VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.






Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

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

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

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

Lab Data:

Allergies: None

Symptom List: Dysphagia, Epiglottitis

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

Other Meds: Premarin 0.625mg

Current Illness: None

ID: 0969756
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

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

Other Meds:

Current Illness:

ID: 0969757
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

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

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

Other Meds:

Current Illness:

ID: 0969758
Sex: F
Age: 23
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Fever, headache, muscle aches and chills

Other Meds:

Current Illness:

ID: 0969759
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

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

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

Other Meds:

Current Illness:

ID: 0969760
Sex: U
Age:
State: CA

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

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

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

Other Meds:

Current Illness:

ID: 0969761
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

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

Other Meds:

Current Illness:

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

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

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

Lab Data:

Allergies: None

Symptom List: Pharyngeal swelling

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

Other Meds: Omeprazole 20 mg

Current Illness: NA

ID: 0969763
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

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

Other Meds:

Current Illness:

ID: 0969764
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

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

Other Meds:

Current Illness:

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

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

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

Lab Data:

Allergies: Various food allergies

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

Symptoms: Cough, shortness of breath wheezing

Other Meds: None

Current Illness: None

ID: 0969766
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

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

Other Meds:

Current Illness:

ID: 0969767
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

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

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

Other Meds:

Current Illness:

ID: 0969768
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

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

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

Other Meds:

Current Illness:

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

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

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

Lab Data:

Allergies: none

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Tiresome and some chips

Other Meds: none

Current Illness: none

ID: 0969770
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

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

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

Other Meds:

Current Illness:

ID: 0969771
Sex: U
Age:
State: CA

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

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

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

Other Meds:

Current Illness:

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

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

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

Lab Data:

Allergies: penicillan

Symptom List: Ear pain, Hypoaesthesia

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

Other Meds: vitamin c and d

Current Illness: none

ID: 0969773
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

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

Other Meds:

Current Illness:

ID: 0969774
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

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

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

Other Meds:

Current Illness:

ID: 0969775
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

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

Other Meds:

Current Illness:

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

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

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

Lab Data:

Allergies: penecillin amoxicillin Microbid

Symptom List: Unevaluable event

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

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

Current Illness: none

ID: 0969777
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

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

Other Meds:

Current Illness:

ID: 0969778
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

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

Other Meds:

Current Illness:

ID: 0969779
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

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

Other Meds:

Current Illness:

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

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

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

Lab Data:

Allergies: none

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

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

Other Meds: none

Current Illness: none

ID: 0969781
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

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

Other Meds:

Current Illness:

ID: 0969782
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

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

Other Meds:

Current Illness:

ID: 0969783
Sex: M
Age: 43
State: WA

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

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

Lab Data:

Allergies: Cashew nut oil Poison Oak

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

Symptoms: Received the vaccine on January 22, 2021 at approximately 14:30 hours. Started feeling muscle soreness in the left arm later that night. I woke up on January 23rd, 2021 at approximately 0800 hours and felt general soreness in my muscles and joints. By 0900 hours, joint pain was much worse as it hurt just to stand. At approximately 1130 hours, I started feeling chills. I wore two layers of sweatshirts and sweatpants plus blankets. I could not get warm. By approximately 1300 hours, I had a low grade fever of 100.3 - 100.6. I went to bed at approximately 2200 hours, woke up at approximately 1030 hours on Sunday the 24th, 2021 and had no longer felt the pain, chills or fever.

Other Meds: amLODIPine 10mg lisinopril 40mg Maxide 75mg omeprazole 20mg traZODone HCI 50mg

Current Illness: None

ID: 0969784
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Nausea

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

Other Meds:

Current Illness:

ID: 0969785
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

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

Other Meds:

Current Illness:

ID: 0969786
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

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

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

Other Meds:

Current Illness:

ID: 0969787
Sex: F
Age: 32
State: CA

Vax Date: 01/04/2021
Onset Date: 01/11/2021
Rec V Date: 01/25/2021
Hospital:

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

Lab Data:

Allergies: Penicillin, ingested alcohol

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

Symptoms: I had a delayed reaction with a red and itchy rash at site of injection about 7 days later. It was also warm to the touch. It resolved 2 days later. I also had a very low grade fever that was also delayed (I believe it was 4 days later which was momentary and resolved after an hour). No other side effects.

Other Meds: None

Current Illness: None

ID: 0969788
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Tremor

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

Other Meds:

Current Illness:

ID: 0969789
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

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

Other Meds:

Current Illness:

ID: 0969790
Sex: F
Age: 55
State: CA

Vax Date: 01/13/2021
Onset Date: 01/21/2021
Rec V Date: 01/25/2021
Hospital:

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

Lab Data:

Allergies: penicillin, sulfa

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

Symptoms: small rash at injection site on 7th day, with severe itchiness radiating all the way down the arm to hand, the rash quadrupled in size by next day, with continued severe itchiness radiating all the way down to hand, and rash still large and severe itchiness on 9th day. There is still pain at injection site and a sensation of warm with mild swelling. Treated with hydrocortisone cr?me and Neosporim but no real benefit from those treatments.

Other Meds: Synthroid and propranolol daily

Current Illness: none

ID: 0969791
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

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

Other Meds:

Current Illness:

ID: 0969792
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

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

Other Meds:

Current Illness:

ID: 0969793
Sex: F
Age: 28
State: OR

Vax Date: 01/20/2021
Onset Date: 01/24/2021
Rec V Date: 01/25/2021
Hospital:

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

Lab Data:

Allergies: no

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

Symptoms: 4 days after getting the first Moderna shot, I developed an intense headache that has lasted for 10 hours.

Other Meds: Junel Fe birth control

Current Illness: none

ID: 0969794
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

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

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

Other Meds:

Current Illness:

ID: 0969795
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

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

Other Meds:

Current Illness:

ID: 0969796
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

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

Other Meds:

Current Illness:

ID: 0969797
Sex: F
Age: 33
State: FL

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

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

Lab Data:

Allergies: None

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

Symptoms: Facial tingling 30 minutes post injection, facial swelling and flushing at 12 hours post injection, fever (99.0 F-101.0 F), chills, body aches, and shivering starting at 16 hours post injection and continuing for 48 hours post injection, headache and neck ache from 48-72 hours post injection.

Other Meds: Synthroid, Blisovi, Bisoprolol

Current Illness: None

ID: 0969798
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

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

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

Other Meds:

Current Illness:

ID: 0969799
Sex: U
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

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

Other Meds:

Current Illness:

ID: 0969800
Sex: F
Age: 27
State: LA

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

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

Lab Data:

Allergies: N/A

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: within minutes after my shot, I started to have difficulty swallowing. i was monitored for 30 minutes at the vaccine site before being escorted to the medical observation area. While in the medical observation area I tried to take a sip of water but could not swallow it. At that moment I began having a tight feeling in my chest. I began to hyperventilate followed by difficulty breathing or talking. This was accompanied by feelings of impending doom, and uncontrollable trembling and inability to concentrate on what the medical observation area Doctor was saying. The time from the drink of water until I was able to breathe, speak, and concentrate normally was about 20 minutes. Tightness in my chest has improved but not fully recovered. General malaise and headache have developed.

Other Meds: N/A

Current Illness: N/A

ID: 0969801
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

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

Other Meds:

Current Illness:

ID: 0969802
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

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

Other Meds:

Current Illness:

ID: 0969803
Sex: U
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

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

Other Meds:

Current Illness:

ID: 0969804
Sex: F
Age: 55
State: TX

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/25/2021
Hospital:

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

Lab Data:

Allergies: Allergic to morphine, codeine products

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: The day after vaccine I started to have a burning, stinging skin reaction on right side of torso. Thinking it was hives, I applied cortisone cream and took Zyrtec. This continued through following week. I went to my personal physician and was diagnosed with shingles though I never had any outward rash or blisters. Just skin sensitivity . I was prescribed triamcinolone acetonide cream 0.5% which I have been applying twice daily. I have not had an outbreak but have had minimal internal pain that feels like strained or pulled muscle in the same area.

Other Meds: Hydrochlorothiazide, Vit D 5000 IUs, Probiotics, Elderberry, Zyrtec

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm