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
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 0969732
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969733
Sex: F
Age: 36
State:

Vax Date: 01/14/2021
Onset Date: 01/19/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: headache, fatigue, muscle aches and nausea

Other Meds:

Current Illness:

ID: 0969734
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969735
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969736
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969737
Sex: M
Age: 35
State: WI

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: I never sought medical attention.

Allergies: None

Symptoms: Moderna COVID-19 Vaccine EUA After receiving the vaccine, I felt my throat swell up a bit, which caused me to slightly panic during the 15 minute observational period; however, it went away after approximately 5 minutes. I initially wasn't convinced it had anything to do with the vaccine. Later that day, I went into work for third shift. At approximately 1:30 am (approx 11 hrs. after the vaccine), I began to feel very ill. I developed flu like symptoms and a headache, which caused me to leave work. I continued having flu symptoms, chills, nausea, body aches, and a very severe migraine on and off until I woke up on 01-22-20 at approximately 6:00 am. At this time, the migraine had subsided and I just had some minor body aches,, which over the next 24 hrs. also went away. The migraine should be noted as debilitating to the point I was dizzy, my mind was foggy, but worst of all, the pain was so bad I was constantly nauseous and my eyes were regularly watering. I never was tested for COVID-19; however, I believe my family had potentially had the virus in October. My wife and I exhibited many of the signs and symptoms of the virus, including my wife losing taste and smell for an extended period of time.

Other Meds: None

Current Illness: None

ID: 0969738
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969739
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969740
Sex: F
Age: 53
State: CA

Vax Date: 01/16/2021
Onset Date: 01/21/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: Persistent itching, redness, and swelling. Left armpit pain and swelling. Body aches and fatigue.

Other Meds: zolpidem

Current Illness: none

ID: 0969741
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969742
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969743
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969744
Sex: M
Age: 39
State:

Vax Date: 01/15/2021
Onset Date: 01/21/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: swollen lymph nodes, fever of 103, malaise

Other Meds:

Current Illness:

ID: 0969745
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969746
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969747
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969748
Sex: F
Age: 34
State: CA

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 01/25/2021
Hospital:

Lab Data: N/a

Allergies: Tree pollen

Symptoms: Lymphadenopathy of left axillary on the side of injection

Other Meds: Singulair, Advair, albuterol, Flonase

Current Illness:

ID: 0969749
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969750
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969751
Sex: F
Age: 43
State: UT

Vax Date: 01/15/2021
Onset Date: 01/18/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: I don't know if this was from the vaccine but it has been abnormal for me. Three days after the vaccine I got a cold sore. I took acyclovir and it subsided. Two days later I got another cold sore in the same location. That was very different. Usually when I take acyclovir it clears up very well. I took acyclovir again. Then today (1/24) I have another cold sore, this time in a different location. I have not had excessive stress or bad sleep which can sometimes trigger cold sores for me. I have never had multiple in a week. I will get one cold sore every 6 months or so on average. I wondered if it is due to an immune response from the vaccine. Also, I have some large cancer sores inside my mouth. (I had arm pain for three days after the vaccine and some fatigue the day after)

Other Meds: None

Current Illness: None

ID: 0969752
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969753
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969754
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969755
Sex: F
Age: 53
State: CA

Vax Date: 01/16/2021
Onset Date: 01/23/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies: None

Symptoms: Sudden severe swelling, heat, redness at injection site 1 week after injection. Joint and muscular pain in left arm (side of injection).

Other Meds: Premarin 0.625mg

Current Illness: None

ID: 0969756
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969757
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969758
Sex: F
Age: 23
State:

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fever, headache, muscle aches and chills

Other Meds:

Current Illness:

ID: 0969759
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969760
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969761
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969762
Sex: M
Age: 78
State: CA

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: NA

Allergies: None

Symptoms: Injection site soreness, headache, fever to 101 F, myalgia, fatigue Duration of symptoms 18 hours Back to normal 48 hours after injection

Other Meds: Omeprazole 20 mg

Current Illness: NA

ID: 0969763
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969764
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969765
Sex: F
Age: 22
State: NY

Vax Date: 01/01/2021
Onset Date: 01/23/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies: Various food allergies

Symptoms: Cough, shortness of breath wheezing

Other Meds: None

Current Illness: None

ID: 0969766
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report \ was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969767
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969768
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969769
Sex: F
Age: 23
State: CA

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: Tiresome and some chips

Other Meds: none

Current Illness: none

ID: 0969770
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969771
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969772
Sex: F
Age: 45
State: WI

Vax Date: 01/22/2021
Onset Date: 01/24/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies: penicillan

Symptoms: hard lump and red spot the size of a half dollar coin at injection site

Other Meds: vitamin c and d

Current Illness: none

ID: 0969773
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969774
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969775
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969776
Sex: F
Age: 35
State: IL

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: Pulse oximeter used only

Allergies: penecillin amoxicillin Microbid

Symptoms: Within 10 minutes of receiving the vaccine on 01/22/21, slight tickle in back of throat, wave came over me, heart rate increased to 118, nauseous, chest slightly tight, light headed; heart rate regulated (about 70-72 bpm) and chest felt okay then body went tingly from arms to legs with some light headedness. Oxygen fine the whole time; heart rate regulated after the beginning and no fever - feeling a bit better within 1 hour. Headache started that night and lasted until midnight the next day. Very tired the whole next day until about 5:30pm.

Other Meds: Pantoprazoline B12 Injections monthly Centrum Women's Multivitamin Iron Calcium, magnesium, & zinc with D3 Fish oil Vitamin C

Current Illness: none

ID: 0969777
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969778
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969779
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 0969780
Sex: F
Age: 32
State: WA

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: fever of 99.6 fahrenheit, moderate headache, fatigue, malaise

Other Meds: none

Current Illness: none

ID: 0969781
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/25/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature. On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM. On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM. On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm