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: 1353877
Sex: M
Age: 88
State:

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 01/21/2021
Hospital:

Lab Data:

Allergies:

Symptoms: diaphoresis Narrative: Patient was clammy and pale and vomited after receiving Moderna Covid-19 vaccine. Patient BP dropped to 70/40 and HR 120. Patient felt dizzy. 2L of oxygen by nasal cannula given. 911 was called and patient taken to hospital and seen in ER. Patient was discharged from hospital. Patient previously tested positive for COVID-19

Other Meds:

Current Illness:

ID: 1353878
Sex: M
Age: 80
State:

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

Lab Data:

Allergies:

Symptoms: SORENESS AT INJECTION SITE Narrative:

Other Meds:

Current Illness:

ID: 1353879
Sex: M
Age: 62
State:

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

Lab Data:

Allergies:

Symptoms: SORENESS AT INJECTION SITE Narrative:

Other Meds:

Current Illness:

ID: 1353880
Sex: M
Age: 64
State:

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 01/21/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fatigue, shortness of breath, chills Narrative:

Other Meds:

Current Illness:

ID: 1353881
Sex: M
Age: 73
State:

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 01/21/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 2nd dose administered 4 days to early

Other Meds:

Current Illness:

ID: 1353882
Sex: M
Age: 43
State:

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

Lab Data:

Allergies:

Symptoms: CHILLS

Other Meds:

Current Illness:

ID: 1353883
Sex: M
Age: 78
State:

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 01/21/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Chills, loss of taste and smell, weakness, shallow breathing Narrative: Patient referred to facility ER for COVID- 19 testing and evaluation of symptoms

Other Meds:

Current Illness:

ID: 1353884
Sex: M
Age: 86
State: PA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 01/21/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Narrative: Patient received inadvertently early 2nd dose of Pfizer- BioNTech COVID-19 vaccination. He received his 1st dose 1/14/2021 while at dialysis. On 1/19/2021 he then came to the vaccination clinic and received what was thought to be his 1st dose, but after the fact was recognized as his 2nd dose. This 2nd dose on 1/19/21 was only 5 days after his 1st dose on 1/14/21, instead of the recommended 21 days. Symptoms: & Inadvertant early 2nd dose Treatments:

Other Meds:

Current Illness:

ID: 1353885
Sex: M
Age: 76
State: FL

Vax Date: 11/14/2020
Onset Date: 01/16/2021
Rec V Date: 01/21/2021
Hospital:

Lab Data: Collection DT Spec PT INR 01/20/2021 04:00 PLASMA 14.4 H 1.30 H 01/19/2021 04:00 PLASM 14.9 H 1.35 H 01/18/2021 04:00 PLASM 13.7 H 1.24 H 01/17/2021 14:00 PLADM 14.8 H 1.34 H 01/17/2021 04:00 PLASM 14.3 H 1.29 H 01/16/2021 22:50 PLASM 14.0 H 1.27 H 01/16/2021 17:30 PLASM 215.7 H 18.48 H*01/16/2021 12:35 PLASM 222.0 H 19.00 H* 01/16/2021 10:58 PLASM 196.2 H 16.84 H* 01/05/2021 09:56 PLASM 30.6 H 2.73 H Collection DT Spec AST ALT Plts 01/20/2021 04:00 BLOOD 67.0 L 01/20/2021 04:00 PLASM 60 H 168 H 01/19/2021 04:00 PLASM 72 H 211 H 01/19/2021 04:00 BLOOD 72.0 L 01/18/2021 04:00 PLASM 92 H 288 H 01/18/2021 04:00 BLOOD 57.0 L 01/17/2021 14:00 BLOOD 59.0 L 01/17/2021 14:00 PLASM 90 H 287 H 01/17/2021 06:20 BLOOD 43.0 L* 01/17/2021 04:00 PLASM101 H 356 H 01/17/2021 04:00 BLOOD 54.0 L 01/16/2021 17:30 PLASM 166 H 580 H 01/16/2021 17:30 BLOOD 45.0 L* 01/16/2021 10:58 PLASM 241 H 824 H 01/16/2021 10:58 BLOOD 56.0 L 01/05/2021 09:56 BLOOD 189.0 01/05/2021 09:56 PLASM 24 28 Collection DT Spec D-dimer CRP Ferritn 01/20/2021 04:00 PLASM 13.3 H 01/19/2021 04:00 PLASM 21.9 H 01/18/2021 04:00 PLASM 18:20 H 01/17/2021 02:00 PLASM 17.5 H 01/17/2021 02:00 SERUM 14154 H 01/16/2021 22:50 PLASM 1037 H 01/16/2021 17:30 PLASM 1158 H

Allergies:

Symptoms: Patient remains hospitalized but respiratory symptoms are improving, AST/ALT are down-trending, & PT/INR returned to normal. Symptoms: Bleeding, Abnormal INR & ElevatedLiverEnzymes

Other Meds: Tamsulosin, amiodarone, pomalidomide, dexamethasone, metoprolol, hydromorphone, lisinopril, pravastatin, miconazole topical, warfarin, acetaminophen, aspirin, cholecalciferol

Current Illness:

ID: 1353886
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: lip swelling, right side Narrative:

Other Meds:

Current Illness:

ID: 1353887
Sex: M
Age: 61
State:

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 01/21/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Narrative: Patient was found to be short of breath with heart rate in the 140s. Initially he was thought to possibly be having an allergic reaction to the vaccine. For this, he received prednisone, Benadryl and famotidine. These medications did not improve his symptoms. He was then discovered to be in atrial flutter. He was admitted to the ICU for close monitoring. There he remained hemodynamically stable. He was treated with beta blockade that improved his heart rate and his symptoms. He was discharged to home the following day.

Other Meds:

Current Illness:

ID: 1353888
Sex: M
Age: 83
State:

Vax Date: 01/14/2021
Onset Date: 01/19/2021
Rec V Date: 01/21/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Narrative:

Other Meds:

Current Illness:

ID: 1353889
Sex: M
Age: 72
State:

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 01/21/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No, Primary Care Provider recommends for patient still get 2nd dose of vaccine.

Other Meds:

Current Illness:

ID: 1353890
Sex: M
Age: 71
State:

Vax Date: 01/14/2021
Onset Date: 01/17/2021
Rec V Date: 01/21/2021
Hospital:

Lab Data:

Allergies:

Symptoms: lethargy Narrative:

Other Meds:

Current Illness:

ID: 1353891
Sex: F
Age: 36
State:

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

Lab Data:

Allergies:

Symptoms: FATIGUE AND SORENESS AT INJECTION SITE Narrative: FATIGUE RESOLVED WITH NAP THAT DAY. SORENESS LASTED 3 DAYS

Other Meds:

Current Illness:

ID: 1353896
Sex: M
Age: 79
State:

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

Lab Data:

Allergies:

Symptoms: SORENESS AT INJECTION SITE FEVER AND SORENESS LASTED THREE DAYS

Other Meds:

Current Illness:

ID: 0963728
Sex: U
Age:
State: CA

Vax Date: 09/22/2020
Onset Date:
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administration of improperly stored PROQUAD (20.5F); No adverse event; Information has been received from a certified medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided. On 22-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Lot # T015598, recombinant Human albumin (rHA), expiration date on 02-NOV-2021, dosage, route and anatomical location were not provided) for prophylaxis. The dose was stored at 20.5 Fahrenheit degrees for 1 hour and 54 minutes. Previously the dose experienced a temperature excursion from 6 to 14 Fahrenheit degrees (12.3 Fahrenheit degrees) for 23 hours. The report was because of data logger. No adverse event was reported.

Other Meds:

Current Illness:

ID: 0963729
Sex: U
Age: 0
State: MI

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional adverse events reported; a dose of ROTATEQ was administered during a temperature excursion; This spontaneous report was received from a medical assistant referring to a 7 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported. On 18-DEC-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength was not reported, lot # 1684149, expiration date was reported as 21-JUN-2021, but upon internal validation established as 25-JUN-2021) 2 ml orally for prophylaxis (product storage error). It was reported that the suspect vaccine was exposed to a temperature of 8.5 degree Celsius for a time frame of 3 minutes. Data logger was not involved. There were no previous temperature excursions. No further adverse event (AE) information was provided.

Other Meds:

Current Illness:

ID: 0963730
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Caller called to inquiere about components in the PNEUMOVAX23 vaccine and wether or not the COVID 19 vaccine has the same components due to an allergic reaction she experienced when the caller received PNEUMOVAX23 in 2013; This spontaneous report had been received from a female consumer of unknown age regarding herself. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported. On unspecified date in 2013, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) intramuscularly (dose, anatomical location, vaccine scheme, lot number, and expiration date were not provided), as prophylaxis. On an unspecified date, the reporter called to inquired about components in the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) vaccine and whether or not the COVID 19 vaccine had the same components due to an allergic reaction she experienced when she received Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) in an unspecified date in 2013 (Drug hypersensitivity). Therefore, she sought medical attention due the event. The outcome of the event Drug hypersensitivity was not provided. The causal relationship between the event Drug hypersensitivity and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was related.

Other Meds:

Current Illness:

ID: 0963800
Sex: F
Age: 23
State: TX

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Anaphylactic reaction; A spontaneous report was received from a 23-year-old, female consumer who was also a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction. The patient's medical history included allergy to amoxicillin. Concomitant medications reported included gabapentin, escitalopram oxalate, and montelukast sodium. On 04 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, within 24 hours of vaccination, the patient experienced anaphylactic reaction. Treatment for the event included Diphenhydramine. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, anaphylactic reaction, was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 23 year old female patient, who experienced a serious unexpected event of Anaphylactic reaction. Event occurred apparently within 24 hrs. after first dose of mRNA-1273 (Lot# 011L20A) vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: GABAPENTIN; LEXAPRO; SINGULAIR

Current Illness: Allergy to antibiotic (Amoxicillin)

ID: 0963801
Sex: F
Age: 83
State:

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Blooded stools; Eyes are a little bit itchy; Right eye swollen; A spontaneous report was received from a consumer who was an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blooded stools, eyes are a little bit itchy, and right eye swollen. The patient's medical history was not provided. Concomitant medications reported included magnesium. On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J00/NA) intramuscularly for prophylaxis of COVID-19 infection. On the evening of 04 Jan 2021, the patient experienced blooded stools, eyes are a little bit itchy, and right eye swollen. The patient reported having blooded stools that were not diarrhea, but had occurred three or four times. Treatment for the events included non specified allergy medicine for the eyes. On 06 Jan 2021, the patient reported feeling better in regard to the blooded stools and was unsure if it was actually blood or not in her stools and she had ate spicy and red food. Action taken with mRNA-1273 in response to the events was not provided. The event, blooded stools, was considered resolved. The outcome for the events, eyes are a little bit itchy and right eye swollen was unknown.; Reporter's Comments: This case concerns an 83-year-old female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot 025J00/NA), and who experienced the unlisted serious event of Haematochezia and the unlisted non-serious events of Eye pruritus and Eye swelling. Based on the current available information and temporal association between the use of the product and the start date of the event on the day of vaccination, a causal relationship cannot be excluded making the events possibly related to the vaccine.

Other Meds: MAGNESIUM

Current Illness:

ID: 0963802
Sex: F
Age: 68
State: FL

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fainted; Did not feel well; Hit head; A little pain in arm; A spontaneous report was received from a 68-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the events, fainted, hit head, did not feel well, and a little pain in arm. The patient's medical history was not provided. Relevant concomitant medications reported included ezetimibe, atorvastatin, and atenolol. On 04 Jan 2021 at 9:00 am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection. On 06 Jan 2021, the patient reported that she took the vaccine on 04 Jan 2021 and she did not feel anything after but a little pain in her arm. On 05 Jan 2021 around 7:00 pm, the patient went to her fridge for a drink and told her husband she did not feel very well, and then fainted. The patient reported that she hit her head and has never fainted before. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, fainted, hit head, did not feel well, and a little pain in arm, were unknown.; Reporter's Comments: This case concerns a 68-year-old female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of Syncope, the non-serious listed event of Pain in extremity, and the non-serious unlisted events of Head injury and Malaise. Based on the current available information and temporal association between the use of the product and the onset of the events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.

Other Meds: EZETIMIBE; ATORVASTATIN; ATENOLOL

Current Illness:

ID: 0963803
Sex: U
Age:
State: KS

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Intentionally received two doses of vaccine back to back; Intentionally received two doses of vaccine back to back; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and intentionally received two doses of vaccine back to back. The patient's medical history was not provided. No relevant concomitant medications were reported. On 4 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 7 Jan 2021, the patient received a second dose of mRNA-1273. The patient intentionally received the two doses of the Moderna COVID-19 vaccine back to back. No treatment information was provided. No other adverse event was reported. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, intentionally received two doses of vaccine back to back, was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration and intentional product use issue for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 0963804
Sex: U
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: Plunger broke loose and vaccine leaked while administering; Given less or more of the dose; A spontaneous report was received from a physician concerning a patient who received Moderna's Vaccine (mRNA-1273) and experienced syringe issue and incorrect dose administered by device. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection, and during the administration of the vaccine, the plunger broke loose, and the vaccine leaked out. The patient was likely given less than a full dose. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The events, syringe issue and incorrect dose administered by device, were considered resolved on unknown date.; Reporter's Comments: This report refers to a case of syringe issue and incorrect dose administered for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 0963805
Sex: U
Age:
State: NH

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

Lab Data:

Allergies:

Symptoms: 0.1ml instead of 0.5ml dose given; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had 0.1ml instead of 0.5ml dose given. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) for prophylaxis of COVID-19 infection. On an unknown date, during vaccine administration, the patient was given a 0.1 milliliters (ml) dose of vaccine instead of 0.5 ml. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, 0.1ml instead of 0.5ml dose given, was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # 039K20A). There were no reported AEs associated with this case of incorrect dose administered.

Other Meds:

Current Illness:

ID: 0963806
Sex: F
Age: 82
State: OK

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Only a third of the vaccine was given; Patient felt liquid dripping on her right arm; The needle messed up; A spontaneous report was received from a consumer who was a 82-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the needle messed up, the patient felt liquid dripping on her right arm, and only a third of the vaccine was given. The patient's medical history was not provided. No relevant concomitant medications were reported. On 06 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 06 Jan 2021, during vaccine administration, the needle messed up and the patient felt liquid dripping on her right arm. The patient was given only one third of the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events, needle messed up, the patient felt liquid dripping on her right arm, and only a third of the vaccine was given, were considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered, exposure via skin contact and needle issue for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 0963807
Sex: F
Age: 64
State: NJ

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

Lab Data:

Allergies:

Symptoms: tingling in figures of both arms on and off; injection given to her is little lower and not properly in muscle; Headache; A spontaneous report was received from a dentist concerning a 64-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, tingling in fingers of both arms, and injection given to her is little lower and not properly in muscle. The patient's medical history was not provided. Concomitant medication included rosuvastatin calcium. On 01 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced headache, tingling in fingers of both arms, and injection given to her is little lower and not properly in muscle. The treatment information included paracetamol and ibuprofen. Action taken with mRNA-1273 in response to the events was not provided. The event, injection given to her is little lower and not properly in muscle, was considered resolved on 01 Jan 2021. The outcome for the events, headache and tingling in figured of both arms, was unknown.; Reporter's Comments: This case concerns 64-year-old, female, who experienced the non-serious unexpected events of paraesthesia, a non-serious expected event of headache and incorrect route of product administration for mRNA-1273 (Lot# 011L20A). The events of paraesthesia and headache occurred 1 day after the first dose of mRNA-1273 (Lot# 011L20A). There were no reported AEs associated with this case of incorrect route of product administration. The treatment details were not provided. Based on temporal association between the use of the product and the start date of the events (paraesthesia and headache), a causal relationship cannot be excluded.

Other Meds: CRESTOR

Current Illness:

ID: 0963808
Sex: M
Age:
State: TX

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: received dose 1 of the Moderna vaccine past the 6 hr used-by time; A spontaneous report was received from a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received dose 1 of the Moderna vaccine past the 6 hour used-by time. The patient's medical history was not provided. No relevant concomitant medications were reported. On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly for prophylaxis of COVID-19 infection. On 31 Dec 2020, the patient stated that he received 1 dose of the vaccine past the 6 hour used-by time. He stated that his dose of the vaccine was administered 48 hours after the bottle was opened on 29 Dec 2020. No treatment information was reported. Action taken with mRNA-1273 in response to the event was not reported. The event, received dose 1 of the Moderna vaccine past the 6 hour used-by time, was considered resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a male patient who received their first of two planned doses of mRNA-1273 (Lot 025L20A), reporting Out of specification product use without any associated adverse events.

Other Meds:

Current Illness:

ID: 0963809
Sex: M
Age:
State: AZ

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccine injected into shoulder joint; A spontaneous report was received from a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine was injected into shoulder joint. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 30 Dec 2020, during vaccine administration, the vaccine was injected into the patient's shoulder joint instead of the muscle. Treatment for the event was not provided. Action taken with mRNA-1273 in response to the event was not provided. The event, vaccine injected into shoulder joint, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 0963810
Sex: F
Age: 51
State: MI

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: We think an empty syringe was administered to a patient; A spontaneous report was received from a pharmacist concerning a 51-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) who experienced empty syringe administered to patient. The patient's medical history was not provided. No relevant concomitant medications were reported. On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The pharmacist reported that they thought an empty syringe was administered to the patient. They wanted to administer a confirmed dose to the patient, so a second dose was administered. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, empty syringe administered to patient, was resolved on 08 Jan 2021.; Reporter's Comments: This report refers to a case of 51- year-old female patient who experienced non-serious unexpected event of empty syringe was administered to the patient (Product dose omission in error). There were no reported AEs associated with this case of product dose omission in error.

Other Meds:

Current Illness: No adverse event (No reported medical history)

ID: 0963811
Sex: F
Age:
State: NJ

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

Lab Data:

Allergies:

Symptoms: Received first dose of moderna vaccine but it was administered 1 cm below the deltoid muscle; A spontaneous report was received from a physician concerning a female patient who was received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced received first dose of Moderna vaccine but it was administered 1 cm below the deltoid muscle. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 on an undisclosed date intramuscularly for prophylaxis of COVID-19 infection and experienced product administered at inappropriate site when the vaccine was administered one centimeter below the deltoid by a medical student. Treatment information was not provided. Action taken with mRNA-1273 in response to the event, received first dose of Moderna vaccine but it was administered 1 cm below the deltoid muscle, was not provided. The event, received first dose of Moderna vaccine but it was administered 1 cm below the deltoid muscle, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 0963812
Sex: F
Age: 44
State: NC

Vax Date: 12/29/2020
Onset Date: 01/06/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Left arm cellulitis; Multiple other bumps going down her arm; Itchiness on her left arm close to the vaccination site; One big welt approximately the size of a nickel; A spontaneous report was received from a 44 year-old, female health care professional, who was also the patient, who received Moderna's COVID-19 vaccine and experienced left arm cellulitis, multiple other bumps going down her arm, itchiness on her left arm close to the vaccination site, and one big welt approximately the size of a nickel. The patient's medical history was not provided. Concomitant product use was not provided. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) in their left arm for prophylaxis of COVID-19 infection. On the morning of 06 Jan 2021, the patient felt itchiness on her left arm close to the vaccination site. The patient had one big welt approximately the size of a nickel, with multiple other bumps going down her arm. The patient took a diphenhydramine hydrochloride, and her symptoms were improving. The bumps going down her arm were resolving, but not fully resolved. Later, the patient noted that she had experienced cellulitis on her left arm starting eight days after vaccination (06 Jan 2021). She received an injection of triamcinolone acetonide on 11 Jan 2021 that helped with the cellulitis's noticeability. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event cellulitis was unknown. The events multiple other bumps going down her arm, itchiness on her left arm close to the vaccination site, and one big welt approximately the size of a nickel, were considered recovering/resolving.; Reporter's Comments: This case concerns a 44- year old, female, healthcare professional. The patient's medical history was not provided. The patient experienced a serious event of cellulitis, injection site pruritis, vaccination site inflammation and papules. The event occurred 9 days after first dose of mRNA-1273 (Lot number: 025J20A). Vaccination site inflammation is listed on the factsheet and is related to mRNA. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 0963813
Sex: F
Age: 16
State: TX

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Moderna vaccine given to a 16 year old; A spontaneous report was received from a nurse concerning a female 16 year old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given to a 16 year old. The patient's reported medical history included severe intellectual disabilities. No relevant concomitant medications were reported. On 7 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 7 Jan 2021, the nurse reported the Moderna COVID vaccine was given to a 16 year old female patient. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccine given to 16 year old, was considered resolved on 7 Jan 2021.; Reporter's Comments: This case concerns a 16-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 037K20A), reporting Product administered to patient of inappropriate age without any associated adverse events.

Other Meds:

Current Illness: Intellectual disability

ID: 0963814
Sex: F
Age: 56
State: FL

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Felt a sudden rush of weird sensation that went from her feet to her head; Face went beat red; Face started to swell; Couldn't speak; Blood pressure went from 120/70 to 210/107; A spontaneous report was received from a nurse, who was also a 56-years-old, female patient, who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced a sudden rush of a weird sensation that went from her feet to her head, face went beat red, face started to swell, couldn't speak, and blood pressure went from 120/70 to 210/107. The patient's medical history was not provided. Concomitant product use was not provided. On 05 Jan 2021, fifteen minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) for prophylaxis of COVID-19 infection. The patient reported she felt a sudden rush of a weird sensation that went from her feet to her head, and her face went beat red and started to swell. She could not speak. Her blood pressure went from 120/70 to 210/107. Treatment included diphenhydramine, intravenous fluids, and famotidine. Within 15 to 20 minutes after treatment was given, the patient reported that all the symptoms went down (blood pressure, swelling, and the rushed feeling she experienced). Action taken with mRNA-1273 in response to the events was not provided. The events, a sudden rush of a weird sensation that went from her feet to her head, face went beat red, face started to swell, couldn't speak, blood pressure went from 120/70 to 210/107, were considered resolved on 05 Jan 2021.; Reporter's Comments: This case concerns a nurse who is 56- year old, female patient, who experienced a serious, unexpected event of feeling abnormal, erythema, swelling of face, aphasia and increased blood pressure.The event occurred on 05 Jan 2021, fifteen minutes after receiving the first dose of mRNA-1273 (Lot number: 025J20A). Treatment for the event included diphenhydramine, intravenous fluids, and famotidine. The patient's medical history was not provided. Based on the current available information and temporal association between the use of mRNA-1273 (Lot number: 025J20A) and the start of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 0963815
Sex: F
Age: 68
State: FL

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fainted; a little pain in arm; A spontaneous report was received from a consumer concerning a 68-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting and pain in her arm. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 04 Jan 2021, at approximately 09:00am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left deltoid prophylaxis of COVID-19 infection. On 04 Jan 2021, after receiving the vaccine, the patient felt a little pain in her arm. On 05 Jan 2021, at approximately 19:00 the patient fainted after standing up. She hit her head on the floor and had a small bump on her head. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, fainting and pain in her arm, were considered unknown.; Reporter's Comments: This case concerns a 68-year-old female subject with who experienced a serious, unexpected event of fainting and pain her arm. Her medical history and con meds were not provided. The fainting event occurred 1 day after the first dose of the mRNA-1273 study medication administration, after patient stood up, fainted, and hit her head on the floor and sustained a small bump on her head. Treatment for this event was not provided. Very limited information regarding the fainting event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 0963816
Sex: F
Age:
State: NJ

Vax Date: 12/24/2020
Onset Date:
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Facial weakness - palsy; A spontaneous report report was received from a physician concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273)" and developed facial weakness - palsy. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on 24 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection. On 24 Dec 2020, the patient received the vaccine and a week later on an unknown date had developed chronical complication, facial weakness ? palsy. Treatment information included prednisone. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, facial weakness - palsy, was resolved.; Reporter's Comments: This case concerns a female patient with medical history not provided, who developed a serious unexpected event of facial paralysis. The event occurred approximately 2 weeks after first dose of the mRNA-1273 (Lot# unknown). The patient was treated with prednisone and the event was resolved. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 0963817
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

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

Other Meds:

Current Illness:

ID: 0963818
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report (United States) 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: 0963819
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

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

Other Meds:

Current Illness:

ID: 0963820
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

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

Other Meds:

Current Illness:

ID: 0963821
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

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

Other Meds:

Current Illness:

ID: 0963822
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

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

Other Meds:

Current Illness:

ID: 0963823
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

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

Other Meds:

Current Illness:

ID: 0963824
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

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

Other Meds:

Current Illness:

ID: 0963825
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

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

Other Meds:

Current Illness:

ID: 0963826
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

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

Other Meds:

Current Illness:

ID: 0963827
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

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

Other Meds:

Current Illness:

ID: 0963828
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

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

Other Meds:

Current Illness:

ID: 0963829
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

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

Other Meds:

Current Illness:

ID: 0963830
Sex: U
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/22/2021
Hospital:

Lab Data:

Allergies:

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

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm