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: 1001620
Sex: F
Age:
State: GA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No further AE; 12 month old patient received both PROQUAD and VARlVAX; 12 month old patient received both PROQUAD and VARlVAX; This spontaneous report as received from a medical assistant refers to a 12-month-old, non-pregnant female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 27-JAN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly, lot # T010314 has been verified to be a valid lot number, expiration date: 24-MAR-2022 (exact dose, anatomical location were not reported) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA, intramuscularly, lot # T013540 has been verified to be a valid lot number, expiration date: 17-OCT-2021 (exact dose, anatomical location were not reported); both for prophylaxis. Therefore the patient experienced inappropriate schedule of product administration and overdose. The patient was not exhibiting any adverse symptoms and no treatment was given. The outcome of the events was reported as recovered on 27-JAN-2021.

Other Meds:

Current Illness:

ID: 1001621
Sex: U
Age:
State: IL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: improperly stored vaccine was administered; Information has been received from a registered nurse referring to a patient of unknown gender and age. The patient's medical history, concurrent condition and concomitant medication were not provided. On 25-JAN-2021, the patient was administered an improperly stored dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) (1 injection, lot # T004378 has been verified to be a valid lot number for hepatitis b vaccine (recombinant), expiration date reported as 31-OCT-2022, but upon internal validation established as 01-NOV-2022; strength and route were unknown) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 injection, oral, lot # 1688504 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported as 18-NOV-2021, but upon internal validation established as 19-NOV-2021; strength was unknown) for prophylaxis. The vaccines underwent temperature excursions prior to being administered at above 9 degrees Celsius (13.4 degrees Celsius) for 2 hours and 9 minutes (incorrect product storage). There was no previous temperature excursion. The data logger was involved.

Other Meds:

Current Illness:

ID: 1001622
Sex: U
Age:
State:

Vax Date: 12/06/2020
Onset Date: 12/06/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: massive amount of congestion; This case was reported by a consumer and described the occurrence of respiratory tract congestion in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 6th December 2020 13:00, the patient received Shingrix. On 6th December 2020, less than a day after receiving Shingrix, the patient experienced respiratory tract congestion. On an unknown date, the outcome of the respiratory tract congestion was unknown. It was unknown if the reporter considered the respiratory tract congestion to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The reporter's friend got a shingles shot and had a massive amount of congestion but no fever, also asked if there could be a connection. The congestion was conservatively coded as nasal congestion.

Other Meds:

Current Illness:

ID: 1001623
Sex: U
Age:
State:

Vax Date: 12/04/2020
Onset Date: 12/01/2020
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: large red itchy hot circle at the injection site; large red itchy hot circle at the injection site; large red itchy hot circle at the injection site; This case was reported by and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On 4th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient received 2nd injection of Shingrix on Friday morning, 2.5 days before the date of reporting. The patient was experiencing a large red itchy hot circle at the injection site. The patient asked if it was normal.

Other Meds:

Current Illness:

ID: 1001624
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I'm allergic to ingredients.; This case was reported by a consumer via interactive digital media and described the occurrence of allergy in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown. It was unknown if the reporter considered the allergy to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient allergic to the ingredients of Flu shot. No other information was available.

Other Meds:

Current Illness:

ID: 1001625
Sex: F
Age: 69
State: CT

Vax Date: 08/30/2020
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: rash on right hip that itched and tingled; rash on right hip that itched and tingled; This case was reported by a consumer and described the occurrence of itchy rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 30th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced itchy rash and tingling. On an unknown date, the outcome of the itchy rash and tingling were unknown. It was unknown if the reporter considered the itchy rash and tingling to be related to Shingrix. Additional details were reported as follows: The patient received Shingrix and no reaction until 1 month later she developed a rash on right hip that itched and tingled it was not terrible but it lasted for a while 1.5 month. For tolerances of 2nd dose, refer case US2020244414, reported by same reporter for the same patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2020244414:same reporter

Other Meds:

Current Illness:

ID: 1001626
Sex: F
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sore arm after receiving a Shingrix shot; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The reporter was friend. The age at vaccination was not reported. The patient was in her 60's and had complained about having a sore arm (at injection site) after receiving a Shingrix shot. No further information was gathered such as the patient's initials or whether it was dose 1 or dose 2(or both). The reporter also stated that patient did not experience a fever after receiving the Shingrix shot. This is 1 of 5 linked cases, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021013457:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014254:Same reporter. US-GLAXOSMITHKLINE-US2021013450:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014110:Same reporter.

Other Meds:

Current Illness:

ID: 1001627
Sex: F
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sore arm after receiving a Shingrix shot; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The reporter was friend. The age at vaccination was not reported. The patient was in her 60's and had complained about having a sore arm after receiving a Shingrix shot. No further information was gathered such as the patient's initials or whether it was dose 1 or dose 2(or both). The reporter also stated that patient did not experience a fever after receiving the Shingrix shot. This is 1 of 5 linked cases, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021013457:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014253:Same reporter. US-GLAXOSMITHKLINE-US2021013450:Same reporter. US-GLAXOSMITHKLINE-US2021AMR014110:Same reporter.

Other Meds:

Current Illness:

ID: 1001628
Sex: F
Age: 68
State: NJ

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: couldn't get up or move; extreme lethargy that was so extreme; panicked because she thought that she had COVID; feeling like she was frozen and she was so cold; fever; didn't get out of bed for two days; This case was reported by a consumer via call center representative and described the occurrence of immobile in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 15th January 2021 11:00, the patient received the 1st dose of Shingrix (intramuscular). On 15th January 2021, less than a day after receiving Shingrix, the patient experienced immobile (serious criteria GSK medically significant), lethargy, panic reaction, feeling cold, fever and bedridden. On an unknown date, the outcome of the immobile, lethargy, panic reaction, feeling cold and fever were unknown and the outcome of the bedridden was recovered/resolved. It was unknown if the reporter considered the immobile, lethargy, panic reaction, feeling cold, fever and bedridden to be related to Shingrix. Additional details were provided as follows: After receiving 1st dose of Shingrix, the patient experienced bad reaction that including feeling like she was frozen and she was so cold that she couldn't get up or move and then she got a fever and she didn't get out of bed for two days. The patient also reported that during this experience she was panicked because she thought that she had COVID. The patient described her experience as having extreme lethargy that was so extreme. The patient couldn't move on Saturday and Sunday and then on Monday she felt like she never had anything. The reporter consent to follow up.

Other Meds:

Current Illness:

ID: 1001629
Sex: F
Age: 54
State: FL

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Date: 20210108; Test Name: Diastolic blood pressure; Test Result: Inconclusive ; Result Unstructured Data: 190; Test Date: 20210109; Test Name: Diastolic blood pressure; Test Result: Inconclusive ; Result Unstructured Data: 106; Test Date: 20210108; Test Name: Blood Pressure; Test Result: Inconclusive ; Result Unstructured Data: 188/80; Test Date: 20210108; Test Name: Heart Rate; Result Unstructured Data: 135 heart beats per minute

Allergies:

Symptoms: ringing in her ears described as piercingly loud; Injection site itchy, red, swollen, and hard as a rock; Injection site itchy, red, swollen, and hard as a rock; Injection site itchy, red, swollen, and hard as a rock; Injection site itchy, red, swollen, and hard as a rock; fatigue; headache; Did not feel well enough to drive; Blood pressure increased; heart rate went to 135 bpm; Expired vaccine administered; felt like her heart was beating out of her chest; irregular heartbeat; did not feel right; A spontaneous report was received from a 54 year old female patient who experienced expired vaccine administered, felt like her heart was beating out of her chest; irregular heartbeat, ringing in her ears described as piercingly loud, did not feel right, blood pressure increased, heart rate went to 135 bpm, injection site itchy, red, swollen, and hard as a rock, did not feel well enough to drive, fatigue, and headache with the use of mRNA-1273. The patient's medical history included fatigue going back months, iron deficiency diagnosed Dec 2020, heart Arrhythmia, Allergy to penicillin, Allergy to nubain, several environmental allergies, Allergy to topical Metrogel, allergy to topical benzyl peroxide. There were no concomitant medications provided. On 08 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot # 026L20A) intramuscularly, in her left deltoid, for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient experienced expired vaccine administered, noting that the facility where she was vaccinated saying they had a dose that was going to expire in 10 minutes and if she could come get vaccinated. She stated by the time the dose was administered if was about 50 minutes. She noted that the first 15 minutes she felt fine and and after bending over to pick up some papers, she did not feel right and felt like her heart was beating out of her chest. She denied feeling stressed, denied throat swelling, difficulty breathing, and no rash. At that time she was laid down on a gurney. Her blood pressure had increased to 190/unknown number and her heart rate went to 135 bpm. The patient declined to go to the emergency room and sat in the outpatient waiting room for two hours. She reported she did not feel well enough to drive and had to get a ride home. That same night she experienced an irregular heartbeat, but felt it was due to donating blood. She woke up around midnight and her blood pressure was 188/80 and she experienced ringing in her ears described as piercingly loud. The next morning her blood pressure was back down to 106/unknown number. She noted it took a long time to get her heart rate and blood pressure back down to normal. She felt it was due to not having enough water the previous day and night. On 09 Jan 2021 she experienced fatigue, headache, and injection site itchy, red, swollen, and hard as a rock. She took paracetamol and the headache was relieved. Additionally, she took diphenhydramine hydrochloride for the injection site reaction which resolved from 11 Jan 2021 until 15 Jan 2021, when it started itching again, described as "like it reactivated again." At that time, she treated with unspecified topical cream. As of 19 Jan 2021 the injection site still had a reaction. Action taken with mRNA-1273 in response to the event was not provided. The outcome for the event of fatigue was unknown at the time of this report. The events of expired vaccine administered, felt like her heart was beating out of her chest; irregular heartbeat, ringing in her ears described as piercingly loud, did not feel right, headache, blood pressure increased, did not feel well enough to drive, and heart rate went to 135 bpm was recovered/resolved. The events of injection site itchy, red, swollen, and hard as a rock were not recovered/not resolved at the time of this report.; Reporter's Comments: This case concerns 54-year-old, female, with a medical history of fatigue going back months, iron deficiency (Dec 2020), heart Arrhythmia, Allergy to penicillin, Nubain, and topical creams including Metro-gel and benzyl peroxide, among others, who experienced out of specification product use and non-serious unexpected event of heart rate irregular, tinnitus, feeling abnormal, blood pressure increased, heart rate increased and malaise, and non-serious expected events of injection site pruritus, injection site induration, injection site erythema, injection site swelling, fatigue and headache. There was no AEs associated with out of specification product use. However, the event of heart rate irregular, heart rate irregular, and malaise occurred 1 days after mRNA-1273 (Lot# 026L20A), while the events of headache, tinnitus, injection site pruritus, injection site induration, injection site swelling and fatigue occurred 2 days after mRNA-1273 (Lot# 026L20A). The event of feeling abnormal occurred on an unspecified date after mRNA-1273 (Lot# 026L20A). Treatment included Tylenol, Benadryl and topical cream. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.

Other Meds:

Current Illness: Arrhythmia cardiac (NOS) (had recent echo and halter monitoring); Drug allergy (ER visit due to lip and eye swelling from topical Metrogel); Drug allergy; Environmental allergy (tons of environmental allergies); Fatigue (going back months); Iron deficiency; Penicillin allergy

ID: 1001630
Sex: F
Age: 69
State: CA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: Potassium; Test Result: Inconclusive ; Result Unstructured Data: 4.3 to 3.9 millimole per litre; Test Date: 20210119; Test Name: Potassium; Test Result: Inconclusive ; Result Unstructured Data: 1 millimole per litre; Test Date: 20210119; Test Name: Blood pressure; Result Unstructured Data: 223/105-110 mmHg

Allergies:

Symptoms: Anaphylactic shock; Potassium "dropped to 1%"; Cold and numb sensation; Sweating; Chest pressure; Blood pressure was 223/105-110; Neck swelling; Numb lips; Throat swelling; Disability NOS; A spontaneous report was received from a 69-year-old, female, patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced anaphylactic shock, potassium dropped to 1%, cold and numb sensation, sweating, chest pressure, blood pressure was 223/105-110,Neck swelling, Throat swelling, Numb lips and disability. The patient's medical history, as provided by the reporter, included allergies to yellow 5 (tartrazine), shellfish, and bee stings. Concomitant product use was not provided by the reporter. On 19 Jan 2021 at 11:42 AM, approximately two minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, minutes after receiving the vaccine, the patient experienced a cold and numb sensation on the upper right part of her back. The sensation extended around her shoulder and into her clavicle region. Approximately 30 minutes after vaccination she started sweating and felt like she was going into anaphylactic shock, which she had experienced in the past. The patient felt like her throat was swelling and her neck started to visibly swell. One hour after vaccination, the patients lips went numb, the clavicular numbness continued, and she started to experience chest pressure. A paramedic then evaluated the patient, her blood pressure was 223/105-110 mmHg, she was placed in an ambulance, given diphenhydramine and solumedrol, then taken to the emergency room. At the emergency room, the patient received a chest x-ray, computed tomography scan, blood tests, and an electrocardiogram. Previously, the patient had a blood test which showed a potassium of 4.3 to 3.9 "or something." At the emergency room, her potassium had "dropped to 1%." The patient was administered potassium in the hospital and was held for observation until approximately 10:00 PM, then discharged. On 20 Jan 2021, the patient continued to experience chest tightness. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events anaphylactic shock, potassium dropped to 1%, cold and numb sensation, sweating,blood pressure was 223/105-110 ,Neck swelling, Throat swelling, Numb lips and disability was unknown. The event, chest pressure was considered not resolved.; Reporter's Comments: This case concerns a 69-year-old, female patient with medical history of allergies to yellow 5 (tartrazine), shellfish, and bee stings, who experienced a serious, unexpected event of anaphylactic shock, sweating, hypoaesthesia, pharyngeal swelling, neck swelling, numb lips, chest discomfort, hypertension, hypokalemia and disability NOS. The event occurred the day the first dose of mRNA-1273 was administered. 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: Allergy (Yellow #5 (tartrazine)); Bee sting hypersensitivity; Shellfish allergy

ID: 1001631
Sex: F
Age: 84
State: VA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Rectal bleeding; Vomiting blood; A spontaneous report was received from an 84-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced rectal bleeding and vomited blood. The patient's medical history was not reported. No concomitant medications were reported. On 11 Jan 2021, the patient received their first two planned doses of mRNA-1273 (Batch number: 012L20A) intramuscularly, for the prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient experienced rectal bleeding and vomited blood. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, rectal bleeding and vomited blood were considered resolved on 11 Jan 2021.; Reporter's Comments: This case concerns an 84-year-old female patient. The medical history is not provided. The patient experienced a medically significant and unexpected event of Rectal bleeding and Vomited blood the same day after receiving their first of two planned doses of mRNA-1273 (Lot 012L20A). Treatment information is not provided. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 1001632
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Myocarditis; A spontaneous report was received from an healthcare professional, regarding a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Myocarditis. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On Unknown date, after receiving the vaccine, the patient experienced Myocarditis. Treatment for the event was not provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, Myocarditis is Unknown.; Reporter's Comments: This case concerns a patient, who experienced a serious unexpected event of myocarditis. The event occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment was not reported. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1001633
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Given an injection of >.5mL of Moderna COVID-19 vaccine; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was given an injection of more than 0.5mL of Moderna Covid-19 vaccine. 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: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the physician reported that a patient was given an injection of greater than .5mL of Moderna Covid-19 vaccine and was seeking advice on what to do. Action taken with mRNA-1273 in response to the event was not reported. The event given an injection of more than .5mL of Moderna Covid-19 vaccine was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of Incorrect dose administered.

Other Meds:

Current Illness:

ID: 1001634
Sex: M
Age:
State: NJ

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Had the flu quadrivalent shot and got the 1st dose of Moderna Covid-19 vaccine 10 days later; A spontaneous report was received from a consumer, concerning himself, a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and had the flu quadrivalent shot and got the 1st dose of Moderna Covid-19 vaccine 10 days later. The patient's medical history was not provided. Concomitant medications reported included flu quadrivalent shot. On 22-Jan-2021, prior to the onset of event, the patient received his first of two planned doses of mRNA-1273 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 12-Jan-2021, the patient received flu quadrivalent shot and 10 days later, on 22-Jan-2021, the patient received the Moderna COVID-19 vaccine. Patient also claimed that he was feeling fine. No further information was provided at the time of this report. Reporter provided consent to follow up. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, had the flu quadrivalent shot and got the 1st dose of Moderna Covid-19 vaccine 10 days later, was resolved on 22-Jan-2021.; Reporter's Comments: This case concerns a male of unknown age who received his first of two planned doses of mRNA-1273 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection and had the flu quadrivalent shot and got the 1st dose of Moderna Covid-19 vaccine 10 days later. There were no reported adverse events after the vaccine was administered in this case of inappropriate schedule of product administration.

Other Meds: QUADRIVALENT INFLUENZA VACCINE

Current Illness:

ID: 1001635
Sex: M
Age:
State: MI

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Needle separated from the syringe during administration; Was able to administer some of the vaccine before needle was separated from syringe and was not sure how much dose was given to the patient; A spontaneous report was received from a nurse, concerning a 73-year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and noted needle separated from the syringe during administration and was able to administer some of the vaccine before needle was separated from syringe and was not sure how much dose was given to the patient. The patient's medical history was not reported. Concomitant medications were not specified. On 07-Jan-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 07-Jan-2021, the nurse reported that, the needle got separated from the syringe during administration of the vaccine. Hence, the nurse was able to administer some of the vaccine but was unsure of how much of the dose was given to the patient. The patient has been monitored and no adverse event has been reported. Patient was on concomitant medications but the name of which was not known. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not reported. The events, needle separated from the syringe during administration and was able to administer some of the vaccine before needle was separated from syringe and was not sure how much dose was given to the patient were considered to be resolved on 07-Jan-2021.; Reporter's Comments: This case concerns a 73 year old male who received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection and noted needle separated from the syringe during administration and was able to administer some of the vaccine before needle was separated from syringe and was not sure how much dose was given to the patient. There were no reported adverse events after the study drug was administered in this case of syringe connection issue and incorrect dose administered.

Other Meds:

Current Illness:

ID: 1001636
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Name: Blood pressure

Allergies:

Symptoms: Throat started closing; Blood pressure went to 185 over 125; A spontaneous report was received concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat started to close and blood pressure went to 185 over 125. The patient's medical history included allergies to shellfish. Concomitant product use was not provided. On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On the unknown date, approximately 18 minutes after receiving the vaccine, the patient's throat started to close and her blood pressure went to 185/125 mmHg. The patient had ice packs placed on her and she was hooked up to electrodes. Within 45 minutes, the patient's blood pressure went back down. No additional treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The events, throat started to close and blood pressure went to 185 over 125, were considered resolved.; Reporter's Comments: This case concerns a senior, female patient, with a history of allergies to shellfish, who experienced a serious unexpected event of throat tightness and hypertensive crisis. The events occurred on 1 day (approximately 18 min) after first dose of mRNA-1273, lot # unknown. Treatment included ice pack. Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.

Other Meds:

Current Illness: Shellfish allergy

ID: 1001637
Sex: F
Age: 16
State: ID

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Patient was vaccinated being 16 years old; A spontaneous report was received from a 16-year old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. Concomitant medications were not provided. On 21 Jan 2021, the patient received her first dose of two planned doses of mRNA-1273 (Lot Number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient received the mRNA-1273 vaccine at the age of 16-years old. No treatment for the event was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, patient was vaccinated being 16 years old was considered Resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 16 year old female who received her first dose of two planned doses of mRNA-1273 (Lot Number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events after vaccine was administered in this case of product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 1001638
Sex: F
Age: 15
State: ID

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccine was given to a 15 year old; A spontaneous report was received from a pharmacist, concerning a 15-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had event vaccine was given to a 15-year-old. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 20-Jan-2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 20-Jan-2021, there might have been a mix up and the 15-year-old patient received the Moderna COVID-19 vaccine instead of the Pfizer vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine was given to a 15-year-old was considered resolved on 20-Jan-2021.; Reporter's Comments: This case concerns a 15-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 1001639
Sex: F
Age:
State:

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: some of the liquid leaked and fell on patient's arm; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 Vaccine, in which some of the liquid leaked and fell on patient's arm. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 26 Jan 2021, the patient received two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 26 Jan 2021, some of the liquid leaked and fell on patient's arm while receiving their second dose of Moderna COVID-19 vaccine due to the needle not securely attached to the syringe. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event some of the liquid leaked and fell on patient's arm was not reported.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 1001640
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Women might have received a less dose than the recommended because she saw some liquid left in the syringe when the administration of the vaccine was ended; A spontaneous report was received from a consumer concerning a female patient (age unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and the woman thought that she might have received a less dose than the recommended because she saw liquid left in the syringe when the administration of the vaccine was ended. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first dose of MRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the woman thought that she might have received a less dose than the recommended because she saw liquid left in the syringe when the administration of the vaccine was ended. No treatment for the event was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, the woman thinks that she might have received a less dose than the recommended because she saw liquid left in the syringe when the administration of the vaccine was ended was not reported.; Reporter's Comments: This case concerns a female patient who received her first dose of MRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and the woman thought that she might have received a less dose than the recommended because she saw liquid left in the syringe when the administration of the vaccine was ended. There were no reported adverse events after the vaccine was administered associated with the event of incorrect dose administered

Other Meds:

Current Illness:

ID: 1001641
Sex: F
Age: 63
State: TX

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: felt that some amount of the vaccine dripped onto her arm; A spontaneous report was received from a pharmacist concerning a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and felt that some amount of the vaccine dripped onto her arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 25 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. Date of first dose of the vaccine was not provided. On 25 Jan 2021, the patient was given her 2nd dose of the Moderna COVID-19 vaccine and claimed that she felt that some amount of the vaccine dripped onto her arm. Consent to follow up obtained. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, felt that some amount of the vaccine dripped onto her arm, was resolved on 25 Jan 2021.; Reporter's Comments: This case concerns a 63 year old female patient who received her second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection and felt that some amount of the vaccine dripped onto her arm. There were no reported adverse events associated with this case of incomplete dose administered.

Other Meds:

Current Illness:

ID: 1001642
Sex: F
Age:
State: AZ

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The vial was open for 48 hours in refrigerated condition, administered to patient; A spontaneous report was received from a pharmacist concerning a 32-year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and that the vial was open for 48 hours in refrigerated condition and vaccine was administered to patient. The patient's medical history was not provided. No concomitant medications were reported. On 24 Jan 2021 at approximately 12:01pm, the patient received first dose of mRNA-1273 (Lot number: 062G20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 24 Jan 2021, a dose of the vaccine was administered after the vial had been in refrigerated conditions for 48 hours. The pharmacist wants to know what the efficacy of a vial that was administered to a patient after 6 hours and is inquiring if the dose should be repeated. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event "the vial was open for 48 hours in refrigerated condition, administered to patient' was not provided.; Reporter's Comments: This case concerns a 32 year old female who received first dose of mRNA-1273 (Lot number: 062G20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection and the vial was open for 48 hours in refrigerated condition and vaccine was administered to patient. There were no reported adverse events after the vaccine was administered in this case of product storage error.

Other Meds:

Current Illness:

ID: 1001643
Sex: F
Age: 16
State: NJ

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered to a 16 year old by mistake; Sore arm; A spontaneous report was received from a nurse concerning a 16-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced sore arm. The patient's medical history was not provided. Concomitant product use was not reported. On 23 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient was 16 years of age when she was administered the mRNA-1273 vaccine by mistake. Additionally, the patient experienced a sore arm. No treatment information was provided. The second dose of mRNA-1273 was discontinued in response to the events. It was reported the patient would be receiving Pfizer's COVID-19 vaccine as their second dose. The outcome of the event, given vaccine to a 16-year-old by mistake, was considered resolved. The outcome of the event, sore arm, was unknown.; Reporter's Comments: This case concerns a 16 year old female patient received her first of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced a non-serious unlisted event of sore arm. There were no other reported adverse events after the vaccine was administered in this event of product administered to patient of inappropriate age. Patient cannot be contacted and no further queries are issued.

Other Meds:

Current Illness:

ID: 1001644
Sex: F
Age:
State: MA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Large volume of vaccine ran down arm during the shot; Large volume of vaccine ran down her arm; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and a large volume of vaccine ran down her arm during the shot. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection. During the administration, a large volume of vaccine ran down the patient's arm during her shot. No treatment information was reported. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, large volume of vaccine ran down her arm during the shot, was resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a female patient of unknown age who received her first of two planned doses of mRNA-1273 (Lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection and during the vaccine administration, a large volume of vaccine ran down the patient's arm. There were no reported adverse events after the vaccine was administered in this case of underdose and exposure via skin contact.

Other Meds:

Current Illness:

ID: 1001645
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Inappropriate administration (drip down arm); dripped down his arm; A spontaneous report was received from a consumer who was a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine was not administered correctly and dripped down his arm. The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. While receiving the vaccine, the patient suspected that the vaccine was not administered correctly and dripped down his arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The event, vaccine was not administered correctly and dripped down his arm, was considered resolved on an unknown date.; Reporter's Comments: This case concerns a male patient who received his first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection the vaccine was not administered correctly and dripped down his arm. There were no reported adverse events after the vaccine was administered in this case of Incomplete dose administered and exposure via skin contact.

Other Meds:

Current Illness:

ID: 1001646
Sex: M
Age: 76
State: VA

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: chills from neck to waist; received it up on my shoulder higher than normal; A spontaneous report was received from a consumer who was also a 76-years-old, white, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received it up on my shoulder higher than normal and experienced chills from the neck to waist. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, six days prior to the onset of the event, the patient received their first dose of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient received his vaccine and reported that he "received it up on my shoulder higher than normal". On 26 Jan 2021, the patient experienced chills from his neck to waist. He felt fine the next day. Treatment for the events, included 3 teapots of Earl Grey Tea, which did not help. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, received it up on my shoulder higher than normal, was not reported. The outcome of the event, chills from the neck to waist, was resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a white male patient who received their first dose of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection and received shot up on shoulder higher than normal and experienced non-serious listed event of chills from the neck to waist. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event of chills, a causal relationship cannot be excluded and the event of chills is possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 1001647
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine that patient got; Luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine that patient; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine patient got and leaked down the patient's arm. The patient's medical history was not provided. No concomitant product use was reported. On unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On the unknown date, the luer lock between the syringe and the needle came undone. Some of the vaccine leaked down the patient's arm and was unknown how much of the vaccine the patient actually received. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, the luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine patient got and leaked down the patient's arm, was considered resolved.; Reporter's Comments: This spontaneous report concerns a female patient who experienced a non-serious event of luer lock between the syringe and needle came undone and we are not sure what percent of the vaccine patient got and leaked down the patient's arm (Syringe connection issue and incomplete dose administered ). The event occurred during the administration of the first dose of the mRNA-1273 vaccine (Lot #: Unknown, expiration date-Unknown). There were no reported AEs associated with the events of syringe connection issue and incomplete dose administered.

Other Meds:

Current Illness:

ID: 1001648
Sex: M
Age:
State: CO

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: inadvertently vaccinated an elderly gentleman that had just been vaccinated; A spontaneous report was received from a nurse concerning a male, elderly, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and inadvertently vaccinated an elderly gentleman that had just been vaccinated. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, it was reported that the outreach team inadvertently vaccinated an elderly gentleman that had just been vaccinated on Friday, 22 Jan 2021. The patient had forgotten that had received the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, inadvertently vaccinated an elderly gentleman that had just been vaccinated, was resolved.; Reporter's Comments: This case concerns a male elderly patient who received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection, however, the outreach team inadvertently vaccinated an elderly gentleman that had just been vaccinated five days earlier. The patient had forgotten that he had received the vaccine. There were no reported adverse events after the vaccine was administered in this case of inappropriate schedule of vaccine administered.

Other Meds:

Current Illness:

ID: 1001649
Sex: M
Age: 35
State: MN

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Did not get the full dose due to a faulty needle; Did not get the full dose due to a faulty needle; A spontaneous report was received from a pharmacist concerning a 35-year old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive the full dose due to faulty needle. The patient's medical history was not provided. Concomitant product use was not reported. On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 028L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 19 Jan 2021, during vaccine administration, the patient did not get the full dose due to a faulty needle. Treatment for the event was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, did not receive the full dose due to faulty needle, was considered resolved on 19 Jan 2021.; Reporter's Comments: This case concerns a 35 year old male patient received their first of two planned doses of mRNA-1273 (Lot Number: 028L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection and did not receive the full dose due to faulty needle. There were no reported adverse events after the vaccine was administered in this case of the patient did not get the full dose due to a faulty needle.

Other Meds:

Current Illness:

ID: 1001650
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: decent size lump; redness; Vaccine given in the middle of their arm; A spontaneous report was received from a consumer who is a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event of vaccine administered at inappropriate site and experienced descent size lump and redness which seemed to grow. The patient's medical history was not provided. Concomitant medications were not reported. On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient received vaccine in the middle of her arm. The patient stated that she experienced descent size lump and redness which seemed to grow, which is now stopped but is still there. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, vaccine administered at inappropriate site, was considered resolved and descent size lump and redness which seemed to grow, was considered unknown.; Reporter's Comments: This case concerns a female patient, who experienced a product administration error of product administration at inappropriate site and non-serious expected events of injection site induration, and injection site erythema . There were no AEs associated with product administration at inappropriate site. The events of injection site induration, injection site erythema occurred 1 day (same day) after first dose of mRNA-1273 . Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1001651
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Didn't get the full dose; saw a bubble in the needle; A spontaneous report was received from a consumer concerning a 75 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced wrong technique in device usage process and didn't get the full dose. The patient's medical history was not provided. Concomitant medications were not provided. On an unknown date the patient received their first of two planned doses of mRNA-1273 (lot number 026C20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient states that when she was getting her first dose she saw a bubble in the needle and wasn't sure if she received a full dose. Treatment information was not provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, experienced wrong technique in device usage process and didn't get full dose were considered resolved.; Reporter's Comments: This case concerns a 75 year old female patient who received her first of two planned doses of mRNA-1273 (lot number 026C20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection and experienced wrong technique in device usage process and didn't get the full dose. There were no reported adverse events after the vaccine was administered in this case of wrong technique in device usage process and incomplete dose administered. .

Other Meds:

Current Illness:

ID: 1001652
Sex: U
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Received 1ml instead of 0.5ml on first dose; A spontaneous report was received from a pharmacist, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) 1ml on first dose. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number: not provided) for prophylaxis of COVID-19 infection. On an unspecified date, for the first dose, the patient received 1mL of vaccine instead of 0.5mL in one of their clinics and the patient had already received their second dose as well. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event received 1mL on first dose was considered resolved on an unspecified date.; Reporter's Comments: This case concerns a patient of unspecified age and gender who received their first of two planned doses of mRNA-1273 (lot number: not provided) for prophylaxis of COVID-19 infection and received 1mL of vaccine instead of 0.5mL in one of their clinics. There were no reported adverse events after the vaccine was administered in this case of incomplete dose.

Other Meds:

Current Illness:

ID: 1001653
Sex: F
Age:
State: PA

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: She thinks the vaccine provider may not have pushed the plunger after she stuck the needle in; A spontaneous report was received from a female consumer of unknown age who received Moderna COVID-19 vaccine on 16-JAN-2021 thought that the vaccine provider may not have pushed the plunger after she stuck the needle in. The patient's medical history was not provided. The concomitant product use was not provided by the reporter. On 16 JAN 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) through intramuscular route in her left arm for prophylaxis of COVID-19 infection. The patient thought that the vaccine provider may not have pushed the plunger after she stuck the needle in her left arm because the nurse was abruptly distracted. The provider told the patient that after two weeks she could get an antibody test to see if she actually got the vaccine. The patient reported that the establishment where she got her original vaccine was shut down. The patient asked about time frame for receiving the Moderna vaccine. The patient has been advised to reach out to her Healthcare Professional for any concerns which she may had. Treatment information was not provided. The Action taken with the second dose of mRNA-1273 in response to the event was not provided. The outcome of the event, she thought the vaccine provider may not have pushed the plunger after she stuck the needle in was resolved.; Reporter's Comments: This report refers to a case of Product administration error - wrong technique in device usage process ,for mRNA-1273 , COVID-19 vaccine. There were no reported AEs associated with this case of Product administration error ?wrong technique in device usage process .

Other Meds:

Current Illness:

ID: 1001654
Sex: U
Age:
State: OR

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: May not have received the full dose; A spontaneous report was received from a physician, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and may not have received the full dose. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the physician reported that someone may not have received the full dose. Action taken with mRNA-1273 in response to the event was not reported. The event may not have received the full dose was considered resolved on an unspecified date.; Reporter's Comments: This case concerns a patient of unknown age who received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection and may not have received the full dose. There were no reported adverse events after the vaccine administered in this case of incomplete dose administered.

Other Meds:

Current Illness:

ID: 1001655
Sex: F
Age: 57
State: MD

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Felt like the person didn't puncture her correctly; Arm Felt really Heavy; Stiff neck; A spontaneous report was received from a consumer regarding herself, a 57-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and felt like the person didn't puncture her correctly, arm felt very heavy and stiff neck. The patient's medical history was not provided. Concomitant medications were not provided. On 28 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot Number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection. On 28 Jan 2021, immediately after receiving vaccine, patient felt like the person didn't puncture her correctly (A little bit over the shoulder), hence her arm felt very heavy and had stiff neck. No treatment for the event was provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events felt like the person didn't puncture her correctly was considered resolved on 28 Jan 2021. The outcome of the events, arm felt very heavy and stiff neck were unknown.; Reporter's Comments: This report refers to a case of wrong technique in device usage process (the person didn't puncture her correctly) for mRNA-1273 and concerns a 57 year-old, female patient, who experienced the events of arm felt very heavy and stiff neck. The events occurred immediately after the first and only dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.

Other Meds:

Current Illness:

ID: 1001656
Sex: F
Age: 71
State: CA

Vax Date: 01/17/2021
Onset Date: 01/17/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Administered the vaccine much lower on her arm about 5 inches below where it was supposed to be injected; A spontaneous report was received from a nurse, concerning herself, a 71-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and administered the vaccine much lower on her arm about 5 inches below where it was supposed to be injected. The patient's medical history was not provided. No concomitant medications were reported. On 17-Jan-2021, prior to the onset of the event, the patient received her first of two planned doses of mRNA-1273 (lot number 029L20A) intramuscularly in arm for prophylaxis of COVID-19 infection. On 17-Jan-2021, the vaccine was administered much lower on patient's arm, about 5 inches below where it was supposed to be injected. Treatment information was not provided Action taken with mRNA-1273 in response to the event was not provided. The event administered the vaccine much lower on her arm about 5 inches below where it was supposed to be injected was considered resolved on 17-Jan-2021.; Reporter's Comments: This case concerns a 71 year old female patient who received their first of two planned doses of mRNA-1273 (lot number 029L20A) intramuscularly in arm for prophylaxis of COVID-19 infection and the vaccine was administered much lower on patient's arm. There were no reported adverse events after the vaccine was administered in this case of incorrect route of product administration.

Other Meds:

Current Illness:

ID: 1001657
Sex: U
Age:
State: NY

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Temperature excursion; A spontaneous report was received from a physician concerning twenty patients who received Moderna's COVID-19 vaccine (mRNA-1273) that underwent a temperature excursion The patients' medical history was not provided. No relevant concomitant medications were reported. On 11 Jan 2021, mRNA-1273 vaccines were exposed to a temperature excursion (peak temperature 51 degrees Fahrenheit) for 1 hour and 18 minutes. It is unknown how long the temperature was at 51 degrees Fahrenheit. From two (2) vials exposed to temperature excursions, twenty(20) doses were given. On 12 Jan 2021, the twenty patients received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event, temperature excursion, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of Out of specification product use for mRNA-1273. There were no reported AEs associated with this case.

Other Meds:

Current Illness:

ID: 1001658
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Vaccination administered more subcutaneous than intramuscular.; A spontaneous report was received from a consumer of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) more subcutaneous than intramuscular. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, prior to the onset of event, the patient received one of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. On an unspecified date, the patient received a dose of vaccine more subcutaneously than intramuscularly. Treatment information was not provided. Action taken with mRNA-1273 in response to event was not reported. The outcome of the event, vaccination administered more subcutaneous than intramuscular was resolved on an unspecified date.; 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: 1001659
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Employee received her second dose of Moderna COVID-19 vaccine 20 days after her first dose; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 Vaccine, and who received her second Moderna Covid-19 vaccine 20 days after her first dose. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received her first of two planned doses of mRNA-1273 on an undisclosed date. On an undisclosed date, the patient received her second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection twenty days after her first dose. Treatment information was unknown. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome of the event, received her second Moderna Covid-19 vaccine 20 days after her first dose, was resolved.; Reporter's Comments: This case concerns a female patient of unknown age, who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration.

Other Meds:

Current Illness:

ID: 1001660
Sex: F
Age: 16
State: MA

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 16 year old inadvertently received the vaccine; sore arm; supposed to receive the Pfizer vaccine but received the Moderna covid-19 vaccine by mistake; A spontaneous report was received from a healthcare professional (HCP) concerning a 16-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) was less than 18 years old and had a sore arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 06 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number : 025J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 06 Jan 2021, a 16-year-old patient was inadvertently vaccinated. The patient was supposed to receive Pfizer vaccine but received Moderna COVID- 19 vaccine by mistake. The patient experienced a sore arm but no other known symptoms. No treatment was received for the sore arm. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, vaccine given to a patient less than 18-years-old, and wrong drug administered was considered resolved. The outcome for the patient's sore arm was not reported.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age and Wrong product administered with an associated non-serious expected event of Injection site pain. No treatment received for the event. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1001661
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Received 1st dose of Moderna vaccine lot number 041L20A; A spontaneous report was received from a consumer who was also a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received 1st dose of Moderna vaccine lot number 041L20A. 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 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. The lot number was later recalled. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, received 1st dose of Moderna vaccine lot number 041L20A, was resolved on unknown date.; Reporter's Comments: This report refers to a case of a female consumer of an unknown age who received a first dose Moderna's COVID 19 vaccine (Lot # 041L20A), that had been recalled, for prophylaxis of COVID-19 infection. No relevant medical history or con meds were provided. There were no reported AEs associated with this case of female consumer who received a recalled Moderna's COVID-19 vaccine.

Other Meds:

Current Illness:

ID: 1001662
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: DTaP-IPV Component was administered to a patient without the ActHIB component, with no reported adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information (Reference number- 00436605) was received from a physician and transmitted to Sanofi on 19-Jan-2021. This case involved a patient of unknown age who administered dtap-ipv component without the acthib component (off label use), while patient received vaccines DIPHTHERIA/ TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. Past vaccination(s) included MMRVAXPRO. Medical history, past medical treatment(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received DIPHTHERIA/ TETANUS/5 HYBRID AC PERTUSSIS/ IPV (MRC5) /HIB(PRP/T) VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, patient administered dtap-ipv component without the acthib component (off label use) (latency: unknown) following the administration of suspect vaccine. No laboratory data was reported. It was not reported if the patient received a corrective treatment. There will be no information available regarding batch number in this case.

Other Meds:

Current Illness:

ID: 1001663
Sex: M
Age: 0
State: NY

Vax Date: 05/21/2019
Onset Date: 01/04/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: Test Name: respiratory culture was performed; Result Unstructured Data: Sinus infection with thick green material coming out of nostril; Test Date: 20210104; Test Name: being positive for Haemophilus B Influenza with heavy growth of Beta-lactamases negative; Test Result: Positive ; Test Date: 20210104; Test Name: being positive for Haemophilus B Influenza with heavy growth of Beta-lactamases negative; Test Result: Negative

Allergies:

Symptoms: presenting with a Sinus infection with thick green material coming out of nostril; Sinus infection with thick green material coming out of nostril; being positive for Haemophilus B Influenza with heavy growth of Beta-lactamases negative; being positive for Haemophilus B Influenza with heavy growth of Beta-lactamases negative; Initial information received on 20-Jan-2021 regarding an unsolicited valid serious case from other health professional. This case involves a 21-month-old male patient who was found positive for Haemophilus B influenza with heavy growth of beta-lactamases negative (haemophilus infection), sinus infection with thick green material coming out of nostril (sinusitis) (rhinorrhea), after receiving PENTACEL VACCINE and ACT-HIB. Medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was given to the patient. On 21-May-2019, the patient received a first dose of suspect HIB VACCINE (lot UI906AAB and expiration date not reported) via intramuscular route in unknown administration site for prophylactic vaccination. The patient received three doses of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ225AAA, UJ101AAA and UJ059AAA and expiration date not reported) via intramuscular route in unknown administration site for prophylactic vaccination on 08-Jul-2020, 19-Jul-2019 and 25-Sep-2019. On 04-Jan-2021, the patient was found positive for Haemophilus B influenza with heavy growth of beta-lactamases negative (haemophilus infection), 1 year 7 months 14 days following the administration of HIB VACCINE and 5 months 27 days following first dose, 1 year 3 months 10 days following the second dose and 1 year 5 months 16 days following the administration of third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a serious sinus infection with thick green material coming out of nostril (sinusitis) (rhinorrhea) (unknown latency) following the vaccination. These events were assessed as medically significant. This was also a case of vaccination failure (unknown latency) as the patient was positive for Haemophilus B influenza, despite being vaccinated with PENTACEL and ACT-HIB VACCINES. Relevant laboratory test results included: respiratory culture was performed on an unknown date and the patient was presented with sinus infection with thick green material coming out of nostril. On 04-Jan-2021: Haemophilus test: Positive and Pathogen resistance: Negative. The patient was prescribed Cefdinir. At the time of reporting, the outcome was unknown for all the events. The reporter also wanted to know if vaccine was resistant to their strain of the virus and would like a call back as soon as possible. Sender's Comments: This case involves a 21-month-old male patient who presented with Haemophilus infection, sinusitis and rhinorrhea, after vaccination with PENTACEL and ACT-HIB. The time to onset is compatible with the Haemophilus infection and unknown with the other reported events. It was also a case of vaccination failure. However, no information regarding patient's condition at time of vaccination, immune status and predisposition to respiratory infections is provided. Based upon the reported information, the role of an individual vaccine and a case of vaccination failure cannot be assessed.

Other Meds:

Current Illness:

ID: 1001664
Sex: M
Age:
State: KY

Vax Date: 01/16/2021
Onset Date: 01/29/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: I took the first shot of the Pfizer COVID vaccine on January 16, 2021. Two days later I started to feel a fullness in my left ear. This continued nonstop, save for one day, until January 29, the, after inclining my head at an unnatural angle, I experienced vertigo, vomiting, and intense ringing in my left ear for hours. The following morning, all symptoms were gone. But that afternoon, the ringing in my left ear returned and got progressively worse. The next day, the feeling of fullness in the ear returned as well, and I experienced a second bout of vertigo, and the ringing persists. This suggested that the vaccine has triggered Meniere's disease, a condition that is related to Bell's Palsy, which has also been observed in patients who took the Pfizer COVID vaccine.

Other Meds: Albuterol for asthma. Multivitamin.

Current Illness:

ID: 1001665
Sex: F
Age: 71
State: SC

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/04/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Pfizer Covid-19 vaccine treatment under Emergency Use Authorization(EUA): 71 yo female was administered the Pfizer vaccine. During post vaccine monitoring, the patient's entire chest and face were bright read. She had red sponts on her upper chest and shoulders. She reported feeling very hot, but denied any itching, shortness of breath, chest tightness, or itchiness in her throat. Benadryl 50 mg was administered IM into left deltoid. Patient reported allergies to bee stings and IV dye. Vitals were stable. EMS was called and took patient to the hospital per protocol

Other Meds:

Current Illness:

ID: 1001666
Sex: M
Age:
State: PA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: TIA (10 minutes of altered consciousness, encephalopathy) while sitting in a chair 6 hours after first Pfizer covid vaccine. Has a h/o similar TIA. No ongoing symptoms sequelae. Advance his anti platelet therapy to plavix and aspirin.

Other Meds:

Current Illness:

ID: 1001667
Sex: F
Age: 53
State: IN

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data: Spoke with Dr on way to bring more prednisone if worse to ER -

Allergies: Amoxicillin Eggs, sulfa, Tdap, Flu vaccine Iodine Benzoine, desensitization shots

Symptoms: Hives, itching dermatographism with 1st vaccine need 200 mg Benadryl Spoke with Dr. told to take prednisone 10mg & Zyrtec yesterday today took prednisone 10mg Zyrtec & Benadryl 50mg Prior 10 minutes after started but progressed.

Other Meds: desensitizations allergy injections 3xwkly Topamax, Bystolic, Zyrtec, Lodeine, Zinc, vitc, vitD

Current Illness: chronic Allergies - doing

ID: 1001668
Sex: F
Age: 35
State: FL

Vax Date: 12/29/2020
Onset Date: 01/26/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies:

Symptoms: [MODERNA COVID VACCINE] treatment under Emergency Use Authorization(EUA):MODERNA COVID VACCINE With second injection patient became very impulsive, and erratic. Dissociative fugue state. Changes in judgement and delusions. Possible neuropsychiatric side effects from the vaccination, which seems perfectly reasonable given potential for severe neuropsychiatric sequelae from actual COVID infection. Drug should possibly include this warning,

Other Meds: levothyroxine

Current Illness: Allergies: amoxicillin, History of secondhand smoke exposure, occasional alcohol use, past pregnancy x1

ID: 1001670
Sex: M
Age:
State: NY

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 02/04/2021
Hospital:

Lab Data:

Allergies: none

Symptoms: My father got vaccination on 1/26/2020 in the evening and got high temperature and body ache next morning on 1/27/2020 Vaccination was made by pharmacist. My father is also himself PhD Internal Medicine doctor presently practices

Other Meds:

Current Illness: none

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm