VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1725383
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: extra warmth on my upper arm; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (extra warmth on my upper arm) and VACCINATION SITE ERYTHEMA (Redness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (extra warmth on my upper arm) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE WARMTH (extra warmth on my upper arm) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

Date Died: 04/12/2021

ID: 1725384
Sex: M
Age: 77
State: CA

Vax Date: 02/11/2021
Onset Date: 03/21/2021
Rec V Date: 09/23/2021
Hospital: Y

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

Lab Data: Test Date: 20210411; Test Name: Blood pressure; Result Unstructured Data: Low

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: very agitated; couldn't breathe/ lungs were low; stroke; weak/ very bad; yellow; was sweating a lot; I am not feeling well; blood pressure was very low; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke), AGITATION (very agitated), DYSPNOEA (couldn't breathe/ lungs were low), ASTHENIA (weak/ very bad), YELLOW SKIN (yellow), HYPERHIDROSIS (was sweating a lot), MALAISE (I am not feeling well) and HYPOTENSION (blood pressure was very low) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stomach ulcer. Concurrent medical conditions included Bone cancer (In treatment for past 5 years), Hypercholesteremia and Hypertension. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 11-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (weak/ very bad) (seriousness criterion hospitalization), YELLOW SKIN (yellow) (seriousness criterion hospitalization), HYPERHIDROSIS (was sweating a lot) (seriousness criterion hospitalization), MALAISE (I am not feeling well) (seriousness criterion hospitalization) and HYPOTENSION (blood pressure was very low) (seriousness criterion hospitalization). On 12-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced AGITATION (very agitated) (seriousness criterion hospitalization) and DYSPNOEA (couldn't breathe/ lungs were low) (seriousness criterion hospitalization). The patient was hospitalized from 11-Apr-2021 to 12-Apr-2021 due to AGITATION, ASTHENIA, CEREBROVASCULAR ACCIDENT, DYSPNOEA, HYPERHIDROSIS, HYPOTENSION, MALAISE and YELLOW SKIN. On 21-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 12-Apr-2021, HYPOTENSION (blood pressure was very low) outcome was unknown. The patient died on 12-Apr-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. At the time of death, AGITATION (very agitated), DYSPNOEA (couldn't breathe/ lungs were low), ASTHENIA (weak/ very bad), YELLOW SKIN (yellow), HYPERHIDROSIS (was sweating a lot) and MALAISE (I am not feeling well) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Blood pressure measurement: low (Low) Low. Relevant concomitant medications included, cancer medications, cholesterol medications, blood pressure medications and some other unspecified medications were reported. Treatment information was not provided. The reporter was not sure if the patient has got Moderna vaccine itself. Patient was in treatment for cancer for past 5 years. His doctor has changed the pills a few years ago and he was not able to tolerate this change of pills as they were too strong. In an appointment with the doctor, patient was very agitated and could not breathe. Patient's lungs were mentioned as too low. So the patient was with a machine that helped him to breathe properly. On 11-April-2021, patient was sent to the hospital. On 12-April-2021 past midnight, the patient died of a stroke. Company comment: This is a case of inappropriate schedule of vaccine administered for this 77-year-old male patient with medical history of stomach ulcer, hypercholesteremia and hypertension, who experienced the unexpected events of cerebrovascular accident, agitation, dyspnoea, asthenia, yellow skin, hyperhidrosis, malaise and hypotension. The events of asthenia yellow skin, hyperhidrosis, occurred 22 days after the second dose of mRNA-1273, and the remaining events occurred a day later. The rechallenge was not applicable as the events occurred after the second dose and no information about the first dose was disclosed. Causality for the events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Cerebrovascular accident is confounder by the history of bonecancer, hypercholesteremia, hypertension and advanced age. Reporter did not allow further contact; Sender's Comments: This is a case of inappropriate schedule of vaccine administered for this 77-year-old male patient with medical history of stomach ulcer, hypercholesteremia and hypertension, who experienced the unexpected events of cerebrovascular accident, agitation, dyspnoea, asthenia, yellow skin, hyperhidrosis, malaise and hypotension. The events of asthenia yellow skin, hyperhidrosis, occurred 22 days after the second dose of mRNA-1273, and the remaining events occurred a day later. The rechallenge was not applicable as the events occurred after the second dose and no information about the first dose was disclosed. Causality for the events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Cerebrovascular accident is confounder by the history of bonecancer, hypercholesteremia, hypertension and advanced age.; Reported Cause(s) of Death: Stroke

Other Meds:

Current Illness: Bone cancer (In treatment for past 5 years); Hypercholesteremia; Hypertension

ID: 1725385
Sex: F
Age:
State: IN

Vax Date: 08/31/2021
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: passed out; severe reaction/Idiosyncratic Vaccine Reaction; severe right thigh and buttock pain; developed sweats; severe right thigh and buttock pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included PHENTERMINE (ADIPEX [PHENTERMINE]) and PIROXICAM (PAXIL [PIROXICAM]) for an unknown indication. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), VACCINATION COMPLICATION (severe reaction/Idiosyncratic Vaccine Reaction), PAIN IN EXTREMITY (severe right thigh and buttock pain), HYPERHIDROSIS (developed sweats) and MUSCULOSKELETAL PAIN (severe right thigh and buttock pain). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), VACCINATION COMPLICATION (severe reaction/Idiosyncratic Vaccine Reaction), PAIN IN EXTREMITY (severe right thigh and buttock pain), HYPERHIDROSIS (developed sweats) and MUSCULOSKELETAL PAIN (severe right thigh and buttock pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication information was mentioned by reporter. Company comment: This case concerns a 39-year-old, female patient with no relevant medical history who experienced the unexpected event of Loss of consciousness. The event occurred twelve hours after receiving the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273is not affected by this report.; Sender's Comments: This case concerns a 39-year-old, female patient with no relevant medical history who experienced the unexpected event of Loss of consciousness. The event occurred twelve hours after receiving the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273is not affected by this report.

Other Meds: ADIPEX [PHENTERMINE]; PAXIL [PIROXICAM]

Current Illness:

ID: 1725386
Sex: F
Age: 71
State: NC

Vax Date: 05/14/2021
Onset Date: 09/10/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Her biggest fear is that the rash comes back.; Pain after 3rd vaccine; Discomfort after 3rd vaccine; Rash spread even more and it was itching; Rash got worst, Rash spreading into genital and upper thighs, Rash spread even more 5 hours after took medicine, Rash spread again despite taking oral steroid/ Rash around hip; Mild itching and had mild redness on both hands; Mild itching and had mild redness on both hands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain after 3rd vaccine), DISCOMFORT (Discomfort after 3rd vaccine) and RASH (Rash got worst, Rash spreading into genital and upper thighs, Rash spread even more 5 hours after took medicine, Rash spread again despite taking oral steroid/ Rash around hip) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A, 032B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chemotherapy (Chemotherapy Pertuzumab IV, Trastuzumab IV every 2 weeks) since 2020. Concurrent medical conditions included Breast cancer (on Chemotherapy) since 2020. Concomitant products included PERTUZUMAB from 2020 to an unknown date and TRASTUZUMAB from 2020 to an unknown date for Breast cancer. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced PRURITUS (Mild itching and had mild redness on both hands) and ERYTHEMA (Mild itching and had mild redness on both hands). On 11-Sep-2021, the patient experienced RASH (Rash got worst, Rash spreading into genital and upper thighs, Rash spread even more 5 hours after took medicine, Rash spread again despite taking oral steroid/ Rash around hip) (seriousness criterion medically significant). On 12-Sep-2021, the patient experienced DISCOMFORT (Discomfort after 3rd vaccine) (seriousness criterion medically significant) and RASH PRURITIC (Rash spread even more and it was itching). On 13-Sep-2021, the patient experienced PAIN (Pain after 3rd vaccine) (seriousness criterion medically significant). On 14-Sep-2021, the patient experienced FEAR (Her biggest fear is that the rash comes back.). The patient was treated with LORATADINE (CLARITINE) on 12-Sep-2021 for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 12-Sep-2021 for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) on 12-Sep-2021 for Adverse event, at an unspecified dose and frequency; PREDNISONE (oral) on 12-Sep-2021 for Adverse event, at an unspecified dose and frequency and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) (intravenous) on 13-Sep-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Pain after 3rd vaccine), DISCOMFORT (Discomfort after 3rd vaccine), RASH (Rash got worst, Rash spreading into genital and upper thighs, Rash spread even more 5 hours after took medicine, Rash spread again despite taking oral steroid/ Rash around hip), PRURITUS (Mild itching and had mild redness on both hands), ERYTHEMA (Mild itching and had mild redness on both hands) and RASH PRURITIC (Rash spread even more and it was itching) was resolving and FEAR (Her biggest fear is that the rash comes back.) outcome was unknown. The patient did not have any side effects after the first two doses. On Saturday night 11 SEP 2021, She started having a rash around her hip. On 12 SEP 2021, she got worst, the rash was spreading into genital and upper thighs. She visited Urgent care and the doctor prescribed medications.She took the medications but 4 - 5 hours later the rash spread even more and it was itching. On same day they visited the ER again. This time they gave her Prednisone Pack, after taking the oral prednisone, she was a little better. On 13 SEP 2021 around 6-7PM, the rash spread again, and she had pain this time. At 10 PM same night, went back to the ER again and received IV solumedrol and fluids. On 14 SEP 2021, she is doing better. She cancelled the chemotherapy infusion for 14 SEP 2021 and rescheduled it for next day. On 14 SEP 2021, at the time of reporting she was fine, and her biggest fear was that the rash comes back. Other treatments reported included IV fluids. This case concerns a 71 year-old, female with a history of breast cancer under chemotherapy, who experienced the unexpected serious events of pain, discomfort and rash (criteria: medically significant based on info avail and medical judgment). The events occurred between 2-4 days after the 3rd dose of mRNA-1273 Moderna vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.; Sender's Comments: This case concerns a 71 year-old, female with a history of breast cancer under chemotherapy, who experienced the unexpected serious events of pain, discomfort and rash (criteria: medically significant based on info avail and medical judgment). The events occurred between 2-4 days after the 3rd dose of mRNA-1273 Moderna vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.

Other Meds: PERTUZUMAB; TRASTUZUMAB

Current Illness: Breast cancer (on Chemotherapy); Chemotherapy (Chemotherapy Pertuzumab IV, Trastuzumab IV every 2 weeks)

ID: 1725387
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: went into coma; had no energy; was knocked out/ was in bed for 30hrs; very tired; This spontaneous case was reported by a consumer and describes the occurrence of COMA (went into coma) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Flu-like illness in March 2021. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COMA (went into coma) (seriousness criterion medically significant), ASTHENIA (had no energy), KNEE DEFORMITY (was knocked out/ was in bed for 30hrs) and FATIGUE (very tired). At the time of the report, COMA (went into coma), ASTHENIA (had no energy), KNEE DEFORMITY (was knocked out/ was in bed for 30hrs) and FATIGUE (very tired) outcome was unknown. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter This case concerns a 61 year-old, male subject with no significant medical history, who experienced the unexpected event of coma and non-serious events of asthenia, knee deformity and fatigue. The event occurred on an unknown date. The rechallenge is not applicable in this case. The reporter's assessment is not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 61 year-old, male subject with no significant medical history, who experienced the unexpected event of coma and non-serious events of asthenia, knee deformity and fatigue. The event occurred on an unknown date. The rechallenge is not applicable in this case. The reporter's assessment is not provided. The benefit-risk relationship of the vaccine is not affected by this report

Other Meds:

Current Illness:

ID: 1725388
Sex: F
Age: 59
State: AL

Vax Date: 09/08/2021
Onset Date: 09/11/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Date: 20210911; Test Name: fever; Result Unstructured Data: fever ( 102.7 F )

Allergies:

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

Symptoms: hair hurting; fever ( 102.7 F ); chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of HAIR INJURY (hair hurting), PYREXIA (fever ( 102.7 F )), CHILLS (chills) and MYALGIA (body ache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced HAIR INJURY (hair hurting), PYREXIA (fever ( 102.7 F )), CHILLS (chills) and MYALGIA (body ache). At the time of the report, HAIR INJURY (hair hurting), CHILLS (chills) and MYALGIA (body ache) outcome was unknown and PYREXIA (fever ( 102.7 F )) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2021, Body temperature: 102.7 (High) fever ( 102.7 F ). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were not reported. No treatment medications were not provided.

Other Meds:

Current Illness:

ID: 1725389
Sex: F
Age:
State: SC

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: COVID arm immediately after vaccination; a red COVID arm immediately after vaccination; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (COVID arm immediately after vaccination) and VACCINATION SITE ERYTHEMA (a red COVID arm immediately after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm immediately after vaccination) and VACCINATION SITE ERYTHEMA (a red COVID arm immediately after vaccination). At the time of the report, VACCINATION SITE REACTION (COVID arm immediately after vaccination) and VACCINATION SITE ERYTHEMA (a red COVID arm immediately after vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1725390
Sex: U
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: expired 26Aug2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired 26Aug2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired 26Aug2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired 26Aug2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product information was not provided. Treatment information was not provided. The physician received notice from lab director that a vial with lot number 036A21A expired 26Aug2021. Since 27Aug2021, has provided 1-2 vaccines per day. She states there was a total of 9 doses administered to 9 different patients. The physician states that the information for the 9 patients are not available.

Other Meds:

Current Illness:

ID: 1725391
Sex: F
Age:
State: PR

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: like a lot of itchy/stopped itching; started to get red; reaction; started having bruises on the legs and hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (like a lot of itchy/stopped itching), ERYTHEMA (started to get red), CONTUSION (started having bruises on the legs and hands) and VACCINATION COMPLICATION (reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No medical history was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced CONTUSION (started having bruises on the legs and hands). On an unknown date, the patient experienced PRURITUS (like a lot of itchy/stopped itching), ERYTHEMA (started to get red) and VACCINATION COMPLICATION (reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (like a lot of itchy/stopped itching) had resolved and ERYTHEMA (started to get red), CONTUSION (started having bruises on the legs and hands) and VACCINATION COMPLICATION (reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Patients information lost while documenting and RA crashed.

Other Meds:

Current Illness:

ID: 1725392
Sex: F
Age: 75
State: OH

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Red spot at the injection site; Soreness and pain (at injection site); Itched a little bit (Injection site); Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Red spot at the injection site), VACCINATION SITE PAIN (Soreness and pain (at injection site)) and VACCINATION SITE PRURITUS (Itched a little bit (Injection site)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included LISINOPRIL for Rise in blood pressure. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced HEADACHE (Headache). On 10-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot at the injection site), VACCINATION SITE PAIN (Soreness and pain (at injection site)) and VACCINATION SITE PRURITUS (Itched a little bit (Injection site)). The patient was treated with HYDROCORTISONE for Itch, at an unspecified dose and frequency. On 31-Aug-2021, HEADACHE (Headache) had resolved. On 10-Sep-2021, VACCINATION SITE PRURITUS (Itched a little bit (Injection site)) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red spot at the injection site) and VACCINATION SITE PAIN (Soreness and pain (at injection site)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient also had concomitants for cholesterol (NOS).

Other Meds: LISINOPRIL

Current Illness: Blood pressure high; Cholesterol

ID: 1725393
Sex: F
Age: 57
State: IA

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Not sleeping well; "how do I report a side effect"; Full body muscle aches; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Full body muscle aches), POOR QUALITY SLEEP (Not sleeping well) and VACCINATION COMPLICATION ("how do I report a side effect") in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Nerve pain and Fibromyalgia. Concomitant products included PREGABALIN (LYRICA) for nerve pain and Fibromyalgia. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Full body muscle aches), POOR QUALITY SLEEP (Not sleeping well) and VACCINATION COMPLICATION ("how do I report a side effect"). At the time of the report, MYALGIA (Full body muscle aches) had resolved and POOR QUALITY SLEEP (Not sleeping well) and VACCINATION COMPLICATION ("how do I report a side effect") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment medication was not provided . This case was linked to MOD-2021-320061 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Significant follow up appended- vaccination site complication added as an event

Other Meds: LYRICA

Current Illness: Fibromyalgia; Nerve pain

ID: 1725394
Sex: M
Age: 60
State: PA

Vax Date: 08/06/2021
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: body temperature; Result Unstructured Data: 100.8-101? F

Allergies:

Symptom List: Rash, Urticaria

Symptoms: knocked out; sweaty/had sweats; slept all day; did not eat much; felt like he had flu; could not take a shower; had no energy; fever; achiness; extremely tired/extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (knocked out), HYPERHIDROSIS (sweaty/had sweats), SOMNOLENCE (slept all day), EATING DISORDER (did not eat much) and INFLUENZA LIKE ILLNESS (felt like he had flu) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066D21A and 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product INFLUENZA VACCINE for Prophylaxis. Concurrent medical conditions included Hypercholesterolemia. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (knocked out), HYPERHIDROSIS (sweaty/had sweats), SOMNOLENCE (slept all day), EATING DISORDER (did not eat much), INFLUENZA LIKE ILLNESS (felt like he had flu), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take a shower), ASTHENIA (had no energy), PYREXIA (fever), MYALGIA (achiness) and FATIGUE (extremely tired/extreme fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (knocked out), HYPERHIDROSIS (sweaty/had sweats), SOMNOLENCE (slept all day), EATING DISORDER (did not eat much), INFLUENZA LIKE ILLNESS (felt like he had flu), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take a shower), ASTHENIA (had no energy), PYREXIA (fever), MYALGIA (achiness) and FATIGUE (extremely tired/extreme fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100.8-101 (High) 100.8-101? F. Additional concomitant medications included blood pressure medication and Vitamins. Company Comment: This case concerns a 62 year-old, male with no relevant medical history, who experienced the unexpected events of HYPERHIDROSIS, SOMNOLENCE, EATING DISORDER, INFLUENZA LIKE ILLNESS, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, ASTHENIA and FEELING ABNORMAL . The event occurred after the second dose of mRNA-1273 Moderna vaccine (onset date of events were not provided). The patient received "flu vaccine" on the same day of 2nd dose of Moderna, this could be a potentially confounder/cosuspect for the events. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. This case was linked to MOD-2021-320223 (Patient Link).; Sender's Comments: This case concerns a 62 year-old, male with no relevant medical history, who experienced the unexpected events of HYPERHIDROSIS, SOMNOLENCE, EATING DISORDER, INFLUENZA LIKE ILLNESS, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, ASTHENIA and FEELING ABNORMAL . The event occurred after the second dose of mRNA-1273 Moderna vaccine (onset date of events were not provided). The patient received "flu vaccine" on the same day of 2nd dose of Moderna, this could be a potentially confounder/cosuspect for the events. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.

Other Meds: LIPITOR

Current Illness: Hypercholesterolemia

ID: 1725395
Sex: F
Age:
State: MN

Vax Date: 08/20/2021
Onset Date: 08/21/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pneumonia; cough; feel sick; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced MALAISE (feel sick). On 29-Aug-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and COUGH (cough). At the time of the report, PNEUMONIA (pneumonia) and MALAISE (feel sick) outcome was unknown and COUGH (cough) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by reporter. Treatment information was not provided. Company Comment: This case concerns a female patient of an unknown age with no relevant medical history who experienced unexpected event of pneumonia. The event occurred 10 days after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The event pneumonia is marked serious by the auto-seriousness tool. Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint, and reporter assessed the case as non-serious.; Sender's Comments: This case concerns a female patient of an unknown age with no relevant medical history who experienced unexpected event of pneumonia. The event occurred 10 days after the first dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The event pneumonia is marked serious by the auto-seriousness tool. Case downgraded to non-serious due to the lack of evidence of seriousness from a clinical or regulatory standpoint, and reporter assessed the case as non-serious.

Other Meds:

Current Illness:

ID: 1725396
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Ended up with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Ended up with COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Ended up with COVID). At the time of the report, COVID-19 (Ended up with COVID) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1725397
Sex: F
Age: 69
State: TX

Vax Date: 03/06/2021
Onset Date: 09/13/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Cold; shivering, Chills; fever ramped up all day long; horrible joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), CHILLS (shivering, Chills), PYREXIA (fever ramped up all day long) and ARTHRALGIA (horrible joint pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A, #016B21A and #048F21A) for COVID-19 vaccination. The patient's past medical history included Blood disorder NOS (that makes her susceptible to Deep vein thrombosis), Fever (from January until February) and Fatigue (from January until February). Concurrent medical conditions included Allergy to antibiotic (Allergic to tetracycline) and Allergy to antibiotic (Allergic to clindamycin). Concomitant products included VALSARTAN and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced NASOPHARYNGITIS (Cold), CHILLS (shivering, Chills), PYREXIA (fever ramped up all day long) and ARTHRALGIA (horrible joint pain). On 13-Sep-2021, CHILLS (shivering, Chills) and ARTHRALGIA (horrible joint pain) had resolved. On 14-Sep-2021, PYREXIA (fever ramped up all day long) had resolved. At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No treatment information provided. It was reported that she might had COVID-19 in January 2021 but there were no available COVID-19 test that time. This case was linked to MOD-2021-320892 (Patient Link).

Other Meds: VALSARTAN; VITAMIN D 2000

Current Illness: Allergy to antibiotic (Allergic to tetracycline); Allergy to antibiotic (Allergic to clindamycin)

ID: 1725398
Sex: M
Age:
State: KY

Vax Date: 03/27/2021
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: >36 days after getting first dose; Covid diagnosis after getting first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>36 days after getting first dose) and COVID-19 (Covid diagnosis after getting first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (>36 days after getting first dose) and COVID-19 (Covid diagnosis after getting first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>36 days after getting first dose) had resolved and COVID-19 (Covid diagnosis after getting first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications were not reported. Patient was scheduled to get the second dose on 24-Apr-2021 but did not. Patient was diagnosed with COVID 19 and has been under quarantine for a week and will continue until the 16-Sep-2021.

Other Meds:

Current Illness:

ID: 1725399
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: her patients who did receive the vaccine were already pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (her patients who did receive the vaccine were already pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (her patients who did receive the vaccine were already pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (her patients who did receive the vaccine were already pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported . No treatment medication reported . The nurse stated that pregnancy is not a side effect of the vaccine. This case concerns a female patient of unknown age who experienced vaccine exposure during pregnancy after the a dose of the vaccine. Last menstrual period and estimated date of delivery were not provided. Dechallenge is unknown and rechallenge is not applicable. The benefit-risk relationship is not affected by this report; Sender's Comments: This case concerns a female patient of unknown age who experienced vaccine exposure during pregnancy after the a dose of the vaccine. Last menstrual period and estimated date of delivery were not provided. Dechallenge is unknown and rechallenge is not applicable. The benefit-risk relationship is not affected by this report

Other Meds:

Current Illness:

ID: 1725400
Sex: F
Age: 64
State: CO

Vax Date: 03/04/2021
Onset Date: 04/16/2021
Rec V Date: 09/23/2021
Hospital: Y

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

Lab Data: Test Date: 202108; Test Name: EKG; Result Unstructured Data: Abnormal.

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: POTS Syndrome after 2nd dose; Could not breath while walking after 2nd dose; Did not make it walking to the end of the hallway after 2nd dose; Passed out again after 2nd dose; Wearing a heart monitor after 2nd dose; Passed out after 2nd dose; Sternum hurting after 2nd dose; Thinks had chest pain after 2nd dose; Fatigue after 2nd dose,Very tired fast if works; Hard time breathing,Out of breath fast if works; Could not work for months after after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS Syndrome after 2nd dose), DYSPNOEA (Could not breath while walking after 2nd dose), GAIT DISTURBANCE (Did not make it walking to the end of the hallway after 2nd dose), LOSS OF CONSCIOUSNESS (Passed out after 2nd dose) and LOSS OF CONSCIOUSNESS (Passed out again after 2nd dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cardiopulmonary resuscitation and Gastrointestinal surgery. Concurrent medical conditions included Autoimmune disorder and Chest pain. Concomitant products included OMALIZUMAB (XOLAIR) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced DYSPNOEA (Hard time breathing,Out of breath fast if works), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not work for months after after 2nd dose), CHEST PAIN (Thinks had chest pain after 2nd dose) and FATIGUE (Fatigue after 2nd dose,Very tired fast if works). In July 2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out after 2nd dose) (seriousness criterion medically significant) and CHEST PAIN (Sternum hurting after 2nd dose). In August 2021, the patient experienced POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS Syndrome after 2nd dose) (seriousness criterion hospitalization), DYSPNOEA (Could not breath while walking after 2nd dose) (seriousness criterion hospitalization), GAIT DISTURBANCE (Did not make it walking to the end of the hallway after 2nd dose) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (Passed out again after 2nd dose) (seriousness criterion medically significant) and CARDIAC ASSISTANCE DEVICE USER (Wearing a heart monitor after 2nd dose). The patient was hospitalized from sometime in August 2021 to sometime in August 2021 due to DYSPNOEA, GAIT DISTURBANCE and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME. At the time of the report, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS Syndrome after 2nd dose), DYSPNOEA (Could not breath while walking after 2nd dose), GAIT DISTURBANCE (Did not make it walking to the end of the hallway after 2nd dose), LOSS OF CONSCIOUSNESS (Passed out after 2nd dose), LOSS OF CONSCIOUSNESS (Passed out again after 2nd dose), DYSPNOEA (Hard time breathing,Out of breath fast if works), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not work for months after after 2nd dose), CHEST PAIN (Sternum hurting after 2nd dose), CARDIAC ASSISTANCE DEVICE USER (Wearing a heart monitor after 2nd dose), CHEST PAIN (Thinks had chest pain after 2nd dose) and FATIGUE (Fatigue after 2nd dose,Very tired fast if works) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Electrocardiogram: abnormal (abnormal) Abnormal. Patient thought the breathing difficulty was due to her allergies. Patient was not admitted, but she was in the ER for 3 days. Treatment medications were not reported. Company comment: The case concerns a 54-year-old-female patient with previous relevant medical history of cardiopulmonary resuscitation, who experienced the unexpected event of postural orthostatic tachycardia syndrome, dyspnoea, gait disturbance and loss of consciousness. The events occurred approximately 4 months after the second dose of Spikevax. The rechallenge was not applicable since the events have not been reported after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to MOD-2021-320279 (Patient Link).; Sender's Comments: The case concerns a 54-year-old-female patient with previous relevant medical history of cardiopulmonary resuscitation, who experienced the unexpected event of postural orthostatic tachycardia syndrome, dyspnoea, gait disturbance and loss of consciousness. The events occurred approximately 4 months after the second dose of Spikevax. The rechallenge was not applicable since the events have not been reported after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds: Xolair

Current Illness: Autoimmune disorder; Chest pain

ID: 1725401
Sex: M
Age:
State: IL

Vax Date: 06/04/2021
Onset Date: 06/04/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: administered the first dose of Moderna to a 15-year-old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered the first dose of Moderna to a 15-year-old patient) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered the first dose of Moderna to a 15-year-old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered the first dose of Moderna to a 15-year-old patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug details were reported. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1725402
Sex: M
Age: 81
State: TX

Vax Date: 04/27/2021
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: 160/50

Allergies:

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

Symptoms: blood pressure 160/50, looked terrible; Dizzy; dizzy spells lasted for 1 -2 minutes; dizzy while walking, can't walk in a straight line; 2-3 hot flashes almost every night lasting 30 seconds to 1 minute; pretty hot; shoulder and chest creating perspiration; occasionally having a chill; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE ABNORMAL (blood pressure 160/50, looked terrible), DIZZINESS (Dizzy), VERTIGO (dizzy spells lasted for 1 -2 minutes), GAIT DISTURBANCE (dizzy while walking, can't walk in a straight line) and HOT FLUSH (2-3 hot flashes almost every night lasting 30 seconds to 1 minute) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Blood pressure low. Concomitant products included LOSARTAN for Blood pressure. On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (blood pressure 160/50, looked terrible), DIZZINESS (Dizzy), VERTIGO (dizzy spells lasted for 1 -2 minutes), GAIT DISTURBANCE (dizzy while walking, can't walk in a straight line), HOT FLUSH (2-3 hot flashes almost every night lasting 30 seconds to 1 minute), FEELING HOT (pretty hot), HYPERHIDROSIS (shoulder and chest creating perspiration) and CHILLS (occasionally having a chill). At the time of the report, BLOOD PRESSURE ABNORMAL (blood pressure 160/50, looked terrible), DIZZINESS (Dizzy), VERTIGO (dizzy spells lasted for 1 -2 minutes), GAIT DISTURBANCE (dizzy while walking, can't walk in a straight line), HOT FLUSH (2-3 hot flashes almost every night lasting 30 seconds to 1 minute), FEELING HOT (pretty hot), HYPERHIDROSIS (shoulder and chest creating perspiration) and CHILLS (occasionally having a chill) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 160/50 mmHg (Low) 160/50. Patient has not taken any medication as treatment. Patient takes losartan for his blood pressure once a day or every 2-3 days. Patient reported that 2 to 3 days after the second dose, he was scheduled to continue his therapy on his lower spine and had 3 sessions left to go. Reporter did not allow further contact

Other Meds: LOSARTAN

Current Illness:

ID: 1725403
Sex: F
Age: 62
State: LA

Vax Date: 08/07/2021
Onset Date: 09/09/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Did not yet received her second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not yet received her second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not yet received her second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not yet received her second dose) had resolved. No concomitant drug information was provided by reporter. No treatment drug information was provided by reporter

Other Meds:

Current Illness:

ID: 1725404
Sex: F
Age: 55
State: SC

Vax Date: 09/12/2021
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Head cold; Stuffy nose; Sneezing; Runny nose; Sinus congestion; Occasional cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Head cold), NASAL CONGESTION (Stuffy nose), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and SINUS CONGESTION (Sinus congestion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Head cold), NASAL CONGESTION (Stuffy nose), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), SINUS CONGESTION (Sinus congestion) and COUGH (Occasional cough). At the time of the report, NASOPHARYNGITIS (Head cold), NASAL CONGESTION (Stuffy nose), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), SINUS CONGESTION (Sinus congestion) and COUGH (Occasional cough) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medication were reported No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1725405
Sex: M
Age: 62
State: SC

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 09/23/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: massive heart attack; hypoglycemic; kidney failure; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (kidney failure), MYOCARDIAL INFARCTION (massive heart attack) and HYPOGLYCAEMIA (hypoglycemic) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced RENAL FAILURE (kidney failure) (seriousness criteria hospitalization, medically significant and life threatening) and HYPOGLYCAEMIA (hypoglycemic) (seriousness criterion hospitalization). On 22-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (massive heart attack) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized until 01-Apr-2021 due to HYPOGLYCAEMIA, MYOCARDIAL INFARCTION and RENAL FAILURE. At the time of the report, RENAL FAILURE (kidney failure), MYOCARDIAL INFARCTION (massive heart attack) and HYPOGLYCAEMIA (hypoglycemic) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. On 24-Mar-2021 patient had a heart surgery. Company Comment: This case concerns a 62-year-old male patient with no details on past medical history, presented with unexpected events of Myocardial Infarction, Renal failure and Hypoglycemia , these events happened on the same day of the 1st dose of vaccination with Moderna .Patient was hospitalized and underwent heart surgery. The benefit risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 62-year-old male patient with no details on past medical history, presented with unexpected events of Myocardial Infarction, Renal failure and Hypoglycemia , these events happened on the same day of the 1st dose of vaccination with Moderna .Patient was hospitalized and underwent heart surgery. The benefit risk relationship of Moderna vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1725406
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: reaction to vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (reaction to vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to vaccine). At the time of the report, VACCINATION COMPLICATION (reaction to vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1725407
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Date: 202104; Test Name: Antibody test; Result Unstructured Data: titers were high

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Developed flu like symptom (after second dose); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Developed flu like symptom (after second dose)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised (Patient considered immunocompromised as she receives a Pegasys injection every two weeks.). Concomitant products included PEGINTERFERON ALFA-2A (PEGASYS) for Immunocompromised, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM and PROGESTERONE for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Developed flu like symptom (after second dose)). At the time of the report, INFLUENZA LIKE ILLNESS (Developed flu like symptom (after second dose)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Antibody test: high (High) titers were high. No treatment information was provided by the reporter. Patient received a full dose and not half, and patient was a classic example of someone who is small. It's been 6 months since patient received the second dose. Before receiving third dose, patient asked doctor to test again for antibody, but doctor said they didn't believe in Ab testing. Patient is considered immunocompromised as patient takes Pegasys injection every two weeks. Last time received it was on 8Sep2021. This case was linked to MOD-2021-320389 (Patient Link).

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; CALCIUM; PROGESTERONE; PEGASYS

Current Illness: Immunocompromised (Patient considered immunocompromised as she receives a Pegasys injection every two weeks.)

ID: 1725408
Sex: F
Age: 65
State: FL

Vax Date: 09/10/2021
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Name: heart rate; Result Unstructured Data: over 100 and is normally 65

Allergies:

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

Symptoms: Blurry vision; Throat tightened; Could not sleep; Throat hurt; Shakes; brain spazzing; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), THROAT TIGHTNESS (Throat tightened), INSOMNIA (Could not sleep), OROPHARYNGEAL PAIN (Throat hurt) and TREMOR (Shakes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Migraine, Brain tumor (Benign brain tumor.) and Consciousness loss (2 concussions.). On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurry vision), THROAT TIGHTNESS (Throat tightened), INSOMNIA (Could not sleep), OROPHARYNGEAL PAIN (Throat hurt), TREMOR (Shakes), CEREBRAL DISORDER (brain spazzing) and HEADACHE (headaches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and ACETYLSALICYLIC ACID (BABY ASPIRIN) at a dose of 1 dosage form. At the time of the report, VISION BLURRED (Blurry vision), THROAT TIGHTNESS (Throat tightened), INSOMNIA (Could not sleep), OROPHARYNGEAL PAIN (Throat hurt), TREMOR (Shakes), CEREBRAL DISORDER (brain spazzing) and HEADACHE (headaches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 100 (High) over 100 and is normally 65. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant drugs provided. Other treatment drug is steroids.; Sender's Comments: This case concerns a 65 year old female with significant medial history of Concussions time two, Migraines and Benign brain tumor who experienced the unlisted events of Blurry vision, Oropharyngeal pain, Throat tightness, Tremor, Cerebral disorder and listed event of Headache. The event occurred the same day as the first dose of Moderna COVID-19 vaccine and a re-challenge has not be noted. The medical history of Brain tumor, Concussions and Migraines remain confounders. The benefit-risk relationship is not affected by this report.

Other Meds:

Current Illness: Brain tumor (Benign brain tumor.); Consciousness loss (2 concussions.); Migraine

ID: 1725409
Sex: F
Age: 80
State: NE

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: left breast so sore; pain; she had in left arm and they were so so sore; left arm and left side of her body are so sore; the lymph nodes went crazy and they were so so sore; It's really really really tender/it sure hurt; Under the armpit it was almost as big as a golf ball,it sure hurt,now it's the size of a marble; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (left breast so sore), PAIN (pain), VACCINATION SITE PAIN (she had in left arm and they were so so sore), MYALGIA (left arm and left side of her body are so sore) and LYMPHADENOPATHY (the lymph nodes went crazy and they were so so sore) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M202 and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history provided by reporter. Concomitant products included FUROSEMIDE (LASIX M) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (left breast so sore), PAIN (pain), VACCINATION SITE PAIN (she had in left arm and they were so so sore), MYALGIA (left arm and left side of her body are so sore), LYMPHADENOPATHY (the lymph nodes went crazy and they were so so sore), LYMPH NODE PAIN (It's really really really tender/it sure hurt) and LYMPHADENOPATHY (Under the armpit it was almost as big as a golf ball,it sure hurt,now it's the size of a marble). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BREAST PAIN (left breast so sore), PAIN (pain), VACCINATION SITE PAIN (she had in left arm and they were so so sore), MYALGIA (left arm and left side of her body are so sore), LYMPHADENOPATHY (the lymph nodes went crazy and they were so so sore), LYMPH NODE PAIN (It's really really really tender/it sure hurt) and LYMPHADENOPATHY (Under the armpit it was almost as big as a golf ball,it sure hurt,now it's the size of a marble) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication also include blood pressure medication and diabetic. Patient had mammogram and an ultrasound (Results not provided.)and it brought back the pain and everything. They thought she had a cyst under her breast but it was her lymph node. Cancer doctor told her to not wear a bra. This case was linked to MOD-2021-022641 (Patient Link).

Other Meds: LASIX M

Current Illness:

ID: 1725410
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: has serious issues; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (has serious issues) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (has serious issues). At the time of the report, ADVERSE EVENT (has serious issues) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided. No treatment medications provided.

Other Meds:

Current Illness:

ID: 1725411
Sex: F
Age: 63
State: FL

Vax Date: 02/11/2021
Onset Date: 09/07/2021
Rec V Date: 09/23/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: ascites; Gradually lost eyesight; Complete kidney shutdown; Confused; Disoriented; Dizzy; Unabalanced; This spontaneous case was reported by a consumer and describes the occurrence of RENAL IMPAIRMENT (Complete kidney shutdown), BLINDNESS (Gradually lost eyesight), ASCITES (ascites), CONFUSIONAL STATE (Confused), DISORIENTATION (Disoriented), DIZZINESS (Dizzy) and BALANCE DISORDER (Unabalanced) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002FZ1A, 001A21A and 031620A) for COVID-19 vaccination. The patient's past medical history included Paracentesis (5 liters of fluid was drained by paracentesis on 2sep2012) on 02-Sep-2012. Concomitant products included ALBUTEROL [SALBUTAMOL] for COPD. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced CONFUSIONAL STATE (Confused) (seriousness criterion hospitalization), DISORIENTATION (Disoriented) (seriousness criterion hospitalization), DIZZINESS (Dizzy) (seriousness criterion hospitalization) and BALANCE DISORDER (Unabalanced) (seriousness criterion hospitalization). On 08-Sep-2021, the patient experienced RENAL IMPAIRMENT (Complete kidney shutdown) (seriousness criteria hospitalization, disability and medically significant). On 09-Sep-2021, the patient experienced BLINDNESS (Gradually lost eyesight) (seriousness criteria hospitalization, disability and medically significant). On an unknown date, the patient experienced ASCITES (ascites) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 07-Sep-2021 due to ASCITES, BALANCE DISORDER, BLINDNESS, CONFUSIONAL STATE, DISORIENTATION, DIZZINESS and RENAL IMPAIRMENT. At the time of the report, RENAL IMPAIRMENT (Complete kidney shutdown), BLINDNESS (Gradually lost eyesight), ASCITES (ascites), CONFUSIONAL STATE (Confused), DISORIENTATION (Disoriented), DIZZINESS (Dizzy) and BALANCE DISORDER (Unabalanced) outcome was unknown. No treatment information was provided. This case concerns a 63-year-old, female patient with previous relevant medical history of chronic obstructive pulmonary disease, (COPD) , paracentesis and use of concomitant medication, who experienced the unexpected events of renal impairment, blindness, ascites, confusional state, disorientation, dizziness and balance disorder. The events occurred approximately 10 days after the third dose of mRNA-1273. The rechallenge was positive due the patient developed ascites after the second dose. The medical history of chronic obstructive pulmonary disease, (COPD), paracentesis and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-320732, MOD-2021-320769 (Patient Link).; Sender's Comments: This case concerns a 63-year-old, female patient with previous relevant medical history of chronic obstructive pulmonary disease, (COPD) , paracentesis and use of concomitant medication, who experienced the unexpected events of renal impairment, blindness, ascites, confusional state, disorientation, dizziness and balance disorder. The events occurred approximately 10 days after the third dose of mRNA-1273. The rechallenge was positive due the patient developed ascites after the second dose. The medical history of chronic obstructive pulmonary disease, (COPD), paracentesis and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds: ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1725412
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Got another dose of the Moderna COVID-19 vaccine although he was not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Got another dose of the Moderna COVID-19 vaccine although he was not immunocompromised) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Got another dose of the Moderna COVID-19 vaccine although he was not immunocompromised). At the time of the report, OFF LABEL USE (Got another dose of the Moderna COVID-19 vaccine although he was not immunocompromised) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. It was reported that patient was doing fine. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1725413
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: I had the first shot 3 months ago- it is safe to get 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I had the first shot 3 months ago- it is safe to get 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I had the first shot 3 months ago- it is safe to get 2nd shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had the first shot 3 months ago- it is safe to get 2nd shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1725414
Sex: U
Age:
State:

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sore arm; some fatigue in the joints; felt a feverish sensation; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (some fatigue in the joints) and PYREXIA (felt a feverish sensation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: influenza vaccine in 2017. Past adverse reactions to the above products included Adverse event with influenza vaccine. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (some fatigue in the joints) and PYREXIA (felt a feverish sensation). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (some fatigue in the joints) and PYREXIA (felt a feverish sensation) outcome was unknown. Patient allergist/immunologist and cardiologist were very pleased my COVID vaccinations went so well. Patient was having hereditary alpha tryptasemia genetic trait, confirmed by a Gene-by-Gene genetic test. No concomitant medications were reported. No treatment information were reported. This case was linked to MOD-2021-318734 (Patient Link).

Other Meds:

Current Illness:

ID: 1725415
Sex: F
Age: 51
State: MN

Vax Date: 07/22/2021
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Has not recieved second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not recieved second dose yet) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041D21A or 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not recieved second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not recieved second dose yet) had resolved. Concomitant product use was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1725416
Sex: F
Age:
State: CA

Vax Date: 09/16/2021
Onset Date: 09/16/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Expired vaccine administered beyond 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours after first puncture) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours after first puncture). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours after first puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The vial was punctured at 9 AM on 15-Sep-2021 and used beyond the 12 hour expiry date in room temp on 16-Sep-2021. No concomitant medications were reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1725417
Sex: U
Age:
State:

Vax Date: 01/19/2021
Onset Date: 02/21/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Body aches; Migraine; Their arm felt heavy/Arm ache; Had fever of 100.2?F; Strong headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), MIGRAINE (Migraine), PAIN IN EXTREMITY (Their arm felt heavy/Arm ache), PYREXIA (Had fever of 100.2?F) and HEADACHE (Strong headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cancer in remission. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced PAIN (Body aches), MIGRAINE (Migraine), PAIN IN EXTREMITY (Their arm felt heavy/Arm ache), PYREXIA (Had fever of 100.2?F), HEADACHE (Strong headache) and CHILLS (Chills). On 22-Feb-2021, PAIN (Body aches), MIGRAINE (Migraine), PYREXIA (Had fever of 100.2?F), HEADACHE (Strong headache) and CHILLS (Chills) had resolved. On 23-Feb-2021, PAIN IN EXTREMITY (Their arm felt heavy/Arm ache) had resolved. Concomitant product use was unknown by the reporter. Treatment information was not provided.

Other Meds:

Current Illness: Cancer in remission

ID: 1725418
Sex: M
Age: 43
State: WA

Vax Date: 09/16/2021
Onset Date: 09/16/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Administered a dose from a vial that had expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose from a vial that had expired) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose from a vial that had expired). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered a dose from a vial that had expired) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported No treatment medications were reported. It was reported that that there was no expiration date on vial but reporter assumed that it was 15-Oct-2021.

Other Meds:

Current Illness:

ID: 1725420
Sex: M
Age:
State: MA

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Date: 202105; Test Name: ELEVATED THYROID PEROXIDASE ANTIBODIES; Test Result: Positive ; Comments: ELEVATED THYROID PEROXIDASE ANTIBODIES; Test Date: 20210629; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: SCALP HAIR BECAME DRY, THIN, AND BRITTLE; SCALP HAIR BECAME DRY, THIN, AND BRITTLE; DIFFUSE SHEDDING OF SCALP HAIR; HEART PALPITATIONS; HOT FLASHES; INSOMNIA; FATIGUE AND WEAKNESS; FATIGUE AND WEAKNESS; CHEST PAIN; DIFFICULTY TAKING A DEEP BREATH; MOOD SWINGS; DIFFICULTY CONCENTRATING AND MEMORY LAPSES; DIFFICULTY CONCENTRATING AND MEMORY LAPSES; ACHING AND STIFFNESS IN KNEES, THIGHS, HIPS, AND LOWER BACK; ACHING AND STIFFNESS IN KNEES, THIGHS, HIPS, AND LOWER BACK; HAIR LOSS ON FOREARMS, EDGE OF EYEBROWS, AND LOWER LEGS/ DIFFUSE SHEDDING OF SCALP HAIR; HEAT INTOLERANCE; ELEVATED THYROID PEROXIDASE ANTIBODIES; GOITER / THYROIDITIS; GOITER / THYROIDITIS; NECK TENDERNESS IN THE AREA AROUND ADAM'S APPLE; This is a spontaneous report from a contactable consumer or other health care professional. A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), (Lot Number: EWO173, Expiry date not reported) via unspecified route of administration administered in left arm on 01May2021 at 15:30 (at age of 46-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine within four weeks. Patient received other medications in two weeks include dietary supplements. Patient previously took beta lactam antibiotics, azithromycin, ibuprofen, and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EWO150, Expiry date not reported) via unspecified route of administration, administered in left arm on 10Apr2021 at 15:30 (at age of 46-years-old) as single dose for COVID-19 Immunisation. On unspecified date in May2021 (after vaccination) patient experienced scalp hair became dry, thin and brittle, diffuse shedding of scalp hair, heart palpitations, hot flashes, insomnia, fatigue ,weakness, chest pain, difficulty taking a deep breath, mood swings, difficulty concentrating and memory lapses, aching and stiffness in knees, thighs, hips, and lower back, hair loss on forearms, edge of eyebrows, and lower legs, heat intolerance, elevated thyroid peroxidase antibodies, goiter / thyroiditis, neck tenderness in the area around adams apple. Patient did not receive treatment for the events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The Patient underwent lab test and procedures include PCR test was negative on 29Jun2021; Anti-thyroid antibody test result was elevated thyroid peroxidase antibodies on unspecified date in May 2021. The Outcome of the events was not recovered. Follow-Up (06Sep2021): Follow-up attempts are completed. No further information is expected. Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1725421
Sex: F
Age:
State: PA

Vax Date: 04/23/2021
Onset Date: 06/02/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Most food (besides sweets) don't taste the same; Metallic taste in mouth at all times; This is a spontaneous report from a contactable consumer (patient, self-reported). A 42-year-old non pregnant female received second dose of f BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: Ew0171 and expiry date was not reported), intramuscularly in Arm Left, on 23Apr2021 at 02:30 PM (age at vaccination: 42 years), as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient did not test for COVID post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0150 and expiry date: 31Aug2021), intramuscularly in Arm Left, on 01Apr2021 at 07:30 AM, as dose 1, single for COVID-19 immunization. The patient reported that, on 02Jun2021, she had metallic taste in mouth at all times. Most food (besides sweets) did not taste the same and very metallic or ferric. She also experienced constant burning smell/taste. Sweet foods were ok, but any other food such as meat and vegetables taste like metal and were gross. This change in smell ability could be a serious issue if she would be unable to do her job as a scientist in a chemical lab since she cannot determine chemical potency. The patient did not receive any treatment for the events. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected. Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101128399 same patient, different dose/events

Other Meds:

Current Illness:

ID: 1725422
Sex: F
Age:
State: ID

Vax Date: 06/30/2021
Onset Date: 07/01/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: nauseous; Fever; Dry heaves; This is a spontaneous report from a contactable Consumer (parent). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 14 years), dose 1 intramuscular in Arm left on 30Jun2021 as dose 1, single and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0180, Expiry date: unknown, at the age of), dose 2 intramuscular on 26Jul2021 15:00 as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Jul2021 the patient experienced fever and was nauseous with dry heaves after receipt of the Pfizer-BioNTech COVID-19 Vaccine and requested any management recommendations. She wanted to ask about use of Tylenol for the fever and anything to help with nausea. Early this morning, the patient's mother found the patient on bathroom floor next to toilet because of the nausea. This was the same reaction after she got her first dose on 30Jun2021. The outcome of the event nauseous was recovered on 01Jul2021 and that of fever and dry heaves was recovered on 02Jul2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1725423
Sex: F
Age:
State: OH

Vax Date: 04/18/2021
Onset Date: 08/02/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: have a 12x12x5 mm Mass in the Back of my Left Breast / Right Under where the Shot was Given; My Vaccination Arm is Magnetic, when I hold a Fork above the Area given the Shot the Fork is Drawn to the Arm; This is a spontaneous report from a contactable consumer (patient herself). A 49-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 18Apr2021 16:00 (age at vaccination: 49 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included breast cancer last year but now its gone, latex and peanuts allergy. The patient's concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number:ER8727) via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. On 02Aug2021 16:00, the patient had a 12x12x5 mm mass in the back of her left breast / right under where the shot was given, vaccination arm was magnetic, when she holds a fork above the area given the shot the fork is drawn to the arm. Leaning forward the fork doesn't fall off but It dangles from her arm. The patient did not receive any treatment for the adverse event. The patient did not have covid prior to vaccination not was tested since vaccination. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1725424
Sex: F
Age:
State: WA

Vax Date: 06/30/2021
Onset Date: 07/02/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: mouth sores; This is a spontaneous report from a contactable other HCP. A 47-years-old non pregnant female patient received (BNT162B2 formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 30Jun2021 12:00PM (at the age of 47-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included asthma and Paper tape allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included salbutamol sulfate and montelukast sodium all for unknown indications from unknown dates and unknown if ongoing.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported Dose 1 mouth sores and Multiple on each side of my mouth, Upper and lower. 6-8 at a time, They went away, Dose 2 mouth ulcers. she have been getting constant sore. As they heal she get new sores. she constantly have 2. she last dose was 14Jul2021. she at the end of 2. It seems though as she think they are gone a new one starts. The patient experienced mouth sores on 02Jul2021. The clinical outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.

Other Meds: Proair [Salbutamol Sulfate]; Singulair

Current Illness:

ID: 1725425
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient has a very very big rash its just growing its all over her back or her bottom, her arm and her hand; break into hives; This is a spontaneous report from a contactable nurse or other hcp (parent). A 17-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (at the age of 17-years-old) as single dose for covid-19 immunization. Reporter stated regarding first dose date as there was about 4 to 6 weeks ago. The patient's medical history was not reported. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. It was reported that its not helping, getting worse. On unspecified date 4 weeks ago, patient has a very big rash it's just growing it's all over her back or her bottom, her arm and her hand. Reporter stated that patient taken allegra but It's not getting any better we haven't she was never had a rash like this and also experienced hives on unspecified date in 2021. Consumer stated, she has 2 questions both mother and daughter have a very big rash on their back and is spreading to her bottom 4 weeks ago and they were supposed to get the second dose both. she guesses it has been about seven weeks then they have a very big rash. Further reporter stated, they will get second one but if she has this bad over result from it they would want me to DCA write right now until they should know what going on. She is having second dosages and she had all this fever and all that from the beginning of the first dose but now what we just break into hives mother and daughter, she has been on quinidine and everything shall three weeks. Reporter stated, yes please they probably call her because reporter want to know if they want to give the second one because I am still for the second one because it's been about 6 weeks. The outcome of the event hives was not recovered, and the outcome of event patient has a very big rash it's just growing it's all over her back or her bottom, her arm and her hand was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101015552 (same reporter, different patient, parent case)

Other Meds: ALLEGRA

Current Illness:

ID: 1725426
Sex: F
Age:
State: WA

Vax Date: 07/14/2021
Onset Date: 07/01/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dose 2 mouth ulcers; I have been getting constant sore.As they heal I get new sores; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 14Jul2021 (age at vaccination was 47 years and patient was not pregnant at the time of vaccination) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. The patient's medical history included asthma and known allergies to paper tape. The patient's concomitant medications included fluticasone propionate (PROAIR) and montelukast sodium (SINGULAIR). The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported), via an unspecified route of administration, administered in arm left on 30Jun2021 12:00 PM (age at vaccination was 47 years) as dose 1, single for COVID-19 immunisation and experienced mouth sores, multiple on each side of her mouth, upper and lower, 6-8 at a time on 02Jul2021. They went away. After dose 2, She experienced mouth ulcers in Jul2021. She had been getting constant sore. As they healed, she got new sores. She constantly had 2. Her last dose was 14Jul2021. She was at the end of 2. It seemed though as she thought they were gone a new one started. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no hospitalization prolonged. The patient was not received any treatment for adverse events. Prior to vaccination, she was not diagnosed with COVID-19 and since the vaccination, she had not tested for COVID-19. Outcome of event at the time of last observation was not resolved. No follow-up attempts were completed. No further information was expected.

Other Meds: PROAIR [FLUTICASONE PROPIONATE]; SINGULAIR

Current Illness:

ID: 1725427
Sex: F
Age:
State: CO

Vax Date: 07/17/2021
Onset Date: 08/08/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: painful and swollen armpits, worse after the second shot; painful and swollen armpits, worse after the second shot; painful and swollen armpits, worse after the second shot; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: FA6780; Expiration date: unknown) via an unspecified route of administration on 17Jul2021 10:00 (at the age of 60-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had not any known allergies. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0198; Expiration date: unknown) via an unspecified route of administration on Arm right on 17Jul2021 10:00 as DOSE 1, SINGLE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced painful and swollen armpits, worse after the second shot on 08Aug2021. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The outcome of events was not recovered.

Other Meds:

Current Illness:

ID: 1725428
Sex: F
Age:
State: NY

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: getting a funny taste in her mouth/described as metallic; This is a spontaneous report received from a contactable consumer (Patient) reported for herself. A 86-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL3247) via an unspecified route of administration on 19Jan2021 (at the age of 86-year-old) as dose 1, single and second dose of bnt162b2 ((Batch/Lot number was not reported) via an unspecified route of administration at left arm on 09Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included Blood pressure high, bad back, Parkinson's disease, Neuropathy and acid reflux. Concomitant medications included hydralazine hydrochloride (HYDRALAZINE [HYDRALAZINE HYDROCHLORIDE]) taken for blood pressure measurement with a daily dose of 50 mg three times a day, gabapentin with a daily dose of 600 mg three times a day, carbidopa, levodopa one in the morning and afternoon and two at night, spironolactone with a daily dose of 25 mg once a day, famotidine with a daily dose of 1 capsule once a day, propranolol with a daily dose of 80 mg once a day, cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) with daily dose of 2500 mg ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE) with once daily, ascorbic acid (VIT C), calcium carbonate, colecalciferol (CALCIUM + D3 [CALCIUM CARBONATE;COLECALCIFEROL]) and omeprazole taken for Acid reflux. Patient did not receive any other vaccines within 4 weeks prior to this vaccine and patient do not have any adverse events prior to vaccination. It was none history of all previous immunization with the Pfizer vaccine considered as suspect and additional Vaccines Administered on Same Date of the Pfizer Suspect. It was reported that Caller is a 86 year-old female who received the first dose of the Pfizer Covid-19 vaccine on 19Jan2021 and the second dose on 09Feb2021. Before or after the second dose (Caller unable to state exactly when) the Caller started getting a funny taste in her mouth that she still experiences to this day when she puts food in her mouth on unspecified date in 2021. Caller states that the funny taste could possibly be described as metallic. HCP advised Caller to "double up" on her omeprazole due to possible increased acid reflux but Caller stated that she stopped using the omeprazole as advised by her HCP due to complaints of diarrhea. Caller is asking if the funny taste that she is experiencing has been reported as a side effect for the Pfizer Covid-19 vaccine? The caller got her last shot in Feb and she was not sure if it was before or after the second dose, she started to get this funny taste in her mouth and she still has it 6 months later. Has anyone else reported this. As soon as the caller puts food in her mouth she can taste this taste. Patient did not visit the emergency room but visits the physician office for the events. Outcome of event was not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: HYDRALAZINE [HYDRALAZINE HYDROCHLORIDE]; GABAPENTIN; LEVODOPA-CARBIDOPA; SPIRONOLACTONE; FAMOTIDINE; PROPRANOLOL; VITAMIN B12 [CYANOCOBALAMIN]; AIRBORNE; VIT C; CALCIUM + D3 [CALCIUM CARBONATE;COLECALCIFEROL]; OMEPRAZOLE

Current Illness:

ID: 1725429
Sex: F
Age:
State: PA

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: headache; This is a spontaneous report from a contactable other hcp (patient). This report was received via a sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced headache. It was reported that after shot 1 the patient experienced headache that would come and go and after shot 2 the patient also experienced a headache that would come and go and a little bit of chest pain after the second shot. It was reported that she received both shots in April 2021. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1725430
Sex: U
Age:
State: CA

Vax Date: 12/29/2020
Onset Date: 01/01/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: mild itching; This is a spontaneous report from a contactable Other HCP (patient) via Medical Information Team. A patient of an unspecified gender and age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 29Dec2020 as a dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient received the Pfizer COVID-19 vaccine initially on 29Dec2020 and the final dose on 19Jan2021. After initial dose, patient had some mild itching a week after on an unspecified date in Jan2021. Suspected it was from the vaccine. Nevertheless, completed the second dose and a week after that the itching got worse with rashes then maculae and papulae. Went to see an allergist and he ruled possible allergy to the vaccine. After initial dose, patient experienced mild itching on an unspecified date in Jan2021 (reported as a week after). The outcome of the event was unknown. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1725431
Sex: M
Age:
State: FL

Vax Date: 07/01/2021
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: had no smell; had no taste; Stated that he has sensations in his legs; he has sensations in his legs was reported as worsened; stated that when he walks that it is like pens and needles; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer (patient's mother) reported for a patient (reporter's son). A 19-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Jul2021 (age at vaccination was 19 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was 19 years) as dose 1, single for COVID-19 immunization. It was unknown if there was history of any previous immunization with the Pfizer vaccine considered as suspect. It was unknown if any additional vaccines were administered on same date of the Pfizer suspect. The facility where the most recent COVID-19 vaccine was administered was Pharmacy/Drug Store. The vaccine was not administered at Military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller reported that her son received his second Pfizer COVID 19 vaccine two weeks ago. The patient experienced side effects that were described as a unique situation. On an unspecified date in 2021, the patient had no smell, no taste, sensation in legs, when he walked it felt like pens and needles. The caller stated that the patient lost sense of smell and taste about a week ago. The caller stated that when the patient walked that it was like pens and needles and had sensations in his legs that started about 3-4 days ago. The caller stated that the sensations vary from day to day. The caller asked if the symptoms were normal and if the symptoms will go away. The caller stated that the patient went to urgent care and was given medication and recommended that he see a neurologist for walking like pens and needles. The caller stated that the patient stopped taking medication because he did not like the way it made him feel. The event did not require visit to Physician Office. No relevant tests were done. The outcome of the events was not resolved. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1725432
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:104 degrees; Comments: after 2nd shot high fever of 104 degrees for 2 days

Allergies:

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

Symptoms: high fever of 104 degrees for 2 days; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 79-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as DOSE 2 SINGLE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. It was reported that read that booster shot has same side effects as second shot. On unspecified date, she had after 2nd shot high fever of 104 degrees for 2 days and inquired that should he still get a booster shot since he was 79. The patient underwent lab tests and procedures which included body temperature: 104 degrees on unspecified date. The outcome of the event was unknown. Information on lot number/batch number has been requested. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1725433
Sex: F
Age:
State: OH

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: chills; Tired; loss of appetite; Headache; She felt like she had a little bug; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 59-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm (reported as left or right arm) on an unspecified date in Dec2020 (also reported as Dec2021) as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm (reported as left or right arm) on an unspecified date in Jan2021 as dose 2, single (at the age of 59-years-old) for COVID-19 immunization. Vaccination facility type was reported as hospital. Vaccine was not administered at military facility. List any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was noted as none. Patient medical history noted that patient have other medical conditions, but none that are relevant. Patient medical history (including any illness at time of vaccination) she stated that she does have other medical conditions, but none that are relevant. Family medical history relevant to AEs were reported as none. The concomitant medications was not reported. Patient experienced after she got her shots, she was tired, and got chills, headache, and loss of appetite on an unspecified date in Dec2020. The reported seriousness of the event was non-serious. Stated that those side effects went away, but periodically the tired, chills and loss of appetite comes back, and she feels like she has a little bug, then it goes away again. Stated that the headache had not been reoccurring on an unspecified date in Jan2021. Patient stated that she planned to talk to her doctor about all this when she goes to see him on 26Aug2021. Patient received both doses of the vaccine, one dose in Dec2020 (reported as Dec2021) and the second dose in Jan2021. She had experienced side effects like chills, tiredness and loss of appetite. These side effects reoccurred and resolved periodically. She stated this started when she got the vaccine and was asking was it possible to have these reoccurring side effects from the vaccine. Stated that she got both doses of the shot, but it had been a while. She thought she got them at the beginning of the year. She had the little side effects and they went away. Stated that she will still get them periodically and then they will go away again and she will be fine. Stated that she plans to talk to her doctor about all this when she goes to see him on 26Aug2021. After she got her shots she was tired, and got chills, headache, and loss of appetite. Stated that those side effects went away, but periodically the tired, chills and loss of appetite comes back, and she felt like she had a little bug then it goes away again. Stated that the headache has not been reoccurring. She did not have her vaccine card with her to provide the dates of her vaccines or the Lot numbers, but caller stated that she thought she got her first dose in Dec2020 and the second dose in Jan2021. She got her shots in opposite arms, so one dose was in the right arm and the other dose was in the left arm, but she did not know which dose was in which arm. She stated that she did have other medical conditions, but none that are relevant. The adverse events did not result in visit to emergency room or physician office. The outcome of the events of tired, chills and loss of appetite, feeling abnormal was not recovered and the outcome of headache was resolved on an unspecified date in Jan2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am