VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1751914
Sex: M
Age:
State: MO

Vax Date: 09/09/2021
Onset Date: 09/09/2021
Rec V Date: 10/01/2021
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: Expired vaccine was given to 10 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to 10 patients) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to 10 patients). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was given to 10 patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was reported. No concomitant medication was reported. Initially, other Health Care professional reported AE patients who received second dose, and Consent for Safety to follow up: Provided Further, query was updated from Safety in follow-up, regarding the incident which was occurred in a jail, where all patients are male, and where they administered expired vaccine in three different instances to 10 patients each time: 2 of these instances were first doses, while the third instance (described in case MOD21-146004) were second doses. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up was received on 22-Sep-2021 which included no new information

Other Meds:

Current Illness:

ID: 1751915
Sex: F
Age: 58
State: IA

Vax Date: 04/12/2021
Onset Date: 05/11/2021
Rec V Date: 10/01/2021
Hospital: Y

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: after the Covid shot, her cancer came back out of remission,her doctor said "it came back with a vengeance; she has nerve damage in her leg; she has a tingly feeling when she touches her bottom teeth.; her entire chin area and bottom teeth became numb/it is just numb; Nerve pain; her lower lip, straight down on both sides , and her entire chin area and bottom teeth became numb/ it has not gotten worse or better/ it is just numb/When she brushes her teeth she has to be careful because she doesn't have feeling/She can't say; This spontaneous case was reported by a consumer and describes the occurrence of PLASMA CELL MYELOMA (after the Covid shot, her cancer came back out of remission,her doctor said "it came back with a vengeance) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 407B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Multiple myeloma in remission since December 2020 and Stem cell transplant in October 2020. Concurrent medical conditions included Multiple myeloma since 2020, Asthma, Acid reflux (esophageal) and Nerve pain. Concomitant products included LANSOPRAZOLE for Acid reflux (esophageal), MONTELUKAST SODIUM for Asthma, GABAPENTIN for Nerve pain, VITAMIN D NOS, VITAMIN B COMPLEX, CALCIUM, MAGNESIUM, SULFAMETHOXAZOLE, Acyclovir and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced HYPOAESTHESIA ORAL (her lower lip, straight down on both sides , and her entire chin area and bottom teeth became numb/ it has not gotten worse or better/ it is just numb/When she brushes her teeth she has to be careful because she doesn't have feeling/She can't say he.). On 20-May-2021, the patient experienced PLASMA CELL MYELOMA (after the Covid shot, her cancer came back out of remission,her doctor said "it came back with a vengeance) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced NERVE INJURY (she has nerve damage in her leg), DENTAL PARAESTHESIA (she has a tingly feeling when she touches her bottom teeth.), HYPOAESTHESIA (her entire chin area and bottom teeth became numb/it is just numb) and NEURALGIA (Nerve pain). At the time of the report, PLASMA CELL MYELOMA (after the Covid shot, her cancer came back out of remission,her doctor said "it came back with a vengeance), NERVE INJURY (she has nerve damage in her leg), HYPOAESTHESIA ORAL (her lower lip, straight down on both sides , and her entire chin area and bottom teeth became numb/ it has not gotten worse or better/ it is just numb/When she brushes her teeth she has to be careful because she doesn't have feeling/She can't say he.), DENTAL PARAESTHESIA (she has a tingly feeling when she touches her bottom teeth.), HYPOAESTHESIA (her entire chin area and bottom teeth became numb/it is just numb) and NEURALGIA (Nerve pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. She was diagnosed in 2020 with Multiple Mieloma. She states that in December2020 her cancer went into remission, and she was taking Revlimid as a maintenant. In May2021, after the Covid shot, her cancer came back out of remission, and her doctor said "it came back with a vengeance", it got worse, it was around 20May2021. She spent the entire month of June in the hospital (she was admitted to the hospital), was admitted for 28 days, and she had chemo in the hospital, and since then she has had weekly chemo treatment that stopped 2 weeks ago, because the chemo was having an effect on her numbers. She states she is on a resting period now, and in October they will do a bone biopsy to check how much cancer is still there, and a new treatment will be in October. It was reported that the patient can't say it was 100% not because of the vaccine, but feels it was weird that it happened the day after the second dose. Company Comment: This case concerns a 58 year-old female patient with history of multiple myeloma in remission and stem cell transplant, who experienced the unexpected serious event of Multiple myeloma. The event occurred approximately 10 days after the second dose of mRNA-1273 vaccine. The natural history of malignancy, including remission and reoccurrence, remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 58 year-old female patient with history of multiple myeloma in remission and stem cell transplant, who experienced the unexpected serious event of Multiple myeloma. The event occurred approximately 10 days after the second dose of mRNA-1273 vaccine. The natural history of malignancy, including remission and reoccurrence, remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds: VITAMIN D NOS; VITAMIN B COMPLEX; CALCIUM; MAGNESIUM; SULFAMETHOXAZOLE; Acyclovir; GABAPENTIN; MONTELUKAST SODIUM; LANSOPRAZOLE; MULTIVITAMIN [VITAMINS NOS]

Current Illness: Acid reflux (esophageal); Asthma; Multiple myeloma; Multiple myeloma in remission; Nerve pain

ID: 1751916
Sex: F
Age: 46
State: CA

Vax Date: 02/15/2021
Onset Date: 09/17/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she started getting hives all over her body along with intense itching; she started getting hives all over her body along with intense itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (she started getting hives all over her body along with intense itching) and PRURITUS (she started getting hives all over her body along with intense itching) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced URTICARIA (she started getting hives all over her body along with intense itching) and PRURITUS (she started getting hives all over her body along with intense itching). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives and Itching, at a dose of 1 dosage form; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Hives and Itching, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives and Itching, at a dose of 1 dosage form. At the time of the report, URTICARIA (she started getting hives all over her body along with intense itching) and PRURITUS (she started getting hives all over her body along with intense itching) was resolving. No Concomitant medications were reported. Patient reported that she has taken Zyrtec, Claritin, and Benadryl. She said that the Zyrtec and Claritin didn't really work but the Benadryl seemed to have worked in alleviating her symptoms somewhat. She said that it made her too sleepy, so she is not sure if it really worked. She said that she just had an appointment with her Internal Medicine doctor who said that it may be an allergic reaction to the Moderna vaccine. She will be getting food allergy testing done to rule out allergies to anything else.

Other Meds:

Current Illness:

ID: 1751917
Sex: F
Age:
State: NY

Vax Date: 09/23/2021
Onset Date: 09/23/2021
Rec V Date: 10/01/2021
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: 17 year old female patient was administered the 1st dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female patient was administered the 1st dose of the Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female patient was administered the 1st dose of the Moderna vaccine). On 23-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old female patient was administered the 1st dose of the Moderna vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Nurse declined that the patient had any side effects that she was aware of. Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Reporter's address and additional hone number was added.

Other Meds:

Current Illness:

ID: 1751918
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: tingling in legs; Numbness in legs; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling in legs) and HYPOAESTHESIA (Numbness in legs) in a female 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 PARAESTHESIA (tingling in legs) and HYPOAESTHESIA (Numbness in legs). At the time of the report, PARAESTHESIA (tingling in legs) and HYPOAESTHESIA (Numbness in legs) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter reported that a patient received first Moderna COVID-19 vaccine 3 or 4 weeks ago and stated that stated the tingling and numbness was currently a bit better. No concomitant medication was reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1751919
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 09/17/2021
Rec V Date: 10/01/2021
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 Bleeding; had a horrible crazy accident; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Was Bleeding) and ROAD TRAFFIC ACCIDENT (had a horrible crazy accident) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for an unreported indication: Flu shot. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced HAEMORRHAGE (Was Bleeding) (seriousness criteria disability and medically significant) and ROAD TRAFFIC ACCIDENT (had a horrible crazy accident) (seriousness criterion disability). At the time of the report, HAEMORRHAGE (Was Bleeding) and ROAD TRAFFIC ACCIDENT (had a horrible crazy accident) outcome was unknown. Relevant concomitant product usage were not reported by the reporter. He is disabled and had a horrible crazy accident on Friday, he was bleeding and at the emergency room they put staples on his head. Patient was taken to ER and treatment included Staples on head. Company Comment: This case concerns an elderly male who experienced serious unexpected event of bleeding and road traffic accident on unknown date after receiving both doses of the vaccine. No relevant medical history. Rechallenge is not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns an elderly male who experienced serious unexpected event of bleeding and road traffic accident on unknown date after receiving both doses of the vaccine. No relevant medical history. Rechallenge is not applicable. The benefit-risk relationship is not affected by this report.

Other Meds:

Current Illness:

ID: 1751920
Sex: F
Age: 67
State: MT

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Date: 20210827; Test Name: Rapid heart beats; Result Unstructured Data: Rapid heart beats

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: I thought i was having heart attack; rapid heart beats; shortness of breath; I felt like I was a 107 years old; I felt like I was gonna faint; rash in the top side of my thigh; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (I thought i was having heart attack), HEART RATE INCREASED (rapid heart beats), DYSPNOEA (shortness of breath), FEELING ABNORMAL (I felt like I was a 107 years old) and PRESYNCOPE (I felt like I was gonna faint) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ESCITALOPRAM, LAMOTRIGINE and LISINOPRIL 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 CHEST DISCOMFORT (I thought i was having heart attack), HEART RATE INCREASED (rapid heart beats), DYSPNOEA (shortness of breath), FEELING ABNORMAL (I felt like I was a 107 years old), PRESYNCOPE (I felt like I was gonna faint) and RASH (rash in the top side of my thigh). In September 2021, CHEST DISCOMFORT (I thought i was having heart attack), HEART RATE INCREASED (rapid heart beats), FEELING ABNORMAL (I felt like I was a 107 years old), PRESYNCOPE (I felt like I was gonna faint) and RASH (rash in the top side of my thigh) had resolved. At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Heart rate: increased (High) Rapid heart beats. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient mentioned that she had heart issues and was afraid to get the second dose. No treatment information were reported by the reporter.

Other Meds: ESCITALOPRAM; LAMOTRIGINE; LISINOPRIL

Current Illness:

ID: 1751921
Sex: M
Age: 30
State: AL

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 10/01/2021
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: first dose received on 24-MAR-2021/ Hasn't received second dose yet (6 months since first dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose received on 24-MAR-2021/ Hasn't received second dose yet (6 months since first dose)) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013J20A) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose received on 24-MAR-2021/ Hasn't received second dose yet (6 months since first dose)). On 24-Mar-2021, PRODUCT DOSE OMISSION ISSUE (first dose received on 24-MAR-2021/ Hasn't received second dose yet (6 months since first dose)) had resolved. No concomitant and treatment medication was reported by the reporter.

Other Meds:

Current Illness:

ID: 1751922
Sex: U
Age:
State: FL

Vax Date: 09/21/2021
Onset Date: 09/21/2021
Rec V Date: 10/01/2021
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: Patient was administered dose form a vial punctured more than 12hs before; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered dose form a vial punctured more than 12hs before) 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 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered dose form a vial punctured more than 12hs before). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered dose form a vial punctured more than 12hs before) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter had stated that the vial was opened on 16 SEP 2021 and was administered on 21 Sep 2021, which was 5 days past the limit and was given to 2 patients. Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1751923
Sex: M
Age:
State: PA

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 10/01/2021
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: Patient didn't get the second dose; lymph nodes swelled all over his body; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY (lymph nodes swelled all over his body) and PRODUCT DOSE OMISSION ISSUE (Patient didn't get the second dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced LYMPHADENOPATHY (lymph nodes swelled all over his body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient didn't get the second dose). At the time of the report, LYMPHADENOPATHY (lymph nodes swelled all over his body) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient didn't get the second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1751924
Sex: F
Age: 76
State: NJ

Vax Date: 09/15/2021
Onset Date:
Rec V Date: 10/01/2021
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: weakness; dizzy; Sleeping constantly, not even waking up to eat; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizzy), HYPERSOMNIA (Sleeping constantly, not even waking up to eat) and CHILLS (chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder NOS (autoimmune condition). On 15-Sep-2021, the patient 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 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 ASTHENIA (weakness), DIZZINESS (dizzy), HYPERSOMNIA (Sleeping constantly, not even waking up to eat) and CHILLS (chills). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizzy) and CHILLS (chills) had not resolved and HYPERSOMNIA (Sleeping constantly, not even waking up to eat) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This case concerns a 76-year-old, female patient with medical history of an autoimmune condition, who experienced the unexpected non-serious adverse event of special interest of hypersomnia and other non-serious adverse events. The event occurred on unknown date after the third dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred after the third dose of vaccine and no additional dosing will be given. The medical history of an autoimmune condition could be a potential confounder for the event. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.

Other Meds:

Current Illness: Autoimmune disorder NOS (autoimmune condition)

ID: 1751925
Sex: F
Age:
State: TX

Vax Date: 08/30/2021
Onset Date: 08/31/2021
Rec V Date: 10/01/2021
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: Still does not feel right, like when she swallows/Touch or swallow feels different like she has a lump in her throat but she does not; The right side of her neck swelled up the size of two baseballs. It would get smaller then get bigger for two days ever since 31AUG2021 and after two days; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (The right side of her neck swelled up the size of two baseballs. It would get smaller then get bigger for two days ever since 31AUG2021 and after two days) and DYSPHAGIA (Still does not feel right, like when she swallows/Touch or swallow feels different like she has a lump in her throat but she does not) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The patient's past medical history included Aortic dissection in 2012 and Splenectomy. On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced SWELLING (The right side of her neck swelled up the size of two baseballs. It would get smaller then get bigger for two days ever since 31AUG2021 and after two days). On an unknown date, the patient experienced DYSPHAGIA (Still does not feel right, like when she swallows/Touch or swallow feels different like she has a lump in her throat but she does not). The patient was treated with IBUPROFEN for Neck swelling, at an unspecified dose and frequency. At the time of the report, SWELLING (The right side of her neck swelled up the size of two baseballs. It would get smaller then get bigger for two days ever since 31AUG2021 and after two days) was resolving and DYSPHAGIA (Still does not feel right, like when she swallows/Touch or swallow feels different like she has a lump in her throat but she does not) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. On 31-Aug-2021, The right side of neck swelled up the size of two baseballs. It would get smaller then get bigger for two days ever since 31-Aug-2021 and after two days, the swelling went down, and it stopped doing that. Since then the right side of her neck has not been the same. it looks good, but it still did not feel right, like when she swallows. She could touch the left side it feels fine, but the right side does not feel fine. She did not think she would be getting her second vaccine due to the swelling of her neck. Touch or swallow felts different like she has a lump in her throat but she did not.

Other Meds:

Current Illness:

ID: 1751926
Sex: F
Age: 65
State: FL

Vax Date: 09/22/2021
Onset Date: 09/22/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Doses were administered after 12-hours in syringes; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Pharmacist stated that 3 doses of the Moderna COVID-19 vaccine drawn in syringes were administered to patients on 22SEPT2021. The doses were beyond the 12-hours recommended by Moderna. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1751927
Sex: M
Age: 20
State: HI

Vax Date: 09/20/2021
Onset Date: 09/20/2021
Rec V Date: 10/01/2021
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: Test Date: 20210920; Test Name: Blood pressure; Result Unstructured Data: 130/90

Allergies:

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

Symptoms: Chest pain; Headache; Body ache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (Fatigue) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-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. On 20-Sep-2021, the patient experienced CHEST PAIN (Chest pain), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (Fatigue). On 22-Sep-2021, CHILLS (Chills) had resolved. At the time of the report, CHEST PAIN (Chest pain), HEADACHE (Headache), MYALGIA (Body ache) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2021, Blood pressure measurement: 130/90 (High) 130/90. No concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-328763 (Patient Link).

Other Meds:

Current Illness:

ID: 1751928
Sex: F
Age: 52
State: WA

Vax Date: 08/10/2021
Onset Date: 09/21/2021
Rec V Date: 10/01/2021
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: expired vaccine used; incorrect product storage; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (incorrect product storage) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (incorrect product storage). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (incorrect product storage) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medication were reported.The vial was suppose to be wasted since it was set to expire after the 12 hour mark at 10:30PM 17-Sep-2021 (Friday). However, no one was available to throw it in the waste. Accidentally, yesterday, 21-Sept-2021, a Medical Assistant drew up the expired dose and gave it to one of their providers.

Other Meds:

Current Illness:

ID: 1751929
Sex: U
Age:
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: vertigo; dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) and DIZZINESS (dizziness) 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, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization) and DIZZINESS (dizziness) (seriousness criterion hospitalization). At the time of the report, VERTIGO (vertigo) and DIZZINESS (dizziness) outcome was unknown. No concomitant and treatment information were reported by the reporter. Company Comment: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious events of Vertigo and Dizziness. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious events of Vertigo and Dizziness. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1751930
Sex: M
Age: 21
State: AZ

Vax Date: 09/21/2021
Onset Date: 09/21/2021
Rec V Date: 10/01/2021
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: vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1751931
Sex: F
Age: 58
State: UT

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Injection site pain/it hurt a lot more than the first one; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain/it hurt a lot more than the first one) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, 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 PAIN (Injection site pain/it hurt a lot more than the first one). At the time of the report, VACCINATION SITE PAIN (Injection site pain/it hurt a lot more than the first one) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medication was mentioned. No treatment medication was mentioned. This case was linked to MOD-2021-328742 (Patient Link).

Other Meds:

Current Illness:

ID: 1751932
Sex: M
Age: 18
State: CO

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Dose given past the 12 hour post puncture time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided. This case was linked to MOD-2021-328946, MOD-2021-328010 (Patient Link).

Other Meds:

Current Illness:

ID: 1751933
Sex: F
Age: 72
State: CO

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

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

Lab Data:

Allergies:

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

Symptoms: Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication was reported No treatment drug was reported

Other Meds:

Current Illness:

ID: 1751934
Sex: M
Age: 56
State: IN

Vax Date: 08/28/2021
Onset Date: 08/28/2021
Rec V Date: 10/01/2021
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: Fever; Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 in 2021. On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). In August 2021, PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was mentioned. No treatment medication was mentioned. Patient stated that he experienced the events after 12 hours of vaccinations and lasted for about 36 hours.

Other Meds:

Current Illness:

ID: 1751935
Sex: F
Age: 78
State: PA

Vax Date: 01/21/2021
Onset Date: 09/21/2021
Rec V Date: 10/01/2021
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: affecting my social life; it is worse today/not life threatening; upper lip is swollen; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (upper lip is swollen), CONDITION AGGRAVATED (it is worse today/not life threatening), SOCIAL PROBLEM (affecting my social life) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 023M20A and 032L20A) for COVID-19 vaccination. The patient's past medical history included Dermal filler injection (Dermatological filler called "Restylane Silk" in upper lip.). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced LIP SWELLING (upper lip is swollen) and EXTRA DOSE ADMINISTERED (Extra dose administered). On 22-Sep-2021, the patient experienced CONDITION AGGRAVATED (it is worse today/not life threatening). On an unknown date, the patient experienced SOCIAL PROBLEM (affecting my social life). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 21-Sep-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, LIP SWELLING (upper lip is swollen), CONDITION AGGRAVATED (it is worse today/not life threatening) and SOCIAL PROBLEM (affecting my social life) had not resolved. Concomitant drug was not reported. It was reported that patient received 3rd dose of vaccine as suggested by her physician due to age. It was advised by dermatologist to take Motrin as treatment drug to the patient.Consumer does not have Motrin and is taking Aleve. Consumer states she has no problems to 1st and 2nd dose of the vaccine.

Other Meds:

Current Illness:

ID: 1751936
Sex: F
Age: 74
State: WA

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 10/01/2021
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: my heart hurt so bad/terrible pain in my heart; I thought I was gonna die; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (my heart hurt so bad/terrible pain in my heart) and FEELING ABNORMAL (I thought I was gonna die) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) and METFORMIN for an unknown indication. On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CHEST PAIN (my heart hurt so bad/terrible pain in my heart) and FEELING ABNORMAL (I thought I was gonna die). At the time of the report, CHEST PAIN (my heart hurt so bad/terrible pain in my heart) and FEELING ABNORMAL (I thought I was gonna die) outcome was unknown. No treatment medications were reported. Concomitant medication includes: Thyroid pill

Other Meds: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; METFORMIN

Current Illness: Thyroid disorder

ID: 1751937
Sex: M
Age: 54
State: CO

Vax Date: 09/17/2021
Onset Date: 09/18/2021
Rec V Date: 10/01/2021
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: 20210922; Test Name: Body temperature; Result Unstructured Data: 96F but could be wrong

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel good), ILLNESS (has been sick since then/kind a little sick), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), HYPERHIDROSIS (sweats) and INCOHERENT (incoherent) in a 54-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. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) for Blood pressure high. On 17-Sep-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. On 18-Sep-2021, the patient experienced MALAISE (didn't feel good), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), HYPERHIDROSIS (sweats), NAUSEA (nauseous) and MYALGIA (body aches). On 20-Sep-2021, the patient experienced ILLNESS (has been sick since then/kind a little sick). On 22-Sep-2021, the patient experienced INCOHERENT (incoherent), DIARRHOEA (has diarrhea), VOMITING (throwing up/was spitting on the floor with throw up while on the toilet) and CHILLS (chills). At the time of the report, MALAISE (didn't feel good), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), NAUSEA (nauseous) and MYALGIA (body aches) outcome was unknown and ILLNESS (has been sick since then/kind a little sick), HYPERHIDROSIS (sweats), INCOHERENT (incoherent), DIARRHOEA (has diarrhea), VOMITING (throwing up/was spitting on the floor with throw up while on the toilet) and CHILLS (chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2021, Body temperature: abnormal (abnormal) 96F but could be wrong. No Treatment medications were reported. Patient went to the urgent care, they performed a COVID test, whose results is still pending.

Other Meds: LISINOPRIL/HCTZ

Current Illness:

ID: 1751938
Sex: F
Age: 30
State: AZ

Vax Date: 09/21/2021
Onset Date: 09/21/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial punctured for more than 12 hours) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial punctured for more than 12 hours). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vial punctured for more than 12 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided. The patient received dose of Moderna vaccine (unknown if it is first or second dose) from a vial which was punctured for more than 12 hours.The pharmacist said the vial was punctured on Monday 20 -Sep-2021 at 12 pm, they left it in the fridge and would have expired by 12 AM on Tuesday 21-Sep-2021. It was administered then at 3.59 PM, 4.53 PM, 9.15 PM and 9.16 PM.

Other Meds:

Current Illness:

ID: 1751939
Sex: F
Age: 58
State: UT

Vax Date: 03/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/01/2021
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: 202104; Test Name: Body temperature; Result Unstructured Data: Fever; Test Date: 202104; Test Name: MRI; Result Unstructured Data: MRI shows the bursa going through the joint, all of the joints are torn and partial tear to rotator cuff.; Test Date: 202104; Test Name: Pulse; Result Unstructured Data: High

Allergies:

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

Symptoms: extreme pain in left arm at time of second injection; felt dizzy; shoulder turned red all the way down to her elbow was swollen and hot; shoulder turned red all the way down to her elbow was swollen and hot; shoulder turned red all the way down to her elbow was swollen and hot; felt lethargic; couldn't sleep because arm washttps://ilssafety1f.quintiles.com/img/tabs/tab_left_move.gif so painful.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme pain in left arm at time of second injection), DIZZINESS (felt dizzy), ERYTHEMA (shoulder turned red all the way down to her elbow was swollen and hot), PERIPHERAL SWELLING (shoulder turned red all the way down to her elbow was swollen and hot) and INJECTION SITE WARMTH (shoulder turned red all the way down to her elbow was swollen and hot) in a 59-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. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (extreme pain in left arm at time of second injection), DIZZINESS (felt dizzy), ERYTHEMA (shoulder turned red all the way down to her elbow was swollen and hot), PERIPHERAL SWELLING (shoulder turned red all the way down to her elbow was swollen and hot), INJECTION SITE WARMTH (shoulder turned red all the way down to her elbow was swollen and hot), LETHARGY (felt lethargic) and INSOMNIA (couldn't sleep because arm so painful). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (extreme pain in left arm at time of second injection), DIZZINESS (felt dizzy), ERYTHEMA (shoulder turned red all the way down to her elbow was swollen and hot), PERIPHERAL SWELLING (shoulder turned red all the way down to her elbow was swollen and hot), INJECTION SITE WARMTH (shoulder turned red all the way down to her elbow was swollen and hot), LETHARGY (felt lethargic) and INSOMNIA (couldn't sleep because arm was so painful.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 102 (High) Fever. In April 2021, Magnetic resonance imaging: abnormal (abnormal) MRI shows the bursa going through the joint, all of the joints are torn and partial tear to rotator cuff.. In April 2021, Oxygen saturation: 130 bpm (High) High. The patient stated that she has talked to Physicians, and they feel something in the bursa is effected by the vaccine, because the cells in the bursa are very different than a deltoid muscle, and they feel she is only about 35 percent vaccinated because it works differently in a bursa The patient is scheduled for cortisone shot in November and also applies ice for 20 min, heat for 20 min ice 20 min on affected area No concomitant medications were reported This case was linked to MOD-2021-328653 (Patient Link).

Other Meds:

Current Illness:

ID: 1751940
Sex: M
Age:
State: OH

Vax Date: 09/21/2021
Onset Date: 09/21/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of inappropriate schedule of product administration (2nd dose administered 5 weeks, 4 days after 1st dose) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 21, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 13, 2021, patient experienced inappropriate schedule of product administration (2nd dose administered 5 weeks, 4 days after 1st dose). On Sep 21, 2021, inappropriate schedule of product administration (2nd dose administered 5 weeks, 4 days after 1st dose) resolved. No concomitant medication or treatment information reported. This case linked to MOD-2021-329095 (patient link).

Other Meds:

Current Illness:

ID: 1751941
Sex: M
Age:
State: HI

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: experienced a sore arm after the first vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (experienced a sore arm after the first vaccination) in a 20-year-old male patient 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 PAIN IN EXTREMITY (experienced a sore arm after the first vaccination). At the time of the report, PAIN IN EXTREMITY (experienced a sore arm after the first vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment details were reported. This case was linked to MOD-2021-328621.

Other Meds:

Current Illness:

ID: 1751942
Sex: U
Age:
State: WA

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

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

Lab Data:

Allergies:

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

Symptoms: vaccination adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (vaccination adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. A friend was going through similar symptoms as the caller. No concomitant medication was reported. No treatment medication use was reported.

Other Meds:

Current Illness:

ID: 1751943
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: Given expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1751944
Sex: U
Age:
State: WA

Vax Date: 09/21/2021
Onset Date: 09/21/2021
Rec V Date: 10/01/2021
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: dose had been administered outside of the 12 hour puncture viability window; 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 (dose had been administered outside of the 12 hour puncture viability window) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose had been administered outside of the 12 hour puncture viability window). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose had been administered outside of the 12 hour puncture viability window) 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. No concomitant medication information provided by the reporter. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up document received contains Dose details of suspect drug were added

Other Meds:

Current Illness:

ID: 1751945
Sex: F
Age: 63
State: FL

Vax Date: 09/22/2021
Onset Date: 09/22/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Doses were administered after 12-hours in syringes; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) had resolved. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1751946
Sex: F
Age: 67
State:

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore arm; a little bit of chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and CHILLS (a little bit of chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination. Concurrent medical conditions included Osteoporosis, High cholesterol and Blood pressure high. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-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 PAIN IN EXTREMITY (sore arm) and CHILLS (a little bit of chills). At the time of the report, PAIN IN EXTREMITY (sore arm) and CHILLS (a little bit of chills) outcome was unknown. Concomitant medication of the patient included medication for osteoporosis, medication for high cholesterol and medication for high blood pressure. No treatment information was provided by the reporter. This case was linked to MOD-2021-328976 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness: Blood pressure high; High cholesterol; Osteoporosis

ID: 1751947
Sex: U
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: Patients given vaccine later than 12 hours after puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients given vaccine later than 12 hours after puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) 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) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients given vaccine later than 12 hours after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients given vaccine later than 12 hours after puncture) 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. No concomitant medication was reported. No treatment was treatment. This case was linked to MOD-2021-328674, MOD-2021-327879 (Patient Link).

Other Meds:

Current Illness:

ID: 1751948
Sex: F
Age: 56
State: FL

Vax Date: 08/08/2021
Onset Date: 09/06/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: could barely talk to the point of people understanding; to the point she was crying; she could not function. When she tried to walk, she almost passed out/someone had to grab her; Had flu like symptoms the day after receiving the second dose of the vaccine; running eyes/tears were really warm; body aches; to a point where It is nausea with the headaches; suffering from extremely bad headache/headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she could not function. When she tried to walk, she almost passed out/someone had to grab her) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A. and 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure. Concomitant products included AMLODIPINE from 22-Sep-2021 to an unknown date for Blood pressure abnormal. On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (Had flu like symptoms the day after receiving the second dose of the vaccine), LACRIMATION INCREASED (running eyes/tears were really warm), PAIN (body aches), NAUSEA (to a point where It is nausea with the headaches), HEADACHE (suffering from extremely bad headache/headaches) and CHILLS (chills). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (she could not function. When she tried to walk, she almost passed out/someone had to grab her) (seriousness criterion medically significant), DYSARTHRIA (could barely talk to the point of people understanding) and CRYING (to the point she was crying). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (she could not function. When she tried to walk, she almost passed out/someone had to grab her), INFLUENZA LIKE ILLNESS (Had flu like symptoms the day after receiving the second dose of the vaccine), LACRIMATION INCREASED (running eyes/tears were really warm), DYSARTHRIA (could barely talk to the point of people understanding), CRYING (to the point she was crying), PAIN (body aches), NAUSEA (to a point where It is nausea with the headaches), HEADACHE (suffering from extremely bad headache/headaches) and CHILLS (chills) outcome was unknown. The patient did not experience any side effects after receiving first dose.; Sender's Comments: This case concerns a 56-year-old, female patient with previous relevant medical history of hypertension and use of concomitant medication, who experienced the unexpected event of loss of consciousness. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of hypertension and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. The event was downgrade to non-serious due there was no information in the source document supporting that the event resulted in a persistent or permanent incapacity or meet the criteria to be medically significant. The patient refers she almost passed out.

Other Meds: AMLODIPINE

Current Illness: Blood pressure

ID: 1751949
Sex: M
Age:
State: MD

Vax Date: 04/27/2021
Onset Date: 09/10/2021
Rec V Date: 10/01/2021
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: 20210910; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: tested positive for Covid-19

Allergies:

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

Symptoms: I tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I tested positive for COVID-19) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced COVID-19 (I tested positive for COVID-19). At the time of the report, COVID-19 (I tested positive for COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: positive (Positive) tested positive for Covid-19. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant information was reported. No treatment information was reported. The patient tested positive for Covid-19, and reported that his daughter caught it from school, and the patient caught it from her.; Sender's Comments: This case concerns a 46-year-old, male patient with no relevant medical history, who experienced the unexpected event of COVID 19. The event occurred approximately four and a half months after the second dose of Moderna COVID-19 Vaccine. The rechallenge was unknown since no information about the second dose was disclosed. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1751950
Sex: F
Age: 67
State: FL

Vax Date: 01/15/2021
Onset Date: 09/22/2021
Rec V Date: 10/01/2021
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: sore right arm; headache; a little bit of nausea; loose bowel movement, very sudden; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (loose bowel movement, very sudden), PAIN IN EXTREMITY (sore right arm), HEADACHE (headache) and NAUSEA (a little bit of nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination. Concurrent medical conditions included Osteoporosis, High cholesterol and Blood pressure high. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (loose bowel movement, very sudden). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore right arm), HEADACHE (headache) and NAUSEA (a little bit of nausea). At the time of the report, DIARRHOEA (loose bowel movement, very sudden), PAIN IN EXTREMITY (sore right arm), HEADACHE (headache) and NAUSEA (a little bit of nausea) outcome was unknown. Concomitant medication of the patient included medication for osteoporosis, medication for high cholesterol and medication for high blood pressure. No treatment information was provided by the reporter. This case was linked to MOD-2021-328939 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness: Blood pressure high; High cholesterol; Osteoporosis

ID: 1751951
Sex: M
Age: 40
State: NJ

Vax Date: 07/28/2021
Onset Date: 07/30/2021
Rec V Date: 10/01/2021
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: discoloration on both forearms up to shoulders/dark patch; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (discoloration on both forearms up to shoulders/dark patch) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 002F2119) for COVID-19 vaccination. No Medical History information was reported. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced SKIN DISCOLOURATION (discoloration on both forearms up to shoulders/dark patch). At the time of the report, SKIN DISCOLOURATION (discoloration on both forearms up to shoulders/dark patch) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No Concomitant medication was reported. No treatment Drug was reported.

Other Meds:

Current Illness:

ID: 1751952
Sex: M
Age: 78
State: FL

Vax Date: 09/22/2021
Onset Date:
Rec V Date: 10/01/2021
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: Doses were administered after 12-hours in syringes; Doses were administered after 12-hours in syringes; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) and PRODUCT STORAGE ERROR (Doses were administered after 12-hours in syringes) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) and PRODUCT STORAGE ERROR (Doses were administered after 12-hours in syringes). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) and PRODUCT STORAGE ERROR (Doses were administered after 12-hours in syringes) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was unknown Treatment information was unknown

Other Meds:

Current Illness:

ID: 1751953
Sex: F
Age: 59
State: NC

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 10/01/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: She found out at the hospital that she had polynephritis; She had pain in her back and stomach; She had pain in her back; By Sunday morning, she had fatigue; She felt lethargic; Same day after receiving 2nd dose, she had body aches; She had sore throat/ She had persistent sore throat; She had headaches; This spontaneous case was reported by a consumer and describes the occurrence of PYELONEPHRITIS (She found out at the hospital that she had polynephritis), ABDOMINAL PAIN UPPER (She had pain in her back and stomach), BACK PAIN (She had pain in her back), FATIGUE (By Sunday morning, she had fatigue), HEADACHE (She had headaches), LETHARGY (She felt lethargic), PAIN (Same day after receiving 2nd dose, she had body aches) and OROPHARYNGEAL PAIN (She had sore throat/ She had persistent sore throat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included CARVEDILOL (COREG) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced HEADACHE (She had headaches) (seriousness criterion hospitalization), PAIN (Same day after receiving 2nd dose, she had body aches) (seriousness criterion hospitalization) and OROPHARYNGEAL PAIN (She had sore throat/ She had persistent sore throat) (seriousness criterion hospitalization). On 23-May-2021, the patient experienced PYELONEPHRITIS (She found out at the hospital that she had polynephritis) (seriousness criteria hospitalization and medically significant), ABDOMINAL PAIN UPPER (She had pain in her back and stomach) (seriousness criterion hospitalization), BACK PAIN (She had pain in her back) (seriousness criterion hospitalization), FATIGUE (By Sunday morning, she had fatigue) (seriousness criterion hospitalization) and LETHARGY (She felt lethargic) (seriousness criterion hospitalization). The patient was hospitalized on 23-May-2021 due to ABDOMINAL PAIN UPPER, BACK PAIN, FATIGUE, HEADACHE, LETHARGY, OROPHARYNGEAL PAIN, PAIN and PYELONEPHRITIS. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYELONEPHRITIS (She found out at the hospital that she had polynephritis), ABDOMINAL PAIN UPPER (She had pain in her back and stomach), BACK PAIN (She had pain in her back), FATIGUE (By Sunday morning, she had fatigue), HEADACHE (She had headaches), LETHARGY (She felt lethargic) and PAIN (Same day after receiving 2nd dose, she had body aches) outcome was unknown and OROPHARYNGEAL PAIN (She had sore throat/ She had persistent sore throat) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medication included Tylenol Company Comment: This case concerns a 59 years-old, female subject without significant clinical history, who experienced the unexpected events of PYELONEPHRITIS, ABDOMINAL PAIN UPPER, BACK PAIN, FATIGUE, HEADACHE, LETHARGY, PAIN and OROPHARYNGEAL PAIN. The event occurred between the first and the third day after the most recent (2nd) dose of [Spikevax]. The rechallenge is not applicable. The events were considered related to the study drug per the reporter's assessment. The benefit-risk relationship of the vaccine is not affected by this report. This case was linked to MOD-2021-328985 (Patient Link).; Sender's Comments: This case concerns a 59 years-old, female subject without significant clinical history, who experienced the unexpected events of PYELONEPHRITIS, ABDOMINAL PAIN UPPER, BACK PAIN, FATIGUE, HEADACHE, LETHARGY, PAIN and OROPHARYNGEAL PAIN. The event occurred between the first and the third day after the most recent (2nd) dose of [Spikevax]. The rechallenge is not applicable The events were considered related to the study drug per the reporter's assessment The benefit-risk relationship of the vaccine is not affected by this report

Other Meds: COREG; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1751954
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No treatment medication was reported No Concomitant medication was reported. This case was linked to MOD-2021-329029 (Patient Link).

Other Meds:

Current Illness:

ID: 1751955
Sex: F
Age:
State:

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 10/01/2021
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: Palpitations; felt tingle all over; did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), PARAESTHESIA (felt tingle all over) and PRODUCT DOSE OMISSION ISSUE (did not get the second dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0700C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations), PARAESTHESIA (felt tingle all over) and PRODUCT DOSE OMISSION ISSUE (did not get the second dose). At the time of the report, PALPITATIONS (Palpitations) and PARAESTHESIA (felt tingle all over) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not get the second dose) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. Concomitant medication was not reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1751956
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: I received a second dose. The vial was punctured more than 12 hours since opening.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I received a second dose. The vial was punctured more than 12 hours since opening.) 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, the patient experienced EXPIRED PRODUCT ADMINISTERED (I received a second dose. The vial was punctured more than 12 hours since opening.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I received a second dose. The vial was punctured more than 12 hours since opening.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. no concomitant medications are provided. treatment to the events not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1751957
Sex: M
Age: 67
State: AR

Vax Date: 08/31/2021
Onset Date:
Rec V Date: 10/01/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Body Temperature; Result Unstructured Data: 96; Test Date: 20210821; Test Name: COVID test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: vision blindness, he could not see; Fainting; severe diarrhea; Did not have any strenght/lack of energy; Had real bad itching general in all the body; Heart felt like it was racing; Had real harsh breathing, was breathing real hard; Pain; He's kinda lost out, does not feel like his normal self, is like 90% normal; Had lots of anxiety; fatigued, totally fatigued; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (vision blindness, he could not see) and SYNCOPE (Fainting) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical reported history provided by the reporter. Concomitant products included OXYCODONE for Chronic pain, KETOPROFEN (AMAPROGEL) and IBUPROFEN for an unknown indication. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (vision blindness, he could not see) (seriousness criterion medically significant), SYNCOPE (Fainting) (seriousness criterion medically significant), DIARRHOEA (severe diarrhea), ASTHENIA (Did not have any strenght/lack of energy), PRURITUS (Had real bad itching general in all the body), PALPITATIONS (Heart felt like it was racing), DYSPNOEA (Had real harsh breathing, was breathing real hard), PAIN (Pain), FEELING ABNORMAL (He's kinda lost out, does not feel like his normal self, is like 90% normal), ANXIETY (Had lots of anxiety) and FATIGUE (fatigued, totally fatigued). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BLINDNESS (vision blindness, he could not see), SYNCOPE (Fainting), DIARRHOEA (severe diarrhea), ASTHENIA (Did not have any strenght/lack of energy), PRURITUS (Had real bad itching general in all the body), PALPITATIONS (Heart felt like it was racing), DYSPNOEA (Had real harsh breathing, was breathing real hard), PAIN (Pain), FEELING ABNORMAL (He's kinda lost out, does not feel like his normal self, is like 90% normal), ANXIETY (Had lots of anxiety) and FATIGUE (fatigued, totally fatigued) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 96 (normal) 96. On 21-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Company Comment: This case concerns a 67 year old male with no relevant medical history who experienced serious unexpected events of blindess and syncope on unknown date. Patient received 1st dose of Moderna Covid 19 vaccine. Rechallenge is not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a 67 year old male with no relevant medical history who experienced serious unexpected events of blindess and syncope on unknown date. Patient received 1st dose of Moderna Covid 19 vaccine. Rechallenge is not applicable. The benefit-risk relationship is not affected by this report.

Other Meds: AMAPROGEL; OXYCODONE; IBUPROFEN

Current Illness:

ID: 1751958
Sex: F
Age: 76
State: CA

Vax Date: 01/23/2021
Onset Date: 02/01/2021
Rec V Date: 10/01/2021
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: Limited energy; Extremely tired; Almost passed out/Thought she was going to pass out; Lightheaded; Knocked her down; Could not do things/Unable to get in the kitchen to eat, brush teeth etc; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Almost passed out/Thought she was going to pass out) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 9B333ADA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension (HBP) since 2019 and High cholesterol (Hi cholesterol) since 2020. Concomitant products included AMLODIPINE and ROSUVASTATIN for an unknown indication. On 23-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced LOSS OF CONSCIOUSNESS (Almost passed out/Thought she was going to pass out) (seriousness criterion medically significant). February 2021, the patient experienced DIZZINESS (Lightheaded), FALL (Knocked her down) and IMPAIRED WORK ABILITY (Could not do things/Unable to get in the kitchen to eat, brush teeth etc). February 2021, the patient experienced FATIGUE (Extremely tired). On 25-Feb-2021, the patient experienced ASTHENIA (Limited energy). In February 2021, LOSS OF CONSCIOUSNESS (Almost passed out/Thought she was going to pass out), DIZZINESS (Lightheaded), FALL (Knocked her down) and IMPAIRED WORK ABILITY (Could not do things/Unable to get in the kitchen to eat, brush teeth etc) had resolved. At the time of the report, ASTHENIA (Limited energy) and FATIGUE (Extremely tired) outcome was unknown. Treatment information was not provided. Concomitant medication dose detail: amlodipine (2.5 unit not provided) and rosuvastatin (5.0 unit not provided). The patient had two Moderna shots, and was wondering about getting third one. The patient had somewhat event effect in the second Moderna. The first day after getting the second dose of the vaccine patient was fine but the second day was lightheaded and thought was going to pass out, it knocked the patient down, patient could not do things, but it was just that day. The patient was extremely tired the day after the vax and in the early eve (evening) patient took a shower and almost passed out, was unable to get in the kitchen to eat, brush teeth etc. That was Friday 24-Feb-2021. On 25-Feb-2021, the patient was able to take care of self but limited energy. Company Comment: This case concerns a 77 year old female with history of HTN and High cholesterol who experienced serious unexpected event of loss of consciousness 2 days after receiving the second dose of Moderna Covid 19 vaccine. Medical conmed of amlodipine and age are confounders. Rechallenge is not applicable as it now known if there were events after the first dose. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Included patient demographics, past relevant history, batch number for 1st dose, anatomical location, concomitant medications, new events and narrative updated.; Sender's Comments: This case concerns a 77 year old female with history of HTN and High cholesterol who experienced serious unexpected event of loss of consciousness 2 days after receiving the second dose of Moderna Covid 19 vaccine. Medical conmed of amlodipine and age are confounders. Rechallenge is not applicable as it now known if there were events after the first dose. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.

Other Meds: AMLODIPINE; ROSUVASTATIN

Current Illness: High cholesterol (Hi cholesterol); Hypertension (HBP)

ID: 1751959
Sex: F
Age: 69
State: OR

Vax Date: 08/24/2021
Onset Date: 09/21/2021
Rec V Date: 10/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: second dose administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion). On 21-Sep-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion) had resolved. 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 medications reported. No treatment reported This case was linked to MOD21-146513, MOD21-146835, MOD21-146840, MOD21-146854, MOD-2021-329506 (Patient Link).

Other Meds:

Current Illness:

ID: 1751960
Sex: F
Age:
State: CA

Vax Date: 09/22/2021
Onset Date:
Rec V Date: 10/01/2021
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: 16 year old was given the vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was given the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was given the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was given the vaccine) 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. No concomitant medication information was provided. No treatment medication information was provided.

Other Meds:

Current Illness:

ID: 1751961
Sex: F
Age: 23
State: OR

Vax Date: 09/20/2021
Onset Date: 09/18/2021
Rec V Date: 10/01/2021
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: first dose administered after temperature excursion; vaccines experienced a temperature excursion for a duration of 1 hour and 24 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines experienced a temperature excursion for a duration of 1 hour and 24 minutes) and EXPIRED PRODUCT ADMINISTERED (first dose administered after temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines experienced a temperature excursion for a duration of 1 hour and 24 minutes). On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (first dose administered after temperature excursion). On 18-Sep-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines experienced a temperature excursion for a duration of 1 hour and 24 minutes) had resolved. On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (first dose administered after temperature excursion) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported. On 18-Sep-2021, the fridge and freezer storing vaccines experienced a temperature excursion for a duration of 1 hour and 24 minutes. When excursion occurred, 10 vials(1 carton) of Moderna COVID-19 vaccine was reported to be stored in the fridge. On 17-Sep-2021, the vials were moved from freezer to fridge, a day prior to the excursion. On 20-Sep-2021, two doses out of the vial of the affected Moderna COVID-19 vaccine was administered to two patients and the remainder of the vial was discarded after use. This case was linked to MOD-2021-329344, MOD-2021-329370 (Patient Link).

Other Meds:

Current Illness:

ID: 1751962
Sex: M
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 10/01/2021
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: Testicles pain; Testicles swelling; slight arm pain sensation; slight disorientation; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR PAIN (Testicles pain), TESTICULAR SWELLING (Testicles swelling), PAIN IN EXTREMITY (slight arm pain sensation) and DISORIENTATION (slight disorientation) in a 63-year-old male patient 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 TESTICULAR PAIN (Testicles pain), TESTICULAR SWELLING (Testicles swelling), PAIN IN EXTREMITY (slight arm pain sensation) and DISORIENTATION (slight disorientation). At the time of the report, TESTICULAR PAIN (Testicles pain), TESTICULAR SWELLING (Testicles swelling), PAIN IN EXTREMITY (slight arm pain sensation) and DISORIENTATION (slight disorientation) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported No treatment medications were reported. Patient reported that he received the vaccine and dont have Lot or any other information regarding vaccine. He experienced testicles pain and swelling days after getting vaccine and it was resolved shortly. Patient reports slight arm pain sensation and slight disorientation all resolved later.

Other Meds:

Current Illness:

ID: 1751963
Sex: M
Age: 27
State: AZ

Vax Date: 09/21/2021
Onset Date: 09/21/2021
Rec V Date: 10/01/2021
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: vial punctured for more than 12 hours/punctured vial left in the fridge; vial punctured for more than 12 hours/punctured vial left in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vial punctured for more than 12 hours/punctured vial left in the fridge) and EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours/punctured vial left in the fridge) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (vial punctured for more than 12 hours/punctured vial left in the fridge) and EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours/punctured vial left in the fridge). On 21-Sep-2021, PRODUCT STORAGE ERROR (vial punctured for more than 12 hours/punctured vial left in the fridge) and EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours/punctured vial left in the fridge) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. The pharmacist reported that the vial was punctured on Monday at 12 P.M, the vial was then left in fridge and the vial would have expired by 21-Sep-2021 at 12 A.M. The vaccine was then administered from the vial on 3.59 P.M, 4.53 P.M, 9.15 P.M and 9.16 P.M. The patient presented with no symptoms.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am