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: 0980566
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980567
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980568
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980569
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980570
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980571
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980572
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980573
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980574
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980575
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980576
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980577
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980578
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980579
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980580
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980581
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980582
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/28/2021
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: 0980583
Sex: M
Age: 44
State: MA

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

Lab Data:

Allergies:

Symptoms: Vaccine administered to left shoulder joint; A spontaneous report was received from a consumer concerning a 44-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine administered to left shoulder joint. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Jan 2021, approximately 0 days prior to the onset of the event, the patient received his first dose of mRNA-1273 (Lot number 012L20A) for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient noticed the site of the injection was more on his shoulder joint rather than the upper arm. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine administered to left shoulder joint, was considered resolved on 13 Jan 2021.; Reporter's Comments: This case concerns concerning a 44-year old, male patient who received his first dose of mRNA-1273 (Lot number 012L20A) for prophylaxis of COVID-19 infection and the patient noticed the site of the injection was more on his shoulder joint rather than the upper arm. There were no reported adverse events associated with the event of product administered at inappropriate site.

Other Meds:

Current Illness:

ID: 0980584
Sex: M
Age: 64
State: CA

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

Lab Data:

Allergies:

Symptoms: like a slight paralysis; stiffness in the face; numbness in the face; A spontaneous report was received from a 64-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced like a slight paralysis, stiffness in the face and numbness in the face. The patient's medical history, as reported, included high blood pressure. Concomitant medications reported included losartan. On 13 Jan 2021, about 5 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Jan 2021, about 5 minutes after getting the Moderna COVID-19 vaccine, the patient experienced a stiffness and numbness in the face, like a slight paralysis. It started in the nose and spread out to the eyes and forehead. After about half an hour, he still experienced it a little bit. No medications were taken for the events. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, like a slight paralysis, stiffness in the face and numbness in the face, was recovering/resolving.; Reporter's Comments: This spontaneous report refers to a case of a 64-year-old, male patient with medical history of high blood pressure who experienced a serious event slight paralysis and non-serious events of stiffness in the face and numbness in the face. The events occurred 5 minutes after the administration of the mRNA-1273 vaccine (lot # unknown, expiration date-unknown). No treatment was administered, and patient is recovering. Based on the information provided which includes a temporal association, a causal association cannot be excluded.

Other Meds: LOSARTAN

Current Illness: Blood pressure high

ID: 0980585
Sex: F
Age: 70
State:

Vax Date: 01/01/2021
Onset Date: 01/12/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: On 01Jan2021 received the dose of the Moderna vaccine, and today 12Jan2021 took the second dose; A spontaneous report was received from a consumer who was also a 70-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) on 1st Jan 2021 and 12th Jan 2021, resulting in the event inappropriate schedule of product administration. The patient's medical history was not provided. No relevant concomitant medications were reported. On 1st Jan 2021, the patient received their first dose of two planned doses of mRNA-1273 (Lot Number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. On 12th Jan 2021, the patient received the second dose of two planned doses of mRNA-1273 (Lot Number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection. The four weeks dosing schedule was not observed. The patient did not present any side effects. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, inappropriate schedule of product administration, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 70-year-old female patient who received their second of two planned doses of mRNA-1273 (Lot Number: 025L20A) reporting Inappropriate schedule of product administration without any associated adverse events.

Other Meds:

Current Illness:

ID: 0980586
Sex: F
Age: 48
State: CA

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

Lab Data:

Allergies:

Symptoms: patient who got the Pfizer vaccine 22DEC2020 got the Moderna vaccine today 13JAN2021; A spontaneous report was received from a professional concerning a 48-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who got the Pfizer vaccine 22 Dec 2020 got the Moderna vaccine today 13 Jan 2021. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 22 Dec 2020, the patient received the Pfizer COVID-19 vaccine for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient received mRNA-1273 (Lot number 029L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced receiving the Moderna vaccine after receiving the Pfizer vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event patient who got the Pfizer vaccine 22 Dec 2020 got the Moderna vaccine today 13 Jan 2021 was not reported.; Reporter's Comments: This case concerns a 48-year-old female patient who received their first of two planned doses of Pfizer COVID-19 vaccine and second of two planned doses of mRNA-1273 (Lot number 029L20A), reporting Wrong product administered.

Other Meds:

Current Illness:

ID: 0980587
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. The physician reported that four Moderna vaccine doses were administered from vials which had been more than 6 hours post initial puncture. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture was considered resolved on an unspecified date.; 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 Out of specification product use.

Other Meds:

Current Illness:

ID: 0980588
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. The physician reported that four Moderna vaccine doses were administered from vials which had been more than 6 hours post initial puncture. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture was considered resolved on an unspecified date.; 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 Out of specification product use.

Other Meds:

Current Illness:

ID: 0980589
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. The physician reported that four Moderna vaccine doses were administered from vials which had been more than 6 hours post initial puncture. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture was considered resolved on an unspecified date.; 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 Out of specification product use.

Other Meds:

Current Illness:

ID: 0980590
Sex: F
Age:
State: KY

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

Lab Data: Test Date: 20210111; Test Name: temperature; Result Unstructured Data: Test Result:low grade fever

Allergies:

Symptoms: her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; Tiredness; scratchy throat which got worse with time; tenderness around the injection site; it felt really bad almost like a flu; it felt really bad almost like a flu; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: 30Apr2021, NDC number: 59267100001), intramuscular in the left deltoid, on 08Jan2021, at 0.3 mL, single, for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported she had side effects after receiving the first dose (Jan2021). She had a scratchy throat which got worse with time. She had a general muscle ache, tenderness around the injection site. The muscle ache increased with chills and low grade fever. She said it felt really bad almost like a flu. She reported her eye is still swollen with chills and low grade fever. She further clarified that she was given the vaccine on 08Jan2021, Friday afternoon. On 09Jan2021, Saturday, she had muscle aches, tiredness, and by Saturday night she had a scratchy throat. On 10Jan2021, Sunday, she experienced tiredness and muscle cramps. She worked half day on 11Jan2021, Monday, and by the afternoon she had chills and low grade fever. On 12Jan2021, Tuesday morning, she woke up and her eyes were swollen. She noticed the swelling has decreased a little bit. She didn't have any symptoms such as difficulty breathing. The reporter asked what have caused these side effects and why did her immune response react this way after receiving the vaccine. She mentioned that her second dose is set up for the end of January and asked if she will be able to get the second dose since she had a reaction and she was wondering if had an illness when she got the vaccine could that have caused her to have a hyper response in her immune system to the vaccine. The outcome of the events scratchy throat which got worse with time, general muscle ache, tiredness, muscle cramps, eye swelling and low grade fever was recovering; chills was not recovered; and the outcome of the remaining events was unknown.

Other Meds:

Current Illness:

ID: 0980591
Sex: F
Age:
State: MA

Vax Date: 12/28/2020
Onset Date: 01/06/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data: Test Date: 20210106; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptoms: She received the 1st dose on 28Dec2020. She taShe received the 1st dose on 28Dec2020. She tested positive to COVID-19 on 06Jan2021ested positive to COVID-19 on 06Jan2020.; She received the 1st dose on 28Dec2020. She tested positive to COVID-19 on 06Jan2021; This is a spontaneous report from a contactable nurse. A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: )Mar2021 , via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. There were no relevant medical history and concomitant medications. The patient received the 1st dose on 28Dec2020. She tested positive to COVID-19 on 06Jan2021. She was still currently in isolation and symptomatic. Her second dose was scheduled on 18Jan2020. The outcome of the event was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive to COVID-19 based on the known safety profile. However the short duration of 9 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.

Other Meds:

Current Illness:

ID: 0980592
Sex: M
Age:
State: NC

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: twisted his back a little bit/strained his back; he is having some muscle pain; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 13Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) reported that a 79-year-old male patient 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 stated that he is in good physical health. The patient stated that he is 79 years old, and received his first dose of the COVID vaccine 48 hours ago, on Monday at noon (11Jan2021). The patient strained his back last night (12Jan2021), and he is having some muscle pain, and he would like to know if it is okay to take Ibuprofen, following having received the vaccine. The patient clearly stated that he has had no side effects and he is fine from the vaccine. He also added that it was while he was in the shower last night, he twisted his back a little bit, and that happens to him now and then and that was normally when this happens to him, it takes a few days to get better. But patient stated that this event is totally unrelated to the COVID vaccine. The patient normally just takes a Motrin, and it clears the pain up, it relieves it. But he was just wondering if it is contraindicated to take Motrin after having had the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The events back strain and muscle pain were intercurrent conditions and unrelated to BNT162B2 vaccination.

Other Meds:

Current Illness:

ID: 0980593
Sex: U
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she has pulled some of the vials that were used out of the sharps container and peeled off the label to find that the dots and lines disappeared. We didn't inject the vial into the patient; This case has been considered as invalid due to no adverse effect, only product complaint. This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiry date: unknown, NDC number: 59267- 1000-1 ) via an unspecified route of administration, on an unspecified date, at 30mg/0.3mL, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that she has multiple vials of the COVID-19 vaccine that have either dots or fixed lines on the vials, presumably what could be a potential crack in the vial. The vials were all smooth on the outside. There are no particles and the vaccine looks normal, even after its been reconstituted. She pulled some of the vials that were used out of the sharps container and peeled off the label to find that the dots and lines disappeared. She felt that they may be a result of air trapped between the label and the vial but she states that she is not sure and would like to know if she can still use the product or should discard them. In follow-up the pharmacist reported seeing something strange in the vial after reconstituting it with the diluent. She noticed what looks like a core as she injected the syringe and on further injection, she noticed that the piece was reflecting and picking up light and this piece was not moving in the solution. And she added that there are 2 vials with this appearance, and they have the same LOT#. Pharmacist stated, they didn't inject the vial into the patient. Pharmacist stated, "It is not floating, it is a fixed spot on the vial where, when I look from one angle it looks like there could potentially be a core. So, it shows almost grey. When I move the vial, I can see the reflected light within the particle slightly and then if I move the vial further over where there is no fluid covering the spot, the spot is not noticeable. One vial is one spot, the other vial is a spot and what looks almost to be scraped on the inside. It is grey in color until I move the vial as such to where there is no fluid covering it, then it disappears. And when I move the vial further when there is fluid covering it, it will reflect light, so it's not really a true like particles, it's hard to describe. It is very, very small in 1 vial, may be the size like of a, I don't know like similar to like a 21 gauge needle. And then on the other vial it is one spot that's larger than that almost like the end of paper clip and then the part that almost appears to be like 'dry are faded' (voice distortion) and those are very, very faint lines. This happened after dilution of the vial with Sodium Chloride. I did not notice this prior to, I inspected the vial prior to dilution and I did not notice that either. At this point I completed the dilution around 8:55 for one of the vials and 9 o' clock for the other so. It has been at as far as I am aware I have access to our continual monitor but we do keep a paper log of the refrigerator temp every day and it has been under refrigeration. It was removed from the ultra-low freezer at 8 o' clock on 11th, on Monday." Follow-up (13Jan2021): New information received from a contactable pharmacist includes: clinical course and confirmed they didn't inject the vial into the patient. Sodium Chloride added as suspect drug.

Other Meds: Sodium Chloride

Current Illness:

ID: 0980594
Sex: F
Age:
State: NY

Vax Date: 01/09/2021
Onset Date: 01/11/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: head numbness and tingling; head numbness and tingling; This is a spontaneous report from a contactable consumer (patient) reported that a 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on the left deltoid on 09Jan2021 12:00 at a single dose for Covid-19 immunization. The vaccine was administered at a hospital. Medical history was reported as none. Family medical history included her mother has multiple sclerosis and her sister has lupus. There were no concomitant medications. On the 9th, this past Saturday, she had first dose of COVID vaccine. Then on Monday, the 11th around 2:00 pm (14:00), she started having in her head numbness and tingling. Still has numbness and tingling in the head. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 0980595
Sex: F
Age:
State: WI

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: hot and cold chills; body aches; tired; nausea; did not sleep the rest of the night; This is a spontaneous report from a contactable consumer. A 32-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL0142, via an unspecified route of administration in the left arm on 12Jan2021 10:30 at a SINGLE DOSE for covid-19 immunization. Medical history included Gluten and dairy allergy. Prior vaccination, patient has had covid-19 from an unknown date to 30Dec2020. Patient was not pregnant during vaccination. Concomitant medications included curcumin, acetylcysteine, ascorbic acid, quercetin, vitamin b complex, vitamin c and colecalciferol. The patient previously took minocycline and zithromax and experienced allergy to both. The patient received the vaccine on 12Jan2021 at 10:30 and started feeling symptoms hot and cold chills, body aches on 13Jan2021 around 1:00 AM. She did not sleep the rest of the night and throughout the day was tired, chills, body aches, nausea. Patient also stated that she started her period the day she received the vaccine which she was not sure if did help her immune system. The outcome of events was recovering. Patient did not received any treatment due to the events. Since the vaccination, the patient hasn't been tested for COVID-19. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

Other Meds: CURCUMIN; NAC [ACETYLCYSTEINE]; QUERCITIN; VITAMIN B; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 0980596
Sex: F
Age:
State:

Vax Date: 12/27/2020
Onset Date: 12/31/2020
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: diagnosed with shingles; a lump on my left ear; This is a spontaneous report from a contactable nurse(patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 27Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 31Dec2020 there was a lump on her left ear. On 04Jan2021 there was a rash on her eyes. On 05Jan2021, the patient had a rash like shingles and the doctor diagnosed with shingles. She was taking an antiviral: acyclovir. The doctor said it's a side effect from the vaccine. The patient had no history of sickness. It's so rare. The doctor said shingles was dormant, a sleeping virus that's in her spine. She was not sure if it's because Covid was virus, and it activated her dormant virus. Her 2nd vaccine was soon, 5 days from now. She asked that "Is it ok to get the 2nd dose? Do I need to wait? I spoke with my doctor and infectious disease and they stated after a month; if my immune system was better". The outcome of events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0980597
Sex: F
Age:
State: IN

Vax Date: 12/26/2020
Onset Date: 01/01/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: hives on back of my head neck ,ears that progressed that day to bilateral arms, abdomen groin/hives also on my thighs; This is a spontaneous report from contactable nurse reporting for herself (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), via an unspecified route of administration on 26Dec2020 20:15 (reported as 08:15 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history was reported as none. No known allergies. There were no concomitant medications (reported as "I take no meds"). No other vaccine in four weeks. No COVID prior vaccination. On 01Jan2021 10:15 PM, 6 days after 1st vaccine, patient started having hives on back of her head, neck, ears that progressed that day to bilateral arms, abdomen groin. The next day hives were also on her thighs. The patient had hives for a week. Treatment for the event was reported as "Zyrtec Pepcid atarax prednisone". Event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the event was recovered in Jan2021. Patient was not tested for COVID post vaccination.

Other Meds:

Current Illness:

ID: 0980598
Sex: M
Age:
State: CA

Vax Date: 01/08/2021
Onset Date: 01/10/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: abnormally enlarged bilateral (left greater than right) painful axillary lymph nodes; abnormally enlarged bilateral (left greater than right) painful axillary lymph nodes; This is a spontaneous report from a contactable physician (patient). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EL3246) via an unspecified route of administration on left arm on 08Jan2021 07:30 at a single dose for covid-19 immunization. The patient got allergies to fluoroquinolones and dairy (milk protein allergy). Prior to vaccination, the patient did not diagnose with COVID 19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included famotidine and cetirizine hydrochloride (ZYRTEC). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EH9899) on left arm on 19Dec2020 01:30 PM for covid-19 immunization. The patient experienced abnormally enlarged bilateral (left greater than right) painful axillary lymph nodes on 10Jan2021 16:00. It began about 48hrs after 2nd shot and still persisted to 5 days later. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID 19. The patient received Ibuprofen to treat the events. The outcome of the events was not recovered.

Other Meds: FAMOTIDINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 0980599
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: had 2 other patients who have reported metallic taste in their mouth after the vaccine; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 2 patients. This is second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that she also had 2 other patients who had reported metallic taste in their mouth after the vaccine on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027150 same reporter/drug/event; different patient

Other Meds:

Current Illness:

ID: 0980600
Sex: F
Age:
State: KY

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data: Test Date: 20210113; Test Name: Temp; Result Unstructured Data: Test Result:100.3; Comments: up to 100.3 at 04:30 PM

Allergies:

Symptoms: Temp up to 100.3; Body aches; Nausea; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 12Jan2021 11:00 at a single dose on right arm for COVID-19 immunization. Medical history included Hypothyroidism and allergies to Latex, Cephlosporins, Kiwi. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 22Dec2020 11:00 AM at a single dose on right arm for COVID-19 immunization. The patient experienced common listed side effects, Temp up to 100.3, Body aches; Not Listed as common, Nausea on 13Jan2021 16:30. No treatment received for the events. The outcome of the events was recovering. The events were considered as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was the Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: SYNTHROID

Current Illness:

ID: 0980601
Sex: F
Age:
State: MI

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Nausea; muscle pain; joint pain; headache; tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: Apr2021), via an unspecified route of administration on the left arm, on 12Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included high blood pressure; patient was not pregnant at time of vaccination. Concomitant medications were unspecified (received within 2 weeks of vaccination). The patient experienced nausea, muscle pain, joint pain, headache and tiredness on 13Jan2021 14:00. Treatment was not received for the events. Patient was recovering from the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.

Other Meds:

Current Illness:

ID: 0980602
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Mild reaction: hives; Mild reaction: Tachycardia; This is a spontaneous report from a contactable other HCP. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced mild reaction hives and tachycardia on an unspecified date with outcome of unknown. The reporter asked if patient can still continue with the second dose. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0980603
Sex: F
Age:
State: WI

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 01/28/2021
Hospital:

Lab Data: Test Date: 20200609; Test Name: SARS-COV-2 IGG; Test Result: Negative ; Test Date: 20201230; Test Name: SARS-COV-2 BY PCR (2019-NCOV) via Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Breakthrough bleeding/spotting menses; soreness at injection site; fatigue; muscle aches; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 35-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 10:00 at single dose in Left arm for COVID-19 immunization. Medical history included Alports, Alopecia Areata, eczema, all from an unknown date and unknown if ongoing. There were no known allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC), lisinopril. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient experienced Breakthrough bleeding/spotting menses, soreness at injection site, fatigue, muscle aches on 23Dec2020 20:30. No treatment received for all reported events Breakthrough bleeding/spotting menses, soreness at injection site, fatigue, muscle aches. The patient underwent lab tests which included blood test for covid-19 which named SARS-COV-2 IGG on 09Jun2020 was with result Negative and covid-19 test which named SARS-COV-2 BY PCR (2019-NCOV) via Nasal Swab post vaccination on 30Dec2020 was with result Negative. The outcome of the events was recovered on an unspecified date.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LISINOPRIL

Current Illness:

ID: 0980604
Sex: F
Age:
State: MA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: seeing flashing lights out of the left side of the left eye; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the left arm on 11Jan2021 12:30 at single dose for COVID-19 immunization at a hospital. The patient has allergies whisk laundry detergent and mosquitoes. There were no concomitant medications. Patient previously took tetracycline, metronidazole (METROGEL) and experienced allergies. The patient also took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 21Dec2020 12:30, at the left arm. Approximately 7-8 hour post vaccination, patient started seeing flashing lights out of the left side of her left eye on 11Jan2021 19:30. No treatment for the event. The patient has not recovered from the event.

Other Meds:

Current Illness:

ID: 0980605
Sex: F
Age:
State: LA

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data: Test Name: blood sugar; Result Unstructured Data: Test Result:145

Allergies:

Symptoms: dizzy; She is kind of weak; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 14Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. An 86-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, expiration date not reported), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history included diabetes from an unknown date. The patient experienced dizzy and she is kind of weak on 14Jan2021. It was further reported that the events started this morning, she was fine yesterday. The patient underwent lab tests and procedures which included blood glucose: 145 on an unspecified date. The patient did not recover from the events.

Other Meds:

Current Illness:

ID: 0980606
Sex: F
Age:
State: VA

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Discoloration of skin on left hand (side where vaccine was administered); This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL8982), via an unspecified route of administration in left arm, on 13Jan2021 at 17:30, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took amoxicillin and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 14Jan2021 at 06:00 AM, the patient experienced discoloration of skin on left hand (side where vaccine was administered). The patient has not been tested for COVID-19 post-vaccination. No treatment was administered for the event. The patient had not recovered from the event.

Other Meds:

Current Illness:

ID: 0980607
Sex: F
Age:
State: AZ

Vax Date: 01/12/2021
Onset Date: 01/13/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Very painful lymphnode in arm of injection; pain radiating down arm into fingers; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 12Jan2021 at 16:00 at a single dose in the clinic for COVID-19 immunization. The patient received the first dose on 22Dec2020 at 16:00 on the left arm for COVID-19 immunization. The patient's medical history was not reported. Patient is not pregnant at the time of vaccination and did not have COVID prior to vaccination. Concomitant medication included ibuprofen and tramadol. The patient experienced very painful lymphnode in arm of injection, pain radiating down arm into fingers on 13Jan2021 at 17:00. Outcome of the events was not recovered. Information of lot/batch number has been requested.

Other Meds: IBUPROFEN; TRAMADOL

Current Illness:

ID: 0980608
Sex: F
Age:
State: MN

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Decreased sensation in the L side of the face; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), intramuscular via the left arm on 30Dec2020 18:00 at a single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ciprofloxacin. It was reported that the patient experienced decreased sensation in the L side of the face that lasted 3 days initially and now comes and goes on 30Dec2020 21:00. No treatment was given for the event. The outcome of the event was not recovered.

Other Meds: CIPROFLOXACIN

Current Illness:

ID: 0980609
Sex: F
Age:
State: WA

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data: Test Date: 20210106; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.

Other Meds: ALBUTEROL [SALBUTAMOL]; SINGULAIR; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 0980610
Sex: F
Age:
State: NC

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: fever; Result Unstructured Data: Test Result:fever to 100

Allergies:

Symptoms: fever to 100; chills; myalgias; headache; axillary lymphadenopathy with swelling and pain; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140 expiration date unknown), via an unspecified route of administration in the left arm on 11Jan2021 at 10:45 at a single dose for COVID-19 immunisation. Medical history included non-celiac gluten induced enteropathy, COVID from 27Sep2020 to an unknown date (had COVID with mild course x2 days), and allergies to NSAIDS and SSRIs. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), amlodipine besilate (NORVASC), colecalciferol (VITAMIN D [COLECALCIFEROL]), and omeprazole (PRILOSEC [OMEPRAZOLE]) on unspecified dates for unspecified indications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899 expiration date unknown) on 22Dec2020 at 10:45AM in the left arm for COVID-19 immunization; also previously took amoxicillin and experienced allergies. The patient was not pregnant. On 12Jan2021, at 12:00 AM, 12 hours after vaccine, the patient experienced fever to 100, chills, myalgias, headache. The patient was better 12 hours later after one dose of Tylenol. The patient also had axillary lymphadenopathy with swelling and pain, present since day 1 post vaccine (12Jan2021) and still swollen but pain improving. There was no treatment received for the adverse events. The outcome of the events was recovering at the time of report.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; NORVASC; VITAMIN D [COLECALCIFEROL]; PRILOSEC [OMEPRAZOLE]

Current Illness:

ID: 0980611
Sex: M
Age:
State: TX

Vax Date: 12/28/2020
Onset Date: 01/11/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data: Test Date: 20210111; Test Name: covid; Result Unstructured Data: Test Result:positive

Allergies:

Symptoms: Tested positive on 11Jan2021; Tested positive on 11Jan2021; This is a spontaneous report from a contactable consumer (daughter reporter for her father). An 88-year-old male patient 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 28Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Daughter calling on behalf of father, aged 88, who lives in assisted living received his first dose on 28Dec2020. However, patient tested positive on 11Jan2021, and was moved to a covid facility. He is scheduled to receive his second dose on 18Jan2021. The daughter asked if her father could get the second covid vaccine after being sick. She also asked what if his father can't go back to his regular nursing home in time? Does he have to restart the vaccination schedule? The outcome of the events was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0980612
Sex: F
Age:
State: NY

Vax Date: 01/06/2021
Onset Date: 01/01/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data: Test Date: 20210113; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: Intense abdominal cramps; chronic diarrhea; chills; feeling unwell; soreness in injection site; muscle aches; This is a spontaneous report from a contactable other healthcare professional (reported for self). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular (right arm) on 06Jan2021 at single dose for Covid-19 immunization. The patient's medical history included sciatica and Allergy: sulphur drugs. Concomitant medication included Multivitamins (unspecified). The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that initially after the vaccine (Jan2021; unspecified date), she experienced soreness in injection site and muscles aches, but these symptoms were mild. On 11Jan2021, the patient experienced intense abdominal cramps, chronic diarrhea, muscle aches, chills, and feeling unwell (also reported that these symptoms developed 5 days after vaccine). The adverse events resulted in Doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse events. The patient has been tested for COVID-19 post vaccination: Covid test type post vaccination was Nasal Swab, Covid test name post vaccination=Pcr; Covid test date=13Jan2021; Covid test result=Negative. The outcome of events was not recovered.

Other Meds:

Current Illness:

ID: 0980613
Sex: U
Age:
State: MA

Vax Date: 01/03/2021
Onset Date: 01/01/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptoms: Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the first of 20 reports. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) on an unspecified date. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection. Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021042231 same reporter, same drug/event, different patient;US-PFIZER INC-2021042229 same reporter, same drug/event, different patient;US-PFIZER INC-2021042217 same reporter, same drug/event, different patient;US-PFIZER INC-2021042222 same reporter, same drug/event, different patient;US-PFIZER INC-2021042224 same reporter, same drug/event, different patient;US-PFIZER INC-2021042225 same reporter, same drug/event, different patient;US-PFIZER INC-2021042230 same reporter, same drug/event, different patient;US-PFIZER INC-2021042220 same reporter, same drug/event, different patient;US-PFIZER INC-2021042218 same reporter, same drug/event, different patient;US-PFIZER INC-2021042234 same reporter, same drug/event, different patient;US-PFIZER INC-2021042233 same reporter, same drug/event, different patient;US-PFIZER INC-2021042221 same reporter, same drug/event, different patient;US-PFIZER INC-2021042219 same reporter, same drug/event, different patient;US-PFIZER INC-2021042223 same reporter, same drug/event, different patient;US-PFIZER INC-2021042228 same reporter, same drug/event, different patient;US-PFIZER INC-2021042226 same reporter, same drug/event, different patient;US-PFIZER INC-2021042216 same reporter, same drug/event, different patient;US-PFIZER INC-2021042232 same reporter, same drug/event, different patient;US-PFIZER INC-2021042227 same reporter, same drug/event, different patient

Other Meds:

Current Illness:

ID: 0980614
Sex: F
Age:
State: NY

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff; slight tingling and numbness of her face and cheeks/little tingling numbness in her face; slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff/she has not had symptoms for years, potentially initiated by being vaccinated; Headache; Diarrhea; Stomach upset; warm flushed feeling; heavy metallic taste to her mouth; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing multiple sclerosis (MS) from 2012 (she has not had symptoms for years), tingly stuff/tingling and numbness (MS symptoms). There were no concomitant medications. The patient experienced metallic taste in her mouth, a slight tingling and numbness of her face and cheeks. The patient reported that she also has a history of MS that has been controlled and she has been without symptoms for years. She stated the tingling could be a symptom of MS, potentially initiated by being vaccinated. She stated that the tingly stuff concerned her, she got a little panicky because that can be a symptom of MS and she did not have symptoms for years. The patient clarified that on 07Jan2021, she took the vaccine. On 07Jan2021, she experienced heavy metallic taste to her mouth two hours after the injection, headache, diarrhea, stomach upset, and warm flushed feeling. On 08Jan2021, she experienced little tingling numbness in her face. She stated that she has MS prior to the vaccine and reported that numbness and tingling can be MS symptoms. She has not had symptoms for years. The patient did not receive treatment for the events. The outcome of "heavy metallic taste to her mouth" was recovering (reported as "improved but persisting"); paraesthesia and hypoeasthesia were recovering; headache, diarrhea, stomach upset, and warm flushed feeling were resolved on 09Jan2021.

Other Meds:

Current Illness: Multiple sclerosis (she has not had symptoms for years)

ID: 0980615
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 01/28/2021
Hospital:

Lab Data:

Allergies:

Symptoms: experienced side effect of rash 2 to 3 hours later; This is a spontaneous report from a non-contactable physician (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received vaccine 2 days ago and experienced side effect of rash 2 to 3 hours later. The patient wanted guidance on 2nd dose. She was unsure if it was due to taking a shower with warm water. She took Benadryl and was fine afterwards. She was asking if she can take steroids before the second dose, if there is any contraindication of steroids and the vaccine, and about taking Benadryl before the second dose. She was asking for any specific data on participants in the study that had taken steroids that were permitted in the study. She also stated that they were doing a great job. Therapeutic measures were taken as a result of experienced side effect of rash. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm