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: 1056437
Sex: F
Age:
State: CO

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210205; Test Name: Body temperature; Result Unstructured Data: 100.4 Fahrenheit

Allergies:

Symptoms: Injected the Moderna Vaccine into the joint space of proximal head of right humerus/posterior; Pain raditaing from injection site to right hand; local aching pain 5-6(10) at site; Fever; A spontaneous report received from a Consumer concerning, 72-year-old female patient who received 2nd dose of the Moderna COVID-19 vaccine that was not injected into the muscle. /MedDRA PT: [Injection error] ~ The patient's medical history included Asthma. Patient's concomitant was not included. On 05-FEB-2021 date, the patient received their 2nd dose of the two planned doses of mRNA-1273 in right arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient stated the she received her 2nd dose of the Moderna COVID 19 vaccine on 05FEB2021 and the person who gave the vaccine, injected the Moderna COVID-19 vaccine into the joint space of proximal head of right humerus/ posterior. Patient stated that the injection was exquisitely painful for 3 days and she had a fever of 101.2. Patient stated that she had local aching pain 5-6(10) days and radiating pain from injection site to right hand for 4 days. Patient stated that she would like to know is the dose invalid since it was not given intramuscularly. Dose she needs to repeat 2nd dose of the vaccine. What are the concerns injecting into tendon/ ligament? Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of inappropriate route of administration with reported non-serious events of pain in extremity, fever, and vaccination site pain. 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: Asthma

ID: 1056438
Sex: M
Age: 76
State: FL

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: pneumonia; Tired; Achy; Muscle weakness in left arm; Arm was swollen; This spontaneous report was received on 10FEB2021 from a consumer which refers to a 76-year-old male patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced injection arm swelling, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and pneumonia. The patient's medical history was not provided. Concomitant medications were not reported. On 15JAN2021, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 intramuscularly (Lot number: 026L20A). On 16JAN2021, the patient noted a start date for Pneumonia. On 10FEB2021, the patient called the medical information call center and reported, "he is on antibiotics for pneumonia. His 2nd question is can he delay the 2nd dose since he is suffering from pneumonia. Patient was administered 1st dose of vaccine on 15/Jan/2021 in his left non dominant arm. The lot# was provided, but expiration date is unknown. Patient experienced some expected side effects, which he is not concerned about". The event(s) were arm swollen, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and tested positive for pneumonia 1 day after receiving the vaccine. The action taken for Moderna COVID-19 (mRNA-1273) Vaccine was reported by the patient as Tylenol. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the events of fatigue, arm swelling, myalgia, muscle weakness, a causal relationship cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Pneumonia is assessed as unlikely related. Further information has been requested.

Other Meds:

Current Illness:

ID: 1056439
Sex: M
Age:
State: TX

Vax Date: 01/13/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Volume difference in syringe from first dose and second dose; A spontaneous report was received from a consumer concerning a 69 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a medication error of volume difference in syringe from 1st and 2nd dose/MedDRA PT: inappropriate dose of vaccine administered. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included tamsulosin, clonazepam, apixaban and metoprolol. The patient received their first of two planned doses of mRNA-1273 (Batch number: 041L20A) on 13 Jan 2021. On 10 Feb 2021, approximately 29 days later, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported that he was told by one person at the facility that both doses were the same; however, he reported that the person who administered the second dose told him that the second dose was a lot higher than the first dose because it was a booster dose and that she showed him the volume difference in the syringe from the first dose and what she would be administering. The patient reported that the amount in the syringe for the second dose was significantly more, but he did not remember the amount from the syringe. The patient was told by a third person at the facility that both doses were the same. The patient did not experience any side effects yet but was concerned and confused if he received a potential overdose. Treatment for the event included none. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event was resolved.; Reporter's Comments: This is a case of 69-year-old male patient who was administered volume difference in syringe from 1st and 2nd dose (inappropriate dose of vaccine administered) for mRNA-1273 vaccine Lot # 041L20A. There was no associated adverse event reported for the event of inappropriate dose of vaccine administered.

Other Meds: FLOMAX [MORNIFLUMATE]; CLONAZEPAM; ELIQUIS; METOPROLOL

Current Illness:

ID: 1056440
Sex: U
Age:
State: TN

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

Lab Data:

Allergies:

Symptoms: mixing vials for quite a few patients to make up missing parts; A spontaneous report was received on 10 FEB 2021 from a pharmacist concerning patient of unspecified age and gender, who received Moderna's COVID-19 vaccine. Patients' medical history was not provided. No relevant concomitant medications were reported. On 27 JAN 2021, patient received their one of two planned doses of mRNA-1273(Lot/ batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection. On 27 JAN 2021, when patient received the vaccine, the reporter stated that her office has been mixing vials of Moderna's COVID-19 vaccine for quite a few patients to make up missing parts. She wanted to know, was it efficient to open a different vial and get parts missing for an already punctured vial to administer. Treatment for the event was not provided. Action taken with the other dose of mRNA-1273 in response to the event was not reported. The outcome of the event, mixing vials for quite a few patients to make up parts, was considered recovered/resolved on 27 JAN 2021.; Reporter's Comments: This report refers to a case of "Interchange of vaccine products" for mRNA-1273, lot # unknown, with no associated Adverse Events.

Other Meds:

Current Illness:

ID: 1056441
Sex: F
Age: 72
State:

Vax Date: 01/27/2021
Onset Date: 02/08/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Moderate fever; Fatigue; Chills; Patient received first dose 27Jan2021, and second dose 8Feb2021; A spontaneous report was received on 10 FEB 2021 from a pharmacist concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine first dose on 27 JAN 2021, and second dose on 08 FEB 2021 and experienced moderate fever, fatigue, chills after second dose. The patient's medical history, as reported by pharmacist, include COVID-19 infection. Relevant concomitant medications reported were, include Alendronate ? 70 milligram, Aspirin- 81 milligram, Atorvastatin- 40 milligram, Basaglar Insulin, Vitamin D2, Lexapro- 10 milligram, Gabapentin 100 milligram. On 27 JAN 2021, patient received their first of two planned doses of mRNA-1273(BATCH/LOT number: unknown), for the prophylaxis of COVID-19 infection. On 08 FEB 2021, patient received second dose of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection. On unknown date, after receiving second dose of mRNA-1273 vaccine, patient experienced moderate fever, fatigue and chills. Treatment for the events were not provided. Action taken the second dose of mRNA-1273 in response to the events were not reported. The outcome of the events, moderate fever, fatigue, chills after second dose, were unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered associated with events of pyrexia, fatigue and chills. 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. The causality for inappropriate schedule of vaccine administered remains not applicable.

Other Meds: ALENDRONATE; ASPIRIN 81; ATORVASTATIN; BASAGLAR; VITAMIN D2; LEXAPRO; GABAPENTIN

Current Illness:

ID: 1056442
Sex: U
Age:
State:

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: fever; rigors; muscle aches; during administration the barrel broke off from the needle and most of the vaccine leaked out; Needle issue; feeling faint; A spontaneous report was received by a consumer regarding themselves, a patient. Age and sex were not provided. The patient experienced the barrel breaking off the needle and most of the injection leaking out/incomplete dose administration, feeling faint/dizziness, fever/pyrexia, rigors/chills and muscle aches/myalgia. The patient's medical history was not provided. No concomitant medications provided. On 09 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Batch number: not provided) injected into the arm for prophylaxis of COVID-19 infection. The patient received the second injection on 09 Feb 2021 and reported that the needle broke off the barrel during administration, and most of the vaccine leaked out. They reported that the health care provider offered to administer another dose. The patient declined due to feeling faint. On 10 Feb 2021, the patient woke in the middle of the night with a robust immune response that included fever, rigors and muscle aches. Treatment information was not provided. Patient consented to be contacted. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, the barrel breaking off the needle and most of the vaccine leaked out, feeling faint, immune response fever, rigors and muscle aches was considered resolved/recovered.; Reporter's Comments: This report refers to a case of vaccine underdose and needle issue, for mRNA-1273, lot number unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1056443
Sex: M
Age: 31
State: NH

Vax Date: 02/07/2021
Onset Date: 02/07/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Some of the vaccine leaked out while administered; Some of the vaccine leaked out while administered; A spontaneous report was received from a nurse concerning a 31-years-old, male patient who experienced some of the vaccine leaked out while administered. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 07 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number 011m20a) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 07 Feb 2021, the patient experienced some of the vaccine leaking out while being administered. Treatment information was not provided. 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 some of the vaccine leaked out while administered was unknown.; Reporter's Comments: This report refers to a case of Vaccine underdose and Syringe connection Issue for mRNA-1273 [Lot number 011m20a] with no associated AEs.

Other Meds:

Current Illness:

ID: 1056444
Sex: U
Age:
State: MA

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

Lab Data:

Allergies:

Symptoms: Did not receive the full dose; A spontaneous report was received from a health care professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive full dose/accidental underdose. The patient's medical history was not provided. No concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, during administration of the Moderna COVID-19 vaccine, the nurse pulled the needle out of the patient's arm too quickly and the patient did not receive the full dose of the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, did not receive full dose/accidental underdose, was considered resolved.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273(Lot number: not provided) with no associated AEs.

Other Meds:

Current Illness:

ID: 1056445
Sex: M
Age: 57
State: OR

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Received a lower dose (0.4ml) of the Moderna Vaccine; A spontaneous report was received from a nurse, concerning a 57-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) of lower dose (0.4ml). The patient's medical history was not provided. No concomitant product use was reported. On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A, expiry date: 25-Feb) intramuscularly for prophylaxis of COVID-19 infection. On 08 Feb 2021, a health care professional reported that a patient was given 0.4 milliliters of the Moderna COVID-19 vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, received a lower dose (0.4ml) of the Moderna vaccine, was considered resolved on 08 Feb 2021.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273 (Lot number: 007M20A, expiry date: 25-Feb) with no associated AEs.

Other Meds:

Current Illness:

ID: 1056446
Sex: M
Age:
State: OH

Vax Date: 02/12/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Received the first shot 10 days before; A spontaneous report was received from a consumer concerning a male patient, of unknown age, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and the patient had received the first shot ten days before/inappropriate schedule of product administration. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 FEB 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly prophylaxis of COVID-19 infection. On 22 FEB 2021, at approximately 09:00 am, the patient received the second dose of Moderna vaccine (Lot number: O3OM2OA). The patient did not feel the vaccine went in, there was no blood on the band aid. The patient had received the first shot ten days before. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable. The outcome of event, received the first shot ten days before, was considered as resolved.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273(Lot number: O3OM2OA), with no associated AEs.

Other Meds:

Current Illness:

ID: 1056447
Sex: F
Age:
State: NC

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210205; Test Name: body temperature; Result Unstructured Data: 101.6 Fahrenheit

Allergies:

Symptoms: worsening bilateral infraorbital perioral edema; worsening bilateral infraorbital perioral edema; generalized myalgias; fever of 101.6F; A spontaneous report was received from a literature article regarding, a 36-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Circumoral edema, Orbital Edema, myalgia, and fever/pyrexia. The patient's medical history was not included, other than that she was considered a healthy female. Concomitant medications known to have been used by the patient were not included. In November 2019, prior to the vaccination, the patient received hyaluronic acid injections in the tear troughs and in both the upper and lower lip. On 05 Jan 2021, prior to the onset of the events, the patient received the first of two doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, about 12 hours after the vaccine was administered, the patient presented with a fever of 101.6 Fahrenheit and had generalized myalgia. Treatment included acetaminophen. On 06 Jan 2021, the fever and myalgia were resolved. As the day continued, the patient noticed pain and swelling in the right tear trough and increasing swelling around her mouth. On 07 Jan 2021, approximately 36 hours after vaccination, the patient was administered 10 mg of cetirizine. At 48 hours the patient reported that the swelling was at it's peak and she was unable to open her right eye. The patient then took 20 milligrams of cetirizine. Throughout the morning, the left tear trough began to increase, and the rest of her face remained persistently swollen. The patient was administered 5mg lisinopril. Within about 5 hours of dose of lisinopril, the patient reported that swelling had stopped and was decreasing. Over the next 24 hours, edema was improved, and patient returned to baseline. Action taken with mRNA-1273 was not provided. The outcome of the events, circumoral edema, periorbital edema, myalgia and fever, was considered resolved.; Reporter's Comments: 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: 1056448
Sex: M
Age:
State: MD

Vax Date: 01/20/2021
Onset Date: 01/30/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: myocarditis; pericarditis; Chest pain; rapid heartbeat; A spontaneous report was received from a 20-year- old male patient who experienced chest pain, myocarditis, pericarditis, inflammation of pericardium. The patient's medical history was not provided. Concomitant medications included phenylpropanolamine, diclofenac sodium, and colchicine. The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 20 Jan 2021 intramuscularly for the prophylaxis of COVID-19 infection. On 30 Jan 2021, the patient experienced chest pain, rapid heartbeat and went to emergency room (ER). He was hospitalized and was diagnosed with myocarditis, pericarditis, inflammation of pericardium. The patient was discharged on 31 Jan 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, chest pain, myocarditis, pericarditis, inflammation of pericardium, was considered not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. The use of concomitant medication, Pnenylpropanolamine, which is a sympathomimetic agent, is a risk factor and confounding factor for causality.

Other Meds: PHENYLPROPANOLAMINE; ANTI-INFLAMMATORY; COLCHICINE

Current Illness:

ID: 1056449
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Convulsions due to pain; Severe pain; A spontaneous report was received via voicemail from daughter, concerning her mother, a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced convulsions due to pain and severe pain. 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 unknown date, the reported stated her mother experienced severe pain to the point of convulsing. She mentioned her mother was at the doctor. No treatment information provided. The outcome for the event, convulsions due to pain and severe pain, were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1056450
Sex: U
Age:
State: MI

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: vaccine leaked out during administration of the injection; needle was not snuggly attached to the syringe; A spontaneous report was received from a nurse practitioner concerning a patient (demographics not provided) who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced needle that was not snuggly attached to the syringe/MedDRA PT: device connection issue and vaccine leaked out during administration of the injection/MedDRA PT: underdose. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 28 Jan 2021, the patient received unknown dose number of mRNA-1273 (Lot # not provided) for prophylaxis of COVID-19 infection. On 28 Jan 2021, upon administering Moderna vaccine, the needle was not snuggly attached to the syringe; therefore, some of the vaccine leaked out. Action taken with mRNA-1273 in response to the events was not provided. The events needle was not snuggly attached to the syringe and vaccine leaked out during administration of the injection were considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1056451
Sex: F
Age: 77
State: GA

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Cellulitis; Arm was sore; A spontaneous report was received from a consumer who was also a 77-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced cellulitis and arm was sore/limb discomfort. The patient's medical history was not provided. Concomitant medication included an unspecified low dose blood pressure medication. On 18Jann2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 19 Jan2021, the patient experienced sore arm. On 24Jan2021, the patient experienced itching, swelling and feeling hot at the injection site. The patient was diagnosed with cellulitis and was treated with unspecified antibiotics for 10 days. Action taken with the mRNA-1273 was not reported. The outcome of the events of cellulitis (itching, swelling, hot at the injection site) and limb discomfort was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1056452
Sex: F
Age: 79
State: MO

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: left sided weakness; Stroke like symptoms; Slurred speech; Pneumonia; spontaneous report received from a Consumer concerning, 79-year-old female patient who received the first dose of Moderna COVID-19 vaccine and woke up the next morning not feeling well. /PT: [Not Feeling Well]. The patient's medical history included COPD, hypertension and hyperlipidemia. Patient allergies included sleep medications. Patient's concomitant included Gabapentin, Simvastatin, Advair, Spiriva and Proventil. On 04-FEB-2021, the patient received their first of two planned doses of mRNA-1273 in left arm (Batch #: 016M20A) intramuscularly for prophylaxis of COVID-19 infection. Patient daughter called on behalf of her mother. Patient daughter stated that her mother received the Moderna COVID-19 vaccine on 04FEB2021 and on 05Feb2021 her mother woke up and wasn't feeling well. She stated her mother had weakness on her left side. The daughter stated that ambulance took her mother to hospital. The daughter stated that her mother had stroke like symptoms. The daughter stated her mother had difficulty speaking and slurred speech. The daughter stated the doctor Called it "Neglect for sensation". The daughter stated her mother was treated like she had a stroke. The daughter stated that the doctor gave her mother a "Clot buster" treatment and it started to normalize. The daughter stated the MRI was negative. She daughter that her mother was still hospitalized and now has pneumonia. Wanted to know if this has been previously reported. Treatment that was given in the hospital was a "Clot Buster" Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: The events developed on same day after first dose of mRNA-1372. Hemiparesis, dysarthria, and pneumonia were consistent with increased risk of cerebrovascular accidents related to high blood pressure confounded by elderly age of patient. Very limited information regarding this event/s has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: GABAPENTIN; SIMVASTATIN; FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE; MULTI VITAMINS & MINERALS; TIOTROPIUM BROMIDE; PROVENTIL HFA [SALBUTAMOL SULFATE]

Current Illness: COPD; Drug allergy (Sleep medications); Hyperlipidemia; Hypertension

ID: 1056453
Sex: F
Age:
State: AL

Vax Date: 01/11/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: sepsis regarding to a cancer; A spontaneous report was received from a consumer concerning an unknown aged female patient. Medical history included unspecified cancer No relevant concomitant medication was reported. On 11Jan2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. On 10 Feb2021, the patient was hospitalized due to sepsis regarding a cancer. No treatment was reported. Action taken with the mRNA-1273 was not reported. The outcome of the event, sepsis, was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. However, patient's medical history of unspecified cancer is a confounding factor that may play a possible contributory role. Further information has been requested.

Other Meds:

Current Illness: Cancer

ID: 1056454
Sex: F
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: 17-year-old patient received the first dose of Moderna Covid-19 vaccine; A spontaneous report received from a pharmacist concerning, 17-year-old female patient who has received the first dose of Moderna COVID-19 vaccine The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown. On 01-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Reporter stated that a 17 year-old patient received the vaccine. No further information was provided. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was considered resolved on 01 Feb 2021.; Reporter's Comments: This is a case of 17-year-old female patient who was administered mRNA-1273 (product administered to patient of inappropriate age) (Batch #: unknown). There was no associated adverse event reported for the event of product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 1056455
Sex: U
Age:
State: KY

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

Lab Data:

Allergies:

Symptoms: Received dose in tricep; A spontaneous report received from other Health Professional concerning, unkown age and unknown gender patient who received dose of Moderna COVID-19 vaccine in tricep. The patient's medical history was not included. Patient's concomitant was not included. On unknown date, the patient received their unknown of two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Consumer called in stated that patient received dose of the Moderna COVID-19 vaccine in their tricep. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1056456
Sex: M
Age:
State: NC

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: scheduled his 2nd dose on 17March2021 and he knows that's way passed 42 days; A spontaneous report was received from a consumer of unknown age on 11 FEB 2021 stating that he received his 1st Moderna vaccine on 21Jan2021 through the department of health at Goldsboro, North Carolina. They didn't schedule his 2nd dose until 10 FEB 2021. They called him on 10 FEB 2021 and scheduled his 2nd dose on 17 March2021. He knows that's way past 42 days, so he wants to know if that'd still be effective and if he needs to start over the vaccine series. Patient's medical history was not provided. Action taken with mRNA-1273 was not reported. The outcome of the event was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 with no associated AEs.

Other Meds:

Current Illness:

ID: 1056457
Sex: F
Age: 47
State: WI

Vax Date: 01/07/2021
Onset Date: 02/03/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210204; Test Name: body temperature; Result Unstructured Data: at midnight; Test Date: 20210204; Test Name: body temperature; Result Unstructured Data: highest reading

Allergies:

Symptoms: axillary lymph node was the size of a golf ball; fever of 101.6 then 102.2; hallucinations; dizziness; confusion; severe headache; body aches; nausea; vomiting; A spontaneous report was received from a healthcare professional concerning a 47 years-old, female patient who experienced hallucinations/MedDRA PT: hallucination, confusion/MedDRA PT: confusion, dizziness/MedDRA PT: dizziness, severe headache/MedDRA PT: headache, body aches/MedDRA PT: myalgia, fever of 101.6 then 102.2/MedDRA PT: pyrexia, nausea/MedDRA PT: nausea, vomiting/MedDRA PT: vomiting, and axillary lymph node was the size of a golf ball/MedDRA PT: vaccination site lymphadenopathy. The patient's medical history was not provided. Concomitant product use included levothyroxine, lisinopril, metformin, liraglutide, atorvastatin, furosemide, famotidine, cetirizine hydrochloride and vitamins NOS. The patient received their first of two planned doses of mRNA-1273 (Lot #007M20A) on 07 Jan 2021. On 03 Feb 2021 at 4:00pm, approximately 4 and a half hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot # not provided) intramuscularly, in the left deltoid muscle for prophylaxis of COVID-19 infection. On 03 Feb 2021 at approximately 8:30pm, the patient began to experience severe headache and body aches. By midnight, the patient had a fever of 101.6 then 102.2 which was the highest reading. The patient experienced nausea and vomiting for 36 hours and couldn't keep food down. On Thursday (04 Feb 2021), patient had dizziness, confusion and hallucinations - patient had a conversation with spouse who was not at home. Patient's axillary lymph node was the size of a golf ball. Patient took Tylenol at the 25 hour mark once symptoms began which was about 5:00pm on Thursday. By Friday night (05 Feb 2021) patient was able to keep food down. By Sunday (07 Feb 2021) the patient felt 85% better. The patient still had axillary lymph node swelling but reported 90% improvement. Patient had ongoing headaches at the time of this report for which Tylenol is taken daily. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable. The event severe headache was not resolved. The events hallucinations, confusion, dizziness, body aches, fever of 101.6 then 102.2, nausea, vomiting, and and axillary lymph node was the size of a golf ball were resolving.; Reporter's Comments: This case concerns a 47-year-old female with serious expected Hallucinations, NS unexpected confusion, dizziness and NS expected fever, headache, myalgia, nausea, vomiting, vaccination site lymphadenopathy. Event onset 29 days after first dose and 4 hours after second dose mRNA-1273. Treatment with Tylenol. Events resolving. Based on 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: LEVOTHYROXINE; LISINOPRIL; METFORMIN; LIRAGLUTIDE; ATORVASTATIN; FUROSEMIDE; FAMOTIDINE; CETIRIZINE HYDROCHLORIDE; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1056458
Sex: F
Age: 28
State: NY

Vax Date: 01/14/2021
Onset Date: 02/11/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 90% of the vaccine leaked onto arm/ Did not get a full second dose; A spontaneous report was received from a Consumer concerning a 28-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 90% of the vaccine leaked onto arm/ Did not get a full second dose (incomplete dose administered). The patient's medical history was not provided. No relevant concomitant medications were reported. On 14Jan2021 the patient received first dose of the Moderna Covid-19 vaccine (2:30PM). It was administered on her left arm prophylaxis of COVID-19 infection with unknown dose and route of administration. Lot number 011L20A, unknown expiration date. On 11Feb2021, the patient had her 2nd dose of the Moderna Covid-19 vaccine (3:00PM) at a local hospital. She had it on her left arm with unknown route of administration. Lot number 0B2L20A, expiration date was unknown. During the administration of the 2nd dose, the 90% of the vaccine leaked on to her arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event was resolved on 11 Feb 2021.; Reporter's Comments: This is a case of 28-year-old female patient who was administered second dose of mRNA-1273 vaccine and experienced 90% of the vaccine leaked on to arm (incomplete dose administered) Lot #: 11L20A. There was no associated adverse event reported for the event of incomplete dose administered.

Other Meds:

Current Illness:

ID: 1056459
Sex: F
Age: 83
State: NY

Vax Date: 02/05/2021
Onset Date: 02/11/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Resident received the 1st dose of the Moderna vaccine on 05 Feb 2021. She got the second dose today.; A spontaneous report was received from a nurse concerning an 83-years-old, female patient who experienced inappropriate schedule of product administration (resident received the 1st dose of the Moderna vaccine on 05 Feb 2021. She got the second dose today.) 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 [Lot number 010M20A] on 05 Feb 2021. On 11 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 [Lot number 030M230A] intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 11 Feb2021, the patient received her 2nd dose only six days after her first dose was administered. She reports no side effects from the 1st dose. Treatment information was not provided. 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 event resident received the 1st dose of the Moderna vaccine on 05 Feb 2021. She got the second dose today was considered recovered/resolved on 11 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #030M230A for second dose) with no associated AEs reported. Patient received second dose six days after the first dose.

Other Meds:

Current Illness:

ID: 1056460
Sex: U
Age:
State:

Vax Date: 02/11/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient was given 1ml dose in one setting instead of .5ML; A spontaneous report was received from a physician concerning a patient who experienced accidental overdose (patient was given 1ml dose in one setting instead of .5ML). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 10 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 030M30A) intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, the patient was given 1 mL dose in one setting instead of .5 mL. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event patient was given 1ml dose in one setting instead of .5ML was unknown.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 1056461
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Administered dose of vial that wasn't thawed as recommended; A spontaneous report was received from a consumer concerning a male patient who experienced product preparation issue (administered dose of vial that wasn't thawed as recommended). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, the patient reported that the pharmacist took the vial out and injected him immediately instead of waiting 15 minutes to administer. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event administered dose of vial that wasn't thawed as recommended was unknown.; Reporter's Comments: This report refers to a case of product preparation issue for mRNA-1273 (lot # unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1056462
Sex: F
Age: 53
State: RI

Vax Date: 02/11/2021
Onset Date: 01/14/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: headache; nausea; left the vaccine out for longer than 6 hours after the vial was punctured; A spontaneous report was received from a consumer who was a 53-year-old, female patient, who was administered Moderna's COVID-19 vaccine and the patient received first dose more than six hours after vial was punctured/expired product administered, and had headache and nausea. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 FEB 2021, the patient received her second dose of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. The patient's doctor told her that she received a non-effective first dose of the vaccine because the doctor left the vaccine out for longer than the six hours after the vial was punctured which was on 14 JAN 2021. The patient returned to the healthcare professional for second dose and she was informed her first dose might had been invalid/ineffective. On 11 FEB 2021, the patient experienced headache and nausea. The treatment included ondansetron as an indication for nausea on 12 FEB 2021 in the morning (am). The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable. The outcome of event, received first dose more than six hours after vial was punctured was considered as resolved on 14 JAN 2021. The outcome of the events, headache and nausea were considered as unknown.; Reporter's Comments: This case concerns a 53-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting Expired product administered. Additionally, the patient experienced headache and nausea after receiving their second of two planned doses of mRNA-1273 (Lot number: 029L20A). Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1056463
Sex: M
Age: 77
State: NE

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210211; Test Name: chest x-ray; Result Unstructured Data: results within normal limits; Test Date: 20210211; Test Name: EKG; Result Unstructured Data: results within normal limits; Test Date: 20210211; Test Name: CBC differential with platelets; Result Unstructured Data: CBC differential with platelets - results within normal limits; Test Date: 20210211; Test Name: comprehensive metabolic panel; Result Unstructured Data: results within normal limits; Test Date: 20210211; Test Name: cardiac panel-acute; Result Unstructured Data: cardiac panel acute - results within normal limits; Test Date: 20210211; Test Name: COVID-19 test; Test Result: Negative ; Result Unstructured Data: results negative

Allergies:

Symptoms: felt like crap; became hot; left hand suddenly started jerking and left hand was having spasms; Vasovagal Syncope, Post Immunization Reaction; became cold; sweaty; sore arm; achy; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vasovagal syncope, post immunization reaction (syncope vasovagal). The patient's medical history, as provided by the reporter, included chronic cough, acid reflux, minor allergies, hypercholesterolemia and a penicillin allergy. Concomitant product use included esomeprazole, atorvastatin, famotidine, cetirizine, Montelukast, Vitamin D, zinc, fiber pills and antacids. On 10 Feb 2021, several hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #:030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. After the injection in the evening on 10 Feb 2021, the patient reported experiencing a sore arm. During the night, he became cold, sweaty and achy. On 11 Feb 2021, the patient stated he "felt like crud" and was still achy and his left arm hurt more. The patient sat down at the table and again became "hot" and "sweaty." His left hand suddenly started jerking and having spasms, and the patient's head went back and then forward and he became unresponsive for approximately 2 to 3 minutes. After the episode, he went to a sofa chair and fell asleep for 1 to 1.5 hours. The patient's wife called a nurse at the Hospital to report the events, and the nurse suggested to take him to the emergency room (ER) immediately. At the ER, a series of tests/labs were performed including complete blood count (CBC) differential with platelets, COVID-19 test, cardiac panel-acute, comprehensive metabolic panel, electrocardiogram (EKG), and chest x-ray. All test results were normal. The patient's COVID-19 test was negative. Treatment for the event included IV fluids (sodium chloride IV). The patient was discharged from the ER 2 to 3 hours after treatment with a discharge diagnosis of "vasovagal syncope, post immunization reaction." 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 event, vasovagal syncope, post immunization reaction, was considered recovered/resolved.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events, a causal relationship cannot be excluded.

Other Meds: ESOMEPRAZOLE; ATORVASTATIN; FAMOTIDINE; CETIRIZINE; MONTELUKAST; VITAMIN D NOS; ZINC; METHYLCELLULOSE

Current Illness: Acid reflux (esophageal); Allergy multiple; Chronic cough; Hypercholesterolemia; Penicillin allergy

ID: 1056464
Sex: U
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: pulled the syringe to early that the complete dose could not be injected in the patient body; it spilled off from the needle and on the patient's arm; A spontaneous report was received from a Healthcare Professional, concerning a patient of unknown age, who was administered Moderna's COVID-19 vaccine and the reporter noticed that one of their nurse pulled the syringe to early that the complete dose could not be injected in the patient body and it spilled off from the needle and on the patient's arm/ underdose. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their second dose of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. The reporter noticed that one of their nurse while administering the vaccine to a patient that she pulled the syringe to early that the complete dose could not be injected in the patient body and it spilled off from the needle and on the patient's arm on an unknown date. The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable. The outcome of event, pulled the syringe to early that the complete dose could not be injected in the patient body and it spilled off from the needle and on the patient's arm was considered as resolved.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273, lot # 041L20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1056465
Sex: F
Age: 85
State: FL

Vax Date: 01/06/2021
Onset Date: 01/22/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Second dose was Pfizer's; A spontaneous report was received from a consumer concerning a female patient, of 85-year-old, who was administered Moderna's COVID-19 vaccine and second dose was Pfizer's/wrong product administered. The patient's medical history not reported. Products known to have been used by the patient, within two weeks prior to the event, included were acetylsalicylic acid, lisinopril, centrum vitamins, linagliptin and furosemide sodium from an unknown date for an unknown indication. On 06 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in the right arm for prophylaxis of COVID-19 infection. On 22 JAN 2021, the patient was given second dose of Pfizer's vaccine. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was unknown. The outcome of event, second dose was Pfizer's was considered as resolved on 22 JAN 2021.; Reporter's Comments: This is a case of 85-year-old female patient who was administered mRNA-1273 vaccine and second dose was Pfizer's (wrong product administered) Lot number: unknown. There was no associated adverse event reported for the event of wrong product administered.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; LISINOPRIL; CENTRUM VITAMINTS; TRADJENTA; FUROSEMIDE [FUROSEMIDE SODIUM]

Current Illness:

ID: 1056466
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Anaphylactic reaction; Redness; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed redness and anaphylactic reaction. 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 an unknown date, the patient developed redness and anaphylactic reaction. She took ibuprofen post vaccination and diphenhydramine for the anaphylactic reaction. Her physician assistant also ordered epinephrine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, redness and anaphylactic reaction, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1056467
Sex: M
Age:
State: TX

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: lost 70-80% of sight; dizzy; ringing in ear; all sounds were coming down a tunnel; A spontaneous report was received from a consumer concerning a 34-year-old old, male patient who experienced 70-80% blindness, dizziness, and ringing in his ear. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 10FEB2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient got first dose of Moderna vaccine on 10FEB2021 in left non dominant arm. Patient notes he has always had a reaction to anything external going in his body. After receiving vaccine, he felt fine for about 5 seconds then felt dizzy, lost 70-80% of sight and had ringing in his ear. Patient said all sounds were coming down a tunnel. Patient asked for a place to lie down and symptoms resolved about 2 minutes later. Patient wants to know if it is safe to get second dose. Also wants to know if he can change vaccination facility for second dose. Treatment information was not provided/unknown. The events resolved on same day.; Reporter's Comments: This case concerns a 34 year old, male patient, who experienced a serious unexpected event of blindness transient, among other non-serious events, after receiving first dose mRNA-1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1056468
Sex: F
Age: 16
State: MO

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Received the COVID vaccine at age 16; Injecstion site pain; A spontaneous report was received from a physician regarding his daughter who is a 17-year-old female, unknown race and ethnicity, who was administered Moderna Covid-19 vaccine and experienced pain at injection site. The patient's medical history was not provided. No concomitant medications were reported. No information on allergies. On 22-Jan-2021, prior to the onset of events, patient received her first of two planned doses of Moderna Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection. (Lot#011J20A). The physician who is patient's father would like to give her the second dose. Also, he wanted to consider her for pediatric trials. Action taken with vaccine is physician showed willingness to give his daughter a second dose. The outcome of the events, inappropriate age at vaccination and pain at injection site is unknown at the time of report.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (Lot # 011J20A) with pain at injection site reported. 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: 1056469
Sex: U
Age: 88
State: TX

Vax Date: 02/03/2021
Onset Date: 02/05/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Rapid heart beat; spinning intermittent; off balance leaning left; slow to breath; Appetite; Weakness; Fatigue; Blackout; Nausea; Dizzy/ room spinning; A spontaneous report was received from a consumer ( concerning an 88-year-old, patient of unknown gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blackout, dizziness, nausea, fatigue, room spinning counter clockwise, loss of appetite, weakness, rapid heartbeat, spinning intermittent, off balance leaning left and slow breath. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 3FEB2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:013ML0A) intramuscularly for prophylaxis of COVID-19 infection. On 5 Feb2021,the patient became dizzy. On 6 Feb 2021, the patient experienced blackout and nausea.. On 7 Feb 2021, the patient experienced fatigue. The next day, on 8 Feb 2021,the patient had loss of appetite and weakness .On 10 Feb 2021, the patient had rapid heartbeat, spinning intermittent, off balance leaning left and slow to breath. Treatment information was not provided. The outcome of the events was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported events, a causal relationship cannot be excluded. Nausea and fatigue are consistent with the known safety profile of mRNA-1273.

Other Meds:

Current Illness:

ID: 1056470
Sex: F
Age: 91
State: FL

Vax Date: 01/28/2021
Onset Date: 01/25/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Blood Pressure did not decrease significantly post medication; Blood Pressure increased to 224; Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades; Intestine blockage; Constipation Continued (Initiated 3 days prior to Vaccination); A spontaneous report was received from a consumer concerning a 91-year-old, female patient who developed Pain (Grade 8 out of 10) under breast line, chest and across the back shoulder blades, Constipation Continued (Initiated 3 days prior to Vaccination), Blood Pressure increased to 224, Blood Pressure Did not decrease significantly post medication, Intestine blockage, and Reduced Pain (Grade 4 out of 10 now) post Bowel Movement. The patient's medical history included constipation. Concomitant product use was not provided by the reporter. On 28JAN2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly in the upper arm for prophylaxis of COVID-19 infection. On 28JAN2021 patient received the first dose of Moderna COVID-19 vaccine. For three days prior to vaccination patient was constipated and did not have a Bowel Movement at all. After the vaccination patient had pain (Grade 8 out of 10) under breast line, chest and across the back-shoulder blades. The evening of 28JAN2021 she visited the Emergency Room because of the pain. ER nurse reported patient Blood Pressure went up to 224 and was very high. Patient was treated with BP medication, but BP did not change significantly. This led to patient being admitted to the hospital at for overnight for observations. All tests were negative. She was diagnosed as "Intestines were blocked". She was released on 29JAN2021. She had a BM 6 days later on 03FEB2021. The pain is better (Grade 4 out of 10 now). The outcome of the events was unknown; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness: Constipation

ID: 1056471
Sex: F
Age: 38
State: WI

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she did go to anaphylactic shock; A spontaneous report was received from a consumer concerning a 38-year-old female patient who experienced immediate anaphylactic shock (she did go to anaphylactic shock). The patient's medical history was not provided. No relevant concomitant medications were reported. On 13-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. The reporter stated that her daughter had an immediate anaphylactic shock after receiving the vaccine on 13-JAN-2021 in another state. The reporter's daughter was treated with EpiPen (epinephrine) x 2 and then was transferred to an emergency room (ER) by ambulance where she was observed all day. She reports that her daughter is not allowed to get the second shot. The second dose of mRNA-1273 was discontinued in response to the event. The outcome of the event was not reported.; Reporter's Comments: 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: 1056472
Sex: U
Age:
State: TX

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 16 year old received 1th shot of Moderna vaccine; A spontaneous report was received from a healthcare provider concerning a 16-year-old patient of unknown gender who received the vaccine. The patient's medical history included Sickle Cell Disease. Concomitant product use was not provided by the reporter. On 10FEB2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. HCP reporting 16-year-old patient with Sickle Cell Disease has received 1st shot of Moderna vaccine on 10Feb2021. HCP is asking if the patient should receive 2nd Moderna shot. The event, vaccine at inappropriate age (16 years old), was recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.

Other Meds:

Current Illness: Sickle cell disease

ID: 1056473
Sex: M
Age: 92
State: NY

Vax Date: 02/04/2021
Onset Date: 02/06/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 202102; Test Name: cardiac enzymes test; Test Result: Negative ; Result Unstructured Data: negative

Allergies:

Symptoms: AFib; Jaw and tooth pain; Jaw and tooth pain; Rapid heartbeat/Rapid pulse; Extreme weakness; Irregular heartbeat; blood pressure was 142/80; A spontaneous report was received from a consumer concerning a 92-years-old, male patient who experienced AFib (atrial fibrillation), rapid heartbeat/rapid pulse, extreme weakness, irregular heartbeat, blood pressure was 142/80, jaw and tooth pain. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium, metoprolol tartrate, pravastatin, fexofenadine, vitamin D, acetylsalicylic acid, fluticasone propionate and latanoprost. On 04 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 004M20A] intramuscularly in the for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient woke up that night with jaw and tooth pain. He later experienced rapid heartbeat, extreme weakness, irregular heartbeat, rapid pulse and AFib (atrial fibrillation) which was confirmed by his primary care physician (PCP) on 06 Feb 2021. On 08 Feb 2021, patient repoted his blood pressure was 142/80. Treatment for the event included metoprolol IV. Action taken with mRNA-1273 in response to the events was not provided. The events rapid heartbeat/rapid pulse and extreme weakness were considered recovered/resolved or on 08 Feb 2021 and the outcome of the events AFib (atrial fibrillation), irregular heartbeat, blood pressure was 142/80, jaw and tooth pain were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds: SYNTHROID; METOPROLOL TARTRATE; PRAVASTATIN; FEXOFENADINE; VITAMIN D [VITAMIN D NOS]; BABY ASPIRIN; FLONASE [FLUTICASONE PROPIONATE]; LATANOPROST

Current Illness:

ID: 1056474
Sex: F
Age: 59
State: CA

Vax Date: 01/15/2021
Onset Date: 02/12/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Blood and fluid that leaked out on to arm; Did not get the full dose; A spontaneous report was received from a consumer concerning a 59--year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced when the needle was pulled out she felt that there was blood and fluid that leaked out on to her arm and she thinks she did not get the full dose. 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 (BATCH # 029L20A) on 15 Jan 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 (BATCH # 006M20A) on 12 Feb 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Reporter stated that she had her second dose of the Modera COVID-19 vaccine 12 Feb 2021, at a drive in vaccination clinic. She had it on her left arm. When the needle was pulled out, she felt that there was blood and fluid that leaked out on to her arm and she thinks that she did not get the full dose. Lot number 006M20A, expiration date unknown. The first dose was administered through the same site on 15 Jan 2021 on her left arm with unknown dose and route of administration. Lot number 029L20A, unknown expiration date. Reporter wanted to know what the protocol was for vaccine leakages, if she should get another dose and if she got the full protection from the vaccine. No further information was reported. No treatment information was provided. Action taken with RNA-1273 in response to the event was unknown. The outcome of the events was unknown.; Reporter's Comments: This is a case of 59--year-old, female patient who was administered mRNA-1273 and experienced when the needle was pulled out she felt that there was blood and fluid that leaked (Injection site leaking ) out on to her arm and she thinks she did not get the full dose ( incomplete dose administered) batch # 006M20A. There was no associated adverse event reported for the events of injection site leaking and incomplete dose administered.

Other Meds:

Current Illness:

ID: 1056475
Sex: M
Age: 79
State: GA

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Lung cancer; A spontaneous report was received from a consumer concerning a 79-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced lung cancer. The patient's medical history was not provided. No relevant concomitant medications were reported. On 09 Feb 2021, approximately 0 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient tested positive for lung cancer. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event lung cancer was unknown.; Reporter's Comments: Based on the current available information and the very short duration of onset between the use of the product and the start date of lung cancer, a causal relationship is unlikely. Further information has been requested.

Other Meds:

Current Illness:

ID: 1056476
Sex: M
Age: 73
State: WV

Vax Date: 01/14/2021
Onset Date: 02/10/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data: Test Date: 20210210; Test Name: EEG; Result Unstructured Data: confirmed the patient was having a seizure

Allergies:

Symptoms: Seizures; Mini stroke; Tired; A spontaneous report was received from a consumer concerning a 73-year-old male who received Moderna Covid-19 vaccine and experienced seizures, mini stroke, confused, agitated, eyes were abnormal, memory impairment, and tired. The patient's medical history included heart attack and stent placement in 2011. His relevant concomitant medications include acetylsalicylic acid, candesartan cilexetil, clopidogrel bisulfate, diltiazem hydrochloride, ezetimibe, adenosine, gabapentin, metoprolol tartrate and rosuvastatin calcium. The patient received their first of two planned doses of mRNA-1273 on 14 Jan 2021. On 10 Feb 2021, 30 minutes prior to the onset of the events, the patient received his second of two planned doses of mRNA-1273 (Lot#010M20A) intramuscularly in left deltoid for the prophylaxis of COVID-19 infection. On 10 Feb 2021, With in 30 minutes of receiving the vaccination, the patient had a seizure. They took him to the hospital, where he had a computerized tomography (CT) scan, blood work and had a consult. After consult, they said, it's a mini stroke. They released him and told her if it happens again call 911. He felt so tired and went to sleep at home. Around 17:00 dinner time, he woke up looked very blankly, and his wife reported knowing he had another seizure. She reported he ran to his keys saying, "I have to go", seemed confused, agitated and didn't know where he was. She called 911 andhe was transported to the hospital in an ambulance. Around 19:00 the same day, he was admitted to do scans overnight. Around 21:00, patient's eyes were abnormal, he became agitated again and nurses confirmed he was having another seizure. 30 minutes later, he was talking to his wife and daughter as if he didn't remember anything. He mentioned some metallic taste in his mouth. On 11 Feb 2021, they did an electroencephalogram (EEG) and confirmed that he was having seizure. He was prescribed seizure medication and released him from hospital. However, the patient and his wife reported not wanting him to take the medication as they believe the events were due to the vaccine. Treatment information was not provided. Action taken with vaccine is not applicable as the patient received both the doses. The outcomes of the events, seizures, mini stroke, and tired, were recovered.; Reporter's Comments: Very limited information regarding this event has been provided at this time. The patient's medical history of heart attack and concomitant medication use can be confounding factor. Further information has been requested.

Other Meds: BABY ASPIRIN; ATACAND; PLAVIX; CARDIZEM CD; ZETIA; TRICOR [ADENOSINE]; NEURONTIN; LOPRESSOR; CRESTOR

Current Illness:

ID: 1056477
Sex: F
Age: 76
State: OR

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Saw a lot of blood on the water when she was taking a shower; arthritis act up; dizzy; A spontaneous report was received from a 76-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and felt dizzy, arthritis come up, and saw a lot of blood on the water when she was taking a shower. The patient's medical history included arthritis. No relevant concomitant medications were reported. On 09 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient felt dizzy after receiving the Moderna vaccine. On 10 Feb, 2021 the patient reported that her arthritis had come up and she took two aspirins. The patient reported blood on the water while she was taking a shower. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event of dizziness and arthritis, a causal relationship cannot be excluded. Although a temporal association exist, there is still not enough information to assess the causal association between the event saw blood and mRNA-1273 . Critical details such as the source of blood patient's medical history is lacking. Further information has been requested

Other Meds:

Current Illness: Arthritis

ID: 1056478
Sex: M
Age: 48
State: MI

Vax Date: 01/29/2021
Onset Date: 02/11/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Second dose was taken 14 days after 1st dose; Headache; Body aches; A spontaneous report received from a consumer concerning a 48-year-old male patient who received the second dose of Moderna COVID-19 vaccine and second dose was taken 14 days after 1st dose and experienced headache, and body aches. The patient's medical history was not included/ unknown. Patient's concomitant was not included/ unknown. Patient received 1st vaccine on 29 JAN 2021 (Lot number 029L20A) and had no symptoms. On 11-FEB-2021, the patient received the second of two planned doses of mRNA-1273 (Batch #: 013M20A) intramuscularly for prophylaxis of COVID-19 infection. Patient received the second vaccine on 11 FEB 2021 and reported the development of headache, and body aches. Patient stated having been told by his employer that he needed to take the second dose. Patient realized after receiving the second vaccination that maybe he took the second dose too early. Second dose was taken 14 days after 1st dose. Treatment for events included naproxen . Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event headache, and body aches, were unknown at the time of this report. The outcome of event second dose was taken 14 days after 1st does and experienced was considered resolved on 11 FEB 2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #029L20A, with associated AEs. 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: 1056479
Sex: F
Age:
State: CA

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: During vaccination, needle came loose and 50% of the vaccine was spilled; During vaccination, needle came loose and 50% of the vaccine was spilled; A spontaneous report was received from a physician's assistant concerning a 34-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and during vaccination, needle came loose (device connection issue) and 50% of the vaccine was spilled (underdose). The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (batch number not provided) on an unknown date. On 11 Feb 2021, on the same day as the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number: 038K20A) in the left arm for prophylaxis of COVID-19 infection. On 11 Feb 2021, during vaccination, the needle came loose and 50% of the vaccine was spilled. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, the action taken with the drug in response to the events was not applicable. The outcome of the events, during vaccination, needle came loose and 50% of the vaccine was spilled, was considered recovered/resolved on 11 Feb 2021.; Reporter's Comments: This report refers to a case of Underdose due to loose needle for mRNA-1273, lot # 038K20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1056480
Sex: F
Age: 66
State: NC

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

Lab Data:

Allergies:

Symptoms: Itchy eyes; Redness on the face; Rash just below her neck and above her chest; blotchiness but no hives; Readministered the vaccine to the patient thinking the first vial was empty; A spontaneous report received from a consumer concerning a 66-year-old female patient who received the first dose of Moderna COVID-19 vaccine and where the patient felt the needle go in but didn't feel the liquid and had developed itchy eyes, redness on the face, rash just below her neck and above her chest, and was readministered the vaccine to the patient thinking the first vial was empty. The patient's medical history was not provided. Patient's concomitant was not provided. On 12-FEB-2021, the patient received their first of two planned doses of mRNA-1273 in her right arm (Batch #: 024M20A) intramuscularly for prophylaxis of COVID-19 infection. On 12Feb2021 patient experienced itchy eyes, redness on the face, and a rash just below her neck and above her chest. There was "blotchiness but no hives". She had the same type of reaction as she does to orange peels. She had no trouble breathing. She took some diphenhydramine hydrochloride to help. The nurse also re-administered the vaccine to the patient thinking the first vial was empty and as the patient felt the needle go in but didn't feel the liquid. Action taken with mRNA-1273 in response to the events were not provided. The outcome of events itchy eyes, redness on the face, rash just below her neck and above her chest were unknown at the time of this report. The outcome of events the patient felt the needle go in but didn't feel the liquid was considered resolved on 12-Feb-2021 and readministered the vaccine to the patient thinking the first vial was empty were considered resolved on an unspecified date in Feb-2021.; Reporter's Comments: This case concerns a 66 year old, female patient, who experienced a non-serious unexpected event of eye pruritus, erythema, rash macular, after receiving first dose mRNA-1273. This report refers to a case of overdose for mRNA-1273 (lot # 024M20A), with no associated AEs. 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. Further information has been requested.

Other Meds:

Current Illness:

ID: 1056481
Sex: F
Age: 81
State: HI

Vax Date: 01/15/2021
Onset Date: 01/19/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Bell's Palsy; A spontaneous report received from a Healthcare Professional concerning, 81-year-old female patient who received the first dose of Moderna COVID-19 vaccine and was hospitalized for Bell's Palsy. The patient's medical history was not included/ unknown. There were no concomitant medications provided. On 15-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient was hospitalized on 19Jan2021 because developed Bell's palsy. Patient was observed because it was thought that she had a stroke. It was not a stroke. On 22Jan2021 the patient left the hospital. Second dose of Moderna COVID-19 vaccine is scheduled on 12Feb2021. Reporter wanted to know if patient should get second dose of Moderna COVID-19 vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1056482
Sex: F
Age: 74
State: FL

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Severe flu symptoms; feeling incapacitated; Gagging; Feeling like humming and buzzing (motor-like); Throat constriction/contraction; Eye/vision distorted and were constricted; Felt like head would explode; forehead and headache; Forehead/head constriction; Constriction/contraction of chest; A spontaneous report was received from a consumer, a 74-year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, feeling like humming and buzzing (motor-like), throat constriction/contraction, eye/vision distorted and were constricted, felt like head would explode, forehead/head constriction, constriction/contraction of chest, severe flu symptoms, feeling incapacitated, and gagging. The patient's medical history was not reported. No concomitant medications were reported. On 10 Feb 2021, prior to the onset of events, the patient received their second planned doses of mRNA-1273 (batch number: 030M20A), intramuscular for the prophylaxis of COVID-19 infection. The patient reported that she had adverse reactions after administering the vaccine around 2:00 on 10 Feb 2021. Later, the patient went to bed. On 11 Feb 2021, at midnight, the patient started feeling like that she was humming and buzzing from the waist up; throat was constricted and contracted; gagged a few times; vision/eyes were constricted and vision was distorted; forehead, and head ache felt constricted and felt like it was going to take off and was so tight. Later, it moved to chest, the constriction/contraction was so tight that and felt like someone was standing on it. The patient stated that these feelings were all above the waist and lasted for about an hour and ten minutes and just stopped on the same day. The next day on 12 Feb 2021, about six hours later, the patient had regular side effects which started about 10 hours after the shot. The patient was fine for about six hours then had severe flu symptoms and was feeling just incapacitated. The patient just got rid of these flu symptoms around 1 pm on the same day. The patient wanted to know if these were allergy symptoms. No treatment medication information was provided Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the events, feeling like humming and buzzing (motor-like), throat constriction/contraction, eye/vision distorted and were constricted, felt like head would explode, forehead/head constriction, constriction/contraction of chest, and gagging were recovered on 11 Feb 2021 and that of event severe flu symptoms was recovered on 12 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1056483
Sex: F
Age: 72
State:

Vax Date: 02/01/2021
Onset Date: 02/05/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: cardiomyopathy; A spontaneous report received from a Healthcare Professional concerning, 72-year-old female patient who received the second dose of Moderna COVID-19 vaccine and develop cardiomyopathy. The patient's medical history was not included. Patient's concomitant was not included. On 01-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Physician called and stated that his wife received the second Moderna COVID-19 vaccination on 01-FEB-2021 and on 05-FEB-2021 she developed cardiomyopathy. He stated that he would like for someone in the medical department to call him back. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1056484
Sex: F
Age: 73
State: FL

Vax Date: 02/03/2021
Onset Date: 02/01/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 202102; Test Name: Blood pressure; Test Result: Inconclusive ; Result Unstructured Data: Normal at 93.

Allergies:

Symptoms: Very dizzy; Threw up; Episode of afib; Light headache; A spontaneous report was received from a consumer (patient), 63 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, episode of A-fib (atrial fibrillation), very dizzy (dizziness), threw up (vomiting), and light headache (headache). The patient's medical history included episode of A-fib. Current conditions included diabetic and high blood pressure. No concomitant medications were reported. On 03 FEB 2021, seven days prior to the onset of events, the patient received their first of planned doses of mRNA-1273 (batch number: 038K20A), intramuscular in the left arm for the prophylaxis of COVID-19 infection. It was reported that two days ago, the patient had an episode of atrial fibrillation on 10 FEB 2021. The patient doesn't know if it was from the vaccine or something else. The patient usually has 2-3 times of atrial fibrillation a year. She didn't have any other side effects at all right after the vaccine. The patient was a diabetic and didn't call her doctor about this, because it went away. The patient described the atrial fibrillation episode as uncomfortableness and beating of the heart. The patient has an appointment with her cardiologist 2 days before her second shot, and she'd ask him about it. The patient was also wondering that the side effects occurred 8 or 9 days after the shot. She has high blood pressure and took a measurement, and it was normal at 93 (unknown units). The patient had the injection on her left arm because she has a diabetic monitor on right arm. The patient didn't take any treatment for the side effect except one time she took acetaminophen about three days ago when she had a light headache. On 12 FEB 2021, at about 10 am in the morning, the patient got very dizzy and had to sit down on the floor, and she threw up. After that, the patient was feeling fine. The patient gave consent to follow up from safety and to her doctor. No further treatment medications were reported. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of the events, episode of A-fib, and light headache were unknown and that of events very dizzy, and vomiting was recovering.; Reporter's Comments: 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. The patient's medical history of having 2-3 times of atrial fibrillation a year, diabetic and high blood pressure are the risk factors and confounds to the causality.

Other Meds:

Current Illness: AFib (2-3 times of Afib a year); Blood pressure high; Diabetic

ID: 1056485
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Patient received less than half the dose; the needle and syringe detached; A spontaneous report received from a physician concerning a patient of unknown age and gender, who received dose of Moderna COVID-19 vaccine and think they received half the dose (incorrect dose administered) and the needle and syringe detached (device connection issue). The patient's medical history was not included. Patient's concomitant was not included. On unknown date, the patient received their unknown of two planned doses of mRNA-1273 unknown arm (Batch #: unkown) intramuscularly for prophylaxis of COVID-19 infection. Physician stated that the needle and syringe detached, and they think the patient received less than half the dose. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events was resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1056486
Sex: M
Age: 88
State: FL

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: felt delirious; felt lightheaded; had a terrible dream; felt nauseous; A spontaneous report was received from a consumer reporting on himself, an 88-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt delirious/MedDRA PT: delirious, felt nauseous/MedDRA PT: nausea, felt lightheaded/MedDRA PT: lightheadedness, and had a terrible dream/MedDRA PT: terrifying dreams. The patient's medical history was not provided. Concomitant medication use was not provided. On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. The patient reported that during the night, he felt lightheaded, had a terrible dream, felt nauseous and delirious. The patient felt better the following day and his primary care physician was aware of the side effects. Treatment for the events included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events of felt delirious, felt nauseous, felt lightheaded and had a terrible dream were considered recovering/resolving.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the event to be unlikely related to company product.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm