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: 1056487
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: 17 year old received the 1st dose of the vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old, patient who received the first dose of Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, it was reported that a 17-year-old received the first dose of the vaccine. No treatment information was reported. Action taken with mRNA-1273 in response to the event was not reported The outcome of the event, 17-year-old patient received the 1st dose of the vaccine, was resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1056488
Sex: F
Age: 70
State: MA

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

Lab Data:

Allergies:

Symptoms: Administered the vaccine below the deltoid or at the end of the deltoid; Symptoms are as if got the flu shot; Warm; Hard; Tired; Red area on arm the size of a quarter; Headache; A spontaneous report was received from a nurse who is a 70-year-old, white female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced administered vaccine below the deltoid or at the bottom of the deltoid/incorrect route of product administration, tired/fatigue, headache, red area on arm the size of a quarter/injection site erythema, warm/injection site warmth and hard/injection site induration, and symptoms are as if got the flu shot/influenza like illness. The patient's medical history was not provided. No concomitant medications were reported. On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) in the right arm intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient reported, the Moderna COVID-19 vaccine was administered below the deltoid or at the end of the deltoid. The patient also reported she was tired and had a headache and there was a red, warm and hard area the size of a quarter on her arm. She stated, her symptoms were like that of when she received the flu vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, administered vaccine below the deltoid or at the bottom of the deltoid/incorrect route of product administration, was considered resolved on 11 Feb 2021. The outcome of the events, tired/fatigue, headache, red area on arm the size of a quarter/injection site erythema, warm/injection site warmth and hard/injection site induration, and symptoms are as if got the flu shot/influenza like illness, were considered unknown.; Reporter's Comments: This is a case of 70--year-old, female patient who was administered mRNA-1273 and experienced below the deltoid or at the bottom of the deltoid (vaccine administered at inappropriate site) Lot # BATCH # 026L20A. The other events temporarily association with product and a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1056489
Sex: F
Age: 72
State: CA

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

Lab Data:

Allergies:

Symptoms: I can't move my arm/can't bring my arm up to my breast and obviously over my head/this really limits my mobility; it was that upper joint area that was throbbing; couldn't sleep much because it was excruciating; extreme pain in my shoulder/excruciating pain in my shoulder/that top part, that ball and socket was excruciating to move; Vaccine given too high up in my arm/it felt like it was going into my bone at the top; Chills; my whole arm hurt/it's excruciating when I attempt to be mobile; A spontaneous report was received from a consumer (United States) concerning herself, a 72-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273), who experienced the following events: I'm concerned it was given too high up in my arm/it felt like it was going into m y bone at the top/MedDRA PT: inappropriate route of vaccination, that top part, that ball and socket was excruciating to move/MedDRA PT: joint pain, I can't move my arm/can't bring my arm up to my breast and obviously over my head/this really limits my mobility/MedDRA PT: injected limb mobility decreased, chills, my whole arm hurt/it's excruciating when I attempt to be mobile/MedDRA PT: pain in arm, couldn't sleep much because it was excruciating/MedDRA PT: sleep difficult, it was that upper joint area that was throbbing/MedDRA PT: throbbing pain, band ack to the same pain I had after the injection/MedDRA PT: shoulder pain. The patient's medical history included cancer and child birth x 2. Concomitant medication use was not provided. On 03 Feb 2021, the patient received the first of two planned doses of mRNA-1273 ([LOT 029L20A]) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Action taken with mRNA-1273 in response to the events was not reported. The even of "a couple of patients received their dose at 7 hours" was considered recovered/resolved (date unspecified).; Reporter's Comments: This case concerns a 72-year-old female who had NS unexpected Incorrect route of product administration and NS unexpected injected limb mobility decreased, painful arm, throbbing pain, insomnia and NS expected arthralgia, chills. The events occurred the same day as first dose of mRNA-1273. Treated with Tylenol. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1056490
Sex: F
Age:
State: GA

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

Lab Data:

Allergies:

Symptoms: punctured vial was left out at room temp and opened for more than 6 hours; A spontaneous report was received from a healthcare provider concerning a 32-year-old, female patient who received a vaccine at her work place when the punctured vial was left out at room temperature and opened for more than 6 hours (expired product administered). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient received a vaccine at her work place when the punctured vial was left out at room temperature and opened for more than 6 hours. Treatment information was not provided. The event was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 026L20A) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1056491
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Received first dose of Moderna and second dose was Pfizer; A spontaneous report was received from a consumer who is a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received first dose of Moderna and second dose was Pfizer/wrong product administered 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, the patient reported her first dose of the vaccine was from Moderna and her second dose was from Pfizer. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, received first dose of Moderna and second dose was Pfizer/wrong product administered, was considered resolved.; Reporter's Comments: This report refers to a case of wrong product administered with second dose with Pfizer vaccine and with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1056492
Sex: U
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: patient was administered a dose of the vaccine from punctured vial that was punctured for more; A spontaneous report was received from a pharmacist concerning a patient who experienced patient had been administered a dose from a punctured vial that had been punctured for more than hours. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the event(s) was not reported.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced nonserious unexpected event of Expired product administered with mRNA-1273 (Lot # unknown), with no associated adverse events. Reporter stated that patient was given "vaccine from a punctured vial that had been punctured for more than hours". The event occurred the same day as the first dose of mRNA-1273. Very limited information has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1056493
Sex: F
Age: 16
State: OK

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

Lab Data:

Allergies:

Symptoms: Injection site pain and tenderness; 16 year old patient administered the vaccine; A spontaneous report was received from a health care provider regarding a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) inappropriately at the age of 16 and experienced injection site pain and tenderness/vaccination site pain. The patient's medical history was not included. Products known to have been used by the patient were Vitamin D3 and ethinylestradiol, ferrous fumarate, norethisterone. On 12 Feb 2021, prior to the onset of the events, the patient inappropriately received the first of two doses of mRNA-1273 (Lot number: 031M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 13 Feb 2021, the day after the vaccine was given the patient experienced injection site pain and tenderness. Treatment information was not provided. Action taken with mRNA-1273 was not reported. The outcome of the events, vaccine being given inappropriately to a 16-year-old, was considered resolved on 12 Feb 2021. The event, vaccine site pain and tenderness, was unknown.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 031M20A), reporting Product administered to patient of inappropriate age with associated adverse event of vaccination site pain. 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: VITAMIN D3; NOTREL 7/7/7

Current Illness:

ID: 1056494
Sex: M
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: vaccine was coming out of the syringe and needle; seems that patient did not have the full dose; vaccine came out of syringe running down the patients arm; A spontaneous report was received from a Pharmacist regarding a male patient who received first dose of Moderna Covid-19 vaccine and vaccine came out of syringe (device connection issue) running down the patients arm (exposure via skin contact). It seems that patient did not receive the full dose (underdose). The patient's medical history was not provided. No concomitant medications were provided. No information on allergies. On 13-FEB-2021, prior to the onset of events, the patient received first of two planned doses of Covid-19 vaccine for the prophylaxis of Covid-19 infection. According to Pharmacist, while administering the vaccine using 25G pharmacy needle, as soon as he pushed down the plunger, vaccine came out of syringe and needle running down the patients arm. Patient didn't seem to get the full dose and he is a lean guy, did not feel anything during administration. Pharmacist was enquiring with Medical information center at Moderna whether it is safe to give another dose. He was informed that in case of deviation from recommended dose, dose should not be repeated, and the patient should be closely followed for safety outcomes. Action taken with the 2nd dose of vaccine was not reported. The events, vaccine came out of syringe running down the patients arm and seems that patient did not receive the full dose, were resolved on 13 Feb 2021.; Reporter's Comments: This case concerns a 68-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting device connection issue, underdose and exposure via skin contact without any associated adverse events.

Other Meds:

Current Illness:

ID: 1056495
Sex: M
Age: 82
State: SC

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: angina; a stomachache that lasted for 10 hours; nausea; vomited 1 time; A spontaneous report was received from a consumer concerning an 82-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angina (angina pectoris), stomachache (abdominal pain upper), nausea and vomiting 1 time. The patient's medical history included 3 stents in the heart and angina. Concomitant product use was not reported. On 03 Feb 2021, approximately 26 hours prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number unknown) in the left arm for prophylaxis of COVID-19 infection. The reporter stated that 26 hours after receiving the vaccine, he had a stomachache that lasted for 10 hours. The patient also experienced nausea and vomited 1 time. Early in the week of 08 Feb 2021, the patient reported experiencing angina, which he stated he had not had for a very long time. The patient reported that no treatment medications were taken for these side effects. The patient stated that he will follow up with his cardiologist. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, angina, was unknown. The events, stomachache, nausea, and vomiting, were considered recovered/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 of abdominal pain, nausea and vomitting, a causal relationship cannot be excluded. The patient's medical history of 3 stents in the heart and angina confounds to the causality of Angina Pectoris.

Other Meds:

Current Illness:

ID: 1056496
Sex: F
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 02/07/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Hospitalized; A regulatory report was received from a consumer concerning a female patient who experienced hospitalization. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received her first of two planned doses of mRNA-1273 Batch number not provided on 11-JAN-2021 for prophylaxis of COVID-19 infection. The patient received the first dose of the Moderna COVID-19 vaccine on 11Jan2021. On 07Feb2021 she was hospitalized for reasons she didn't want to specify and returned home on 11Feb2021. She missed her appointment for her second dose on 08Feb2021because of the hospitalization. She didn't want a callback because she says that this was not related to the vaccine, so no further information was gathered. Treatment information was not provided/unknown. The second dose of mRNA-1273 was temporarily withheld in response to the event. The event of hospitalization was considered recovered/resolved on 11 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 the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1056497
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Severe anaphylaxis allergic reaction; Passed out on the ground; A spontaneous report was received from a consumer concerning a 22-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed out on the ground and had a severe anaphylaxis allergic reaction. 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 the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. About 10 minutes after receiving the second dose of the Moderna vaccine, the patient passed out on the ground having a severe anaphylaxis allergic reaction. Treatment for the event included two doses of epinephrine IM in addition to diphenhydramine, ondansetron, and steroids to prevent a rebound reaction. 911 was called and after epinephrine and diphenhydramine were administered, the patient was immediately transported to the hospital where she stayed for 6 more hours for observation, fluids, and further medications. Action taken with mRNA-1273 in response to the events was not applicable. The events, passed out on the ground and severe anaphylaxis allergic reaction, were 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. Anaphylactic reaction is a listed event in CCDS.

Other Meds:

Current Illness:

ID: 1056498
Sex: F
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: Vaccine was withdrawn from arm and some of the vaccine dripped out; A spontaneous report was received from a consumer regarding herself, a 44-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of vaccine leaking out of the injection site/accidental underdose. The patient's medical history was not included. Products known to have been used by the patient were not included. First dose information was not provided. On 11 Feb 2021, prior to the onset of the events, the patient received the second of two doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 11 Feb 2021, as the needle was withdrawn, some of the vaccine leaked out. The patient is concerned about underdose. Treatment information was not provided. Action taken with mRNA-1273 was not applicable. The outcome of the events, vaccine leaking out when needle was withdrawn, was considered resolved.; Reporter's Comments: This case concerns a 44-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Accidental underdose without any associated adverse events.

Other Meds:

Current Illness:

ID: 1056499
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: UTI; cough; A spontaneous report was received from a consumer concerning a patient who developed/experienced hospitalization for 7 days UTI, cough, MedDRA PT: hospitalization, urinary tract infection, cough The patient's medical history was not provided. The patient received their first of two planned doses of mRNA-1273 .Batch number not provided Treatment information was unknown. The patient scheduled to received the second shot of the vaccine. Patients reports having a bad reaction to the first shot; starting cough, and ended up with a UTI and ended up in the hospital for 7 days. Action taken with mRNA-1273 in response to the events were unknown. The outcome of the events were not reported.; Reporter's Comments: This case concerns a female of unknown age who experienced a "bad reaction to the first shot" and then was hospitalized with a serious unexpected event of UTI and a NS unexpected event of cough. The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. 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:

Current Illness:

ID: 1056500
Sex: M
Age: 40
State: OK

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

Lab Data:

Allergies:

Symptoms: Inadvertently given vaccine from a vial that was punctured a day before; A spontaneous report was received from a physician concerning a 41-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was inadvertently given the vaccine from a vial that was punctured a day before (expired product administered). The patients' medical history was not provided. Concomitant product use was not provided. On 13 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: 016M20A) intramuscularly for prophylaxis of COVID-19 infection. The reporter stated that the patient was inadvertently given the vaccine from a vial that was punctured a day before. A single dose was taken out of that vial and put back outside the six-hour window. Treatment information was not provided. The action taken with mRNA-1273 in response to the event was unknown. The event, was inadvertently given the vaccine from a vial that was punctured a day before, was considered resolved on 13 Feb 2021.; Reporter's Comments: This case concerns a 41-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: 016M20A), reporting Expired product administered without any associated adverse events.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-013964:same reporter, different patient US-MODERNATX, INC.-MOD-2021-013965:same reporter, different patient

Other Meds:

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

ID: 1056501
Sex: M
Age: 21
State: OK

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

Lab Data:

Allergies:

Symptoms: inadvertently given vaccine from a vial that was punctured a day before; A spontaneous report was received from a physician regarding a 22-year-old male patient who inadvertently received Moderna's mRNA-1273 vaccine from a vial that was punctured the day before/expired product administered. The patient's medical history was not provided. Concomitant medications were not provided. On 13 February 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: 016M20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 February 2021, it was noticed that the vial being used had been punctured the day before, beyond the 6-hour expiration. Treatment information was not provided. Action taken with mRNA-1273 was not provided. The outcome of the event, inadvertently given a vaccine from a vial that was punctured the day before, was considered resolved.; Reporter's Comments: This case concerns a 22-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: 016M20A), reporting Expired product administered without any associated adverse events.; Sender's Comments: MOD-2021-013965:same reporter, different patient MOD-2021-013964:same reporter, different patient

Other Meds:

Current Illness:

ID: 1056502
Sex: M
Age: 57
State: AL

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

Lab Data:

Allergies:

Symptoms: Vaccine given after sitting in room temperature for 6 hours and 25 minutes; A spontaneous report was received from a 57 year-old, male patient, age who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given after sitting in room temperature for 6 hours and 25 minutes. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007m20A) for prophylaxis of COVID-19 infection. On 14 Feb 2021, a dose of Moderna's vaccine was administered to the patient after sitting in room temperature for 6 hours and 25 minutes. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, expired vaccine used, was considered resolved on 14 Feb 2021.; Reporter's Comments: This report refers to a case of Expired product used for mRNA-1273(Batch number: 007m20A), with no associated AEs.

Other Meds:

Current Illness:

ID: 1056503
Sex: M
Age: 74
State: NY

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

Lab Data:

Allergies:

Symptoms: When needle came out there was a squirt so maybe didn't get the full dose; A spontaneous report was received from a consumer concerning a 74 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced when needle came out there was a squirt so maybe didn't get the full dose (Product administration error, Incomplete dose administered). The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 14-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A) on 14-JAN-2021. On 11-FEB-2021, approximately prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly in the for prophylaxis of COVID-19 infection. On 11-FEB-2021, during administration of the second dose, when the needle came out there was a squirt so he thought maybe he didn't get the full dose. Treatment information was not provided/unknown. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The outcome of the event was recovered on 11 Feb 2021.; Reporter's Comments: This is a case of 74-year-old male patient who was administered second dose of mRNA-1273 vaccine and experienced needle came out there was a squirt so maybe didn't get the full dose (Product administration error, Incomplete dose administered) Lot #: 030L20A. There was no associated adverse event reported for the events of Product administration error, Incomplete dose administered.

Other Meds:

Current Illness:

ID: 1056504
Sex: U
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: 15 patients received doses from vials that were more than 6 hours post initial puncture; A spontaneous report was received from a health care professional concerning a 14 patients who received doses from vials that were more than 6 hours post initial puncture. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The health care professional reported that they had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture. The health care professional wanted to know if they needed to revaccinate those patients? During follow-up call: HCP stated that there were actually 14 patients that received doses from vials that more than 6 hours post initial puncture. The HCP was unable to provide any additional information at the time of the call and stated that a colleague would call back with further details. Consent for Safety to follow up with HCP was not provided as she does not have any additional information to Action taken with mRNA-1273 in response to the event was not provided/unknown. The event,14 patients received doses from vials that were more than 6 hours post initial puncture, was recovered/resolved.; Reporter's Comments: This report refers to a case of Product administration error where total of 15 patients had experienced expired product administration for mRNA-1273(unknown batch). This case had no associated AEs.

Other Meds:

Current Illness:

ID: 1056505
Sex: M
Age:
State: TX

Vax Date: 12/30/2020
Onset Date: 02/11/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient received first dose on 30Dec2020 and has not received second dose yet; A spontaneous report was received from a consumer concerning male patient of unknown age, who received Moderna's COVID-19 vaccine first dose and has not received second dose yet. 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 (Lot number:025L20A) unknown route of administration on 30 Dec 2020 for prophylaxis of COVID-19 infection. Patient stated he had missed his email for being able to return for his second dose. His first dose was on 30-Dec-2020. He returned to the same clinic on 28-Jan-2021 but they turned him away and told he will receive an email and he is still waiting on that. During a follow up call patient stated he was able to get in touch with an alternative vaccination site who advised him to come on 12-Feb-2021 and see if they will vaccinate him. Patient was unsure if they will vaccinate him since last time he showed up without an appointment and he was turned away. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, Patient received first dose on 30-Dec-2020 and has not received second dose yet was considered resolved.; Reporter's Comments: This case concerns a male of unknown age who experienced a nonserious unexpected event of Inappropriate schedule of product administration for mRNA-1273 (lot # 025L20A) without associated adverse events. Patient received first dose mRNA-2173 on 30-Dec-2020 and has not yet received the second dose. The missed second dose of mRNA-1273 occurred 1 month and 13 days after the first dose of mRNA-1273. Further information has been requested.

Other Meds:

Current Illness:

ID: 1056506
Sex: F
Age: 80
State: AL

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

Lab Data:

Allergies:

Symptoms: Headache around her temples and nose; Did not get full shot since syringe messed up; Did not get full shot since syringe messed up; A spontaneous report was received from a consumer concerning an 80-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced that she did not get the full shot since the syringe messed up/device connection issue, vaccine underdose and headache. The patient's medical history was not provided. Concomitant medications were not provided. On 15 FEB 2021, the patient received her second dose of mRNA-1273 (lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. The patient stated that she received her vaccine on 15 FEB 2021, but the syringe messed up and she didn't get the full dose. The healthcare professional (HCP) told her to come back on 18 FEB 2021 for the full dose. On 16 FEB 2021 the patient woke up with a headache around her temples and nose. Treatment for these events were not reported. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, device connection issue and vaccine underdose were recovered. The outcome of the event, headache was unknown.; Reporter's Comments: This case concerns a 80-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 025L20A), reporting device connection issue, vaccine underdose and associated headache. 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: 1056507
Sex: M
Age: 65
State: IL

Vax Date: 01/18/2021
Onset Date: 02/08/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data: Test Date: 20210210; Test Name: CT; Result Unstructured Data: no additional details provided

Allergies:

Symptoms: Bells Palsy; A spontaneous report was received from a consumer concerning a 65 year old male patient who experienced Bells Palsy/Facial Paralysis, Slurred speech/.Dysarthria, Facial droop/Facial droop, Numbness on Facial right side/ Facial Paresthesia, Thumb numbness/ Thumb Paresthesia, Right paralysis/Right Paralysis, Right eye lid will not close/Right Eyelid Paralysis The patient's medical history was not provided. Products known to have been used by the patient, within in two weeks prior to the events, included Insulin Zinc Suspension, Insulin Aspart, Clopidogrel bisulfate, Gabapentin, Mesalamine, and Atorvastatin. On 18-Jan-2021, prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 ( Batch number: 09L20A) intramuscularly into the right arm for prophylaxis of Covid-19 infection. On 15-Feb-2021 the patient received the second of two planned doses of mRNA-1273 ( Batch number: 024M20A) intramuscularly (site not provided) for prophylaxis of Covid-19 infection. On 15 Feb-2021, the patient left a voicemail message to safety and stated "got right paralysis, thought I had stroke, spent 4 days in the hospital and diagnosed me with Bells Palsy". Hospital admission, treatment information, and discharge dates were not provided. On 16-Feb-2021 Safety agent reached the patient to clarify the information provided in his first report (15-Feb-2021). The patient reported his symptoms began on 08-Feb-2021, 21 days following the first dose of mRNA-1273, the patient experienced slurred speech, facial droop , numbness on facial right side, thumb numbness, right paralysis, right eye lid will not close and blurred vision of the right eye. He was hospitalized (date not provided). Treatment information included a CT scan which was reported as normal . He reported seeing a speech therapist to help with his speech and improve swallowing. He reported no treatment was given to him. A physician diagnosed him with Bells Palsy on 10-Feb-2021. Hospital discharge date was not provided. The second dose of mRNA-1273 was temporarily withheld in response to the events rechallenge date 15-Feb-2021 was reported as negative. The outcome of the events, Bells Palsy,slurred speech, facial droop , numbness on facial right side, thumb numbness, right paralysis, right eye lid will not close and blurred vision of the right eye were considered Not recovered/Not resolved. Company Comment: the reported event Bells Palsy was considered possibly related to mRNA-1273.; 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: INSULIN LENTE [INSULIN ZINC SUSPENSION]; PLAVIX; NOVOLOG; GABAPENTIN; MESALAMINE; ATORVASTATIN

Current Illness: Palsy Bells (Symptoms started 08-Feb-2021 Diagnosed by physician 10-Feb-2021)

ID: 1056508
Sex: F
Age: 50
State: TN

Vax Date: 12/19/2020
Onset Date: 01/26/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: anaphylactic reaction; A report was received from a healthcare facility staff member concerning a 50 year old, female patient (a nurse) who was participating in the mRNA-1273 Emergency Use Program and experienced an anaphylactic reaction. No relevant concomitant medications and medical history were reported. The patient received their first of two planned doses of mRNA-1273 on 19-DEC-2020. On 26-JAN-2021, the patient received their second of two planned doses of mRNA-1273 (Batch 030L20A) in her Left deltoid arm (IM injection) and on the same day, experienced the serious adverse event of anaphylactic reaction. She was transported by ambulance to the ER. She stayed there for one day and now is fine. Treatment included Benadryl, epinephrine, steroid, advance, peptide, Motrin. Laboratory details was not provided. The event, anaphylactic reaction, was considered recovered on 26-JAN-2021. Action taken with mRNA-1273 in response to 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. Further information has been requested.

Other Meds:

Current Illness:

ID: 1056509
Sex: F
Age:
State: NJ

Vax Date: 01/30/2021
Onset Date: 01/31/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: heart failure; blood sugar was really high; This is a spontaneous case report sent by a Non-Health Professional which refers to an 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cardiac failure and blood sugar was really high. The following drugs are known to have been taken by the patient prior to the event: Amlodipine ,atorvastatin, Breo, Diovan, furosemide, metoprolol, Xarelto, Trulicity On 30-Jan-2021 the patient took the first dose of the Moderna COVID-19 Vaccine for COVID-19 infection. On the next day ('Sunday") her blood sugar was high and on Monday the patient developed heart failure and she is not attributing the heart failure to the vaccine but is wondering if her blood sugar is high due to the vaccine or CHF. Gliperide and metformin are the treatment for symptoms. Relevant laboratory results included. The hospital discharge summary was not available. The eventual diagnosis made on was cardiac failure . Patient wants to know that she should take second dose of vaccine. The Non-Health Professional did not declare any relatedness between heart failure and Moderna COVID-19 Vaccine Terse Narrative (for narratives and signal review) Brief 3 line summary of above for agency listing: Report Source- Non-Health Professional, Age- 81 Years, Sex- Female, Suspect Drug- Moderna COVID-19 Vaccine, Treatment- Diagnosis\Outcome- heart failure - Unknown,blood sugar was really high - Unknown.; Reporter's Comments: Based on the information provided, a causal association between the reported events and the administration of mRNA-1273 is assessed as unlikely. Causality is confounded by the patient's underlying medical history suggestive in concomitant therapy. Additional information has been requested.

Other Meds: AMLODIPINE; ATORVASTATIN; BREO ELLIPTA; DIOVAN; FUROSEMIDE; METOPROLOL; XARELTO; TRULICITY

Current Illness:

ID: 1056510
Sex: U
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: was accidentally given a second dose of the Moderna version of the shot, instead of a second dose of the Pfizer shot; A spontaneous report was received from a other healthcare professional concerning an unknown patient who was accidentally given a second dose of the Moderna version of the shot, instead of a second dose of the Pfizer shot. Lot number and expiration date for mRNA-1273 were not reported Medical history and concomitant medications were not reported. No additional information relevant to the event was reported. Action taken with the second dose of mRNA-1273 in response to the event was unknown.; Reporter's Comments: This report refers to a case of accidentally given a second dose of the Moderna version of the shot, instead of a second dose of the Pfizer shot for mRNA-1273, lot# (unknown) with no associated adverse events.

Other Meds:

Current Illness:

ID: 1056511
Sex: F
Age: 62
State: NC

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

Lab Data:

Allergies:

Symptoms: lost hearing in right ear; ringing in the ear; A spontaneous report was received from a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ringing in the ear and loss of hearing in the right. The patient's medical history was not provided. Products known to have been used by the patient were not included. On 03 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced ringing in the ear and lost hearing in the right ear. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, ringing in the ear and lost hearing in the right ear was not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1056512
Sex: F
Age: 56
State: OH

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

Lab Data:

Allergies:

Symptoms: Bell's Palsy; body aches; Pain in the head; Neck pain; Jaw pain; A spontaneous reportwas received from a 56-years-old, female patient who experienced jaw pain, neck pain, pain in the head, body aches and bells palsy. 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, fluticasone propionate, loratadine, vitamin E, vitamin B, vitamin C, ibuprofen and tizanidine. On 26 Jan 2021, approximately fifteen days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 2039K20A] intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, the patient experienced jaw pain, neck pain, head pain and body aches. On 14 Feb 2021, she was diagnosed with Bells palsy after going to urgent care . Treatment for the event included valaciclovir hydrochloride, salve for eye, steroid ear drop. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events jaw pain, neck pain, pain in the head, body aches and bell's palsy were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Other Meds: SYNTHROID; FLONASE [FLUTICASONE PROPIONATE]; CLARITIN [LORATADINE]; VITAMIN E [VITAMIN E NOS]; VITAMIN B [VITAMIN B NOS]; VITAMIN C [ASCORBIC ACID]; ADVIL [IBUPROFEN]; TIZANIDINE

Current Illness:

ID: 1056513
Sex: F
Age:
State:

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

Lab Data: Test Date: 202101; Test Name: Body temperature; Result Unstructured Data: 102.7 F

Allergies:

Symptoms: Passed out; Shakes so bad; So sick; Headache; Muscle pain; Temperature for five days (102.7F); A spontaneous report was received from a consumer, female patient of unknown age, with unknown race and ethnicity, who was administered Moderna's COVID-19 Vaccine (mRNA-1273) and experienced passed out (loss of consciousness), shakes so bad (tremor), so sick (malaise), headache, muscle pain (myalgia), and temperature for five days (102.7F) (pyrexia). The patient's medical history was not provided. No concomitant medications were reported. On an unknown date in JAN 2021, the patient received their first of planned doses of mRNA-1273 (batch number: unknown), intramuscularly for prophylaxis of COVID-19 infection. The patient reported that the difficulties which she experienced after the first Moderna vaccine were terrible and so bad. The patient had all the side effects, which includes headache, muscle pain, passed out, fever, and was so sick. The patient wanted to report the side effects and unsure if she should take the second vaccine or not. The patient doesn't think that she can handle the second vaccine. She had a temperature of 102.7 F and was shaking so bad. The patient second vaccine was due in 28 days in February. Upon callback, the patient had a hard of hearing and stated that the vaccine hit her hard and had a temperature for five days. She was concerned about getting the second dose. No treatment medication information was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, passed out, shakes so bad, so sick, headache, muscle pain, and temperature for five days (102.7F), 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 event, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1056514
Sex: M
Age: 17
State: GA

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

Lab Data:

Allergies:

Symptoms: 17 year-old received the Moderna COVID-19 vaccine; A spontaneous report was received from a nurse concerning a 17-year-old, male who received Moderna's COVID-19 vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12-Feb-2021, prior to the onset of the event, the patient received their first of two planned does of mRNA-1273 (Lot number: 012M20A) for prophylaxis of COVID-19 infection. On 12-Feb-2021, the patient was administered mRNA-1273 vaccine. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, 17-year-old received the Moderna COVID-19 vaccine, was considered resolved on 12 Feb 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 012M20A) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1056515
Sex: F
Age: 67
State: FL

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

Lab Data:

Allergies:

Symptoms: left side of face began to tingle and be numb; left side of face began to tingle and be numb; 2 episodes of rapid heartbeat; burning in arm; lips and tongue started swelling; tongue started swelling; severe headache; A spontaneous report was received from a consumer reporting on herself, a 67-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced left side of face began to tingle and be numb/MedDRA PT: Hemiparesthesia, rapid heartbeat/MedDRA PT: tachycardia, burning in arm/MedDRA PT: vaccination site burning, lips started swelling/MedDRA PT: swelling of lips, tongue started swelling/MedDRA PT: swelling of tongue, severe and headache/MedDRA PT: headache. The patient's medical history included allergy to latex and reaction to oseltamivir phosphate (Tamiflu).Products known to have been used by the patient, within two weeks prior to the event, included losartan, potassium citrate, diltiazem, allopurinol, atorvastatin, famotidine and levocetirizine. On 12 Feb 2021, the patient received the first of two planned doses of mRNA-1273 ([LOT# 015M20A]) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Four minutes after the vaccination, the patient felt burning in her arm and the left side of her face began to tingle and feel numb. In addition, the patient's lips and tongue began to swell and she had 2 episodes of rapid heart rate. Within 20 minutes it started to resolved and then she developed a severe headache. On 13 Feb 2021, the patient reported that all of the symptoms were back except the fast heartbeat. The patient called Urgent Care and was prescribed treatment with diphyendramine and famotidine. On 14 Feb 2021, the patient went to the emergency room and received a steroid injection, "liquid to drink", and steroid medication for 5 days. She reported a history of a similar reaction to oseltamivir phosphate (Tamiflu). Action taken with mRNA-1273 in response to the events was not reported. The outcome of events of left side of face began to tingle and be numb, 2 episodes of rapid heartbeat, burning in arm, lips and tongue started swelling and severe headache (12 Feb 2021) were considered recovered/resolved. The outcome of events of left side of face began to tingle and be numb, burning in arm, lips and tongue started swelling and severe headache (13 Feb 2021) were considered unknown; Reporter's Comments: This case concerns a 67-year-old female, with latex and drug allergies, who had serious unexpected hemiparesthesia and hypoaesthesia, NS unexpected lip swelling, swollen tongue, tachycardia, and NS expected vaccination site pain, headache. Event onset 4 minutes after first dose of mRNA-1273. Treated with Benadryl and steroids. 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: LOSARTAN; POTASSIUM CITRATE; DILTIAZEM; ALLOPURINOL; ATORVASTATIN; FAMOTIDINE; LEVOCETIRIZINE

Current Illness: Drug allergy (Unspecified reaction to Tamiflu); Latex allergy (Allergy to latex.)

ID: 1056516
Sex: F
Age:
State: AZ

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sore arm; Pulled the dose from multiple vials (2-3 vials) to complete the 0.5ML; A spontaneous report was received from a pharmacist, concerning her mother, a 57-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) where in pulled the dose from multiple vials (2-3 vials) to complete the 0.5 ML and developed sore arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 16 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot: 00UM20A) for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient's vaccine dose was pulled the from multiple vials (2-3 vials) to complete the 0.5 ML. Patient also experienced sore arm. Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the event Pulled the dose from multiple vials (2-3Vials) to complete the 0.5ML was considered resolved on 16 Feb 2021. The outcome of event sore arm was considered unknown at the time of this report.; Reporter's Comments: This report refers to a case of Inappropriate drug extraction with syringe for mRNA-1273, lot # 00UM20A with sore arm. developed

Other Meds:

Current Illness:

ID: 1056517
Sex: F
Age: 78
State: NE

Vax Date: 02/04/2021
Onset Date: 02/16/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Got their second vaccine earlier than they should have; A spontaneous report was received from a nurse regarding a 78-year-old female patient who received Moderna's mRNA-1273 vaccine earlier then she should have/inappropriate schedule of vaccine administered. The patient's medical history was not provided. Concomitant medications were not provided. On 04 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch: unknown) for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Batch: 024M20A) for prophylaxis of COVID-19 infection. On 16 Feb 2021, accidently patient got through and got their second vaccine earlier than they should have. Patient got their first dose of the Moderna vaccine at a different place, that's how this ended up happening. Treatment information was not provided. Action taken with mRNA-1273 was not applicable. The outcome of the event, receiving the vaccine earlier than she should have, was considered resolved on 16 Feb 2021.; 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:

Date Died: 02/13/2021

ID: 1056518
Sex: M
Age: 84
State: NJ

Vax Date: 01/18/2021
Onset Date: 02/13/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: The coroner said it was some type of heart attack; A spontaneous Report Received from a Health care professional concerning a 84 year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced a heart attack / myocardial infarction. The patient's had undergone triple bypass surgery years ago. Concomitant medications were vitamins. On 18-Jan-2021 prior to onset of events the patient received his first of first two planned doses of (mRNA-1273) COVID-19 vaccine of unknown batch no, unknown route and unknown site of administration for prophylaxis of COVID-19 infection. On 13-Feb-2021 the patient experienced death 27 days after the first dose of the vaccine. The coroner said it was some type of heart attack and think he expired sometime Saturday 13-Feb-2021. On 16-Feb-2021 the patient was supposed to have his second dose of (mRNA-1273) COVID-19 vaccine. The event, heart attack, was fatal.; Reporter's Comments: This is a case of death to heart attack in a 84-year-old female subject with a hx of triple bypass surgery, who died 27 days after receiving first dose of vaccine. Very limited information has been provided at this time. No death certificate provided. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of Death

Other Meds: VITAMINS NOS

Current Illness:

ID: 1056519
Sex: M
Age: 38
State: NY

Vax Date: 01/13/2021
Onset Date: 01/19/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data: Test Date: 20210119; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptoms: COVID 19 infection but asymptomatic; A spontaneous report was received from a (Reporter like HCP and Consumer) concerning a 38 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events COVID 19 infection but asymptomatic. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 19-JAN-2021, The patient experienced the events COVID 19 infection but asymptomatic was given. Laboratory details COVID 19 test positive was provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event, which events are being referenced here was unknown. The reporter assessed the events COVID 19 infection but asymptomatic as related to study drug.; Reporter's Comments: This case concerns a 38-year-old male who experienced a nonserious unexpected event of COVID-19 (COVID 19 infection but asymptomatic). The event of COVID-19 test positive occurred the same day as the first dose of mRNA-1273. No additional information available. Further information has been requested. 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:

Current Illness:

ID: 1056520
Sex: F
Age: 16
State: ID

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

Lab Data:

Allergies:

Symptoms: Headache; 16 years old received vaccine; A spontaneous report was received from a patient concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache and 16 years old received vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21-Jan-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 23-Jan-2021, the patient experienced headache for a couple of days. Treatment for the event included ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, headache and 16 years old received vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of product administration error ? Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with event of headache.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: 1056521
Sex: F
Age: 65
State: IL

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

Lab Data:

Allergies:

Symptoms: Her Behcet's disease was in remission for three years but after 18 hs of the shot it reappeared; tingling; sore arm; A spontaneous case was received from the consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine and experienced sore arm, tingling and Behcet's disease. The patient's medical history was not provided. No relevant concomitant medications was reported. On 29 Jan 2021 prior to the onset of the events, the patient received first of the two planned doses of mRNA-1273 (Lot Number:026L20A) for the prophylaxis of COVID-19 infection. On 29 Jan 2021 the patient experienced sore arm and tingling. Her Behcet's disease / systemic vasculitis (lupus like element) which was in remission for three years reappeared 18 hours after the shot. Treatment of the event was not reported. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, sore arm, tingling was not provided. But the outcome of the event for her Behcet's disease was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Behcet's disease aggravated

ID: 1056522
Sex: U
Age:
State: NY

Vax Date: 01/19/2021
Onset Date: 01/21/2021
Rec V Date: 02/26/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Fatigue; could not walk; A spontaneous report was received from consumer concerning a 39-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue and could not walk. Medical history was not reported. Concomitant medication was not reported. On 19-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in unknown anatomical location for prophylaxis of COVID-19 infection and developed fatigue. On 21-Jan-2021, the patient could not walk and was hospitalized. Laboratory details was not provided. Treatment medication was not provided. Action taken with mRNA-1273 in response to the events fatigue and could not walk was not provided. The outcome of the events fatigue and could not walk was not provided.; 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. Further information has been requested.

Other Meds:

Current Illness:

ID: 1056523
Sex: U
Age: 58
State: MD

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

Lab Data:

Allergies:

Symptoms: drug administered at inappropriate site; injection site hot to touch; Two-inch red circle at injection site; A spontaneous report was received from a Consumer concerning a 58 -Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site erythema and injection site warmth. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 02TJ20A) in the deltoid for prophylaxis of COVID-19 infection. On 13 Feb 2021, The patient was concerned now whether they gave her the shot in the deltoid muscle and concerned if it was still effective? Also about eight days later she developed a 2 inch red circle that was hot to the touch. Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. In Feb-2021, the outcome of the injection site erythema and injection site warmth resolved. On 13 Feb 2021, the event was product administered at inappropriate site 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 of vaccination site erythema and vaccination site warmth, a causal relationship cannot be excluded. The causality for vaccine administered at inappropriate site is not applicable.

Other Meds:

Current Illness:

ID: 1056524
Sex: F
Age:
State: HI

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

Lab Data:

Allergies:

Symptoms: Given 1 ml of vaccine instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a female patient, received Moderna's COVID-19 Vaccine and was given Moderna's vaccine 1ml instead of 0.5ml. 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 (Batch number: 016M20A) on 09 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient received 1ml of the vaccine instead of 0.5ml. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, given Moderna's vaccine 1ml instead of 0.5ml, was considered resolved on 09 Feb 2021.; Reporter's Comments: This reports refers to a case of Accidental overdose for mRNA-1273 (Batch number: 016M20A) with no associated AEs.

Other Meds:

Current Illness:

ID: 1056525
Sex: M
Age:
State: HI

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

Lab Data:

Allergies:

Symptoms: Given 1 ml of vaccine instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a 33-year old, male patient who received Moderna's COVID-19 Vaccine and was given Moderna's vaccine 1ml instead of 0.5ml. 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 (Batch number: 016M20A) on 09 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient received 1ml of the vaccine instead of 0.5ml. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, given Moderna's vaccine 1ml instead of 0.5ml, was considered resolved on 09 Feb 2021.; Reporter's Comments: This reports refers to a case of Accidental overdose for mRNA-1273 (Batch number: 016M20A) with no associated AEs.

Other Meds:

Current Illness:

ID: 1056526
Sex: M
Age:
State: HI

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

Lab Data:

Allergies:

Symptoms: Given 1 ml of vaccine instead of 0.5ml; A spontaneous report was received from a pharmacist concerning a 35-year old, male patient who received Moderna's COVID-19 Vaccine and was given Moderna's vaccine 1ml instead of 0.5ml. 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 (Batch number: 016M20A) on 09 Feb 2021, intramuscularly in left arm for the prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient received 1ml of the vaccine instead of 0.5ml. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, given Moderna's vaccine 1ml instead of 0.5ml, was considered resolved on 09 Feb 2021.; Reporter's Comments: This reports refers to a case of Accidental overdose for mRNA-1273 (Batch number: 016M20A) with no associated AEs.

Other Meds:

Current Illness:

ID: 1056528
Sex: F
Age:
State: IL

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

Lab Data: Test Name: X-ray; Result Unstructured Data: Test Result:doesn't see anything, and it may be the beginning; Comments: phases of Shingles

Allergies:

Symptoms: still a part of her forehead that feels like a live nerve; upper back started hurting/back was very tender and sensitive around the spine area; arm was a little sore; pharmacist had some left over in the vial and gave her that; has post traumatic neuralgia" related to her shingles; Shingles; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 29Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from two contactable consumers via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. Medical history included dental work/specifying a tooth being pulled and an implant (an antibiotic (Amoxicillin)) was used and shingles (7 years ago). The patient's concomitant medications were not reported. It was reported that Pharmacist had some left over in the vial and gave the patient on 28Jan2021. Patient wanted to make sure it was ok. Patient stated "she got shingles on her face, 7 years ago, and had recent dental work done," specifying a tooth being pulled and an implant. She stated she received the first dose of the COVID-19 vaccine last Thursday evening (28Jan2021). On 29Jan2021 and 30Jan2021 (friday and saturday), she mentioned, her "arm was a little sore". On 30Jan2021 and 31Jan2021 (saturday evening and sunday morning) she said her "upper back started hurting" and thought "maybe [she] sat on the couch for too long". On 31Jan2021 (Sunday evening), she added her "back was very tender and sensitive around the spine area" therefore, she "took some tylenol and used a heating pad thinking [she] pulled a muscle". On 01Feb2021 (By Monday) she said her "the back and front were very sensitive" to the point where: when she "touched [her] skin it felt like [she] was touching some live nerves". She explained seeing a physician assistant who "couldn't figure out what was going on" and since it seemed to be getting worst, she thought she could possibly have Shingles. She continued saying she then "went to see an orthopedic doctor who took x-rays and said he doesn't see anything, and it may be the beginning phases of Shingles". She mentioned she has an appointment with her internist today at 4:20. She later mentioned her "brother, who is a doctor, thinks [she] has post traumatic neuralgia" related to her shingles on an unspecified date in Jan2021. She then added there is "still a part of her forehead that feels like a live nerve" to touch, since having Shingles, on 01Feb2021. The outcome of the events was unknown. The outcome of the events was unknown. The information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1056529
Sex: F
Age:
State: IN

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

Lab Data:

Allergies:

Symptoms: Itching; fever; chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female nurse received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 25Jan2021 at 08:15 AM (at the age of 56 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypothyroid and had BNT162B2 vaccine dose 1 on unknown date, lot unknown, administered at 10:45 AM on right arm. The patient had known allergies: Ibuprofen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), sertraline hydrochloride (ZOLOFT), liothyronine sodium (CYTOMEL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received levothyroxine, sertraline hydrochloride, liothyronine sodium within 2 weeks of vaccination. On 25Jan2021, at 12:00 PM, the patient experienced Itching, Fever, Chills. No treatment was received for the events Itching, Fever, Chills. The outcome of the events Itching, Fever, Chills was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: SYNTHROID; ZOLOFT; CYTOMEL

Current Illness:

ID: 1056530
Sex: F
Age:
State: OK

Vax Date: 01/14/2021
Onset Date: 01/16/2021
Rec V Date: 02/26/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contactable 44-year-old female consumer (patient). A 44-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 14Jan2021 at 10:00 AM (at the age of 44 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included allergy to codeine, was diagnosed with COVID-19 prior to vaccination and had BNT162B2 vaccine dose 1 on unknown date, lot unknown. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications was not provided. The patient did not receive any other vaccines within 4 weeks or any medications within 2 weeks prior to the COVID vaccine. On 16Jan2021, at 08:00 AM, the patient experienced sore arm, sore neck and swollen lymph node under my left arm. No treatment was received for the events sore arm, sore neck and swollen lymph node under my left arm. The outcome of the events sore arm, sore neck and swollen lymph node under my left arm was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1056531
Sex: F
Age:
State: GA

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

Lab Data:

Allergies:

Symptoms: racing heart; This is a spontaneous report from a contactable consumer, the patient. This 75 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 , single dose via an unspecified route of administration in the left arm on 25Jan2021 at 15:00 (at the age of 75 years old) for COVID-19 vaccination. There was no relevant medical history. There were no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021, the patient had a racing heart. The event was reported as non-serious. There was no treatment received for the event. The clinical outcome of racing heart was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1056532
Sex: F
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: She has a bump in her mouth; Dental work done gums are inflamed; This is a spontaneous report from a contactable consumer. This is a spontaneous report from a contactable consumer, the patient. This female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 11Jan2021 for COVID-19 vaccination. Medical history included dental work on an unknown date. Concomitant medications were not reported. In Jan2021, the patient had dental work done and gums are inflamed and has a bump in her mouth. The events were reported as non-serious. The clinical outcome of gums are inflamed and has a bump in her mouth was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1056533
Sex: F
Age:
State: TN

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

Lab Data:

Allergies:

Symptoms: had arm soreness in her left arm from the injection; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration in left arm on 22Jan2021 8:00 at single dose for COVID-19 immunization. The patient medical history included Transient ischaemic attack (TIA) which was not ongoing. The patient's concomitant medications were not reported. The patient previously took 2 baby aspirin (162 mg) every evening and has done this for the past 15-20 years for Transient ischaemic attack. Received call from consumer regarding the Pfizer COVID vaccine. The reporter who asks if taking her regular regimen of 2 baby aspirin daily will interfere with the vaccine effectiveness. She had first covid vaccine dose Friday on 22Jan2021 at 8 am. She had no reaction other than a little soreness in her arm from the injection after getting the vaccine in Jan2021 and it went away in a couple of days. She just massaged her arm and it was fine. She reported that due to a history of TIA she took 2 baby aspirin every evening and has done this for the past 15-20 years. After getting her vaccine she was told that taking aspirin may interfere with the antibody response and she called today to ask if that was true and if she should take an antibody test. She was reading on some links yesterday about blood thinners. It kind of freaked her out. She took 2 baby aspirin daily and together it was 162 mg, which she has been taking for years. She used to get trans ischemic attacks and has not had any since she has been taking them. She took them at 6 pm, which she did the evening before she had the vaccine. She called to check, to see if taking 2 baby aspirin every day for the past 15 to 20 years would affect the vaccination that she got. She asked because she had someone telling her after getting the vaccine, oh you shouldn't have done that and so she called to check and to see if that was okay. She would be taking second dose on 12Feb2021. She would like to know if that reduced the effectiveness for her. She had not heard that anywhere previous or she would have stopped taking the aspirin 5 days prior. She was feeling fine. The outcome of the event 'arm soreness in her left arm from the injection' was recovered in Jan2021. Information about lot and batch number has been requested.

Other Meds:

Current Illness:

ID: 1056534
Sex: M
Age:
State: FL

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

Lab Data: Test Date: 202101; Test Name: Height; Result Unstructured Data: Test Result:shrunk to 5'10''

Allergies:

Symptoms: Really bad case of diarrhea/worst case of diarrhea he has ever had; Shrunk to about 5'10''; This is a spontaneous report from a contactable consumer (patient). A 93-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 25Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Jan2021, after the first dose of vaccination, the patient had a really bad case of diarrhea, and mentioned that it was the worst case of diarrhea he has ever had. In Jan2021, the patient had shrunk to about 5'10". The outcome of the events, 'diarrhea' and 'shrunk to about 5'10"', was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1056535
Sex: F
Age:
State: NE

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

Lab Data:

Allergies:

Symptoms: Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer. A 48-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176) via an unspecified route of administration in right arm on 22Jan2021 12:00 at single dose for COVID-19 immunisation. The patient received the vaccine in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever, cough, diarrhea, swelling, burning on 22Jan2021 16:00. The patient didn't receive any treatment for events. The outcome of events was recovering.

Other Meds:

Current Illness:

ID: 1056536
Sex: F
Age:
State: FL

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

Lab Data: Test Name: blood levels; Result Unstructured Data: Test Result:500

Allergies:

Symptoms: She got her blood levels checked for taking warfarin in which they were 500/they have never been this high/Could the vaccine be effecting her blood thinner; could the vaccine be effecting her blood thinner; Experiencing a rash and itching on arms and across the top of her back and hands; Experiencing a rash and itching on arms and across the top of her back and hands; This is a spontaneous report from a contactable consumer (patient's husband) and a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2, via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization and warfarin via an unspecified route of administration from an unspecified date at an unknown dosage for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced a rash and itching on arms and across the top of her back and hands on 19Jan2021. The patient stated that she got her blood levels checked for taking warfarin in which they were 500. She stated that they have never been this high and nothing different had happened other than receiving the vaccine. She asked if these levels could be because of the Covid vaccine. The patient's husband stated that his wife was having some side effects, statesd she had the Pfizer Covid shot, she was having a rash problem with it, also she took Warfarin and it seemed to be effecting the blood thinner. Could the vaccine be effecting her blood thinner. The action taken in response to the events for warfarin was unknown. The outcome of the events was unknown. Information about Lot/batch no has been requested.

Other Meds: Pfizer, Inc. EUA 027034; WARFARIN

Current Illness:

ID: 1056537
Sex: F
Age:
State: TN

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

Lab Data: Test Date: 20210107; Test Name: Fever; Result Unstructured Data: Test Result:102 Fahrenheit

Allergies:

Symptoms: Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb; Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb/Arm still has this sensation (like sleep, cold, numb feeling); Arm still has this sensation (like sleep, cold, numb feeling); Fever 102 degrees Fahrenheight; Feeling sick; Chills; Shakes; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date: Mar2021), intramuscularly on the left arm on 07Jan2021 (09:00) at a single dose for COVID-19 immunization at the school/student health clinic (not a military facility). Medical history included ongoing rheumatoid arthritis diagnosed about 5 years ago; ongoing high blood pressure diagnosed a couple of years ago, and ongoing Grave's disease diagnosed about 30-32 years ago. Concomitant medications included ongoing hydroxychloroquine phosphate (PLAQUENIL) for rheumatoid arthritis; and levothyroxine sodium (SYNTHROID) for Grave's disease. On 07Jan2021, the patient had cold sensation in the arm, tingly sensation down in her arm like her arm was cold/numb; arm still had the sensation (like sleep, cold and numb feeling); had fever with body temperature of 102 degrees Fahrenheit; was feeling sick; had chills; shakes; and fatigue. The outcome of the events was not recovered for 'cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb' and 'arm still had the sensation (like sleep, cold and numb feeling)'; was recovered on 09Jan2021 for 'fever with body temperature of 102 degrees Fahrenheit', 'chills', 'shakes' and 'fatigue'; and was recovered in Jan2021 for 'feeling sick'. The patient was asking if these same symptoms should be expected after the second dose, and if it would be okay to get the second dose of vaccination.

Other Meds: PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]; SYNTHROID

Current Illness: Blood pressure high (diagnosed a couple of years ago); Graves' disease (diagnosed about 30-32 years ago); Rheumatoid arthritis (about 5 years ago)

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm