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: 1665559
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: Rapid heart beat after the first shot; Not sure if it was anxiety after the first shot; 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 HEART RATE INCREASED (Rapid heart beat after the first shot) and ANXIETY (Not sure if it was anxiety after the first shot) 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. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced HEART RATE INCREASED (Rapid heart beat after the first shot) and ANXIETY (Not sure if it was anxiety after the first shot). In 2021, HEART RATE INCREASED (Rapid heart beat after the first shot) and ANXIETY (Not sure if it was anxiety after the first shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment provided. Patient states that she is terrified of getting the second dose.

Other Meds:

Current Illness:

ID: 1665560
Sex: F
Age: 50
State: CA

Vax Date: 04/20/2021
Onset Date: 04/22/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: spreading/it went from a raised bump to a flat, rash kind of thing; it was right above the ring finger/the bump started to flatten out/it went from a raised bump to a flat, rash kind of thing; I had a rash at the injection site that looked like a burnt mark; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (it was right above the ring finger/the bump started to flatten out/it went from a raised bump to a flat, rash kind of thing), RASH (spreading/it went from a raised bump to a flat, rash kind of thing) and VACCINATION SITE RASH (I had a rash at the injection site that looked like a burnt mark) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. no medical history has been reported. Concomitant products included METFORMIN, LOSARTAN, METOPROLOL and ATORVASTATIN for an unknown indication. On 20-Apr-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 22-Apr-2021, the patient experienced VACCINATION SITE RASH (I had a rash at the injection site that looked like a burnt mark). On 23-Apr-2021, the patient experienced SKIN MASS (it was right above the ring finger/the bump started to flatten out/it went from a raised bump to a flat, rash kind of thing). On an unknown date, the patient experienced RASH (spreading/it went from a raised bump to a flat, rash kind of thing). On 24-Apr-2021, VACCINATION SITE RASH (I had a rash at the injection site that looked like a burnt mark) had resolved. At the time of the report, SKIN MASS (it was right above the ring finger/the bump started to flatten out/it went from a raised bump to a flat, rash kind of thing) and RASH (spreading/it went from a raised bump to a flat, rash kind of thing) outcome was unknown. Treatment drug not reported by reporter.

Other Meds: METFORMIN; LOSARTAN; METOPROLOL; ATORVASTATIN

Current Illness:

ID: 1665561
Sex: U
Age:
State:

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

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: fever of 100-101

Allergies:

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

Symptoms: Had fever of 100-101 for over 48 hours after getting 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had fever of 100-101 for over 48 hours after getting 1st shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Had fever of 100-101 for over 48 hours after getting 1st shot). At the time of the report, PYREXIA (Had fever of 100-101 for over 48 hours after getting 1st shot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) fever of 100-101. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1665562
Sex: F
Age: 60
State: TX

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 09/02/2021
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: Worried; Palpitation; Strong side effects; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation), VACCINATION COMPLICATION (Strong side effects) and ANXIETY (Worried) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. Concurrent medical conditions included Hearing impaired. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PALPITATIONS (Palpitation) and VACCINATION COMPLICATION (Strong side effects). On 31-Jul-2021, the patient experienced ANXIETY (Worried). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Palpitation) and VACCINATION COMPLICATION (Strong side effects) was resolving and ANXIETY (Worried) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported.

Other Meds:

Current Illness: Hearing impaired

ID: 1665563
Sex: U
Age:
State:

Vax Date: 04/04/2021
Onset Date: 04/06/2021
Rec V Date: 09/02/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (I was totally deaf in one ear) in a patient of an unknown age and gender 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. On 04-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HYPOACUSIS (had mild hearing loss in the other) and HYPOACUSIS (problems with my hearing). On 07-Apr-2021, the patient experienced DEAFNESS UNILATERAL (I was totally deaf in one ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (I was totally deaf in one ear), HYPOACUSIS (had mild hearing loss in the other) and HYPOACUSIS (problems with my hearing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medication was reported. SD narrative: I received my second Moderna shot on April 4th. By April 6th I was having problems with my hearing. By April 7th I was totally deaf in one ear and had mild hearing loss in the other. Went to a ENT and" No Treatment was reported. Company Comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Events seriousness per IME list; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Events seriousness per IME list

Other Meds:

Current Illness:

ID: 1665564
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: Received a vaccine that was punctured over the weekend then given to her on Monday.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a vaccine that was punctured over the weekend then given to her on Monday.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine that was punctured over the weekend then given to her on Monday.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a vaccine that was punctured over the weekend then given to her on Monday.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications and no treatment medications were reported. Reporter asking about storage and handling.

Other Meds:

Current Illness:

ID: 1665565
Sex: F
Age: 15
State: MS

Vax Date: 07/19/2021
Onset Date: 07/19/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Vaccine given to a 15 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 15 year old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 15 year old). On 19-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 15 year old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant Medications details were provided. No Treatment Medications details were provided.

Other Meds:

Current Illness:

ID: 1665566
Sex: U
Age:
State: NC

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 09/02/2021
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: Received the first dose of the Moderna COVID-19 vaccine in February; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID-19 vaccine in February) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID-19 vaccine in February). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID-19 vaccine in February) had resolved. No Concomitant medication were reported. No treatment medication were reported. The patient now wants to get the second dose. The patient explained they lost their vaccine card and would like to know how to get a replacement?

Other Meds:

Current Illness:

ID: 1665567
Sex: F
Age: 62
State: FL

Vax Date: 04/27/2021
Onset Date: 04/28/2021
Rec V Date: 09/02/2021
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: Missed the second dose more than 3 months a go; Sick with her other medical conditions after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick with her other medical conditions after first dose) and PRODUCT DOSE OMISSION ISSUE (Missed the second dose more than 3 months a go) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. Concurrent medical conditions included Cancer. On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced ILLNESS (Sick with her other medical conditions after first dose). On 26-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose more than 3 months a go). At the time of the report, ILLNESS (Sick with her other medical conditions after first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed the second dose more than 3 months a go) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medication was provided.

Other Meds:

Current Illness: Cancer

ID: 1665568
Sex: M
Age: 49
State: AZ

Vax Date: 04/12/2021
Onset Date: 05/17/2021
Rec V Date: 09/02/2021
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: hard to pick up my son with both hands; range of motion is completely messed up; not sleeping well,cannot find a position to sleep in; exhausted of having shoulder pain; extreme pain in our shoulders on the side where we got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (hard to pick up my son with both hands), MOBILITY DECREASED (range of motion is completely messed up), INSOMNIA (not sleeping well,cannot find a position to sleep in), ARTHRALGIA (exhausted of having shoulder pain) and VACCINATION SITE PAIN (extreme pain in our shoulders on the side where we got the vaccine) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 041B21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced HYPOKINESIA (hard to pick up my son with both hands), MOBILITY DECREASED (range of motion is completely messed up), INSOMNIA (not sleeping well,cannot find a position to sleep in), ARTHRALGIA (exhausted of having shoulder pain) and VACCINATION SITE PAIN (extreme pain in our shoulders on the side where we got the vaccine). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and CYCLOBENZAPRINE for Adverse event, at a dose of Unknown. At the time of the report, HYPOKINESIA (hard to pick up my son with both hands), MOBILITY DECREASED (range of motion is completely messed up), INSOMNIA (not sleeping well,cannot find a position to sleep in), ARTHRALGIA (exhausted of having shoulder pain) and VACCINATION SITE PAIN (extreme pain in our shoulders on the side where we got the vaccine) outcome was unknown. No concomitant medications were reported. It has mentioned that the patient healthcare professional thought that the shoulder pain may be due to an injury during the administration of the vaccine, got recommended physical therapy, using pain killers and taking sleeping pills for the symptoms. This case was linked to MOD-2021-288027 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Patient demographic details were added.

Other Meds:

Current Illness:

ID: 1665569
Sex: M
Age: 31
State: FL

Vax Date: 07/20/2021
Onset Date: 07/01/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: Covid-19; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: contracted COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID-19) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (contracted COVID-19). At the time of the report, COVID-19 (contracted COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. It was reported that patient contracted COVID-19 in the middle on 24 Jul 2 021 or 25 Jul 2021.

Other Meds:

Current Illness:

ID: 1665570
Sex: M
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: Had a metal implant in his right leg and his foot turned in; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Had a metal implant in his right leg and his foot turned in) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Had a metal implant in his right leg and his foot turned in). At the time of the report, LIMB DISCOMFORT (Had a metal implant in his right leg and his foot turned in) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided. The reporter stated that her husband had undergone a surgery in his right leg but was not sure whether it was performed before or after the vaccination. The reporter was also not sure whether he was administered with both doses of vaccine or not.

Other Meds:

Current Illness:

ID: 1665571
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: first shot made me fell like the flu with no temperture; No energy; lot od muscle ackes; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (first shot made me fell like the flu with no temperture), ASTHENIA (No energy) and MYALGIA (lot od muscle ackes) in an 86-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (first shot made me fell like the flu with no temperture), ASTHENIA (No energy) and MYALGIA (lot od muscle ackes). At the time of the report, INFLUENZA LIKE ILLNESS (first shot made me fell like the flu with no temperture), ASTHENIA (No energy) and MYALGIA (lot od muscle ackes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant Product information was provided. No Treatment Medication was provided.

Other Meds:

Current Illness:

ID: 1665572
Sex: F
Age: 78
State: NY

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 09/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she had headache every morning; and is very tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (she had headache every morning) and FATIGUE (and is very tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019M20A or 014M20A) for COVID-19 vaccination. No Medical History information was reported. The patient's past medical history included Chickenpox. Concomitant products included DICLOFENAC for an unknown indication. On 05-Mar-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 (she had headache every morning) and FATIGUE (and is very tired). At the time of the report, HEADACHE (she had headache every morning) and FATIGUE (and is very tired) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No treatment information was provided by the reporter This case was linked to MOD-2021-288281 (Patient Link).

Other Meds: DICLOFENAC

Current Illness:

ID: 1665573
Sex: M
Age: 19
State: TX

Vax Date: 08/10/2021
Onset Date: 08/11/2021
Rec V Date: 09/02/2021
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: coughing up mucus; stuffy nose; lost sense of taste; lost sense of smell; headache; throwing up; The next day was feeling really sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (The next day was feeling really sick), PRODUCTIVE COUGH (coughing up mucus), NASAL CONGESTION (stuffy nose), AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced MALAISE (The next day was feeling really sick). On an unknown date, the patient experienced PRODUCTIVE COUGH (coughing up mucus), NASAL CONGESTION (stuffy nose), AGEUSIA (lost sense of taste), ANOSMIA (lost sense of smell), HEADACHE (headache) and VOMITING (throwing up). At the time of the report, MALAISE (The next day was feeling really sick), PRODUCTIVE COUGH (coughing up mucus), NASAL CONGESTION (stuffy nose), AGEUSIA (lost sense of taste), ANOSMIA (lost sense of smell), HEADACHE (headache) and VOMITING (throwing up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1665574
Sex: M
Age:
State: CA

Vax Date: 07/16/2021
Onset Date: 07/16/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm hurting from first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Arm hurting from first dose) 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 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced VACCINATION SITE PAIN (Arm hurting from first dose). At the time of the report, VACCINATION SITE PAIN (Arm hurting from first dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Medications details were provided. No Treatment Medications details were provided. Pharmacist called regarding a patient who received both doses of Moderna Vaccine but his arm was still hurting from his first dose when getting the second one on the same arm. Pharmacist wanted to know if patient can take painkillers.

Other Meds:

Current Illness:

ID: 1665575
Sex: F
Age: 46
State: SC

Vax Date: 08/07/2021
Onset Date: 06/01/2021
Rec V Date: 09/02/2021
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: Vaccination site hot to touch; developed a rash; Vaccination site very swollen; her arm is still sore; red and blue arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCOLOURATION (red and blue arm), VACCINATION SITE WARMTH (Vaccination site hot to touch), RASH (developed a rash), VACCINATION SITE SWELLING (Vaccination site very swollen) and MYALGIA (her arm is still sore) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. No medical history for the patient was reported. Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM 24HR) for an unknown indication. On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced VACCINATION SITE DISCOLOURATION (red and blue arm), VACCINATION SITE SWELLING (Vaccination site very swollen) and MYALGIA (her arm is still sore). In July 2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site hot to touch) and RASH (developed a rash). The patient was treated with PARACETAMOL (TYLENOL) on 08-Aug-2021 for Vaccination site erythema, at an unspecified dose and frequency and LORATADINE on 08-Aug-2021 for Vaccination site erythema, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (red and blue arm), VACCINATION SITE WARMTH (Vaccination site hot to touch), RASH (developed a rash) and VACCINATION SITE SWELLING (Vaccination site very swollen) was resolving and MYALGIA (her arm is still sore) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: NEXIUM 24HR

Current Illness:

ID: 1665576
Sex: M
Age:
State: TX

Vax Date: 02/03/2021
Onset Date: 03/12/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: low grade fever; Test Date: 20210313; Test Name: oxygen saturation; Test Result: Inconclusive 92 %; Result Unstructured Data: 92 percent oxygen saturation per pulse oximeter

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: low grade fever; experienced pounding tachycardia; Shortness of breath; inappropriate age at the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (experienced pounding tachycardia), DYSPNOEA (Shortness of breath), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at the vaccination) and PYREXIA (low grade fever) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0077727399/012M20A and 0077727399/031A21A) for COVID-19 vaccination. Concurrent medical conditions included Sulfonamide allergy (sulfa(rash)), Allergy (many Airborne allergy), Food allergy (some food) and Autism spectrum disorder since 23-Nov-2003. Concomitant products included MELATONIN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 03-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at the vaccination). On 13-Mar-2021, the patient experienced TACHYCARDIA (experienced pounding tachycardia) and DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced PYREXIA (low grade fever). On 13-Mar-2021, TACHYCARDIA (experienced pounding tachycardia) and DYSPNOEA (Shortness of breath) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at the vaccination) had resolved and PYREXIA (low grade fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Oxygen saturation: 92 percent (Inconclusive) 92 percent oxygen saturation per pulse oximeter. On an unknown date, Body temperature: inconclusive (Inconclusive) low grade fever. No treatment medications were reported. This case was linked to MOD-2021-035571 (Patient Link).

Other Meds: MELATONIN; MULTIVITAMINS [VITAMINS NOS]

Current Illness: Allergy (many Airborne allergy); Autism spectrum disorder; Food allergy (some food); Sulfonamide allergy (sulfa(rash))

ID: 1665577
Sex: F
Age: 63
State: TX

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 09/02/2021
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: Patient received Pfizer vaccine for first two doses and Moderna vaccine for third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer vaccine for first two doses and Moderna vaccine for third dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer vaccine for first two doses and Moderna vaccine for third dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer vaccine for first two doses and Moderna vaccine for third dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medication were not reported. Patient received both doses of the Pfizer vaccine. The patient took a Booster dose of the Moderna Covid-19 Vaccine.

Other Meds:

Current Illness:

ID: 1665578
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: heartburn; lymph node swelling; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (heartburn) and LYMPHADENOPATHY (lymph node swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (heartburn) and LYMPHADENOPATHY (lymph node swelling). At the time of the report, DYSPEPSIA (heartburn) and LYMPHADENOPATHY (lymph node swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1665579
Sex: F
Age: 42
State: GA

Vax Date: 08/02/2021
Onset Date:
Rec V Date: 09/02/2021
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: Since then she has has aches in her thigh area.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Since then she has has aches in her thigh area.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D211A) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Since then she has has aches in her thigh area.). On 02-Aug-2021, PAIN IN EXTREMITY (Since then she has has aches in her thigh area.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient is scheduled for shoulder surgery on 31-Aug and 2nd dose is due 23-Aug-2021. No concomitant medication was reported. The treatment information was unknown.

Other Meds:

Current Illness:

ID: 1665580
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: Received 3rd dose; Bloodshot eyes; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 3rd dose) and OCULAR HYPERAEMIA (Bloodshot eyes) 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 third 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 and 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 EXTRA DOSE ADMINISTERED (Received 3rd dose) and OCULAR HYPERAEMIA (Bloodshot eyes). At the time of the report, EXTRA DOSE ADMINISTERED (Received 3rd dose) had resolved and OCULAR HYPERAEMIA (Bloodshot eyes) outcome was unknown. No concomitant medications information were reported. Patient had 3rd dose of Moderna COVID-19 vaccine and experienced bloodshot eyes at the time of report. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1665581
Sex: F
Age: 50
State: TX

Vax Date: 08/11/2021
Onset Date: 08/01/2021
Rec V Date: 09/02/2021
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: there was a sewer smell and she couldn't smell it; tender; when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her; nausea; had a headache every day for almost a whole week since vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (there was a sewer smell and she couldn't smell it), TENDERNESS (tender), PAIN IN EXTREMITY (when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her), NAUSEA (nausea) and HEADACHE (had a headache every day for almost a whole week since vaccination) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination. The patient's past medical history included Heart failure. Concurrent medical conditions included Diabetes, Blood pressure high and Neuropathy. Concomitant products included METFORMIN, GLIMEPIRIDE, LISINOPRIL, GABAPENTIN (NEURONTIN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ANOSMIA (there was a sewer smell and she couldn't smell it). August 2021, the patient experienced TENDERNESS (tender), PAIN IN EXTREMITY (when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her), NAUSEA (nausea) and HEADACHE (had a headache every day for almost a whole week since vaccination). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 220 mg. At the time of the report, ANOSMIA (there was a sewer smell and she couldn't smell it), TENDERNESS (tender), PAIN IN EXTREMITY (when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her), NAUSEA (nausea) and HEADACHE (had a headache every day for almost a whole week since vaccination) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.

Other Meds: METFORMIN; GLIMEPIRIDE; LISINOPRIL; NEURONTIN; CYMBALTA

Current Illness: Blood pressure high; Diabetes; Neuropathy

ID: 1665582
Sex: U
Age:
State:

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 09/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Red face; Tingly tongue and lips; I did not receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red face), PARAESTHESIA ORAL (Tingly tongue and lips) and PRODUCT DOSE OMISSION ISSUE (I did not receive the second dose) 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 23-Feb-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 ERYTHEMA (Red face), PARAESTHESIA ORAL (Tingly tongue and lips) and PRODUCT DOSE OMISSION ISSUE (I did not receive the second dose). At the time of the report, ERYTHEMA (Red face) and PARAESTHESIA ORAL (Tingly tongue and lips) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (I did not receive the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported by the reporter. Treatment drugs were not reported by the reporter.

Other Meds:

Current Illness:

ID: 1665583
Sex: F
Age: 46
State: MI

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 09/02/2021
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: COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), ALPRAZOLAM (XANAX), IBUPROFEN, ATENOLOL, ALBUTEROL [SALBUTAMOL] and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. On 07-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 VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Treatment information was not provided by the reporter. This case was linked to MOD-2021-289346 (Patient Link).

Other Meds: CYMBALTA; XANAX; IBUPROFEN; ATENOLOL; ALBUTEROL [SALBUTAMOL]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness:

ID: 1665584
Sex: M
Age: 45
State: CA

Vax Date: 08/07/2021
Onset Date: 08/15/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Something hit his shoulder,It's a pretty hard hit; there is a little red on the top of his shoulder; there is a little swelling on the top of his shoulder; Turned red around the skin area where he got the vaccine; something hit his chest; His right hand feels very heavy; He could hardly lift it up to his head level; This spontaneous case was reported by a consumer and describes the occurrence of CHEST INJURY (something hit his chest) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced LIMB DISCOMFORT (His right hand feels very heavy) and MOBILITY DECREASED (He could hardly lift it up to his head level). On an unknown date, the patient experienced CHEST INJURY (something hit his chest) (seriousness criterion medically significant), LIMB INJURY (Something hit his shoulder,It's a pretty hard hit), ERYTHEMA (there is a little red on the top of his shoulder), SWELLING (there is a little swelling on the top of his shoulder) and VACCINATION SITE ERYTHEMA (Turned red around the skin area where he got the vaccine). At the time of the report, CHEST INJURY (something hit his chest), LIMB DISCOMFORT (His right hand feels very heavy), MOBILITY DECREASED (He could hardly lift it up to his head level), LIMB INJURY (Something hit his shoulder,It's a pretty hard hit), ERYTHEMA (there is a little red on the top of his shoulder), SWELLING (there is a little swelling on the top of his shoulder) and VACCINATION SITE ERYTHEMA (Turned red around the skin area where he got the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported No treatment information was provided.

Other Meds:

Current Illness:

ID: 1665585
Sex: F
Age: 66
State:

Vax Date: 08/11/2021
Onset Date: 08/12/2021
Rec V Date: 09/02/2021
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: Stomach Ache; Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach Ache) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002S21A) for COVID-19 vaccination. Concomitant products included DOCUSATE SODIUM (COLACE), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM/VITAMIN D [CALCIUM CARBONATE;ERGOCALCIFEROL]), PHENYTOIN (DILANTIN [PHENYTOIN]), CHLORPROMAZINE, PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]), MIRABEGRON (MYRBETRIQ), OMEPRAZOLE, SIMVASTATIN, PARACETAMOL (TYLENOL), MAGNESIUM HYDROXIDE (MILK OF MAGNESIA) and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE (MAALOX ALUM MILK) for an unknown indication. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nausea). On 14-Aug-2021, the patient experienced DIARRHOEA (Diarrhea). On 17-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach Ache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. On 14-Aug-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach Ache) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: COLACE; ASPIRIN (E.C.); CALCIUM/VITAMIN D [CALCIUM CARBONATE;ERGOCALCIFEROL]; DILANTIN [PHENYTOIN]; CHLORPROMAZINE; METAMUCIL [PLANTAGO OVATA]; MYRBETRIQ; OMEPRAZOLE; SIMVASTATIN; TYLENOL; MILK OF MAGNESIA; MAALOX ALUM MILK

Current Illness:

ID: 1665586
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: First dose was given 6 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose was given 6 months ago) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose was given 6 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose was given 6 months ago) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment medication provided. The patient had already waited more than 1 month for the second dose

Other Meds:

Current Illness:

ID: 1665587
Sex: F
Age: 49
State: FL

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 09/02/2021
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: Injected arm feels like having a knot. It is warm, hot to the touch; like when you are getting sick; scratchy feeling in throat, throat felt weird; dry cough a little bit; sore throat; throat felt weird; Injected arm feels like having a knot; thumb sore in the joint; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injected arm feels like having a knot. It is warm, hot to the touch), ILLNESS (like when you are getting sick), THROAT IRRITATION (scratchy feeling in throat, throat felt weird), COUGH (dry cough a little bit) and OROPHARYNGEAL PAIN (sore throat) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Injected arm feels like having a knot. It is warm, hot to the touch), ILLNESS (like when you are getting sick), THROAT IRRITATION (scratchy feeling in throat, throat felt weird), COUGH (dry cough a little bit), OROPHARYNGEAL PAIN (sore throat), OROPHARYNGEAL DISCOMFORT (throat felt weird), VACCINATION SITE INDURATION (Injected arm feels like having a knot) and ARTHRALGIA (thumb sore in the joint). On 10-Aug-2021, THROAT IRRITATION (scratchy feeling in throat, throat felt weird), OROPHARYNGEAL PAIN (sore throat) and OROPHARYNGEAL DISCOMFORT (throat felt weird) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injected arm feels like having a knot. It is warm, hot to the touch), ILLNESS (like when you are getting sick), COUGH (dry cough a little bit), VACCINATION SITE INDURATION (Injected arm feels like having a knot) and ARTHRALGIA (thumb sore in the joint) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications included Cholesterol medication. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1665588
Sex: M
Age: 53
State: WA

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 09/02/2021
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: mixed normal saline with Moderna COVID19 vial; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT PREPARATION ISSUE (mixed normal saline with Moderna COVID19 vial) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT PREPARATION ISSUE (mixed normal saline with Moderna COVID19 vial). On 17-Aug-2021, PRODUCT PREPARATION ISSUE (mixed normal saline with Moderna COVID19 vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant drugs were reported. No treatment was reported. It was reported that when administering the Moderna COVID-19 vaccine, the medical assistant mixed normal saline with the Moderna vaccine vial. She mixed 2 mLs of normal saline into the vial of the vaccine and administered 0.5 mL to each patient. The patient was not experiencing any symptoms and was monitored for 15 minutes. This was the second dose for the patient.

Other Meds:

Current Illness:

ID: 1665589
Sex: M
Age: 68
State: TX

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 09/02/2021
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: Again, about two weeks later, the hip joint pain returned; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Again, about two weeks later, the hip joint pain returned) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 02SL20A) for COVID-19 vaccination. No medication history information was provided. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN and ATENOLOL for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 ARTHRALGIA (Again, about two weeks later, the hip joint pain returned). At the time of the report, ARTHRALGIA (Again, about two weeks later, the hip joint pain returned) had resolved. Concomitant medication includes Olm ned flesh hctz 40-25. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Additional information received and reporters information added, patient demographics added, concomitant medications added.

Other Meds: SYNTHROID; ATORVASTATIN; ATENOLOL

Current Illness:

ID: 1665590
Sex: M
Age: 42
State: FL

Vax Date: 08/13/2021
Onset Date: 04/15/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: fever broke to 99.5 degrees Fahrenheit at the hospital; Test Date: 20210815; Test Name: Body temperature; Result Unstructured Data: Temperature got to 103 degrees Fahrenheit; Test Name: COVID-19 Test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: Home COVID test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: strep test; Test Result: Negative ; Result Unstructured Data: strep test-Negative

Allergies:

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

Symptoms: ulcers in the side of my mouth/ ulcers on the tongue; glands are still really, really swollen; I'm having a mild fever periodically throughout the day; rash on lips / rash has spread to his chin area and around the lip area; last night I woke up sweating really, really bad; throat glands were swollen; tonsils were swollen; hard to swallow; lost taste and smell; mouth got a bunch of whiteheads / I noticed a pimple on my nose; almost like a weird, euphoric feeling like I was dreaming; cold sweats/ last night I woke up sweating really, really bad; cold shivers; started to feel achy; fever of 103 F / still has a fever; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (almost like a weird, euphoric feeling like I was dreaming), HYPERHIDROSIS (cold sweats/ last night I woke up sweating really, really bad), PHARYNGEAL SWELLING (throat glands were swollen), TONSILLAR HYPERTROPHY (tonsils were swollen) and DYSPHAGIA (hard to swallow) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was reported. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PYREXIA (fever of 103 F / still has a fever). On 14-Aug-2021, the patient experienced ABNORMAL DREAMS (almost like a weird, euphoric feeling like I was dreaming), HYPERHIDROSIS (cold sweats/ last night I woke up sweating really, really bad), CHILLS (cold shivers) and MYALGIA (started to feel achy). On 15-Aug-2021, the patient experienced PHARYNGEAL SWELLING (throat glands were swollen), TONSILLAR HYPERTROPHY (tonsils were swollen), DYSPHAGIA (hard to swallow), ANOSMIA (lost taste and smell) and ACNE (mouth got a bunch of whiteheads / I noticed a pimple on my nose). On 16-Aug-2021, the patient experienced NIGHT SWEATS (last night I woke up sweating really, really bad). On 17-Aug-2021, the patient experienced APHTHOUS ULCER (ulcers in the side of my mouth/ ulcers on the tongue), LYMPHADENOPATHY (glands are still really, really swollen), PYREXIA (I'm having a mild fever periodically throughout the day) and RASH (rash on lips / rash has spread to his chin area and around the lip area). The patient was treated with PREDNISOLONE for Adverse event, at a dose of UNK dosage form; AMOXICILLIN SODIUM, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANIC ACID]) for Adverse event, at an unspecified dose and frequency and MUPIROCIN (BACTROBAN [MUPIROCIN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABNORMAL DREAMS (almost like a weird, euphoric feeling like I was dreaming), HYPERHIDROSIS (cold sweats/ last night I woke up sweating really, really bad), PHARYNGEAL SWELLING (throat glands were swollen), TONSILLAR HYPERTROPHY (tonsils were swollen), DYSPHAGIA (hard to swallow), ANOSMIA (lost taste and smell), ACNE (mouth got a bunch of whiteheads / I noticed a pimple on my nose), APHTHOUS ULCER (ulcers in the side of my mouth/ ulcers on the tongue), LYMPHADENOPATHY (glands are still really, really swollen), NIGHT SWEATS (last night I woke up sweating really, really bad), PYREXIA (I'm having a mild fever periodically throughout the day), CHILLS (cold shivers) and MYALGIA (started to feel achy) outcome was unknown and RASH (rash on lips / rash has spread to his chin area and around the lip area) and PYREXIA (fever of 103 F / still has a fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2021, Body temperature: 103 (High) Temperature got to 103 degrees Fahrenheit. On an unknown date, Body temperature: 99.5 (High) fever broke to 99.5 degrees Fahrenheit at the hospital. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative. On an unknown date, Streptococcus test: negative (Negative) strep test-Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication included shot of steroids and magic mouthwash. Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: follow up received. outcome of event (fever and rash) changed from unknown to not recovered.

Other Meds: PRILOSEC [OMEPRAZOLE]

Current Illness:

ID: 1665591
Sex: F
Age: 47
State: GA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 09/02/2021
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: Numbness on the entire face after the first shot; Pain in left arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on the entire face after the first shot), PAIN IN EXTREMITY (Pain in left arm) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. Concurrent medical conditions included Neuropathy (Mild Neuropathy in feet,) and Vitamin deficiency (B). On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness on the entire face after the first shot), PAIN IN EXTREMITY (Pain in left arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Jan-2021, HYPOAESTHESIA (Numbness on the entire face after the first shot) had resolved. On 21-Jan-2021, PAIN IN EXTREMITY (Pain in left arm) and HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications were not reported. Patient was not sure about Benadryl. This case was linked to MOD-2021-289712, MOD-2021-290616 (Patient Link).

Other Meds:

Current Illness: Neuropathy (Mild Neuropathy in feet,); Vitamin deficiency (B)

ID: 1665592
Sex: M
Age:
State: AZ

Vax Date: 08/06/2021
Onset Date: 08/06/2021
Rec V Date: 09/02/2021
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: storage condition; Vaccine administered after being expired; syringe was given chance to warm up a bit while waiting on the patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after being expired), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (syringe was given chance to warm up a bit while waiting on the patients) and PRODUCT STORAGE ERROR (storage condition) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after being expired) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (syringe was given chance to warm up a bit while waiting on the patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (storage condition). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after being expired), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (syringe was given chance to warm up a bit while waiting on the patients) and PRODUCT STORAGE ERROR (storage condition) 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 concomitants were reported no treatment drugs were reported Vaccine was stored in fridge before administration No visual changes of vaccine Maximum temperature was 41 degrees Fahrenheit with average temperature of 39.8 degrees Fahrenheit and minimum: 38.6 degrees Fahrenheit

Other Meds:

Current Illness:

ID: 1665593
Sex: F
Age:
State: CA

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

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

Lab Data: Test Name: heart rate; Result Unstructured Data: Normal; Test Name: blood oxygen level; Result Unstructured Data: Blood oxygen level normal, more than 94

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Pain in the chest; warm; Arm was sore; Chilly/ it comes and goes 2 or 3 times; This spontaneous case was reported by a non-health professional and describes the occurrence of CHEST PAIN (Pain in the chest), VACCINATION SITE WARMTH (warm), MYALGIA (Arm was sore) and CHILLS (Chilly/ it comes and goes 2 or 3 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Pain in the chest), VACCINATION SITE WARMTH (warm), MYALGIA (Arm was sore) and CHILLS (Chilly/ it comes and goes 2 or 3 times). At the time of the report, CHEST PAIN (Pain in the chest), VACCINATION SITE WARMTH (warm), MYALGIA (Arm was sore) and CHILLS (Chilly/ it comes and goes 2 or 3 times) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: >60 (normal) Normal. On an unknown date, Oxygen saturation: >94 (normal) Blood oxygen level normal, more than 94. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient went to emergency but was told to return 24 hours later since the nurse said it was not an emergency. Concomitant medication was not provided. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1665594
Sex: M
Age:
State: OK

Vax Date: 07/16/2021
Onset Date:
Rec V Date: 09/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: his stomach felt like throwing up; chills; fever; was ill for about 3 to 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (was ill for about 3 to 4 days), VOMITING (his stomach felt like throwing up), CHILLS (chills) and PYREXIA (fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for an unknown indication. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (was ill for about 3 to 4 days), VOMITING (his stomach felt like throwing up), CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (was ill for about 3 to 4 days), VOMITING (his stomach felt like throwing up), CHILLS (chills) and PYREXIA (fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-289826 (Patient Link).

Other Meds: LISINOPRIL

Current Illness: Blood pressure high

ID: 1665595
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: I had a bad reaction to my second moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I had a bad reaction to my second moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (I had a bad reaction to my second moderna vaccine). At the time of the report, VACCINATION SITE REACTION (I had a bad reaction to my second moderna vaccine) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1665596
Sex: M
Age: 18
State: SC

Vax Date: 04/29/2021
Onset Date:
Rec V Date: 09/02/2021
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: Am I outside the window to receive a second dose?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Am I outside the window to receive a second dose?) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031C20A) for COVID-19 vaccination. No Medical History information was reported. On 29-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 PRODUCT DOSE OMISSION ISSUE (Am I outside the window to receive a second dose?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Am I outside the window to receive a second dose?) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported.

Other Meds:

Current Illness:

ID: 1665597
Sex: F
Age: 60
State: FL

Vax Date: 03/26/2021
Onset Date: 03/27/2021
Rec V Date: 09/02/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: "weird things gone on"; never got the second Moderna shot; hives; swollen lip; swollen tongue, back to the emergency room; severe allergic reaction; cellulitis in her left thigh; "big abscess" on her groin; lump in her groin area; looked like a red bump; looked like a swollen lymph node, she squeezed it, but nothing came out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis in her left thigh), HYPERSENSITIVITY (severe allergic reaction), INGUINAL MASS (lump in her groin area), ERYTHEMA (looked like a red bump), ABSCESS ("big abscess" on her groin), FEELING ABNORMAL ("weird things gone on"), URTICARIA (hives), LIP SWELLING (swollen lip), SWOLLEN TONGUE (swollen tongue, back to the emergency room), LYMPHADENOPATHY (looked like a swollen lymph node, she squeezed it, but nothing came out) and PRODUCT DOSE OMISSION ISSUE (never got the second Moderna shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The patient's past medical history included Breast cancer (diagnosed with breast cancer 6 years ago. She stated she has been in breast cancer remission for 5 years.), Lumpectomy and Radiation therapy. Previously administered products included for Product used for unknown indication: Tdap booster and Flu vaccine (she has had reactions and severe symptoms). Past adverse reactions to the above products included Reaction allergic (NOS) with Flu vaccine and Tdap booster. Concurrent medical conditions included Allergy to antibiotic (Keflex). On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced INGUINAL MASS (lump in her groin area) (seriousness criteria hospitalization and medically significant), ERYTHEMA (looked like a red bump) (seriousness criteria hospitalization and medically significant) and LYMPHADENOPATHY (looked like a swollen lymph node, she squeezed it, but nothing came out) (seriousness criteria hospitalization and medically significant). On 28-Mar-2021, the patient experienced CELLULITIS (cellulitis in her left thigh) (seriousness criteria hospitalization and medically significant) and ABSCESS ("big abscess" on her groin) (seriousness criteria hospitalization and medically significant). On 12-Apr-2021, the patient experienced HYPERSENSITIVITY (severe allergic reaction) (seriousness criteria hospitalization and medically significant), URTICARIA (hives) (seriousness criteria hospitalization and medically significant), LIP SWELLING (swollen lip) (seriousness criteria hospitalization and medically significant) and SWOLLEN TONGUE (swollen tongue, back to the emergency room) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL ("weird things gone on") (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (never got the second Moderna shot) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 28-Mar-2021 to 01-Apr-2021 due to ABSCESS, CELLULITIS, ERYTHEMA, FEELING ABNORMAL, HYPERSENSITIVITY, INGUINAL MASS, LIP SWELLING, LYMPHADENOPATHY, PRODUCT DOSE OMISSION ISSUE, SWOLLEN TONGUE and URTICARIA. The patient was treated with VANCOMYCIN from 28-Mar-2021 to 01-Apr-2021 for Adverse event, at an unspecified dose and frequency; CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) from 01-Apr-2021 to 10-Apr-2021 for Adverse event, at an unspecified dose and frequency; CLINDAMYCIN from 01-Apr-2021 to 10-Apr-2021 for Adverse event, at an unspecified dose and frequency and Surgery (drainage surgery of the abscess) for Abscess. At the time of the report, CELLULITIS (cellulitis in her left thigh), HYPERSENSITIVITY (severe allergic reaction), INGUINAL MASS (lump in her groin area), ERYTHEMA (looked like a red bump), ABSCESS ("big abscess" on her groin), FEELING ABNORMAL ("weird things gone on"), URTICARIA (hives), LIP SWELLING (swollen lip), SWOLLEN TONGUE (swollen tongue, back to the emergency room), LYMPHADENOPATHY (looked like a swollen lymph node, she squeezed it, but nothing came out) and PRODUCT DOSE OMISSION ISSUE (never got the second Moderna shot) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Patient stated that she had to have a home health nurse help her do dressing changes for 12 days in her home after being discharged. On 12APR2021, she had a severe allergic reaction, hives, swollen lip and tongue. She stated that she had to go back to the emergency room for the severe allergic reaction. The caller mentioned that she asked her healthcare provider if she should get the second Moderna vaccine and he advised her not to get the vaccine or she could end up on a ventilator. The caller stated that she travels for work and is now housebound because she hasn't received the second dose in the series. She stated since she can't leave the house because she is not fully vaccinated, and it is affecting her ability to earn a living, as her job requires her to travel. Company Comment: This report refers to a case of product dose omission, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.; Sender's Comments: This report refers to a case of product dose omission, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.

Other Meds:

Current Illness: Allergy to antibiotic (Keflex)

ID: 1665598
Sex: F
Age: 65
State:

Vax Date: 03/06/2021
Onset Date: 04/07/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: inflammation at injection site; redness at injection site; joint aches; bit of a headache; muscle aches; flu-like symptoms; felt blah and felt icky; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt blah and felt icky), VACCINATION SITE INFLAMMATION (inflammation at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and ARTHRALGIA (joint aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt blah and felt icky), ARTHRALGIA (joint aches), HEADACHE (bit of a headache) and MYALGIA (muscle aches). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (inflammation at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 08-Apr-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt blah and felt icky), ARTHRALGIA (joint aches), HEADACHE (bit of a headache) and MYALGIA (muscle aches) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (inflammation at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication included statin and blood pressure medicines

Other Meds:

Current Illness: Blood pressure

ID: 1665599
Sex: F
Age: 55
State: CT

Vax Date: 03/27/2021
Onset Date:
Rec V Date: 09/02/2021
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: sinus infection; doctor told it to wait before receiving the vaccine as it was on antibiotics, never received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) and PRODUCT DOSE OMISSION ISSUE (doctor told it to wait before receiving the vaccine as it was on antibiotics, never received the second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Mar-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 SINUSITIS (sinus infection) and PRODUCT DOSE OMISSION ISSUE (doctor told it to wait before receiving the vaccine as it was on antibiotics, never received the second dose). At the time of the report, SINUSITIS (sinus infection) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (doctor told it to wait before receiving the vaccine as it was on antibiotics, never received the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not provided by the reporter. Patient was treated with antibiotics. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1665600
Sex: M
Age: 74
State: FL

Vax Date: 08/05/2021
Onset Date: 08/06/2021
Rec V Date: 09/02/2021
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: He lost his taste on the tongue; After receiving vaccine, he was coughing next day; He had shortness of breath that started on next day; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (After receiving vaccine, he was coughing next day), DYSPNOEA (He had shortness of breath that started on next day) and AGEUSIA (He lost his taste on the tongue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Diabetes and Arrhythmia (flutter arrhythmia). Concomitant products included APIXABAN (ELIQUIS), LISINOPRIL, FOLIC ACID, METFORMIN and VITAMIN B NOS for an unknown indication. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced COUGH (After receiving vaccine, he was coughing next day) and DYSPNOEA (He had shortness of breath that started on next day). On an unknown date, the patient experienced AGEUSIA (He lost his taste on the tongue). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE (ROBITUSSIN DRY COUGH) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COUGH (After receiving vaccine, he was coughing next day) and AGEUSIA (He lost his taste on the tongue) outcome was unknown and DYSPNOEA (He had shortness of breath that started on next day) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ELIQUIS; LISINOPRIL; FOLIC ACID; METFORMIN; VITAMIN B NOS

Current Illness: Arrhythmia (flutter arrhythmia); Diabetes; Hypertension

ID: 1665601
Sex: F
Age: 43
State: AL

Vax Date: 06/03/2021
Onset Date: 06/04/2021
Rec V Date: 09/02/2021
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: Has not received the second dose; Tenderness in both underarms; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in both underarms) and PRODUCT DOSE OMISSION ISSUE (Has not received the second dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced TENDERNESS (Tenderness in both underarms). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Tenderness, at an unspecified dose and frequency. On 05-Jun-2021, TENDERNESS (Tenderness in both underarms) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient stated that she had not received the second dose of the Moderna COVID-19 vaccine. No concomitant product use was provided by the reporter. The patient received the first dose of the Moderna COVID-19 vaccine on 03June2021 and the dose was given in the patients left arms. The next day 04June2021, after the first dose the patient reported experiencing tenderness in both underarms. The patient explained the tenderness under the arms went away within 24 hours. The patient took Tylenol to help with the symptom. The patient does not take any daily medications. The patient stated they lost their vaccine card and they are unable to provide the lot number at this time. The patient has not received the second dose of the Moderna COVID-19 vaccine.

Other Meds:

Current Illness:

ID: 1665602
Sex: F
Age: 44
State: GA

Vax Date: 02/10/2021
Onset Date: 03/10/2021
Rec V Date: 09/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Hot/cold feeling; Sweating; Flu like symptoms; Chills; Fever; bad headache; really tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot/cold feeling), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and PYREXIA (Fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot/cold feeling), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), HEADACHE (bad headache) and FATIGUE (really tired). On 11-Mar-2021, FEELING OF BODY TEMPERATURE CHANGE (Hot/cold feeling), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), HEADACHE (bad headache) and FATIGUE (really tired) had resolved. No concomitant product reported by reporter. No treatment medication reported by reporter. Side effects lasted for about 24 hours. No side effects are present at the time of the call.

Other Meds:

Current Illness:

ID: 1665603
Sex: M
Age:
State: UT

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 09/02/2021
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: Vial was not completely in liquid state prior to the administration; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vial was not completely in liquid state prior to the administration) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vial was not completely in liquid state prior to the administration). On 18-Aug-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Vial was not completely in liquid state prior to the administration) had resolved. No concomitant medication was provided. No treatment medication was provided. Reporter reported that the vial was not fully thawed and the administrator warmed it in her hand "was almost fully liquid" before administration. Nurse stated that she took the vial out of the freezer in the morning around 7AM and the vial thawed for 2 hours but was not completely in liquid state prior to the medical assistant administering the dose to the patient. Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow-up received and contains nonsignificant information.

Other Meds:

Current Illness:

ID: 1665604
Sex: F
Age: 55
State: AL

Vax Date: 07/27/2021
Onset Date: 08/09/2021
Rec V Date: 09/02/2021
Hospital: Y

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

Lab Data: Test Name: EKG; Result Unstructured Data: normal; Test Name: Lab test; Result Unstructured Data: abnormal revealed some irregular numbers

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Severe upper abdominal pain, Recurring episodes upper abdominal pain; Vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Severe upper abdominal pain, Recurring episodes upper abdominal pain) and VOMITING (Vomiting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe upper abdominal pain, Recurring episodes upper abdominal pain) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). On 09-Aug-2021, ABDOMINAL PAIN UPPER (Severe upper abdominal pain, Recurring episodes upper abdominal pain) and VOMITING (Vomiting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Laboratory test: abnormal (abnormal) abnormal revealed some irregular numbers. 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 product information was provided by the reporter. No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1665605
Sex: U
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/02/2021
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: patient got first dose in April and has not gotten the second dose yet.; 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 PRODUCT DOSE OMISSION ISSUE (patient got first dose in April and has not gotten the second dose yet.) 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. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient got first dose in April and has not gotten the second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient got first dose in April and has not gotten the second dose yet.) 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 medications are provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1665606
Sex: M
Age: 61
State: VA

Vax Date: 04/01/2021
Onset Date: 05/04/2021
Rec V Date: 09/02/2021
Hospital: Y

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: low; Test Name: CT Scan; Result Unstructured Data: Diagnosed with congestive heart failure

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Congestive heart failure; Difficulty breathing; Stomach pains; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congestive heart failure) and DYSPNOEA (Difficulty breathing) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Retardation mental (had a reaction to a vaccine in childhood which caused mild retardation), Emphysema (Early stage Emphysema) and Hypercholesterolaemia (He was on rosuvastatin 20 mg for high cholesterol). Concomitant products included ROSUVASTATIN for Hypercholesterolemia. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pains). On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization). The patient was treated with Surgery (Heart Mate III LVAD pump was implanted) for Cardiac failure congestive. At the time of the report, CARDIAC FAILURE CONGESTIVE (Congestive heart failure) was resolving and DYSPNOEA (Difficulty breathing) and ABDOMINAL PAIN UPPER (Stomach pains) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) low. On an unknown date, Computerised tomogram: abnormal (abnormal) Diagnosed with congestive heart failure. Treatment information provided included implantation of Heart Mate III LVAD pump. On 04-May-2021, the patient was having stomach pains and on an unknown date, the patient went to the hospital. The patient was admitted, and a CT scan was performed, and the patient was diagnosed with congestive heart failure. The patient remained hospitalized for 1-2 weeks and was then discharged. Reportedly, later the patient had difficulty in breathing and was admitted to another hospital where the patient underwent another CT scan, x-rays, and other tests. The patient also had a heart catheterization and their vessels were clear. The patient was considered ineligible for a heart transplant and a Heart Mate III LVAD pump was implanted. The patient was released and was recovering at home at the time of report. The reporter who was reporting on behalf of their brother also stated that the patient had a reaction to a vaccine in childhood which caused mild retardation and had early stage emphysema. It was also reported that the patient had normal low blood pressure. Company Comment: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-060008 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: ROSUVASTATIN

Current Illness: Emphysema (Early stage Emphysema); Hypercholesterolaemia (He was on rosuvastatin 20 mg for high cholesterol); Retardation mental (had a reaction to a vaccine in childhood which caused mild retardation)

ID: 1665607
Sex: M
Age: 54
State: FL

Vax Date: 06/02/2021
Onset Date: 07/01/2021
Rec V Date: 09/02/2021
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: COVID-19; Lack of efficacy; numbness 2 fingers; was sick starting 3 days before testing positive; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of efficacy), ILLNESS (was sick starting 3 days before testing positive), HYPOAESTHESIA (numbness 2 fingers) and PYREXIA (fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 003C21A) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis (on Ocrevus infusion twice a year.). Concomitant products included OCRELIZUMAB (OCREVUS) for Multiple sclerosis. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced PYREXIA (fever). On 07-Aug-2021, the patient experienced ILLNESS (was sick starting 3 days before testing positive). On 10-Aug-2021, the patient experienced COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of efficacy) and HYPOAESTHESIA (numbness 2 fingers). At the time of the report, COVID-19 (COVID-19), DRUG INEFFECTIVE (Lack of efficacy), ILLNESS (was sick starting 3 days before testing positive) and HYPOAESTHESIA (numbness 2 fingers) outcome was unknown and PYREXIA (fever) had resolved. No treatment medications were provided by reporter.

Other Meds: OCREVUS

Current Illness: Multiple sclerosis (on Ocrevus infusion twice a year.)

ID: 1665608
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/02/2021
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: I suffer from exhaustion; can barely hold my head up on both shots; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I suffer from exhaustion) and HEAD DISCOMFORT (can barely hold my head up on both shots) 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, 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 FATIGUE (I suffer from exhaustion) and HEAD DISCOMFORT (can barely hold my head up on both shots). At the time of the report, FATIGUE (I suffer from exhaustion) and HEAD DISCOMFORT (can barely hold my head up on both shots) outcome was unknown. No concomitant and treatment medication was provide by patient. Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Reporter is discussing about her husband's AE and medical condition. On 18-Aug-2021: Reporter is discussing about her husband's AE and medical condition.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am