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: 0976684
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976685
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976686
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976687
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976688
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976689
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976690
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976691
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976692
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976693
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976694
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976695
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: A spontaneous report (United States) was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976696
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976697
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976698
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976699
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976700
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976701
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976702
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976703
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976704
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976705
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976706
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976707
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976708
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976709
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976710
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed. At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature. On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, administered with product that was exposed to room temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.

Other Meds:

Current Illness:

ID: 0976711
Sex: F
Age:
State: NY

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vomiting and diarrhea and chills; 7 hours after shot I had severe vomiting and diarrhea and chills; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly into the left arm on 11Jan2021 02:45 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly into the left arm on 21Dec2020 03:00 at a single dose for covid-19 immunization at the age of 67-year-old as well. On 11Jan2021 09:45, 7 hours after the shot she had severe vomiting, diarrhea and chills. The patient received no treatment for the events reported and was not pregnant at the time of administration of the vaccine. Outcome of the events recovered on an unspecified date in Jan2021. Information on lot number/batch number was requested.

Other Meds:

Current Illness:

ID: 0976712
Sex: M
Age:
State: MO

Vax Date: 01/11/2021
Onset Date: 01/01/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: woke up with the shakes; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient woke up with the shakes on an unspecified date in Jan2021 after receiving the vaccine. Outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976713
Sex: M
Age:
State: WI

Vax Date: 12/30/2020
Onset Date: 01/07/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210107; Test Name: COVID Rapid test; Test Result: Positive

Allergies:

Symptoms: received the first dose of the vaccine on 30Dec2020 in a hospital. On 07Jan2021, he tested positive for COVID.; received the first dose of the vaccine on 30Dec2020 / On 07Jan2021, he tested positive for COVID / COVID symptoms; This is a spontaneous report from a contactable healthcare professional (patient) via a Pfizer-sponsored program. A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL1284, unknown lot number), intramuscular in left deltoid on 30Dec2020 at 19:30 at a single dose for COVID-19 immunisation/to prevent getting sick, to prevent the spread. Medical history and concomitant medication reported as none. The patient received the first dose of the vaccine on 30Dec2020 in a hospital. On 07Jan2021, he tested positive for COVID. His second dose is scheduled on 22Jan2021 and wants to know if he should get that or if there is any recommendation. The patient clarified that the COVID symptoms began on 06Jan2021. On the night of the 6th, he started to have chills and a headache throughout the night. He never had a fever or anything. He woke in the morning of 07Jan2021 kind of congested; runny nose, clear discharge. The patient wasn't able to taste his toothpaste, and then he couldn't smell his coffee. So, he experienced a loss of taste and smell. He was then tested for COVID (rapid test) on 07Jan2021 and tested positive. It was worse 2 days after he got sick. The patient progressively gotten better each day. The patient felt good today. He still can't taste or smell fully, some of it is coming back though. No additional vaccines administered on same date and no prior vaccinations within 4 weeks. The patient did not require a visit to emergency room/ physician office. The patient underwent lab tests and procedures which included COVID Rapid test: positive on 07Jan2021. The patient was recovering from the events chills, headache, "congested- runny nose, clear discharge", and Loss of taste and smell, while unknown outcome for the remaining events. The patient would consider the seriousness as not significant.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.

Other Meds:

Current Illness:

ID: 0976714
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Fever chills; Fever chills; This is a spontaneous report from a non-Contactable Consumer (patient sister). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration on unspecified date at a single dose (1st dose and 2nd dose) for covid-19 immunization. Relevant medical history included virus before she got the vaccine. On an unspecified date, patient got the vaccine and had fever chills after it. Patient received 2nd dose took Tylenol and Zyrtec before the dose. The reporter asked if that was not recommended and if could affect the efficacy. The outcome of the events was unknown. No follow up attempts are possible. Information on Lot/Batch number could not be obtained.

Other Meds:

Current Illness:

ID: 0976715
Sex: F
Age:
State:

Vax Date: 12/26/2020
Onset Date: 01/04/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210104; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptoms: received her first dose of the COVID-19 vaccine/she tested positive for COVID-19; received her first dose of the COVID-19 vaccine/she tested positive for COVID-19; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the COVID-19 vaccine on 26Dec2020. Five days later she started having symptoms and then she tested positive for COVID-19 on 04Jan2021. She is scheduled to receive her second dose this Saturday, 16Jan2021, and would like to know if she should still proceed with this scheduled dose on that date since she currently has a COVID-19 infection. The patient stated that the nurse practitioner she went to mentioned waiting 30 days, but she wanted to check with Pfizer. Outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 0976716
Sex: F
Age:
State: MA

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20201224; Test Name: Temp; Result Unstructured Data: Test Result:101.4 Fahrenheit; Comments: about 32 hours after vaccine was given; Test Date: 20201225; Test Name: Temp; Result Unstructured Data: Test Result:98.9 Fahrenheit; Comments: at 44 hours after vaccine; Test Date: 20201226; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Mild headache; mild low back pain; fever/Peak temp was 101.4F; This is a spontaneous report from a contactable physician (patient). A 31-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the left arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a workplace clinic facility. Medical history included known allergies to egg whites and yogurt. The patient has no covid prior vaccination. Concomitant medications included vitamin d3 and cyanocobalamin (VITAMIN B12). The patient has no other vaccine in four weeks. On 24Dec2020, the patient experienced mild headache, mild low back pain, and fever which started 20-24 hours after vaccine was given. Peak temp was 101.4F about 32 hours after vaccine was given (24Dec2020 20:00). The patient did not take any medication for it (no acetaminophen, no NSAIDs). Temperature was 98.9F at 44 hours after vaccine (25Dec2020 08:00). All symptoms resolved on their own within 48 hours (26Dec2020). The covid test post vaccination showed that patient had negative covid test result based on nasal swab on 26Dec2020. Information about the lot/batch number and expiry date were unknown.

Other Meds: VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]

Current Illness:

ID: 0976717
Sex: M
Age:
State: NJ

Vax Date: 12/20/2020
Onset Date: 12/23/2020
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hives scattered on my face, neck and arms; This is a spontaneous report from a contactable physician (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no: EH9899, expiry date not reported), via an unspecified route of administration on 20Dec2020 at a single dose (1st dose) then via an unspecified route of administration on 10Jan2021 (lot no: EK9231, expiry date not reported) at a single dose (2nd dose); both on left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. To his knowledge, patient has no known allergies. Patient had no other vaccine received in four weeks. Patient had One a Day multivitamin in two weeks. The patient stated on 23Dec2020, "The days after the first vaccine I had a couple hives scattered on my face, neck and arms. After the second vaccine, the hives increased in size and number. It really progressed today (3 days after the second shot)". The patient took BENADRYL, PEPCID and prednisone as a treatment for the events. Patient had no prior COVID vaccination and had not tested COVID post vaccination. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 0976718
Sex: M
Age:
State: KY

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

Lab Data:

Allergies:

Symptoms: feel his chest and neck hurting; feel his chest and neck hurting; feeling really sick; feeling tired; arms hurting; head hurting/ neck and all around head area, hurting real bad; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization (reported as "I guess to protect myself from other people, to protect myself"). There were no medical history and concomitant medications. The patient took his first dose on 20Dec2020, 3 weeks from there, he took the second on 10Jan2021 (reported as "it was 10th it was Sunday morning when I took it"). The patient reported that he had his second dose on Sunday morning (10Jan2021) and started feeling tired last Monday (11Jan2021). Then on 12Jan2021 (reported as "yesterday" at the time of reporting), he started to feel his chest and neck hurting. The patient stated that he woke up in the middle of the night (Sunday night) and Monday morning, he was feeling really sick so he called out rest all day on Monday (11Jan2021). Then patient woke up yesterday morning (12Jan2021) feeling good then probably about 6 o'clock last night he started feeling tired, like real bad tired and he got home. Patient lied down and woke up in middle of night, his chest, arms and head were hurting. His neck and all around head area were hurting real bad. The events were assessed as non-serious. The patient does not have the lot number but stated that it was the Pfizer vaccine. When the patient was asked if still experiencing tiredness and chest hurting, he stated "When I started, that was last night on I will go with the 12 before midnight 12 (not clear). Yes right now yeah. This is the first time my chest and my arms and my neck and like all that has been hurting, started last night". When asked for the treatment, the patient answered "I took Ibuprofen to calm it down a little bit. I took Ibuprofen if you count that as a treatment". Outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976719
Sex: F
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 01/13/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea; Chills; Sweating; General unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration at the right arm on 11Jan2021 13:45 at a single dose for covid-19 immunization. Medical history included allergic to shellfish and allergic reaction to bee sting 50 years ago. Concomitant medication included losartan potassium (strength: 100 mg) and atorvastatin calcium (ATORVA). The patient experienced nausea, chills, sweating and general unwell feeling on 13Jan2021 12:15. The patient took two paracetamol (TYLENOL) as treatment for the events. The patient was not pregnant at the time of administration. Outcome of events was recovering.

Other Meds: LOSARTAN POTASSIUM; ATORVA

Current Illness:

ID: 0976720
Sex: F
Age:
State: NY

Vax Date: 12/23/2020
Onset Date: 01/06/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210106; Test Name: Covid-19; Test Result: Positive ; Test Date: 20210108; Test Name: Covid-19; Test Result: Negative

Allergies:

Symptoms: exposure to someone positive to the COVID virus; She was exposed to COVID a week ago and has tested positive; She was exposed to COVID a week ago and has tested positive; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 23Dec2020 at a single dose as she doesn't want COVID. Medical history included occasional mild hypertension since Mar2019 and ongoing anxiety depression. Concomitant medication included sertraline hydrochloride (ZOLOFT) since Aug2020 for anxiety depression. The patient reported that she is supposed to get the second dose of the vaccine today (13Jan2021). She was exposed to COVID a week ago and has tested positive on 06Jan2021. She does not have any symptoms. She tested negative on 08Jan2021. She will be tested again today. She is asking if it is still ok to get the second vaccine after having exposure to someone positive to the COVID virus. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds: ZOLOFT

Current Illness: Anxiety depression; Hypertension

ID: 0976721
Sex: F
Age:
State: FL

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

Lab Data: Test Name: COVID; Test Result: Positive

Allergies:

Symptoms: tested positive for COVID after receiving the first dose; tested positive for COVID after receiving the first dose; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer-sponsored program. A female patient (mother) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter mentioned that her mother tested positive for COVID after receiving the first dose. The reporter wanted to know when will the patient take the second dose since she is COVID positive. The patient is in the nursing home. Outcome of the events was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 0976722
Sex: M
Age:
State: CA

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vigorous chills (afebrile); Some sensitivity over his nose; Painful and tender lymphadenopathy on the axillary area on the same arm as the injection site; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration, on 11Jan2021, at a single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously had his first dose of COVID-19 vaccine on an unspecified date. It was reported that the patient had the second dose of the COVID-19 vaccine on 11Jan2021, and on 12Jan2021, he had a painful and tender lymphadenopathy on the axillary area on the same arm as the injection site. He had no issues with the first shot. He also reported that he has been taking an antihistamine and the lymphadenopathy is going away. He also had vigorous chills (afebrile) when the event first took place for 2-3 hours. He had some sensitivity over his nose which was also improving with the antihistamine. The outcome of the events "painful and tender lymphadenopathy on the axillary area on the same arm as the injection site" and "some sensitivity over his nose" was recovering, and the other event was unknown.

Other Meds:

Current Illness:

ID: 0976723
Sex: F
Age:
State: FL

Vax Date: 01/11/2021
Onset Date:
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: diarrhea; mild abdominal pain; tiredness on legs; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 70, unknown unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 11Jan2021; however, the facility didn't provide the time she should show up on 01Feb2021. She was looking for the time right here at Pfizer MI. She also stated that she has been having diarrhea, mild abdominal pain and tiredness on legs, but she doesn't attribute it entirely to the vaccine, it might be related. She mentioned that her arm was not in such expected pain. The outcome of the events was unknown. Information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976724
Sex: M
Age:
State: MD

Vax Date: 12/24/2020
Onset Date: 01/05/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210105; Test Name: COVID 19; Test Result: Positive

Allergies:

Symptoms: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 24Dec2020 at a single dose for him to not get COVID. Medical history and concomitant medications reported as none. The patient is a surgical technician who received his first dose of vaccine on 24Dec2020 and tested positive for COVID-19 on 05Jan2021. Patient's quarantine ends tomorrow, and he is also due for his second dose, tomorrow (14Jan2021). He is asking what to do as far as taking it or not. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976725
Sex: F
Age:
State:

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210111; Test Name: fever; Result Unstructured Data: Test Result:up to 102; Comments: Fever up to 102 after 12 hours of vaccine; Test Date: 202101; Test Name: fever; Result Unstructured Data: Test Result:still low grade; Comments: Continuing fever throughout next day and still low grade fever at 36h

Allergies:

Symptoms: Fever up to 102 after 12 hours of vaccine/Continuing fever throughout next day; low grade fever at 36h; Aches; chills; This is a spontaneous report from a non-contactable physician (patient). A 28-year-old female patient received the second dose bnt162b2 (reported as COVID 19 vaccine, brand: Pfizer) via an unspecified route of administration in left arm on 11Jan2021 11:30 at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of report. The patient previously received the first dose of bnt162b2 on 21Dec2020 11:30 in left arm for COVID-19 immunization at age 28 years old; azithromycin and experienced allergies. No other vaccines were administered in four weeks. The patient was not covid tested post vaccination. On 11Jan2021 23:30, the patient experienced fever up to 102 after 12 hours of vaccine, aches, chills. Continuing fever throughout next day and still had low-grade fever at 36h. Treatment was not given for AEs. The patient was recovering from the events. No follow-up attempts are possible. Information on lot number, batch number could not be obtained.

Other Meds:

Current Illness:

ID: 0976726
Sex: F
Age:
State: MD

Vax Date: 01/05/2021
Onset Date: 01/10/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: Nasal Swab; Test Result: Positive

Allergies:

Symptoms: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Fever; headache; bodyaches; cough; tiredness; sore throat; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 05Jan2021 at 08:15 AM at a single dose for COVID-19 immunization in a hospital. Medical history included known allergies to mold, dust mites, grass and tree pollen, cockroaches. Concomitant medications included hydroxyzine, ergocalciferol (VITAMIN D), vitamin c, calcium, and glucose (GLUCOS). The patient experienced fever, headache, bodyaches, cough, tiredness, sore throat on 10Jan2021 at 08:30 AM. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received zinc, vitamin D, ibuprofen, and Tylenol as treatment for the events. Since the vaccination, has the patient been tested for COVID-19: Yes. The patient has no COVID prior to vaccination and she was tested for COVID post vaccination (nasal swab; COVID-19 Ag test) with COVID test result as positive on 12Jan2021. The patient did not receive other vaccine in four weeks. Outcome of the event "Since the vaccination, has the patient been tested for COVID-19:Yes" was unknown, while recovering for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for COVID test based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.

Other Meds: HYDROXYZINE; VITAMIN D [ERGOCALCIFEROL]; VITAMIN C [ASCORBIC ACID]; CALCIUM; GLUCOS

Current Illness:

ID: 0976727
Sex: F
Age:
State:

Vax Date: 01/08/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: mouth was dry; sense of taste was not the same; This is a spontaneous report from a contactable other health professional. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Jan2021, the patient experienced that her mouth was dry and her sense of taste was not the same. The outcome of events was unknown. Follow-up attempts are completed. The following information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 0976728
Sex: F
Age:
State: MS

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after); joint pain; intense fatigue; muscle aches; arm was sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 08Jan2021 (11:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2020 (02:45 PM) via an unspecified route (right arm) for Covid-19 immunization. The patient's medical history included drug allergy (reported as known allergies: Cephalosporin (mild reaction of hives one time after having taken it with no issues for years-pending clarification)). There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after [09Jan2021, 12:15AM]). The entire day after her 2nd dose (during the day Saturday) every joint in her body ached and she experienced intense fatigue. There were also some muscle aches in her shoulders and her arm was sore at the injection site as it usually is after a tetanus shot (she stated she had soreness in her arm the day after the first injection but no other adverse events after the first injection). She did not seek medical treatment and did not take any over the counter medications to alleviate the symptoms as she does not typically take medications unless absolutely necessary. By the next day (Sunday), she was much better and had only slight joint pain remaining in her neck. By the following day (Monday;11Jan2021), all symptoms had resolved. She further stated that the symptoms experienced for one day did not make her regret getting the vaccine and she continue to strongly recommend the vaccine. The outcome of events was recovered on 11Jan2021. The patient has not been tested for COVID-19 since the vaccination.

Other Meds:

Current Illness:

ID: 0976729
Sex: F
Age:
State: IL

Vax Date: 01/09/2021
Onset Date: 01/10/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:101.8

Allergies:

Symptoms: Fever (highest at 101.8); Chills; Moderate nausea; Fatigue; Muscle aches in injection arm; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), intramuscular in left arm, on 09Jan2021 at 17:30, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (JUNEL FE). The patient previously took the first dose of BNT162B2 (Lot Number: EL0140) on 19Dec2020 (04:30 PM) for COVID-19 immunization (intramuscular in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a hospital facility. On 10Jan2021 at 05:30 AM (day 1 post-dose number 2), the patient experienced fever (highest at 101.8) twice, chills, moderate nausea, fatigue, and muscle aches in injection arm. No treatment was administered for the events. Post-vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.

Other Meds: JUNEL FE

Current Illness:

ID: 0976730
Sex: F
Age:
State:

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

Lab Data: Test Name: Sars-Cov-2; Test Result: Positive

Allergies:

Symptoms: contracted SARS-COV-2; contracted SARS-COV-2; This is a spontaneous report from a contactable physician (patient) via Medical Information. This physician reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received her first COVID-19 vaccination but contracted SARS-COV-2 from her husband, seven days after vaccination. Outcome of the events was unknown. Information about batch/lot number is requested.; Sender's Comments: Comirnaty's effectiveness is documented after at least seven days from the second vaccination.,Linked Report(s) : US-PFIZER INC-2021036192 same reporter/drug/events, different patients

Other Meds:

Current Illness:

ID: 0976731
Sex: F
Age:
State: NY

Vax Date: 12/29/2020
Onset Date: 01/11/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data: Test Date: 20210111; Test Name: pregnancy test; Test Result: Positive ; Test Date: 20210111; Test Name: covid; Test Result: Positive

Allergies:

Symptoms: I also did the home pregnancy test and I am pregnant; Tested positive for covid; Tested positive for covid; This is a spontaneous report from a contactable nurse (patient). This is a maternal report. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date was not provided), intramuscular via the left deltoid on 29Dec2020 11:15 at a single dose to prevent COVID. Medical history was none. There were no concomitant medications. It was reported that the patient received the Pfizer COVID vaccine on 29Dec2020 at 11:15am. She tested positive for COVID on 11Jan2021. She is supposed to be scheduled for her second dose on 19Jan2021. The patient asked the doctors and they don't know if she should get the second dose of the vaccine or postpone it. The patient called to ask if she should get the second dose. The patient took a home pregnancy test on 11Jan2021 and it came back positive, stated that this all occurred since she got vaccinated. Stated her last period was 13Dec2020. The patient reported that she is experiencing mild covid symptoms. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.

Other Meds:

Current Illness:

ID: 0976732
Sex: F
Age:
State: PA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Mild arm soreness; fatigue; mild body aches; chills; received 1st dose of BNT162B2 on 29Dec2020, second dose received 12Jan2021; This is a spontaneous report from a contactable consumer. An adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiration date not reported) via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 on 29Dec2020 for COVID-19 immunization. The patient experienced mild arm soreness starting about 4 hours after the shot on 12Jan2021 and able to do subsequent work out. About 12 hours after vaccine, developed fatigue and mild body aches followed by about an hour of chills, which resolved. Took some ibuprofen and melatonin and slept well until 6 am. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0976733
Sex: F
Age:
State: NV

Vax Date: 01/08/2021
Onset Date: 01/11/2021
Rec V Date: 01/27/2021
Hospital:

Lab Data:

Allergies:

Symptoms: swollen lymph nodes under arm of injection; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular in the right arm on 08Jan2021 10:45 at a single dose for COVID-19 immunization. The patient's medical history included allergies to penicillin and diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient previously took ciprofloxacin (CIPRO) and experienced allergies to ciprofloxacin. The patient had not been tested for COVID-19 since the vaccination. The patient experienced swollen lymph nodes under arm of injection on 11Jan2021 08:00. No treatment was received for the adverse event. Outcome of the event was not recovered.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm