. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced RASH (Rash in all over her Body). On an unknown date, the patient experienced POISONING (Intoxication) (seriousness criterion medically significant). At the time of the report, POISONING (Intoxication) and RASH (Rash in all over her Body) outcome was unknown. The patient used unidentified medicament to alleviate rash. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Follow up information received 29 August 2021 does not change company causality, however a new event of "intoxication" was reported and added to the case. Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Route of administration suspected product and event added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Follow up information received 29 August 2021 does not change company causality, however a new event of "intoxication" was reported and added to the case.

Other Meds: BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness:

ID: 1681680
Sex: M
Age: 50
State: WV

Vax Date: 03/18/2021
Onset Date: 05/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 202105; Test Name: Blood work; Test Result: Positive ; Result Unstructured Data: Antibodies for the Epstein Barre virus

Allergies:

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

Symptoms: sweating Profusely; lump on the right side of neck; swelling on the right side of face; pressure in ears; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (lump on the right side of neck), SWELLING FACE (swelling on the right side of face), EAR DISCOMFORT (pressure in ears) and HYPERHIDROSIS (sweating Profusely) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced NECK MASS (lump on the right side of neck) (seriousness criterion medically significant), SWELLING FACE (swelling on the right side of face) (seriousness criterion medically significant) and EAR DISCOMFORT (pressure in ears) (seriousness criterion medically significant). In August 2021, the patient experienced HYPERHIDROSIS (sweating Profusely) (seriousness criterion medically significant). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency; CEFALEXIN (CEPHALEXINE) for Adverse event, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Ear discomfort, at an unspecified dose and frequency. At the time of the report, NECK MASS (lump on the right side of neck), SWELLING FACE (swelling on the right side of face), EAR DISCOMFORT (pressure in ears) and HYPERHIDROSIS (sweating Profusely) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood test: positive (Positive) Antibodies for the Epstein Barre virus. Relevant concomitant product usage were not reported by the reporter. On an unknown date, patient underwent CT Scan to rule out Cancer. Results were not received. Biopsy of the lymph nodes was also planned. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.

Other Meds:

Current Illness:

ID: 1681681
Sex: F
Age: 93
State: NY

Vax Date: 01/29/2021
Onset Date: 03/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: bullous pemphigoid; She could not walk she had blisters on her feet; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGOID (bullous pemphigoid) and GAIT INABILITY (She could not walk she had blisters on her feet) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PEMPHIGOID (bullous pemphigoid) (seriousness criteria disability and medically significant) and GAIT INABILITY (She could not walk she had blisters on her feet) (seriousness criterion disability). The patient was treated with PREDNISONE for Bullous pemphigoid, at an unspecified dose and frequency. At the time of the report, PEMPHIGOID (bullous pemphigoid) and GAIT INABILITY (She could not walk she had blisters on her feet) outcome was unknown. The events were treated with steroids, Diuretic, Antibiotic unspecified and was successfully treated but recently had come back again. company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: XANAX

Current Illness:

ID: 1681682
Sex: M
Age: 84
State: NJ

Vax Date: 05/11/2021
Onset Date: 08/26/2021
Rec V Date: 09/08/2021
Hospital: Y

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

Lab Data: Test Date: 202102; Test Name: Blood work; Result Unstructured Data: normal; Test Date: 20210826; Test Name: Hemoglobin; Result Unstructured Data: Decreased; Test Date: 20210826; Test Name: White blood count; Result Unstructured Data: Decreased

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Acute leukemia; Light headedness; Too week to walk; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE LEUKAEMIA (Acute leukemia) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Blood pressure high (High blood pressure). Concomitant products included ATENOLOL for Blood pressure high. On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DIZZINESS (Light headedness), GAIT DISTURBANCE (Too week to walk) and FATIGUE (Fatigue). On 26-Aug-2021, the patient experienced ACUTE LEUKAEMIA (Acute leukemia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 26-Aug-2021 due to ACUTE LEUKAEMIA. At the time of the report, ACUTE LEUKAEMIA (Acute leukemia), DIZZINESS (Light headedness), GAIT DISTURBANCE (Too week to walk) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: normal (normal) normal. On 26-Aug-2021, Haemoglobin: 5.5 (Low) Decreased. On 26-Aug-2021, White blood cell count: 0.2 (Low) Decreased. No treatment medications were reported. Patient was hospitalized with acute leukemia with 5.5 hemoglobin and 0.2 white blood count and was complaining of fatigue and light headedness for the last month. For past two weeks he has been too week to walk. Patient's last bloodwork up in February 2021 was normal. Patient does have high blood pressure and takes Atenolol. Patient was not sure the vaccine was related and did not know exact date of first dose and did not have lot numbers. Company Comment: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds: ATENOLOL

Current Illness:

ID: 1681683
Sex: M
Age: 47
State: TN

Vax Date: 04/01/2021
Onset Date: 05/18/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: EKG; Result Unstructured Data: heart sounded fine

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: trembling and shakiness in my arms & legs; existing tinnitus got worse with the ringing in my ears extremely severe.; severe heat exhaustion; I felt nauseous; felt like maybe I was having a heart attack; I broke out in a massive sweat with big beads of sweat; I could not get comfortable; sensation of getting hot; a very weird feeling / I just did not feel right the entire summer / I feel like my brain is not functioning; very dizzy; anxious / felt massive waves of anxiety; My entire body felt sick; my stomach felt sick; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (felt like maybe I was having a heart attack) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Tinnitus. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced FEELING HOT (sensation of getting hot), FEELING ABNORMAL (a very weird feeling / I just did not feel right the entire summer / I feel like my brain is not functioning), DIZZINESS (very dizzy), ANXIETY (anxious / felt massive waves of anxiety), ILLNESS (My entire body felt sick) and ABDOMINAL DISCOMFORT (my stomach felt sick). On 22-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (felt like maybe I was having a heart attack) (seriousness criterion medically significant), HYPERHIDROSIS (I broke out in a massive sweat with big beads of sweat), DISCOMFORT (I could not get comfortable) and NAUSEA (I felt nauseous). On an unknown date, the patient experienced TREMOR (trembling and shakiness in my arms & legs), TINNITUS (existing tinnitus got worse with the ringing in my ears extremely severe.) and HEAT EXHAUSTION (severe heat exhaustion). At the time of the report, MYOCARDIAL INFARCTION (felt like maybe I was having a heart attack) had resolved and FEELING HOT (sensation of getting hot), FEELING ABNORMAL (a very weird feeling / I just did not feel right the entire summer / I feel like my brain is not functioning), DIZZINESS (very dizzy), ANXIETY (anxious / felt massive waves of anxiety), ILLNESS (My entire body felt sick), ABDOMINAL DISCOMFORT (my stomach felt sick), HYPERHIDROSIS (I broke out in a massive sweat with big beads of sweat), DISCOMFORT (I could not get comfortable), TREMOR (trembling and shakiness in my arms & legs), TINNITUS (existing tinnitus got worse with the ringing in my ears extremely severe.), HEAT EXHAUSTION (severe heat exhaustion) and NAUSEA (I felt nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: heart sounded fine (normal) heart sounded fine. On 18May2021, the patient experienced a sensation of getting hot and a very weird feeling. This was after playing in the yard for 40 minutes. The patient got very dizzy and anxious. This lasted for 8 to 10 minutes. The patient's entire body and stomach felt sick. The patient did not feel right the entire summer. On 22-JUL-2021, the patient started to get the same feeling that he had on 18-May-2021. The patient felt like was having a heart attack. The patient felt massive waves of anxiety. He could not get comfortable. This lasted for 15 to 20 minutes. The patient started coming down from the anxiety. After 22-Jul-2021, the patient felt small mini attacks of waves of anxiety with trembling and shakiness in his arms and legs. The patient felt like his brain was not functioning. Something feels amiss. The patient did notice that if he ate something it would make mini attacks go away. The patient went to go see Physician in late July 2021. The Physician thought that the patient had severe heat exhaustion and had him drink a lot of fluids and electrolytes. The doctor had him wear a heart monitor. The cardiologist read the results of heart monitor. The cardiologist also ordered an electrocardiogram (EKG) and a chest x-ray and observed the patient's heart and its normal. The patient had 4 physician visits. Company Comment: Based on temporal association between the use of the product and the start date of the reported events and the absence of any other etiology factors, a causal association cannot be excluded. Nausea is consistent with the known safety profile of the vaccine.; Sender's Comments: Based on temporal association between the use of the product and the start date of the reported events and the absence of any other etiology factors, a causal association cannot be excluded. Nausea is consistent with the known safety profile of the vaccine.

Other Meds:

Current Illness: Tinnitus

ID: 1681685
Sex: F
Age: 29
State: PA

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

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

Lab Data: Test Date: 2021; Test Name: blood work; Result Unstructured Data: normal

Allergies:

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

Symptoms: itchy/an itching all over on the inside; burning an itching all over on the inside; throw-up; feeling really weird/ horrible/ Miserable; Feeling hot; headache; stomach hurting; chest bothering/uncomfortable feeling in chest; Feeling like I could not breath; nauseous; Chest starting hurting; heart started racing; just said allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy/an itching all over on the inside), BURNING SENSATION (burning an itching all over on the inside), VOMITING (throw-up), FEELING ABNORMAL (feeling really weird/ horrible/ Miserable), FEELING HOT (Feeling hot), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach hurting), CHEST DISCOMFORT (chest bothering/uncomfortable feeling in chest), DYSPNOEA (Feeling like I could not breath), NAUSEA (nauseous), CHEST PAIN (Chest starting hurting), PALPITATIONS (heart started racing) and HYPERSENSITIVITY (just said allergic reaction) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 (5 or 6 days, treatment received: They gave me pain medicine and Benadryl. 11th 12 or 13th of July 2020 (testing done in hospital)) in July 2020. Concurrent medical conditions included Neurofibromatosis, type 1 (von Recklinghausen's disease) (since 4 years old). Concomitant products included GABAPENTIN and MORPHINE for an unknown indication. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRURITUS (itchy/an itching all over on the inside) (seriousness criterion medically significant), BURNING SENSATION (burning an itching all over on the inside) (seriousness criterion medically significant), VOMITING (throw-up) (seriousness criterion medically significant), FEELING ABNORMAL (feeling really weird/ horrible/ Miserable) (seriousness criterion medically significant), FEELING HOT (Feeling hot) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (stomach hurting) (seriousness criterion medically significant), CHEST DISCOMFORT (chest bothering/uncomfortable feeling in chest) (seriousness criterion medically significant), DYSPNOEA (Feeling like I could not breath) (seriousness criterion medically significant), NAUSEA (nauseous) (seriousness criterion medically significant), CHEST PAIN (Chest starting hurting) (seriousness criterion medically significant), PALPITATIONS (heart started racing) (seriousness criterion medically significant) and HYPERSENSITIVITY (just said allergic reaction) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE (EPIPEN) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) for Adverse event, at a dose of 25 milligram; CALCIUM for Adverse event, at an unspecified dose and frequency; ONDANSETRON HYDROCHLORIDE DIHYDRATE (ZOFRAN [ONDANSETRON HYDROCHLORIDE DIHYDRATE]) for Adverse event, at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy/an itching all over on the inside), BURNING SENSATION (burning an itching all over on the inside), FEELING HOT (Feeling hot), CHEST DISCOMFORT (chest bothering/uncomfortable feeling in chest) and HYPERSENSITIVITY (just said allergic reaction) had not resolved and VOMITING (throw-up), FEELING ABNORMAL (feeling really weird/ horrible/ Miserable), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach hurting), DYSPNOEA (Feeling like I could not breath), NAUSEA (nauseous), CHEST PAIN (Chest starting hurting) and PALPITATIONS (heart started racing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. other treatment medications included oxygen therapy, steroidal medications. patient reported, treating with Benadryl 25 mg did not stopped her itching. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.

Other Meds: GABAPENTIN; MORPHINE

Current Illness: Neurofibromatosis, type 1 (von Recklinghausen's disease) (since 4 years old)

ID: 1681686
Sex: F
Age: 77
State: TX

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: suffered severe incident twice; patient exhibited dementia, like a transitional state; she tried to drive caller's car while she was still on her pajamas, but she didn't have the car keys. Patient then went into the kitchen and opened all cupboard doors; Showing a maniac behavior; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (patient exhibited dementia, like a transitional state), ABNORMAL BEHAVIOUR (she tried to drive caller's car while she was still on her pajamas, but she didn't have the car keys. Patient then went into the kitchen and opened all cupboard doors), MANIA (Showing a maniac behavior) and VACCINATION COMPLICATION (suffered severe incident twice) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZ0A) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism and Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE and SPIRONOLACTONE for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism. On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced DEMENTIA (patient exhibited dementia, like a transitional state), ABNORMAL BEHAVIOUR (she tried to drive caller's car while she was still on her pajamas, but she didn't have the car keys. Patient then went into the kitchen and opened all cupboard doors) and MANIA (Showing a maniac behavior). On an unknown date, the patient experienced VACCINATION COMPLICATION (suffered severe incident twice). On 30-Jan-2021, DEMENTIA (patient exhibited dementia, like a transitional state), ABNORMAL BEHAVIOUR (she tried to drive caller's car while she was still on her pajamas, but she didn't have the car keys. Patient then went into the kitchen and opened all cupboard doors) and MANIA (Showing a maniac behavior) had resolved. At the time of the report, VACCINATION COMPLICATION (suffered severe incident twice) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Sixteen hours after the second dose, on 30-JAN-2021, patient exhibited dementia, like a transitional state. Patient thought she was in a different city and home, and that she tried to drive caller's car while she was still on her pajamas, but she didn't have the car keys. Patient then went into the kitchen and opened all cupboard doors. Patient was showing a maniac behavior, looking for something on her phone and trying to make phone calls. Her daughter gave her something to help her sleep. Patient woke up the next morning and felt completely fine. Onset of symptoms was around 15-16 hours post vaccine. Total duration of episodes was 12 hours roughly. This case was linked to MOD-2021-300955, MOD-2021-301074 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up was received. Additional event- Vaccination complication was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the eventa, a causal relationship cannot be excluded. Case downgraded to non-serious due to the lack of evidence of seriousness from a regulatory or clinical standpoint.

Other Meds: SYNTHROID; HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

Current Illness: Blood pressure high; Hypothyroidism

ID: 1681687
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Severe reaction to the vaccine; Lips swollen completely; Lips and eyes are swollen completely; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe reaction to the vaccine), LIP SWELLING (Lips swollen completely) and EYE SWELLING (Lips and eyes are swollen completely) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Lip cosmetic procedure (Had lip filler about a year ago.) in 2020. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Severe reaction to the vaccine), LIP SWELLING (Lips swollen completely) and EYE SWELLING (Lips and eyes are swollen completely). At the time of the report, VACCINATION COMPLICATION (Severe reaction to the vaccine), LIP SWELLING (Lips swollen completely) and EYE SWELLING (Lips and eyes are swollen completely) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided Patient received first dose of Moderna COVID-19 Vaccine on a Saturday. This is a spontaneous report received by phone call of a patient with antecedent of lip dermal filler who presented Lip/Eyes swelling of severe intensity after an unknown period of receiving an unknown dose of the product. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This is a spontaneous report received by phone call of a patient with antecedent of lip dermal filler who presented Lip/Eyes swelling of severe intensity after an unknown period of receiving an unknown dose of the product. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Further information will not be available as per patient did not consent follow up.

Other Meds:

Current Illness:

ID: 1681688
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: seizures/ having seizures since the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizures/ having seizures since the vaccine) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Seizure (Patient hadn't had any seizures since 6 months). 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 SEIZURE (seizures/ having seizures since the vaccine) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizures/ having seizures since the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported No treatment medications provided At this time, very limited information has been provided on this event, the start and end date, and the patient's vaccination date was not documented. Consent for safety to contact the patient was not obtained. Reporter did not allow further contact; Sender's Comments: At this time, very limited information has been provided on this event, the start and end date, and the patient's vaccination date was not documented. Consent for safety to contact the patient was not obtained.

Other Meds:

Current Illness: Seizure (Patient hadn't had any seizures since 6 months)

ID: 1681689
Sex: F
Age: 40
State: VA

Vax Date: 08/02/2021
Onset Date: 08/03/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210803; Test Name: Heart rate; Result Unstructured Data: Increased

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Heart fluttering; Chest pain; This spontaneous case was reported by a pharmacist and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant) and CHEST PAIN (Chest pain). At the time of the report, CARDIAC FLUTTER (Heart fluttering) and CHEST PAIN (Chest pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Heart rate: increased (High) Increased. 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 medication details was provided. No treatment medication details was provided. Patient did not confirm whether or not she had a history of myocarditis or pericarditis. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1681690
Sex: F
Age: 38
State: OR

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210828; Test Name: Blood Pressure; Result Unstructured Data: 140/90 which was high for patients body; Test Date: 20210828; Test Name: Heart rate; Result Unstructured Data: went from 67 bpm to 159 bpm and didn't came back and after 1 hour it went to 110bpm.

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: exhausted tired; my feet feel warm to touch, but it feels like weird red tingly feeling; Headache; Nauseated; I was hallucinating; My legs turned purple around mid-thigh/ my toes turned purple; I couldn't walk; I was numb; I got sick; had the worst migraine; felt drained; Tachycardia; my blood pressure was 140/90; This spontaneous case was reported by an other health care professional and describes the occurrence of HALLUCINATION (I was hallucinating) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bradycardia (Usually have bradycardia), Migraine and Drug allergy (Medication allegy). Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Migraine, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication. On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced TACHYCARDIA (Tachycardia) and HYPERTENSION (my blood pressure was 140/90). On 28-Aug-2021, the patient experienced HALLUCINATION (I was hallucinating) (seriousness criterion medically significant), SKIN DISCOLOURATION (My legs turned purple around mid-thigh/ my toes turned purple), GAIT INABILITY (I couldn't walk), HYPOAESTHESIA (I was numb), ILLNESS (I got sick), MIGRAINE (had the worst migraine), ASTHENIA (felt drained), HEADACHE (Headache) and NAUSEA (Nauseated). On 30-Aug-2021, the patient experienced PARAESTHESIA (my feet feel warm to touch, but it feels like weird red tingly feeling). On an unknown date, the patient experienced FATIGUE (exhausted tired). At the time of the report, HALLUCINATION (I was hallucinating), TACHYCARDIA (Tachycardia), HYPERTENSION (my blood pressure was 140/90), SKIN DISCOLOURATION (My legs turned purple around mid-thigh/ my toes turned purple), GAIT INABILITY (I couldn't walk), HYPOAESTHESIA (I was numb), ILLNESS (I got sick), MIGRAINE (had the worst migraine), PARAESTHESIA (my feet feel warm to touch, but it feels like weird red tingly feeling) and NAUSEA (Nauseated) outcome was unknown and ASTHENIA (felt drained), HEADACHE (Headache) and FATIGUE (exhausted tired) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Blood pressure measurement: 140/90 (High) 140/90 which was high for patients body. On 28-Aug-2021, Heart rate: 159bpm (High) went from 67 bpm to 159 bpm and didn't came back and after 1 hour it went to 110bpm.. 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. Treatment medication were not reported. After 15 mins of vaccination patient had to wait half an hour because he had allergies to medication. On 28 AUG 2021 patient at 2 am in morning was feeling like breathing cold air. Around 5 to 6 am in morning patient was hallucinating. Patient kept trying to walk to 8 years old but was at babysitters. Patient was super tired on 30 AUG 2021 and felt asleep so hard. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: ADDERALL; BOTOX

Current Illness: Bradycardia (Usually have bradycardia); Drug allergy (Medication allegy); Migraine

ID: 1681691
Sex: M
Age: 67
State: NV

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

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

Lab Data: Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: 101.5 to 102

Allergies:

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

Symptoms: He had difficulty breathing; Running a high fever/temperature hits 101.1F/keeps going to 101.5-102/can't get temperature controlled/ not getting better; Terrible headache; Weak legs/legs feel like jello; Back ache; Sleeping 3-4 hours during the day; The skin on face hurt to touch, face and scalp; He states this is like myelitis; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS (He states this is like myelitis) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. E01721A, 025A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised. Concomitant products included DENOSUMAB (PROLIA), INFLIXIMAB (REMICADE) and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced MYELITIS (He states this is like myelitis) (seriousness criterion medically significant) and PAIN OF SKIN (The skin on face hurt to touch, face and scalp). On 21-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCULAR WEAKNESS (Weak legs/legs feel like jello), BACK PAIN (Back ache), HYPERSOMNIA (Sleeping 3-4 hours during the day), PYREXIA (Running a high fever/temperature hits 101.1F/keeps going to 101.5-102/can't get temperature controlled/ not getting better) and HEADACHE (Terrible headache). On 29-Aug-2021, the patient experienced DYSPNOEA (He had difficulty breathing). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 3000 mg around the clock and TRAMADOL for Adverse event, at an unspecified dose and frequency. At the time of the report, MYELITIS (He states this is like myelitis), MUSCULAR WEAKNESS (Weak legs/legs feel like jello), BACK PAIN (Back ache), HYPERSOMNIA (Sleeping 3-4 hours during the day), PAIN OF SKIN (The skin on face hurt to touch, face and scalp), DYSPNOEA (He had difficulty breathing) and HEADACHE (Terrible headache) outcome was unknown and PYREXIA (Running a high fever/temperature hits 101.1F/keeps going to 101.5-102/can't get temperature controlled/ not getting better) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 101.5 to 102 (High) 101.5 to 102. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported that the fever goes down, but spikes when the acetaminophen runs out and was not getting better. On 29 Aug 2021, patient went to urgent care. Patient tested the fever with various thermometers for confirmation. Patient took a COVID test, but the results were not available at the time of this report. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: PROLIA; REMICADE; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]

Current Illness: Immunocompromised

ID: 1681692
Sex: F
Age: 63
State: FL

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210327; Test Name: Ultrasound; Result Unstructured Data: found a DVT blood clot in her ulnar vein; Test Date: 20210327; Test Name: Imaging of lungs; Result Unstructured Data: lungs did not have a blood clot

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Tingling in my legs; Leg pain; Pain in my lower wrist area/every once in a while there was a dull pain; DVT blood clot in her ulnar vein/wrist; Big and swollen arm; Lumps on the inside part of upper arm/ 10 lumps; COVID arm; Itching; Arm being beet red/rash; Hurt like hell /was really sore that night/ painful next day; Bit of hypochondriac and has not received a second dose; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (DVT blood clot in her ulnar vein/wrist) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Hurt like hell /was really sore that night/ painful next day) and PRODUCT DOSE OMISSION ISSUE (Bit of hypochondriac and has not received a second dose). On 25-Mar-2021, the patient experienced PERIPHERAL SWELLING (Big and swollen arm), LIMB MASS (Lumps on the inside part of upper arm/ 10 lumps), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Itching) and RASH (Arm being beet red/rash). On 28-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT blood clot in her ulnar vein/wrist) (seriousness criterion medically significant). On an unknown date, the patient experienced PARAESTHESIA (Tingling in my legs), PAIN IN EXTREMITY (Leg pain) and ARTHRALGIA (Pain in my lower wrist area/every once in a while there was a dull pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 2, every 4 hours and APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. On 23-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Bit of hypochondriac and has not received a second dose) had resolved. On 31-Mar-2021, VACCINATION SITE PRURITUS (Itching) and RASH (Arm being beet red/rash) had resolved. At the time of the report, DEEP VEIN THROMBOSIS (DVT blood clot in her ulnar vein/wrist), VACCINATION SITE PAIN (Hurt like hell /was really sore that night/ painful next day), PERIPHERAL SWELLING (Big and swollen arm), LIMB MASS (Lumps on the inside part of upper arm/ 10 lumps), VACCINATION SITE REACTION (COVID arm), PARAESTHESIA (Tingling in my legs), PAIN IN EXTREMITY (Leg pain) and ARTHRALGIA (Pain in my lower wrist area/every once in a while there was a dull pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Imaging procedure: normal (normal) lungs did not have a blood clot. On 27-Mar-2021, Ultrasound scan: abnormal (abnormal) found a DVT blood clot in her ulnar vein. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Patient called the CDC due to the adverse events. On 27 Mar 2021, patient felt like something wrong. Some of the lumps had gone, but one lump on the inside of her elbow was larger and more painful than the rest. Patient went to the ER and the doctor told her he doesn't know why there was a lump. Patient was sent to cape coral hospital for imaging of her lungs as she cannot take iodine contrast. Patient has been to the ER for pain and tingling in her legs 2 separate time since then. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1681693
Sex: F
Age: 78
State: CT

Vax Date: 01/13/2021
Onset Date: 08/28/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: funny feeling on her scalp; throat looks a little red; throat hurts a little; angioedema of her bottom lip, eyelids, & cheeks under her eyes (little lumps on her cheeks); eyes got funny looking; hives on her chest; Inappropriate schedule of vaccine administered; arm was killing her & she could hardly move it; arm was killing her & she could hardly move it; felt rotten; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (angioedema of her bottom lip, eyelids, & cheeks under her eyes (little lumps on her cheeks)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088B21A, 016M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy (she's a highly allergic person). Concomitant products included FAMOTIDINE, MONTELUKAST SODIUM (SINGULAIR) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Allergy. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced PAIN IN EXTREMITY (arm was killing her & she could hardly move it), HYPOKINESIA (arm was killing her & she could hardly move it) and FEELING ABNORMAL (felt rotten). On 29-Aug-2021, the patient experienced ANGIOEDEMA (angioedema of her bottom lip, eyelids, & cheeks under her eyes (little lumps on her cheeks)) (seriousness criterion medically significant), OCULAR DISCOMFORT (eyes got funny looking) and URTICARIA (hives on her chest). 29-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 30-Aug-2021, the patient experienced PARAESTHESIA (funny feeling on her scalp), PHARYNGEAL ERYTHEMA (throat looks a little red) and OROPHARYNGEAL PAIN (throat hurts a little). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Allergy, at a dose of 10-20; DEXAMETHASONE on 29-Aug-2021 for Adverse event, at an unspecified dose and frequency and FAMOTIDINE on 29-Aug-2021 for Adverse event, at a dose of 40 mg. On 29-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ANGIOEDEMA (angioedema of her bottom lip, eyelids, & cheeks under her eyes (little lumps on her cheeks)), PAIN IN EXTREMITY (arm was killing her & she could hardly move it), OCULAR DISCOMFORT (eyes got funny looking), HYPOKINESIA (arm was killing her & she could hardly move it), URTICARIA (hives on her chest), PARAESTHESIA (funny feeling on her scalp), PHARYNGEAL ERYTHEMA (throat looks a little red), OROPHARYNGEAL PAIN (throat hurts a little) and FEELING ABNORMAL (felt rotten) outcome was unknown. Action taken with mRNA-1273 was not applicable. (Moderna COVID-19 Vaccine). Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the strong history of allergic reaction in this immunocompromised patient remains a contributory factor. This case was linked to MOD-2021-302442 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the strong history of allergic reaction in this immunocompromised patient remains a contributory factor.

Other Meds: FAMOTIDINE; SINGULAIR; BENADRYL A

Current Illness: Allergy (she's a highly allergic person)

ID: 1681694
Sex: U
Age:
State: OR

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

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

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Getting covid after vaccination series; perfusion sweating; didn't feel good; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Getting covid after vaccination series), HYPERHIDROSIS (perfusion sweating) and MALAISE (didn't feel good) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Getting covid after vaccination series) (seriousness criterion hospitalization), HYPERHIDROSIS (perfusion sweating) (seriousness criterion hospitalization) and MALAISE (didn't feel good) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Getting covid after vaccination series), HYPERHIDROSIS (perfusion sweating) and MALAISE (didn't feel good) outcome was unknown. No concomitant drug details were reported. No treatment details were reported. The patient was later discharged 4-58 hours later. Company comment: Very limited information regarding this events has been provided at this time. This report refers to a case of Drug ineffective for mRNA-1273, lot numbers unspecified with AEs. There is no information on date of vaccine doses and start date of events, but case is processed assuming that the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days). For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events, based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this events has been provided at this time. This report refers to a case of Drug ineffective for mRNA-1273, lot numbers unspecified with AEs. There is no information on date of vaccine doses and start date of events, but case is processed assuming that the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days). For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events, based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1681695
Sex: U
Age:
State: NM

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: undisclosed number of patients were given expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (undisclosed number of patients were given expired vaccine) 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 EXPIRED PRODUCT ADMINISTERED (undisclosed number of patients were given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (undisclosed number of patients were given expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Relevant concomitant medications were not provided. Treatment information was not provided. Action taken with vaccine was not applicable. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1681696
Sex: M
Age: 34
State: MN

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: severe chills for several hours, moderate fever for several hours, mild fatigue and body aches for several hours

Other Meds:

Current Illness:

ID: 1681697
Sex: F
Age: 54
State:

Vax Date: 06/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: I have not done any yet

Allergies: No

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

Symptoms: Since the 3rd of July which is the day of the 2nd administration of Pfizer, I have continuous nausea, vertigo to the point that I cannot drive my vehicle. Blurry vision, severe pain in the stomach area under the right breast height of liver. Radiates a little to the left. Strong diarrhea that comes and goes and is very clear. Severe pain in upper back area unable to sleep because of the pain. Pain in calves and sensation of heaviness in the legs. I noticed like a knot in my stomach and heaviness and my stomach is bloated. Sensation of indigestion. Reflux and burning esophagus. Rash on breasts and stomach and lichen planus on the foot and left leg. Before the vaccination I was doing very well. Except for a little lack of iron, mild hypertension controlled and ulcerative colitis mild (proctitis).

Other Meds: Ninguno

Current Illness: Low Ferritin

ID: 1681698
Sex: F
Age: 33
State: TN

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

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

Lab Data: MRI ...appt next week results on oct 15 2021

Allergies: Penicillin

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

Symptoms: Fatigue, cold, sore throat and swollen tonsils, confusion, dizziness, gertie, vomiting, sinusitis, moodiness

Other Meds: Zoloft, meclizine, rizatriptan, albuterol,

Current Illness: N/A

ID: 1681699
Sex: M
Age: 77
State: NC

Vax Date: 01/11/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Surgery to take out 2 encapsulated cancer tumors of his left lung; This spontaneous case was reported by a consumer and describes the occurrence of LUNG NEOPLASM MALIGNANT (Surgery to take out 2 encapsulated cancer tumors of his left lung) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised (because he is taking Tagrisso) and Lung cancer. Concomitant products included OSIMERTINIB MESILATE (TAGRISSO) for Lung cancer, MULTIVITAMIN [VITAMINS NOS], LEVOTHYROXINE SODIUM (SYNTHROID), SODIUM BICARBONATE, AMLODIPINE and DOXYCYCLINE for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LUNG NEOPLASM MALIGNANT (Surgery to take out 2 encapsulated cancer tumors of his left lung) (seriousness criterion medically significant). The patient was treated with Surgery (On 03-May-2021 he got surgery to take out 2 encapsulated cancer tumors of his left lung) for Lung neoplasm malignant. At the time of the report, LUNG NEOPLASM MALIGNANT (Surgery to take out 2 encapsulated cancer tumors of his left lung) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LUNG NEOPLASM MALIGNANT (Surgery to take out 2 encapsulated cancer tumors of his left lung) to be unlikely related. Treatment medication was not provided. Company comment: Based on information provide and considering that the patient had medical history of lung cancer for which the patient underwent surgery the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on information provide and considering that the patient had medical history of lung cancer for which the patient underwent surgery the event is assessed as unlikely related to mRNA-1273.

Other Meds: TAGRISSO; MULTIVITAMIN [VITAMINS NOS]; SYNTHROID; SODIUM BICARBONATE; AMLODIPINE; DOXYCYCLINE

Current Illness: Immunocompromised (because he is taking Tagrisso); Lung cancer

Date Died: 07/01/2021

ID: 1681700
Sex: M
Age: 62
State: IN

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

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

Lab Data: Uncertain. He did have tests conducted in December 2020 prior to surgery and he was cleared for surgery. He had urine testing preformed at PCP in May 2021. I believe he has been attempting to schedule with a colon/rectal doctor as well to schedule colonoscopy. Not sure if this occurred.

Allergies: None

Symptom List: Erythema, Pruritus

Symptoms: After the first dose he complained of bloody stool, severe vomiting, high fever and flu-like symptoms. His symptoms occurred within a few hours of receiving his first dose and lasted approximately 21 days. He said he felt ?run down,? and similar feelings of dehydration and exhaustion. He had the above side effects with second dose but complained that the magnitude of symptoms were much worse and bloody stool increased. He complained of feeling as if he was going to ?pass out,? upon instances of brief aerobic activity. Upon the

Other Meds: Uncertain

Current Illness: Unknown

ID: 1681701
Sex: F
Age:
State: PA

Vax Date: 03/26/2021
Onset Date: 06/17/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210629; Test Name: Skin Biopsy; Result Unstructured Data: Test Result:Dermal Hypersensitivity; Test Date: 20210627; Test Name: Nasal swab; Test Result: Negative

Allergies:

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

Symptoms: Dermal Hypersensitivity; Hives from knees to neck; This is a spontaneous report from a contactable nurse (patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8733, patient was 68-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 26Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included HBP, hypothyroid. Concomitant medication(s) included irbesartan (IRBESARTAN); levothyroxine (LEVOTHYROXINE); melatonin (MELATONIN) all were taken for an unspecified indication within two weeks of vaccination, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6206, patient was 68-year-old at the time of vaccination), via Intramuscular route of administration, administered in Arm Left on 05Mar2021 at 01:PM as DOSE 1, SINGLE for covid-19 immunisation. No other vaccine received in four weeks. No covid prior vaccination: No known allergies were reported. No family Medical History Relevant to AE(S). On 17Jun2021 at 01:00 PM, the patient experienced hives from knees to neck, dermal hypersensitivity. It was reported that events occurred after 3 months of second shot. No medical reason or cause has been established. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No Seriousness Criteria were reported. The patient underwent lab tests and procedures which included biopsy skin: dermal hypersensitivity on 29Jun2021, sars-cov-2 test: negative on 27Jun2021. Therapeutic measures were taken as a result of hives from knees to neck with steroids 60mg daily 1 week, 40mg QD (everyday) X 1 week., 20mg daily X 1 week and Zyrtec 20mg twice a day, plus Depomedrol shot 80 mg In, patient had not changed anything in my daily routine and was not sick. I continue Zyrtec twice a day. Hives left marks on legs and abdomen which are fading. I wonder if shot thru my immune system in overdrive. The outcome of event (hives from knees to neck) was Resolved with Sequel from 30Jul2021 and the outcome of event (Dermal Hypersensitivity) was unknown.

Other Meds: IRBESARTAN; LEVOTHYROXINE; MELATONIN

Current Illness:

ID: 1681702
Sex: F
Age:
State: AL

Vax Date: 06/07/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fatigue; Joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 54-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not provided, Expiry date: Unknown, Age at vaccination: 54) via an unspecified route of administration in Arm Right on 07Jun2021 as dose 1, single for COVID-19 immunisation. The patient medical history included ongoing diabetes mellitus, it was controlled with diet, ongoing hypothyroidism and high cholesterol. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing; pravastatin (PRAVASTATIN) taken for blood cholesterol increased from an unspecified start date and ongoing; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced fatigue and joint pain on an unspecified date. She has had fatigue for the last 2 or 3 days. Joint pain started 3 or 4 days ago. The seriousness of the events was non-serious. The outcome of the event was not recovered. Information on the lot/batch number has been requested.er has been requested.

Other Meds: SYNTHROID; PRAVASTATIN; VITAMIN D [ERGOCALCIFEROL]; BABY ASPIRIN

Current Illness: Diabetes (It is controlled with diet.); Hypothyroidism (Hypothyroidism)

ID: 1681703
Sex: F
Age:
State: TN

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Had a large reaction; Arms are real sore; her lymph node were swollen under her arms; she felt little tired and really fatigue; headache; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, NDC number, UPC number and Expiry Date are unknown, Lot number: not specified (reported as EW0181 but not sure if the lot number belongs to her or the daughter or the husband)), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that her husband, herself and her daughter, three of them had out COVID Shot, the Pfizer at (Facility name) and they all three had a large reaction and all 'three' arms are real sore on an unspecified date. The patient's (daughter) lymph node were swollen under her arms and she felt little tired and really fatigue and had a bad headache on an unknown date. The reporter stated that she spoken to the pharmacist. She just wanted to know with the reaction that she had and her daughter, does they take the second shot or does they not? She was scared, she was afraid to 'fell' into the COVID again. She stated, "It's Pfizer. It says, COVID-19 Vaccine, LOT number, it looks like EWC101 or EWC0101 maybe. Pfizer that is the LOT number and it says come back on the 23rd. Are there different LOT number? She stated expiration date as 30Aug202 (Further not clarified). As reporter was having trouble hearing, hence further probing could not be done. Limited information was available over the call. The outcome of events was unknown. Information about Lot/Batch number is requested

Other Meds:

Current Illness:

ID: 1681704
Sex: F
Age:
State: CA

Vax Date: 03/17/2021
Onset Date: 03/15/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable other hcp (Patient). A 44-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Batch/Lot Number: ER2613) via an unspecified route of administration, administered in Arm Left on 17Mar2021 at 12:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included, adenoma benign from an unknown date and unknown if ongoing Other medical history: papillary adenofibroma; infertility; quamous cell carcinoma (RLL) , infertility from an unknown date and unknown if ongoing Other medical history: papillary adenofibroma; infertility; squamous cell carcinoma (RLL), squamous cell carcinoma from an unknown date and unknown if ongoing Other medical history: papillary adenofibroma; infertility;squamous cell carcinoma (RLL), from an unknown date and unknown if ongoing Known allergies: NKDA. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported.The patient had no covid prior vaccination and no covid tested post vaccination. Historical Vaccine included as bnt162b2 (BNT162B2, Batch/Lot Number: ER2613) via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 02:30 PM as DOSE 1, SINGLE for covid-19 immunisation. On 15Mar2021, The patient experienced extreme fatigue, daily menstrual spotting for 90days and lack of menstrual period for 90 days. Doctor or other healthcare professional office/clinic visit required for events. Treatment reported as No. The outcome of the events was recovered on an unspecified date in 2021.

Other Meds: SYNTHROID

Current Illness:

ID: 1681705
Sex: M
Age:
State: MS

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I had chills and muscle cramps after first shot.; I had chills and muscle cramps after first shot.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6201 and expiry date was not reported), via an unspecified route of administration, on 11Mar2021 at 11:00 AM (age at vaccination: 51 years), on left arm as a dose 1, single for COVID-19 immunization. The patients medical history includes pancreatitis. The patient concomitant medication includes Norvas, Pepcid,protonax, and multi vitamins. It was reported that the patient had no known allergies. It was reported that the patient had not received any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. It was reported that patient was tested to COVID post vaccination. On 11Mar2021 03:00 PM patient had chills and muscle cramps after first shot. Patient had not received any treatment for the events reported. outcome of events recovered on unspecified date in 2021. Follow-up attempts are completed. No further information is expected.

Other Meds: NORVASC; PEPCID [FAMOTIDINE]; PROTONIX [OMEPRAZOLE]; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1681706
Sex: F
Age:
State: NY

Vax Date: 06/01/2021
Onset Date: 07/18/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: Nasal Swab; Result Unstructured Data: Test Result:Unknown

Allergies:

Symptom List: Pain in extremity

Symptoms: This last period (the first since being fully vaccinated) came three days early; I recently stopped breastfeeding; I recently stopped breastfeeding; I recently stopped breastfeeding; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 33-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 01Jun2021 at 12:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization (at the age of 33-years-old). The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was reported by the patient that her period has always been very regular. It has come on the Tuesday of the week expecting every month for the last 15 years with the exception of the months she was pregnant and breastfeeding. She stated that she recently stopped breastfeeding and her period came back, also on a Tuesday. The period following that was also very regular. This last period (the first since being fully vaccinated) came three days early on 18Jul2021. The patient underwent lab tests and procedures which included nasal swab (SARS-CoV-2 test): unknown on an unspecified date. The outcome of the events was unknown. Information about lot and batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100921081 mother/baby

Other Meds:

Current Illness:

ID: 1681707
Sex: M
Age:
State:

Vax Date: 07/12/2021
Onset Date: 07/13/2021
Rec V Date: 09/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: right armpit swelling; This is a spontaneous report from a contactable consumer or other non hcp. A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for in-jection, lot number and expiration date was not reported), via an unspecified route of administra-tion, administered in Right Arm on 12Jul2021 (Age at vaccination was 23 years) as dose 2, single for covid-19 immunization. The patient medical history, family history none and concomitant medications were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on Jun2021 (Age at vaccination was 23 years) as dose 1, single for COVID-19 immunization. On 13Jul2021 the patient had a reaction and he and his family were looking into it. The patient's right armpit which, was the arm that was vaccinated, was getting swollen. Patient wants to know if this is a normal reaction to the vaccine, He also said he read on the internet that it may last until 6 weeks. With that, he wants to know how long he should wait before contacting his HCP. Patient did not go to Emergency Room or Physician Office. The outcome of event was recovering. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1681708
Sex: M
Age:
State: NJ

Vax Date: 05/23/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

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

Allergies:

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

Symptoms: Two weeks ago his son had a cold. It was not Covid. He was tested and was negative for Covid.; This is a spontaneous case received from a contactable consumer (patient's father) via. A 14-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/batch number was not reported) via an unspecified route of administration on 23May2021 09:00 (age at vaccination 14-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history was none. Concomitant medication was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE does not require a visit to emergency room/physician office. Prior Vaccinations (within 4 weeks) list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. AE following prior vaccinations was none. It was stated that two weeks ago his son had a cold. It was not COVID. The patient underwent lab test which included COVID test and was negative. 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: 1681709
Sex: F
Age:
State: OH

Vax Date: 05/23/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: antibody test; Test Result: Negative ; Test Name: Lab test; Test Result: Negative ; Test Name: Covid-19 test; Test Result: Positive

Allergies:

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

Symptoms: headache; muscle ache; Fever; chills; This is a spontaneous report from a contactable consumer (patient) via sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 23May2021 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 14Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history was included cancer B cell lymphoma. She just came back from a 2week treatment of Biaxin. The patient had her last chemo treatment on 28Dec2020. She mentioned she was a part of group that could only receive the Pfizer COVID-19 vaccine in March2021. She mentioned she was tested positive for COVID before getting the vaccine. She was also hospitalized. The patient had a significant reaction to the first dose of the vaccine. The reaction with the first dose was more significant. The reaction with the second dose was milder. On an unknown date, the patient had significant fever with the first dose and second dose. she had chills and muscle ache and headache for a day. She got her antibody test 2 weeks ago later. It came back negative. Patient did another test. This was to test the level of her vaccine. she don't know what test it was. she scared now because of the delta variant. Patient was asking has Pfizer provided a statement on the need for a booster dose (3rd dose). Caller wants to know should she get three doses instead of two to ensure protection against COVID infection. Patient wants to know If MRI Godium contrast can have an impact on the effectiveness of the vaccine? Caller also wanted to know about Lymphoma Clinical Trials. At the time of this report outcome of the event fever was unknown and other event outcome was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1681710
Sex: F
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Feeling jittery; difficulty sleeping; she was not able to sit down; This is a spontaneous report from a Pfizer sponsored Program COVAX US Support. A contactable consumer reported for a female patient (reporter's daughter). A female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. After the vaccine within half an hour the patient felt jittery, could not sit still and could not sleep. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1681711
Sex: M
Age:
State: NM

Vax Date: 07/19/2021
Onset Date: 07/19/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: feel tired with a sore arm; feel tired with a sore arm; he lost smell and taste; he lost smell and taste; woke up sick; faint taste but is unable to smell.; This is a spontaneous report from a contactable consumer or other non hcp(patient).A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,solution for injection,Lot number-not reported),via an unspecified route of administration on 19Jul2021 as DOSE 1, SINGLE for covid-19 immunization.The patient's medical history and concomitant medications were not reported. It was reported that patient received the 1st dose of the Pfizer COVID-19 Vaccine yesterday on 19Jul2021. His symptoms kind of began yesterday and the vaccine provider was aware of them and advised that the patient would feel tired with a sore arm on 20Jul2021.On 19Jul2021 he stated that he has faint taste but was unable to smell. He was calling today to see if loosing taste or anything was normal.He stated that he was not super freaked out or anything.He stated he received his 1st dose of the Pfizer vaccine yesterday and he woke up this morning with common side effects.On 20Jul2021 he stated he lost smell and taste and he doesn't know if that was normal .On 20Jul2021 he stated that he woke up sick on and hasn't been in contact with anyone with Covid.He was asking was this normal.He stated he still has faint taste but he cannot smell anymore.He stated that yesterday he had taken a nap and woke up and noticed that he had lost a little bit of taste and he thought it might be a side effect.He was asking how long it takes to make a report and declines to make a report stating he was looking for information.He clarified it was the Pfizer Covid 19 vaccine.The outcome of all events was unknown. No follow-up attempts are possible. Information about batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1681712
Sex: M
Age:
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: he had his 2nd dose of the vaccine 2 months ago and 7 days after that his lymph nodes were swollen and sore; he had his 2nd dose of the vaccine 2 months ago and 7 days after that his lymph nodes were swollen and sore; the base of his neck is also swollen, not that swollen but it is visible; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot/NDC/UPC number and Expiry date were unknown), via an unspecified route of administration, administered in right arm on an unspecified date as dose 2, single for covid-19 immunization. Medical history included first dose of COVID-19 Vaccine as immunisation. Concomitant medications were not reported.The patient he had his 2nd dose of the vaccine 2 months ago and 7 days after that his lymph nodes were swollen and sore (lymphadenopathy), (lymph node pain), the base of his neck is also swollen, not that swollen but it is visible (swelling). Patient stated he had the second dose of the Pfizer vaccine and 7 days after he got it his lymph nodes were sore and swollen. He added that, he never had a swollen lymph nodes before not until he got the 2nd dose of the Pfizer BioNTech COVID-19 Vaccine. Patient stated, "Yes, mostly it was on the side that I had gotten the shot and it was painful to the touch and lot more than it is now and now I have lymph node (Incomplete sentence)." His right side is now going down to normal but his left lymph nodes are still swollen. Patient said, he already contacted CDC and reported his side effects but according to CDC they don't have information about swollen lymph nodes. He wants to know what to do. He's not capable of seeing an HCP and don't want to spend money for it. He has no insurance and is upset. Caller also stated that we really don't care about them. Caller is upset because of his swollen lymph nodes from 2 months ago for his 2nd dose of the vaccine. About 7 days afterwards his lymph nodes swell and currently now after just being the left side it is in both sides that is swollen after 2 months and he says that it is painful as well." The outcome of the events was unknown. Information on the lot/batch number has been requested. Complainant hung up abruptly/transfer incomplete.

Other Meds:

Current Illness:

ID: 1681713
Sex: U
Age:
State: TN

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: have been having lots of breathing problems ever since; eyes are burning, watering, it's affecting my eye sight and my breathing that's and I must be allergic to these shots or something; eyes are burning, watering, it's affecting my eye sight and my breathing that's and I must be allergic to these shots or something; eyes are burning, watering, it's affecting my eye sight and my breathing that's and I must be allergic to these shots or something; eyes are burning, watering, it's affecting my eye sight and my breathing that's and I must be allergic to these shots or something; have not been able to breath good ever since I got them; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/lot number, Expiry Date, NDC number, UPC number: unknown) as dose 1, single and dose 2 via an unspecified route of administration on 08Mar2021 (Batch/lot number, Expiry Date, NDC number, UPC number: unknown) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she had those the shots, the COVID shots and I had been having lots of breathing problems ever since, she had it, eyes were burning, watering, it was affecting her eye sight and her breathing that's (on an unspecified date) and she must be allergic to these shots or something and had not been able to breath good (on an unspecified date), she stated Probably which would they got one in within 3 weeks and then got the other one and the COVID yes, she confirmed the date of vaccination of second shot as 08Mar2021, Well, it was three months, I mean three weeks before this last one. She did not have my vaccination card, so asked that should she find out the information and then call back. The patient further stated that she better call back, she did not understand how they spell, she was having hard time, was not breathing too well right now anyway. The outcome of all the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1681714
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: tired; This is a spontaneous report from a contactable consumer (patient's mother). A 42-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on Apr2021 (at the age of 42-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included problem with the heart valve diagnosed when the patient was in his 30s, blood pressure and heart operation. The concomitant medications included blood pressure medicine low dose. On Apr2021, patient was tired after the first dose, this started a few hours after he got the vaccine and the next day. The patient rested for the day and then was fine. The outcome of the tired was recovered on Apr2021. Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2

Other Meds:

Current Illness:

ID: 1681715
Sex: F
Age:
State: OH

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

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

Lab Data:

Allergies:

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

Symptoms: Had another friend that reported the same experience /two weeks later she started a period and has not stopped since then; Had another friend that reported the same experience /Her bleeding is also very different, it is blood like she cut her wrist; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number/expiry Date: Unknown), via an unspecified route of administration, on an unspecified date, as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter explains that she had another friend (patient) that reported that 2 weeks later she started her period and it has yet to stop. She explained it has gotten less but it was still going and going since then after having Pfizer vaccine. The caller says she thinks it was a little less; it will get less and she will think it's almost over but then 12 hours later she was back to bleeding again. Her bleeding was also very different, it was blood like she cut her wrist. The outcome of the events was unknown. The lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am