VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
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: 1725282
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 105

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: THOUGHT OF GOING TO DIE; FEVER; MASSIVE AND PAINFUL HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced thought of going to die. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced massive and painful headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 105. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from massive and painful headache, and the outcome of thought of going to die and fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725283
Sex: F
Age:
State: DE

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

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: 20210917; Test Name: COVID-19 virus test negative; Result Unstructured Data: Negative

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: LOSS OF TASTE; LOSS OF SMELL; DEEP COUGH; This spontaneous report received from a patient concerned a 64 year old female. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-SEP-2021, the patient experienced loss of taste. On 06-SEP-2021, the patient experienced loss of smell. On 06-SEP-2021, the patient experienced deep cough. On 17-SEP-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from loss of taste, loss of smell, and deep cough. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725284
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 09/07/2021
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: RASH /RASH SPREAD EVERYWHERE; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-SEP-2021, the patient experienced rash /rash spread everywhere. Treatment medications (dates unspecified) included: triamcinolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash /rash spread everywhere. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725285
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 05/01/2021
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: CANNOT SLEEP; HAD PAIN UP AND DOWN LOWER BACK LIKE SCIATIC PAIN; FELT LIKE A MUSCLE CRAMP IN THE BACK OF LEGS; WHOLE BODY UNDER SKIN WAS ON FIRE; BABY TOE ON RIGHT FOOT WAS NUMB; MILD FLU SYMPTOMS; EXCRUCIATING OVERALL NERVE PAIN INCLUDING FINGERS AND FACE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included: neck pain, and concurrent conditions included: chronic migraine, and other pre-existing medical conditions included: The patient never had reaction before to a vaccine. The patient was previously treated with gabapentin for neck pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 21-SEP-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. Concomitant medications included amitriptyline for chronic migraine, and venlafaxine hydrochloride. On MAY-2021, the patient experienced mild flu symptoms. On MAY-2021, the patient experienced excruciating overall nerve pain including fingers and face. On MAY-2021, the patient experienced baby toe on right foot was numb. On 20-SEP-2021, the patient experienced whole body under skin was on fire. On 21-SEP-2021, the patient experienced felt like a muscle cramp in the back of legs. On an unspecified date, the patient experienced cannot sleep, and had pain up and down lower back like sciatic pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from excruciating overall nerve pain including fingers and face, and the outcome of mild flu symptoms, cannot sleep, had pain up and down lower back like sciatic pain, felt like a muscle cramp in the back of legs, whole body under skin was on fire and baby toe on right foot was numb was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941191.

Other Meds: AMITRIPTYLINE; EFFEXOR

Current Illness: Chronic migraine

ID: 1725286
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 09/21/2021
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: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: EXPIRED VACCINE ADMINISTERED (VACCINE ADMINISTERED TO 2 MALES FROM AN EXPIRED LOT); .This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported. On 21-SEP-2021, the patient experienced expired vaccine administered (vaccine administered to 2 males from an expired lot). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered (vaccine administered to 2 males from an expired lot) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941889.

Other Meds:

Current Illness:

ID: 1725287
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 09/21/2021
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:

Allergies:

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

Symptoms: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 21-SEP-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725288
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 09/21/2021
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: Pyrexia, White blood cell count decreased

Symptoms: EXPIRED VACCINE ADMINISTERED TO THREE FEMALES; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced expired vaccine administered to three females. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered to three females was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941376.

Other Meds:

Current Illness:

ID: 1725289
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: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: STIFF IN THE MORNING; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had other concomitant therapy of steroids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced stiff in the morning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stiff in the morning was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1725290
Sex: F
Age: 94
State: TX

Vax Date: 01/16/2021
Onset Date: 01/16/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: Redness around injection site; Pain, swelling, itchiness at the inejction site; Experienced Itchiness 2 hours after getting it; Swelling at my right arm (injection site); A spontaneous report was received from a consumer concerning a 93-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced itching around injection site, redness around the injection site and swelling around injection site. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Benadryl, Metoprolol, Atorvastatin, Lorazepan, Vitamin C, Euthyrox, Latanoprost, Dorzolamide/Timolol and Mupirocin. On 16 Jan 2021, approximately two hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 042L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 16 Jan 2021, the patient experienced itching around injection site, redness around the injection site and swelling around injection site Treatment for the event included ice pack and Benadryl. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events itching around injection site, redness around the injection site and swelling around injection site was not reported.

Other Meds: METOPROLOL; ATORVASTATIN; LORAZEPAN; EUTHYROX; LATANOPROST; DORZOLAMIDE; MUPIROCIN

Current Illness:

ID: 1725291
Sex: M
Age: 49
State: GA

Vax Date: 04/28/2021
Onset Date: 05/27/2021
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: Test Date: 20210530; Test Name: blood pressure; Result Unstructured Data: 117/82 mmhg blood pressure; Test Date: 20210602; Test Name: blood pressure; Result Unstructured Data: 102/73 mmhg blood pressure; Test Date: 20210608; Test Name: blood pressure; Result Unstructured Data: 125/80 mmhg blood pressure; Test Date: 20210530; Test Name: body temperature; Result Unstructured Data: 98.1 Fahrenheit; Test Date: 20210602; Test Name: body temperature; Result Unstructured Data: 98.1 Fahrenheit; Test Date: 20210608; Test Name: body temperature; Result Unstructured Data: 98.2 Fahrenheit; Test Date: 20210530; Test Name: heart rate; Result Unstructured Data: 82 heart beats per minute; Test Date: 20210602; Test Name: heart rate; Result Unstructured Data: 73 heart beats per minute; Test Date: 20210608; Test Name: heart rate; Result Unstructured Data: 102 heart beats per minute; Test Date: 20210530; Test Name: respiratory rate; Result Unstructured Data: 16 breaths per minute; Test Date: 20210602; Test Name: respiratory rate; Result Unstructured Data: 16 breaths per minute; Test Date: 20210608; Test Name: respiratory rate; Result Unstructured Data: 18 breaths per minute

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: hive reaction to the second dose/hives/urticaria; Itching/pruritus: local; Rash: local; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (hive reaction to the second dose/hives/urticaria), PRURITUS (Itching/pruritus: local) and RASH (Rash: local) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 041C21A) for COVID-19 vaccination. The patient's past medical history included PPD skin test positive. Previously administered products included for an unreported indication: TETANUS TOXOID on 19-May-2021. Concurrent medical conditions included Food allergy (allergic to Tomatoes. Unknown reactions.), Hypertension, HIV infection and Hepatitis B. Concomitant products included DOLUTEGRAVIR SODIUM (TIVICAY) from 01-Apr-2021 to an unknown date and EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) from 01-Apr-2021 to an unknown date for HIV disease, OXCARBAZEPINE (TRILEPTAL) from 17-Mar-2021 to an unknown date, ARIPIPRAZOLE (ABILIFY) and PRAZOSIN from 17-Mar-2021 to an unknown date for Malignant hyperthermia. On 28-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced URTICARIA (hive reaction to the second dose/hives/urticaria) and RASH (Rash: local). 27-May-2021, the patient experienced PRURITUS (Itching/pruritus: local). The patient was treated with LORATADINE (BENADRYL 24 FLASH) (oral) on 30-May-2021 at a dose of 25 mg; PREDNISONE (oral) on 02-Jun-2021 at a dose of 50 mg; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) (intramuscular) on 02-Jun-2021 at a dose of 125 mg and HYDROCORTISONE ACETATE (HYDROCORTISON ACETATE) (topical) on 30-May-2021 at a dose of 1 percent. On 08-Jun-2021, URTICARIA (hive reaction to the second dose/hives/urticaria), PRURITUS (Itching/pruritus: local) and RASH (Rash: local) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Blood pressure measurement: 117/82 mmHg (normal) 117/82 mmhg blood pressure. On 30-May-2021, Body temperature: 36.722 degree Celsius (Low) 98.1 Fahrenheit. On 30-May-2021, Heart rate: 82 heart beats per minute (normal) 82 heart beats per minute. On 30-May-2021, Respiratory rate: 16 breaths per minute (normal) 16 breaths per minute. On 02-Jun-2021, Blood pressure measurement: 102/73 mmHg (normal) 102/73 mmhg blood pressure. On 02-Jun-2021, Body temperature: 36.722 degree Celsius (Low) 98.1 Fahrenheit. On 02-Jun-2021, Heart rate: 73 heart beats per minute (normal) 73 heart beats per minute. On 02-Jun-2021, Respiratory rate: 16 breaths per minute (normal) 16 breaths per minute. On 08-Jun-2021, Blood pressure measurement: 125/80 mmHg (abnormal) 125/80 mmhg blood pressure. On 08-Jun-2021, Body temperature: 36.722 degree Celsius (Low) 98.2 Fahrenheit. On 08-Jun-2021, Heart rate: 102 heart beats per minute (High) 102 heart beats per minute. On 08-Jun-2021, Respiratory rate: 18 breaths per minute (High) 18 breaths per minute. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered URTICARIA (hive reaction to the second dose/hives/urticaria), PRURITUS (Itching/pruritus: local) and RASH (Rash: local) to have an unknown relationship. . Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant follow-up added: conmeds, treatment medications, events were added.

Other Meds: TRILEPTAL; TIVICAY; DESCOVY; ABILIFY; PRAZOSIN

Current Illness: Food allergy (allergic to Tomatoes. Unknown reactions.); Hepatitis B; HIV disease; Hypertension

ID: 1725292
Sex: M
Age: 46
State: IL

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

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

Lab Data:

Allergies:

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

Symptoms: Shakes; Night sweats; sore injections site arm; Fatigue; On and off fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), NIGHT SWEATS (Night sweats), VACCINATION SITE PAIN (sore injections site arm), FATIGUE (Fatigue) and PYREXIA (On and off fever) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The patient's past medical history included Cancer (Cancer 25 years ago.) in 1996. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced TREMOR (Shakes), NIGHT SWEATS (Night sweats), VACCINATION SITE PAIN (sore injections site arm), FATIGUE (Fatigue) and PYREXIA (On and off fever). On 05-Feb-2021, TREMOR (Shakes), NIGHT SWEATS (Night sweats), VACCINATION SITE PAIN (sore injections site arm), FATIGUE (Fatigue) and PYREXIA (On and off fever) 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 listed. No treatment information provided. This case was linked to MOD-2021-265490, MOD-2021-309134 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow up received 06-Sep-21: Medical history was added

Other Meds:

Current Illness:

ID: 1725293
Sex: F
Age: 20
State: WA

Vax Date: 07/11/2021
Onset Date: 08/09/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: They have got a little worse; sore throat; watery eyes; being congested; runny nose; tired / fatigue; back hurt; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (They have got a little worse), BACK PAIN (back hurt), OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (watery eyes) and NASAL CONGESTION (being congested) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088DZ1A and 0910Z1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE, VITAMINS NOS and PROBIOTICS NOS for an unknown indication. On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced BACK PAIN (back hurt) and FATIGUE (tired / fatigue). On 10-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (watery eyes), NASAL CONGESTION (being congested) and RHINORRHOEA (runny nose). On an unknown date, the patient experienced CONDITION AGGRAVATED (They have got a little worse). The patient was treated with PARACETAMOL (TYLENOL) on 11-Aug-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (They have got a little worse) outcome was unknown and BACK PAIN (back hurt), OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (watery eyes), NASAL CONGESTION (being congested), RHINORRHOEA (runny nose) and FATIGUE (tired / fatigue) had not resolved. Patient enquired if the symptoms she was experiencing were normal and were there any recommendations for treatment.

Other Meds: LEVOTHYROXINE; VITAMINS NOS; PROBIOTICS NOS

Current Illness:

ID: 1725294
Sex: M
Age: 80
State: AK

Vax Date: 01/18/2021
Onset Date: 08/31/2021
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: stored in the fridge for 40 days so 10 days over our recommended storage.; vaccine administered after beeing in the fridge for 40 days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage.) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 004M20A and O29L20A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised, Shoulder pain since 15-Aug-2021, Hyperlipidemia, Peripheral neuropathy, CVA, Osteoporosis since May 2017 and Degenerative joint disease (Exacerbation of shoulder arthritis). Concomitant products included PREGABALIN (LYRICA), ROSUVASTATIN, ASA and PRAMIPEXOLE for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage.) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days). On 31-Aug-2021, PRODUCT STORAGE ERROR (stored in the fridge for 40 days so 10 days over our recommended storage.) and EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that on 21 Jul 2021 vial was initially stored in the refrigerator. Total amount of time the vial was exposed to room temperature range noted that (8? to 25?C= 46? to 77? F): went over in a vaccine cooler, so the most would be 3 hours (start and end of the clinic). No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. This case was linked to MOD-2021-304556 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Patient demographics, current conditions, concomitant medication, first and second dose information were added.

Other Meds: LYRICA; ROSUVASTATIN; ASA; PRAMIPEXOLE

Current Illness: CVA; Degenerative joint disease (Exacerbation of shoulder arthritis); Hyperlipidemia; Immunocompromised; Osteoporosis; Peripheral neuropathy; Shoulder pain

ID: 1725295
Sex: F
Age:
State: IL

Vax Date: 01/18/2021
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: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: I'm experiencing all over body pain. Especially in muscles in upper arms.; I'm experiencing all over body pain, Especially in muscles in upper arms.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I'm experiencing all over body pain. Especially in muscles in upper arms.) and MYALGIA (I'm experiencing all over body pain, Especially in muscles in upper arms.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-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 (I'm experiencing all over body pain. Especially in muscles in upper arms.) and MYALGIA (I'm experiencing all over body pain, Especially in muscles in upper arms.). At the time of the report, PAIN IN EXTREMITY (I'm experiencing all over body pain. Especially in muscles in upper arms.) and MYALGIA (I'm experiencing all over body pain, Especially in muscles in upper arms.) outcome was unknown. No concomitant medications provided. No treatment medications provided. Patient asked that - Has anyone complained of sudden muscle and joint pain after a few months of vaccination? This case was linked to MOD-2021-020743 (Patient Link).

Other Meds:

Current Illness:

ID: 1725296
Sex: F
Age: 71
State: CA

Vax Date: 01/15/2021
Onset Date: 08/31/2021
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: 20210906; Test Name: COVID test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: Feeling hot; Palpitations; Shortness of Breath; Patient had a persistent dry cough; Patient had some chest tightnes; Oxygen Saturation 94%-97%; Fatigue; Sore leftarm; 99.1 Temperature; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Sep-2021. The most recent information was received on 11-Sep-2021 and was forwarded to Moderna on 11-Sep-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (Patient had a persistent dry cough), CHEST DISCOMFORT (Patient had some chest tightnes), FATIGUE (Fatigue), MYALGIA (Sore leftarm) and FEELING HOT (Feeling hot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 029L20N and 02UM20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Allergic to pegylated interferon used to treat Hep C in 1999, developed pulmonary sarcoidosis.), Hypertension since 2016, Hypothyroidism since 1999, Sleep apnea since 2017, Dyspnea exertional (Under investigation, started 6 months prior) since 2021 and Palpitations (No cause identified) since 2018. Concomitant products included ROSUVASTATIN for Cholesterol, ETHINYLESTRADIOL, NORETHISTERONE ACETATE (FYAVOLV) for Hormone replacement therapy, LOSARTAN for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Sore leftarm) and PYREXIA (99.1 Temperature). On 01-Sep-2021, the patient experienced COUGH (Patient had a persistent dry cough), CHEST DISCOMFORT (Patient had some chest tightnes) and OXYGEN SATURATION DECREASED (Oxygen Saturation 94%-97%). On 02-Sep-2021, the patient experienced FEELING HOT (Feeling hot), PALPITATIONS (Palpitations) and DYSPNOEA (Shortness of Breath). On 08-Sep-2021, CHEST DISCOMFORT (Patient had some chest tightnes) had resolved. At the time of the report, COUGH (Patient had a persistent dry cough) and FEELING HOT (Feeling hot) had not resolved and FATIGUE (Fatigue), MYALGIA (Sore leftarm), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of Breath), PYREXIA (99.1 Temperature) and OXYGEN SATURATION DECREASED (Oxygen Saturation 94%-97%) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. It was reported that from 03-Sep-2021 to 10-Sep-2021 dry cough slowly lessened, continued episodes of feeling hot but temperature was normal, intermittent fatigue. On 11-Sep-2021 there was occasional dry cough. No further chest tightness. Continued intermittent feeling hot and periods of fatigue. No Treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Significant live Follow-up Append. Event split into two events. Lab data updated. First and second dose start dates added. Patient initials changed. Causality updated. On 11-Sep-2021: Follow-up received contains additional event outcomes, Causality assessment, patient initials, relevant history, concomitant medications, batch number of third dose updated.

Other Meds: SYNTHROID; LOSARTAN; ROSUVASTATIN; FYAVOLV; AMBIEN

Current Illness: Drug allergy (Allergic to pegylated interferon used to treat Hep C in 1999, developed pulmonary sarcoidosis.); Dyspnea exertional (Under investigation, started 6 months prior); Hypertension; Hypothyroidism; Palpitations (No cause identified); Sleep apnea

ID: 1725297
Sex: F
Age:
State: FL

Vax Date: 09/07/2021
Onset Date: 08/09/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Difficulty breathing; chills; sore arm at injection site; Aches; fever; Sore Throat; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), SNEEZING (sneezing), DYSPNOEA (Difficulty breathing), MYALGIA (Aches) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E12D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Swab) on 08-Jan-2021. Concurrent medical conditions included Drug allergy (Codeine), Drug allergy (Darvocet), Drug allergy (Dilaudid), Drug allergy (Compasine), Drug allergy (Ambian) and Asthma (Wheezing, breathing difficulties). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 08-Jan-2020 to an unknown date and MONTELUKAST SODIUM (SINGULAIR) from 08-Jan-2020 to an unknown date for Asthma, CEFIXIME (FLEXERIL [CEFIXIME]) from 02-Jan-2001 to an unknown date for Muscle ache, GABAPENTIN (GABA [GABAPENTIN]) from 02-Jan-2004 to an unknown date for Pain, ROPINIROLE HYDROCHLORIDE (RAPINEROL) from 03-Jan-2011 to an unknown date for Restless legs. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), SNEEZING (sneezing), MYALGIA (Aches) and PYREXIA (fever). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing), CHILLS (chills) and VACCINATION SITE PAIN (sore arm at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), SNEEZING (sneezing), MYALGIA (Aches), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (sore arm at injection site) outcome was unknown and DYSPNOEA (Difficulty breathing) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Updated reporter information. updated patient demographics, added other relevant history. Added concomitant and treatment medication. Added new events.

Other Meds: GABA [GABAPENTIN]; FLEXERIL [CEFIXIME]; ADVAIR; RAPINEROL; SINGULAIR

Current Illness: Asthma (Wheezing, breathing difficulties); Drug allergy (Dilaudid); Drug allergy (Darvocet); Drug allergy (Compasine); Drug allergy (Codeine); Drug allergy (Ambian)

ID: 1725298
Sex: F
Age: 49
State: MA

Vax Date: 04/23/2021
Onset Date: 05/21/2021
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: Test Name: Hearing tests; Result Unstructured Data: normal; Test Date: 20210628; Test Name: Hearing tests; Result Unstructured Data: Hearing loss. patient heard less sound. blocked ear feeling was causing hearing loss; Test Name: Cat scan; Result Unstructured Data: normal; Test Date: 20210901; Test Name: Cat scan; Result Unstructured Data: Normal; Test Date: 20210618; Test Name: Nasal endoscopy; Result Unstructured Data: normal; Test Date: 20210820; Test Name: Nasal endoscopy; Result Unstructured Data: Normal

Allergies:

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

Symptoms: sick for few days; Fever; Hearing loss; both ears became blocked; I did not have good hearing/I am not hearing as well/my hearing has been blocked; When I was lying on my side my left ear would flutter and make noise; when she lays on the right side of the body her left ear flutters; Head strain; Achy all over; Upset stomach; Dry mouth; Hot and cold; Dehydrated; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lactose intolerant. Concomitant products included FERROUS SULFATE (IRON NATURE MADE) from 01-Jan-2018 to an unknown date for Anemic, LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) from 01-Jan-2018 to an unknown date for Dry eyes, CALCIUM from 01-Jan-2018 to an unknown date for Lactose intolerance, MULTIVITAMINS [VITAMINS NOS] from 01-Jan-2018 to an unknown date for an unknown indication. On 23-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), DRY MOUTH (Dry mouth), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), DEHYDRATION (Dehydrated), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Achy all over). On 01-Jun-2021, the patient experienced EAR CONGESTION (both ears became blocked), HYPOACUSIS (I did not have good hearing/I am not hearing as well/my hearing has been blocked), TINNITUS (When I was lying on my side my left ear would flutter and make noise), EAR DISCOMFORT (when she lays on the right side of the body her left ear flutters) and HEADACHE (Head strain). On 28-Jun-2021, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (sick for few days) and PYREXIA (Fever). The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) from 08-Jun-2021 to 15-Jun-2021 for Adverse event, at a dose of UNK, tid; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) (nasal) from 18-Jun-2021 to 25-Jun-2021 for Adverse event, at a dose of UNK, qd; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) from 18-Jun-2021 to 25-Jun-2021 for Adverse event, at a dose of UNK, qd; IBUPROFEN (ADVIL [IBUPROFEN]) from 14-Jul-2021 to 20-Jul-2021 for Adverse event, at a dose of 600 mg three times a day; PHENYLEPHRINE HYDROCHLORIDE (SYNEPHRINE [PHENYLEPHRINE HYDROCHLORIDE]) (nasal) from 05-Aug-2021 to 07-Aug-2021 for Adverse event, at a dose of UNK, tid and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) from 09-Sep-2021 to 11-Sep-2021 for Adverse event, at a dose of UNK, tid. On 24-May-2021, ABDOMINAL DISCOMFORT (Upset stomach), DRY MOUTH (Dry mouth), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), DEHYDRATION (Dehydrated), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Achy all over) had resolved. At the time of the report, DEAFNESS (Hearing loss), EAR CONGESTION (both ears became blocked), HYPOACUSIS (I did not have good hearing/I am not hearing as well/my hearing has been blocked), TINNITUS (When I was lying on my side my left ear would flutter and make noise) and EAR DISCOMFORT (when she lays on the right side of the body her left ear flutters) had not resolved and ILLNESS (sick for few days), PYREXIA (Fever) and HEADACHE (Head strain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jun-2021, Nasoendoscopy: normal (normal) normal. On 28-Jun-2021, Acoustic stimulation tests: abnormal (abnormal) Hearing loss. patient heard less sound. blocked ear feeling was causing hearing loss. On 20-Aug-2021, Nasoendoscopy: normal (normal) Normal. On 01-Sep-2021, Computerised tomogram: normal (normal) Normal. On an unknown date, Acoustic stimulation tests: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was prescribed antibiotics for sinus infection and also took allergy medication. Patient has gone through multiple office exams, nose exam via camera. Patient has issues with her hearing and everything is negative except for a hearing test. This case concerns a 49 Y/O F with serious unexpected deafness, and non-serious ear congestion, hypoacusis, tinnitus, illness, abdominal discomfort, dry mouth, ear discomfort, feeling of body temperature change, dehydration, fatigue, pyrexia, chills, myalgia, headache. Latency 1 day after 2nd dose. Outcome unknown. Rechallenge not applicable. Reporter causality not provided. Possibly related based on temporal association. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-319984 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Patient demographics updated, new medical history lactose intolerance added, Added event hearing loss , hot and cold, fatigue, dehydration, headache, myalgia. treatment medication added, concomitant drugs indication and dosage text updated, lab test added, event outcome and event start date updated. On 16-Sep-2021: Follow-up information included non significant information - Narrative updated.; Sender's Comments: This case concerns a 49 Y/O F with serious unexpected deafness, and non-serious ear congestion, hypoacusis, tinnitus, illness, abdominal discomfort, dry mouth, ear discomfort, feeling of body temperature change, dehydration, fatigue, pyrexia, chills, myalgia, headache. Latency 1 day after 2nd dose. Outcome unknown. Rechallenge not applicable. Reporter causality not provided. Possibly related based on temporal association. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; FLAXSEED OIL [LINUM USITATISSIMUM OIL]; CALCIUM; IRON NATURE MADE

Current Illness: Lactose intolerant

ID: 1725299
Sex: F
Age:
State: NY

Vax Date: 08/27/2021
Onset Date: 08/01/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data: Test Name: antibody test; Result Unstructured Data: my antibody count is high ; Test Date: 20210904; Test Name: Body temperature; Result Unstructured Data: High; Test Name: platelet test; Result Unstructured Data: my platelets are just a bit low. ; Test Date: 202109; Test Name: COVID- 19 test; Test Result: Negative ; Result Unstructured Data: negative

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: ill -since days after this booster; "Booster" felt fatigue crashed and went to bed/extremely tired continued sudden onset every afternoon/minor problem with being tired it passed; my platelets are just a bit low; weak/mostly stayed on the couch. ; got very tired; Lack of appetite; Monday morning tired had to take a nap; loss of appetite; this was a severe fatigue; Minor fever/ Fever 99F-100F; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lack of appetite), ILLNESS (ill -since days after this booster), FATIGUE ("Booster" felt fatigue crashed and went to bed/extremely tired continued sudden onset every afternoon/minor problem with being tired it passed), FATIGUE (got very tired) and FATIGUE (Monday morning tired had to take a nap) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced DECREASED APPETITE (loss of appetite), FATIGUE (this was a severe fatigue) and PYREXIA (Minor fever/ Fever 99F-100F). On 30-Aug-2021, the patient experienced FATIGUE (Monday morning tired had to take a nap). On 04-Sep-2021, the patient experienced DECREASED APPETITE (Lack of appetite), FATIGUE (got very tired) and ASTHENIA (weak/mostly stayed on the couch. ). On an unknown date, the patient experienced ILLNESS (ill -since days after this booster), FATIGUE ("Booster" felt fatigue crashed and went to bed/extremely tired continued sudden onset every afternoon/minor problem with being tired it passed) and PLATELET COUNT DECREASED (my platelets are just a bit low). The patient was treated with PARACETAMOL (TYLENOL) on 04-Sep-2021 for Fever, at an unspecified dose and frequency and Bed rest for Fatigue. On 04-Sep-2021, FATIGUE (Monday morning tired had to take a nap) and FATIGUE (this was a severe fatigue) had not resolved. At the time of the report, DECREASED APPETITE (Lack of appetite), ILLNESS (ill -since days after this booster), FATIGUE ("Booster" felt fatigue crashed and went to bed/extremely tired continued sudden onset every afternoon/minor problem with being tired it passed) and FATIGUE (got very tired) had not resolved, DECREASED APPETITE (loss of appetite), PLATELET COUNT DECREASED (my platelets are just a bit low) and ASTHENIA (weak/mostly stayed on the couch. ) outcome was unknown and PYREXIA (Minor fever/ Fever 99F-100F) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, Body temperature: 99-100 (High) High. In September 2021, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Antibody test: high (High) my antibody count is high . On an unknown date, Platelet count: low (Low) my platelets are just a bit low. . For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient went to the doctor, and she was doing a lot of tests. The third vaccine side effects occurred within 24 hours of receiving it ,she stated that she never takes naps. She felt like something she ever usually feels. She has been to Dr and had lots of blood work has been done.They say its like she is fighing a virus but can not see what. She has No fever no digestive or heart or lung issues. Concomitant medications were not provided. This case was linked to MOD-2021-314933. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Significant follow up appended- Events added, Batch no corrected.,Patient initials and pregnancy status added. Lab tests added.

Other Meds:

Current Illness:

ID: 1725300
Sex: M
Age: 30
State: NJ

Vax Date: 09/08/2021
Onset Date: 09/08/2021
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 with expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) 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) (Intramuscular) .5 ml. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. There were 9 patients instead of 10 as initially reported. All of the patients were administered with the 1st dose, 0.5ml, intramuscular on the left deltoid. Lot number 032N20A, expiration date 27Aug2021. This case is for the 3rd patient. No concomitant medications reported. No treatment reported. This case was linked to MOD21-141642, MOD21-141643, MOD21-141644, MOD21-141645, MOD21-141646, MOD21-141586, MOD21-141427, MOD21-141647, MOD-2021-314573, MOD-2021-314570, MOD-2021-314517, MOD-2021-314545, MOD-2021-314555, MOD-2021-314793, MOD-2021-314805, MOD-2021-314793 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up received on 15-SEP-2021 contains no new information. On 15-Sep-2021: Follow-up received on 15-SEP-2021 contains no new information.

Other Meds:

Current Illness:

ID: 1725301
Sex: M
Age:
State: NY

Vax Date: 09/03/2021
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:

Allergies:

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

Symptoms: Cut their chest open on the chair edge; Groggy,falling asleep; Fell through the baby chair they use; Vertigo kicked; They were falling down and falling asleep while standing; low electrolytes; It hurt a lot. hurt like hell; Red swelling at the injection site; Fatigue; Lymph node were red under the vaccination site ,red patch 4-6 inches long in a circle; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LACERATION (Cut their chest open on the chair edge), SOMNOLENCE (Groggy,falling asleep), FALL (Fell through the baby chair they use), VERTIGO (Vertigo kicked) and BALANCE DISORDER (They were falling down and falling asleep while standing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Eczema (demographic skin) and Allergy (several allergies). On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN LACERATION (Cut their chest open on the chair edge), SOMNOLENCE (Groggy,falling asleep), FALL (Fell through the baby chair they use), VERTIGO (Vertigo kicked), BALANCE DISORDER (They were falling down and falling asleep while standing), BLOOD ELECTROLYTES DECREASED (low electrolytes), INJECTION SITE PAIN (It hurt a lot. hurt like hell), VACCINATION SITE SWELLING (Red swelling at the injection site), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Lymph node were red under the vaccination site ,red patch 4-6 inches long in a circle). The patient was treated with PARACETAMOL (TYLENOL) for Injection site pain, at a dose of 1 dosage form every six hours. At the time of the report, SKIN LACERATION (Cut their chest open on the chair edge), SOMNOLENCE (Groggy,falling asleep), FALL (Fell through the baby chair they use), VERTIGO (Vertigo kicked), BALANCE DISORDER (They were falling down and falling asleep while standing), BLOOD ELECTROLYTES DECREASED (low electrolytes), INJECTION SITE PAIN (It hurt a lot. hurt like hell), VACCINATION SITE SWELLING (Red swelling at the injection site), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Lymph node were red under the vaccination site ,red patch 4-6 inches long in a circle) outcome was unknown. No concomitant medication was reported. Patient mentioned last week, before getting the third dose, they had some blood tests done and they showed low electrolytes. This case was linked to MOD-2021-314917 (Patient Link).; Sender's Comments: This case concerns a 55-years-old, male patient with no medical history, who experienced the non-serious events of inappropriate schedule of product administration, skin laceration, vaccination site swelling, injection site pain, vaccination site erythema, fatigue, somnolence, fall, vertigo, balance disorder and blood electrolytes decreased. The events occurred after the third dose of mRNA-1273, Moderna COVID-19 Vaccine. Event were considered non-seriousness as per the reporter. The rechallenge was considered not applicable. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness: Allergy (several allergies); Eczema (demographic skin)

ID: 1725302
Sex: U
Age:
State:

Vax Date:
Onset Date:
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: can i take anti-inflammatories after taking the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (can i take anti-inflammatories after taking the 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 PAIN (can i take anti-inflammatories after taking the vaccine). At the time of the report, PAIN (can i take anti-inflammatories after taking the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1725303
Sex: F
Age:
State: NY

Vax Date: 01/13/2021
Onset Date: 01/13/2021
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: Test Name: SARS covid-2 test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Unevaluable event

Symptoms: first vaccine she was a little tired about 5 hours later from the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (first vaccine she was a little tired about 5 hours later from the first vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Jan-2021, the patient experienced FATIGUE (first vaccine she was a little tired about 5 hours later from the first vaccine). At the time of the report, FATIGUE (first vaccine she was a little tired about 5 hours later from the first vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment information was provided. This case was linked to MOD-2021-314586, MOD-2021-314934. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Significant follow up received contain Significant information (Patient pregnancy status)

Other Meds:

Current Illness:

ID: 1725304
Sex: F
Age:
State: NC

Vax Date: 02/01/2021
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: Test Name: Blood test; Result Unstructured Data: Blood tests were done and reported to have high levels of CRT and D-dimer.; Test Name: CT Scan; Result Unstructured Data: Patient had undergone a contrast CT looking for pulmonary embolism but found that she did not have that.; Test Name: Fibrin D dimer; Result Unstructured Data: Elevated D-dimer.; Test Name: Heart Rate; Result Unstructured Data: Heart rate increased.

Allergies:

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

Symptoms: Palpitations; Really high heart rate; Chest pain; Had very high fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), HEART RATE INCREASED (Really high heart rate), CHEST PAIN (Chest pain) and PYREXIA (Had very high fever) 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. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 PALPITATIONS (Palpitations), HEART RATE INCREASED (Really high heart rate), CHEST PAIN (Chest pain) and PYREXIA (Had very high fever). At the time of the report, PALPITATIONS (Palpitations), HEART RATE INCREASED (Really high heart rate), CHEST PAIN (Chest pain) and PYREXIA (Had very high fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) Blood tests were done and reported to have high levels of CRT and D-dimer.. On an unknown date, Computerised tomogram: normal (normal) Patient had undergone a contrast CT looking for pulmonary embolism but found that she did not have that.. On an unknown date, Fibrin D dimer: high (High) Elevated D-dimer.. On an unknown date, Heart rate: high (High) Heart rate increased.. No concomitant medications were reported. Treatment information was not provided. The patient was recommended for the booster shot but she was concerned due to high reactions post second shot. Three days later she had visited her doctor because of the symptoms and had undergone lab tests including blood work where reported to have elevated level of CRT. The levels of CRT and D-dimer were still elevated and reported that it took 4 -5 weeks to get past from the symptoms.

Other Meds:

Current Illness:

ID: 1725305
Sex: F
Age: 40
State: WA

Vax Date: 09/10/2021
Onset Date: 09/10/2021
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: expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. Co-suspect product included non-company product LOSARTAN for an unknown indication. Concurrent medical conditions included Allergy to gold (Allergy to gold salts), Latex allergy, Drug allergy (allergy to lisinopril), Drug allergy (Allergy to Balsam Peru-zinc Oxide), ADD, Hypertension and Perioral dermatitis. Concomitant products included TACROLIMUS MONOHYDRATE (PROTOPIC) for Perioral dermatitis, VITAMIN D3 and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 10-Sep-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose and LOSARTAN (Oral) 50 mg once a day. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment drug was provided by reporter. concomitant medication include Multivitamin. Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Patient initial, demographic details, Allergy (Gold Salts, Latex, Lisinopril & Balsam Peru-zinc Oxide) and current conditions (HTN, facial dermatitis) added. Concomitant medications (Vitamin D3, Lexapro, Losartan, Protopic and Multivitamin) added.

Other Meds: VITAMIN D3; LEXAPRO; PROTOPIC

Current Illness: ADD; Allergy to gold (Allergy to gold salts); Drug allergy (allergy to lisinopril); Drug allergy (Allergy to Balsam Peru-zinc Oxide); Hypertension; Latex allergy; Perioral dermatitis

ID: 1725306
Sex: F
Age:
State: OR

Vax Date: 09/03/2021
Onset Date: 09/03/2021
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: Injection site pain, Menorrhagia

Symptoms: shortness breath/difficulty breathing; dizziness; feeling of tremendous pressure on chest; tightening on throat; cough; Swollen hot and red; left arm to top of scalp swollen hot and red; Red; rash all over; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness breath/difficulty breathing), DIZZINESS (dizziness), CHEST DISCOMFORT (feeling of tremendous pressure on chest), THROAT TIGHTNESS (tightening on throat) and COUGH (cough) 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 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced DYSPNOEA (shortness breath/difficulty breathing) (seriousness criterion medically significant), DIZZINESS (dizziness) (seriousness criterion medically significant), CHEST DISCOMFORT (feeling of tremendous pressure on chest) (seriousness criterion medically significant), THROAT TIGHTNESS (tightening on throat) (seriousness criterion medically significant), COUGH (cough) (seriousness criterion medically significant), VACCINATION SITE WARMTH (Swollen hot and red), VACCINATION SITE SWELLING (left arm to top of scalp swollen hot and red), VACCINATION SITE ERYTHEMA (Red) and RASH (rash all over). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Difficulty breathing, at an unspecified dose and frequency and OXYGEN for Difficulty breathing, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness breath/difficulty breathing), DIZZINESS (dizziness), CHEST DISCOMFORT (feeling of tremendous pressure on chest), THROAT TIGHTNESS (tightening on throat), COUGH (cough), VACCINATION SITE WARMTH (Swollen hot and red), VACCINATION SITE SWELLING (left arm to top of scalp swollen hot and red), VACCINATION SITE ERYTHEMA (Red) and RASH (rash all over) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was reported. Company comment: This case concerns a female patient with no relevant medical history reported who experienced serious unexpected events dyspnoea, dizziness, chest discomfort, throat tightness and cough. The events occurred within 24 hours from the first dose of Spikevax. Rechallenge was not applicable due to action taken unknown and lack of information regarding the second dose of Spikevax. The events were consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report; Sender's Comments: This case concerns a female patient with no relevant medical history reported who experienced serious unexpected events dyspnoea, dizziness, chest discomfort, throat tightness and cough. The events occurred within 24 hours from the first dose of Spikevax. Rechallenge was not applicable due to action taken unknown and lack of information regarding the second dose of Spikevax. The events were consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report

Other Meds:

Current Illness:

ID: 1725307
Sex: F
Age: 27
State: CA

Vax Date: 08/05/2021
Onset Date: 09/09/2021
Rec V Date: 09/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: receiving an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving an expired vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving an expired vaccine). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (receiving an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information reported.

Other Meds:

Current Illness:

ID: 1725308
Sex: F
Age:
State: WA

Vax Date: 04/17/2021
Onset Date: 05/18/2021
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: LA

Lab Data: Test Date: 20210708; Test Name: Bacteria; Test Result: Positive ; Result Unstructured Data: 1+(Abnormal); Test Date: 20210519; Test Name: Bilirubin urine; Test Result: Negative ; Result Unstructured Data: Standard range- Negative; Test Date: 20210708; Test Name: Blood urine; Test Result: Negative ; Result Unstructured Data: Reference range-negative; Test Date: 20210726; Test Name: Blood urine; Test Result: Negative ; Result Unstructured Data: Reference range-negative; Test Date: 20210519; Test Name: Glucose,urine; Test Result: Negative ; Result Unstructured Data: Standard Range- NEG mg/dl; Test Date: 20210708; Test Name: Glucose,urine; Test Result: Negative ; Result Unstructured Data: Reference range-negative; Test Date: 20210726; Test Name: Glucose,urine; Test Result: Negative ; Result Unstructured Data: Reference range-negative Glucose, Qualitative urine; Test Date: 20210519; Test Name: Nitrite, URN; Test Result: Negative ; Result Unstructured Data: Standard range-Negative; Test Date: 20210708; Test Name: Nitrite, URN; Test Result: Negative ; Result Unstructured Data: Reference range-negative; Test Date: 20210726; Test Name: Nitrite, URN; Test Result: Negative ; Result Unstructured Data: Reference range-negative; Test Date: 20210519; Test Name: pH, URN; Result Unstructured Data: Standard range-5.0-8.0; Test Date: 20210708; Test Name: pH, URN; Result Unstructured Data: Reference range-5.0-8.0; Test Date: 20210726; Test Name: pH, URN; Result Unstructured Data: Reference range-5.0-8.0; Test Date: 20210519; Test Name: Protein; Test Result: Negative ; Result Unstructured Data: Standard range- NEG-TRACE mg/dl; Test Date: 20210708; Test Name: Protein; Test Result: Negative ; Result Unstructured Data: Reference range-negative; Test Date: 20210726; Test Name: Protein; Test Result: Negative ; Result Unstructured Data: Reference range-negative; Test Date: 20210519; Test Name: Specific Gravity,Urine; Result Unstructured Data: Standard range- 1.005-1.030; Test Date: 20210708; Test Name: Specific Gravity,Urine; Result Unstructured Data: Reference range-1.005-1.030; Test Date: 20210726; Test Name: Specific Gravity,Urine; Result Unstructured Data: Reference range-1.005-1.030; Test Date: 20210708; Test Name: U Sediment; Result Unstructured Data: Abnormal; Test Date: 20210708; Test Name: Epithelial cells; Test Result: Positive ; Result Unstructured Data: 1+; Test Date: 20210519; Test Name: Occult blood, URN; Test Result: Negative ; Result Unstructured Data: Standard range- Negative; Test Date: 20210708; Test Name: Urine C/S Indicated; Result Unstructured Data: Urine C/S; Test Date: 20210519; Test Name: Urobillinogen, URN; Result Unstructured Data: Standard range-0.2-1.0 E.U./dl; Test Date: 20210519; Test Name: Ketones,URN; Test Result: Negative ; Result Unstructured Data: Standard range- NEG mg/dl; Test Date: 20210708; Test Name: Ketones,URN; Test Result: Negative ; Result Unstructured Data: Reference range-negative; Test Date: 20210726; Test Name: Ketones,URN; Test Result: Negative ; Result Unstructured Dat

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Symptoms like UTI; Feeling Discomfort; Pain; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Symptoms like UTI), DISCOMFORT (Feeling Discomfort) and PAIN (Pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced URINARY TRACT INFECTION (Symptoms like UTI), DISCOMFORT (Feeling Discomfort) and PAIN (Pain). The patient was treated with FLUCONAZOLE for Adverse event, at an unspecified dose and frequency; SULFAMETHOXAZOLE for Adverse event, at an unspecified dose and frequency; AZITHROMYCIN (AZO) for UTI, at an unspecified dose and frequency and MANNOSE, D- for Adverse event, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (Symptoms like UTI), DISCOMFORT (Feeling Discomfort) and PAIN (Pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, Bilirubin urine: negative (Negative) Standard range- Negative. On 19-May-2021, Glucose urine: negative (Negative) Standard Range- NEG mg/dl. On 19-May-2021, Nitrite urine: negative (Negative) Standard range-Negative. On 19-May-2021, Protein urine: neg mg/dl (Negative) Standard range- NEG-TRACE mg/dl. On 19-May-2021, Specific gravity urine: 1.010 (normal) Standard range- 1.005-1.030. On 19-May-2021, Urine analysis: negative (Negative) Standard range- Negative and 0.2-1.0 e.u./dl (normal) Standard range-0.2-1.0 E.U./dl. On 19-May-2021, Urine ketone body: negative (Negative) Standard range- NEG mg/dl. On 19-May-2021, White blood cell agglutination present: negative (Negative) Standard range-NEG. On 19-May-2021, pH urine: 6.0 (normal) Standard range-5.0-8.0. On 08-Jul-2021, Bacterial test: 1+(abnormal) (Positive) 1+(Abnormal). On 08-Jul-2021, Blood urine: negative (Negative) Reference range-negative. On 08-Jul-2021, Glucose urine: negative (Negative) Reference range-negative. On 08-Jul-2021, Nitrite urine: negative (Negative) Reference range-negative. On 08-Jul-2021, Protein urine: negative (Negative) Reference range-negative. On 08-Jul-2021, Specific gravity urine: 1.016 (normal) Reference range-1.005-1.030. On 08-Jul-2021, Urinary sediment: abnormal (abnormal) Abnormal. On 08-Jul-2021, Urinary sediment present: 1+ (Positive) 1+. On 08-Jul-2021, Urine analysis: abnormal (abnormal) Urine C/S. On 08-Jul-2021, Urine ketone body: negative (Negative) Reference range-negative. On 08-Jul-2021, Urine leukocyte esterase: 1+abnormal (abnormal) Reference range-negative. On 08-Jul-2021, White blood cells urine: 1+(abnormal) (Positive) 1+(Abnormal). On 08-Jul-2021, pH urine: 7.0 (normal) Reference range-5.0-8.0. On 26-Jul-2021, Blood urine: negative (Negative) Reference range-negative. On 26-Jul-2021, Glucose urine: negative (Negative) Reference range-negative Glucose, Qualitative urine. On 26-Jul-2021, Nitrite urine: negative (Negative) Reference range-negative. On 26-Jul-2021, Protein urine: negative (Negative) Reference range-negative. On 26-Jul-2021, Specific gravity urine: 1.010 (normal) Reference range-1.005-1.030. On 26-Jul-2021, Urine ketone body: negative (Negative) Reference range-negative. On 26-Jul-2021, Urine leukocyte esterase: negative (Negative) Reference range-negative. On 26-Jul-2021, pH urine: 5.5 (normal) Reference range-5.0-8.0. No concomitant medications were reported. Patient took Uquora supplements to treat urinary tract infection. On 19-May-2021, the patient's urine color was yellow with a clear clarity. On 24-May-2021, the patient's urine culture showed 11,000 to 50,000 Col/mL of citrobacter koseri (diversus) infection. The patient's urine culture also indicated positive for Staphylococcus aureus, coagulase within a range of 1,000 to 10,000 Col/mL. Cefazolin susceptibility inferred from oxacillin result. On 08-Jul-2021, Trichomonas Antigen screen test was negative. On 26-Jul-2021, Trichomonas Antigen screen test was negative. Even though the test results did not have any serious abnormalities but due to the slight presence of bacteria, the physician prescribed Flucanazole and sulfamethoxazole to the patient. The treatment did not make any difference for the patient's health. The patient had the practice of drinking about 2.5 litres of water everyday. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Updated vaccine facility information, Updated Patient demographics- Height, Weight, Pregnancy status, Race, Ethnicity. Contains-Suspect drug batch no, The adverse event start date for UTI like symptoms was updated.

Other Meds:

Current Illness:

ID: 1725309
Sex: F
Age: 42
State:

Vax Date: 12/26/2020
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: As of 9/10/2021 my spike protein from the covid 19 moderna vaccine is 2,500 and is not going down from july; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 ANTIBODY TEST POSITIVE (As of 9/10/2021 my spike protein from the covid 19 moderna vaccine is 2,500 and is not going down from july) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 013L20A and 039k20-2A) for COVID-19 vaccination. No Medical History information was reported. On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (As of 9/10/2021 my spike protein from the covid 19 moderna vaccine is 2,500 and is not going down from july). At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (As of 9/10/2021 my spike protein from the covid 19 moderna vaccine is 2,500 and is not going down from july) had not resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No Treatment information was reported. Patient reported that her spike protein from the covid 19 moderna vaccine was 2,500 and was not going down from july and this was also the result of having moderna booster on 13 Aug 2021. This case was linked to MOD-2021-010198, MOD-2021-064882. Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow up Document received and includes no new information.

Other Meds:

Current Illness:

ID: 1725310
Sex: U
Age:
State:

Vax Date: 09/11/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: I feel pretty bad body aches; I've been having a fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (I feel pretty bad body aches) and PYREXIA (I've been having a fever) 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 11-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (I feel pretty bad body aches) and PYREXIA (I've been having a fever). At the time of the report, MYALGIA (I feel pretty bad body aches) and PYREXIA (I've been having a fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1725311
Sex: F
Age: 76
State: IL

Vax Date: 09/11/2021
Onset Date: 09/12/2021
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: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: today she is fine; horribly in discomfort; arm is extremely sore; nausea/all those symptoms that were on the website; chills/all those symptoms that were on the website; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (today she is fine), DISCOMFORT (horribly in discomfort), MYALGIA (arm is extremely sore), NAUSEA (nausea/all those symptoms that were on the website) and CHILLS (chills/all those symptoms that were on the website) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 11-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced DISCOMFORT (horribly in discomfort), MYALGIA (arm is extremely sore), NAUSEA (nausea/all those symptoms that were on the website) and CHILLS (chills/all those symptoms that were on the website). On 13-Sep-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (today she is fine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (today she is fine), DISCOMFORT (horribly in discomfort), MYALGIA (arm is extremely sore), NAUSEA (nausea/all those symptoms that were on the website) and CHILLS (chills/all those symptoms that were on the website) outcome was unknown. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1725312
Sex: F
Age: 57
State: MO

Vax Date: 08/06/2021
Onset Date: 09/07/2021
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: Flu like symptoms; Diarrhea; Headaches; Joint pains; Chills; Fever; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headaches), ARTHRALGIA (Joint pains), CHILLS (Chills) and PYREXIA (Fever) in a 58-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. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headaches), ARTHRALGIA (Joint pains), CHILLS (Chills), PYREXIA (Fever), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN for Fever, at a dose of 1 dosage form. On 10-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headaches), ARTHRALGIA (Joint pains), CHILLS (Chills), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and FATIGUE (Fatigue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications provided. This case was linked to MOD-2021-317521 (Patient Link).

Other Meds:

Current Illness:

ID: 1725313
Sex: M
Age: 61
State: OH

Vax Date: 08/05/2021
Onset Date: 09/10/2021
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: Test Date: 20210911; Test Name: Body temperature; Result Unstructured Data: low grade fever of 99.9

Allergies:

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

Symptoms: "All he does is sleep"; Racing heart; Swallowing difficult; severe rash on his arms, chest, back and neck; low grade fever of 99.9; he noticed a rash under the band-aid after removing band-aid (on the injection arm).; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE ("All he does is sleep"), DYSPHAGIA (Swallowing difficult), PALPITATIONS (Racing heart), INJECTION SITE RASH (he noticed a rash under the band-aid after removing band-aid (on the injection arm).) and RASH (severe rash on his arms, chest, back and neck) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 007D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced INJECTION SITE RASH (he noticed a rash under the band-aid after removing band-aid (on the injection arm).). On 11-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPHAGIA (Swallowing difficult), RASH (severe rash on his arms, chest, back and neck) and PYREXIA (low grade fever of 99.9). On 12-Sep-2021, the patient experienced PALPITATIONS (Racing heart). On an unknown date, the patient experienced SOMNOLENCE ("All he does is sleep"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE ("All he does is sleep"), DYSPHAGIA (Swallowing difficult), PALPITATIONS (Racing heart), INJECTION SITE RASH (he noticed a rash under the band-aid after removing band-aid (on the injection arm).), RASH (severe rash on his arms, chest, back and neck) and PYREXIA (low grade fever of 99.9) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2021, Body temperature: 99.9 (High) low grade fever of 99.9. Concomitant medication were not reported by the reporter.

Other Meds:

Current Illness:

ID: 1725314
Sex: F
Age:
State:

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: RA

Lab Data:

Allergies:

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

Symptoms: felt those were similar to the second shot reaction; increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction; night sweating/We felt those were similar to the second shot reaction; Joint pain/We felt those were similar to the second shot reaction; aching everywhere/We felt those were similar to the second shot reaction; Fever/We felt those were similar to the second shot reaction; chills/We felt those were similar to the second shot reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction) and MYALGIA (aching everywhere/We felt those were similar to the second shot reaction) 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 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 VACCINATION COMPLICATION (felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction). At the time of the report, VACCINATION COMPLICATION (felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction) outcome was unknown. Not Provided no concomitant medications were reported. no treatment medications were reported. This case was linked to MOD-2021-317608 (Patient Link).

Other Meds:

Current Illness:

ID: 1725315
Sex: F
Age:
State:

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: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210912; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative

Allergies:

Symptom List: Tremor

Symptoms: Thrush infection; breakthrough COVID infection 18 days after second vaccine in March; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (breakthrough COVID infection 18 days after second vaccine in March) and CANDIDA INFECTION (Thrush infection) 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. In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COVID-19 (breakthrough COVID infection 18 days after second vaccine in March). On an unknown date, the patient experienced CANDIDA INFECTION (Thrush infection). At the time of the report, COVID-19 (breakthrough COVID infection 18 days after second vaccine in March) had resolved and CANDIDA INFECTION (Thrush infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, SARS-CoV-2 test: negative (Negative) negative. No concomitant medication information were provided. No treatment information provided. This case was linked to MOD-2021-317852 (Patient Link).

Other Meds:

Current Illness:

ID: 1725316
Sex: F
Age:
State: VA

Vax Date: 03/09/2021
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: Erythema, Pruritus

Symptoms: black place; bruise/Vaccination site discoloration; pain got worse; spot in the outside of thighs that hurts/pain in my legs; thigh muscles got tight; spasms in thigh muscles; can't take walks with my dogs; arthritis; lost balance; numbness in thumbs; possible blocked artery being pinched in neck area; muscle aches/muscle problems; Patient also mentioned to be tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (black place), CONTUSION (bruise/Vaccination site discoloration), PAIN (pain got worse), PAIN IN EXTREMITY (spot in the outside of thighs that hurts/pain in my legs) and MUSCLE TIGHTNESS (thigh muscles got tight) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis since September 2020. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (black place), CONTUSION (bruise/Vaccination site discoloration), PAIN (pain got worse), PAIN IN EXTREMITY (spot in the outside of thighs that hurts/pain in my legs), MUSCLE TIGHTNESS (thigh muscles got tight), MUSCLE SPASMS (spasms in thigh muscles), GAIT DISTURBANCE (can't take walks with my dogs), ARTHRITIS (arthritis), BALANCE DISORDER (lost balance), HYPOAESTHESIA (numbness in thumbs), NECK PAIN (possible blocked artery being pinched in neck area), MYALGIA (muscle aches/muscle problems) and FATIGUE (Patient also mentioned to be tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (black place) and CONTUSION (bruise/Vaccination site discoloration) had resolved, PAIN (pain got worse) and MYALGIA (muscle aches/muscle problems) had not resolved and PAIN IN EXTREMITY (spot in the outside of thighs that hurts/pain in my legs), MUSCLE TIGHTNESS (thigh muscles got tight), MUSCLE SPASMS (spasms in thigh muscles), GAIT DISTURBANCE (can't take walks with my dogs), ARTHRITIS (arthritis), BALANCE DISORDER (lost balance), HYPOAESTHESIA (numbness in thumbs), NECK PAIN (possible blocked artery being pinched in neck area) and FATIGUE (Patient also mentioned to be tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient developed a black place where the shot was injected. Patient said it was not a bruise because it was color black and when resolved it was not yellow but the HCP said it was a bruise. It appeared 3-4 days after vaccination, and was pinkish/reddish before that. Patient had muscle aches before the vaccine and went to HCP in Sep 2020. After the second dose, the pain got worse. Patient also reported having a spot in the outside of thighs that hurts. In June, patient reported going to ER. Patient also mentioned being tired, unable to take walks with her dogs and that her muscles would tighten up and have spams if she stood for 5-10 minutes. After picking something up patient lost balance. Patient also experienced thumb numbness and possible blocked artery being pinched in neck area, which was suggested by HCP. X-ray studies were done as well as bloodwork with unspecified results.

Other Meds:

Current Illness: Arthritis

ID: 1725317
Sex: U
Age:
State:

Vax Date:
Onset Date:
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: arm stiff; cold feeling on neck; arm sore; arm sore and radiating down my arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm stiff), FEELING COLD (cold feeling on neck), PAIN (arm sore and radiating down my arm) and PAIN IN EXTREMITY (arm sore) 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 MUSCULOSKELETAL STIFFNESS (arm stiff), FEELING COLD (cold feeling on neck), PAIN (arm sore and radiating down my arm) and PAIN IN EXTREMITY (arm sore). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm stiff), FEELING COLD (cold feeling on neck), PAIN (arm sore and radiating down my arm) and PAIN IN EXTREMITY (arm sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant drug details were reported. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1725318
Sex: F
Age: 75
State: VA

Vax Date: 03/05/2021
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: LA

Lab Data:

Allergies:

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

Symptoms: sore arm; achy; headachy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), MYALGIA (achy) and HEADACHE (headachy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 017B21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high since 1989 and Diabetes since 2010. Concomitant products included ATENOLOL for Blood pressure high, GLIPIZIDE for Diabetes, METFORMIN for Prediabetes, HYDROCHLOROTHIAZIDE, ATORVASTATIN CALCIUM (LIPITOR) and ATORVASTATIN CALCIUM (ATORVASTIN) for an unknown indication. On 05-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021 at 10:00 AM, 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 VACCINATION SITE PAIN (sore arm), MYALGIA (achy) and HEADACHE (headachy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm), MYALGIA (achy) and HEADACHE (headachy) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Treatment information was reported. This case was linked to MOD-2021-317919 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Patient Demographics Added. Medical History Added. Concomitant Medications Information Added.

Other Meds: ATENOLOL; GLIPIZIDE; METFORMIN; HYDROCHLOROTHIAZIDE; LIPITOR; ATORVASTIN

Current Illness: Blood pressure high; Diabetes

ID: 1725319
Sex: F
Age:
State:

Vax Date:
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: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant medications were not provided by reporter. Treatment information was not provided by reporter. This case was linked to MOD-2021-317898, MOD-2021-317907 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1725320
Sex: F
Age:
State: MD

Vax Date: 06/01/2021
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: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: pain in left arm /very painful/ it is not going well; can't use the left arm; the pain is now going to her fingers; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm /very painful/ it is not going well), HYPOKINESIA (can't use the left arm) and PAIN IN EXTREMITY (the pain is now going to her fingers) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In June 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in left arm /very painful/ it is not going well), HYPOKINESIA (can't use the left arm) and PAIN IN EXTREMITY (the pain is now going to her fingers). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in left arm /very painful/ it is not going well) had not resolved and HYPOKINESIA (can't use the left arm) and PAIN IN EXTREMITY (the pain is now going to her fingers) outcome was unknown. Not Provided No relevant concomitant medications were reported. The patient had pain in the left arm after the second shot. can't use the left arm, it was very painful, and it was not going well. The pain was now going to her fingers. Friend got the first shot in June, and second shot days later (reporter said the expected interval for second shot). The patient had been taking medication to treat symptoms, and it alleviates for a time, but then the pain comes back. Treatment medication included Tylenol (it is not helping), ibuprofen, it also doesn't help.

Other Meds:

Current Illness:

ID: 1725321
Sex: U
Age:
State:

Vax Date:
Onset Date:
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: 50 days after I will take second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (50 days after I will take second 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 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 PRODUCT DOSE OMISSION ISSUE (50 days after I will take second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (50 days after I will take second dose) had resolved. The patient was asking what happens if I take second dose of moderna vaccine 50 days after the first one and 50 days between doses was safe. No concomitant medication listed. No treatment information provided.

Other Meds:

Current Illness:

ID: 1725322
Sex: M
Age: 62
State: NJ

Vax Date: 03/04/2021
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: Pain in extremity

Symptoms: A little swollen in the arm which lasted for an hour or two.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (A little swollen in the arm which lasted for an hour or two.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. Concurrent medical conditions included Psoriatic arthritis (Has severe psoriatic arthritis for 22 years). Concomitant products included IXEKIZUMAB (TALTZ) for Psoriatic arthritis, PREDNISONE and OXYCODONE 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 an unknown date, the patient experienced PERIPHERAL SWELLING (A little swollen in the arm which lasted for an hour or two.). At the time of the report, PERIPHERAL SWELLING (A little swollen in the arm which lasted for an hour or two.) 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. Patient stated that she has been on 9 different biologic medicines. Treatment information was not provided. This case was linked to MOD-2021-318127, MOD-2021-318145, MOD21-142970 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow up received contains no new information On 15-Sep-2021: Follow up contains no new information please confirm as NNI.

Other Meds: TALTZ; PREDNISONE; OXYCODONE

Current Illness: Psoriatic arthritis (Has severe psoriatic arthritis for 22 years)

ID: 1725323
Sex: M
Age: 62
State: NJ

Vax Date: 09/11/2021
Onset Date: 09/11/2021
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: Soreness in the arm; From his elbow down to his ear a little pain in the shoulder; Head felt like someone was banging it against a steel wall/ he wouldn't call if it was a minorly bad headache, stated this was vicious/ I never gets headaches (maybe 1 every year), but this was severely bad./ it was like dynamite head against metal/; Felt fatigue; All day sunday he couldn't even move out of bed/ didn't move at all yesterday/got out of bed 3 times to take a couple sips of water or urinate, other than that didn't move; Sweating like crazy; It was hard to think/ was very confused on my thinking; incorrect schedule; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (All day sunday he couldn't even move out of bed/ didn't move at all yesterday/got out of bed 3 times to take a couple sips of water or urinate, other than that didn't move), HYPERHIDROSIS (Sweating like crazy), CONFUSIONAL STATE (It was hard to think/ was very confused on my thinking), HEADACHE (Head felt like someone was banging it against a steel wall/ he wouldn't call if it was a minorly bad headache, stated this was vicious/ I never gets headaches (maybe 1 every year), but this was severely bad./ it was like dynamite head against metal/) and FATIGUE (Felt fatigue) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C219) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Psoriatic arthritis (Since 22 years and has been on 9 different biologic medicines). Concomitant products included IXEKIZUMAB (TALTZ) from an unknown date to 15-Jul-2021 for Psoriatic arthritis, PREDNISONE and OXYCODONE for an unknown indication. On 11-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (incorrect schedule). On 12-Sep-2021, the patient experienced MOBILITY DECREASED (All day sunday he couldn't even move out of bed/ didn't move at all yesterday/got out of bed 3 times to take a couple sips of water or urinate, other than that didn't move), CONFUSIONAL STATE (It was hard to think/ was very confused on my thinking), HEADACHE (Head felt like someone was banging it against a steel wall/ he wouldn't call if it was a minorly bad headache, stated this was vicious/ I never gets headaches (maybe 1 every year), but this was severely bad./ it was like dynamite head against metal/) and FATIGUE (Felt fatigue). 12-Sep-2021, the patient experienced HYPERHIDROSIS (Sweating like crazy). On 13-Sep-2021, the patient experienced ARTHRALGIA (From his elbow down to his ear a little pain in the shoulder) and MYALGIA (Soreness in the arm). On 11-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (incorrect schedule) had resolved. At the time of the report, MOBILITY DECREASED (All day sunday he couldn't even move out of bed/ didn't move at all yesterday/got out of bed 3 times to take a couple sips of water or urinate, other than that didn't move), HYPERHIDROSIS (Sweating like crazy), CONFUSIONAL STATE (It was hard to think/ was very confused on my thinking), HEADACHE (Head felt like someone was banging it against a steel wall/ he wouldn't call if it was a minorly bad headache, stated this was vicious/ I never gets headaches (maybe 1 every year), but this was severely bad./ it was like dynamite head against metal/), FATIGUE (Felt fatigue), ARTHRALGIA (From his elbow down to his ear a little pain in the shoulder) and MYALGIA (Soreness in the arm) outcome was unknown. Treatment details were not provided. This case was linked to MOD-2021-318127. Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Non-Significant Follow up-no new information On 13-Sep-2021: Follow up received contains no new information. On 13-Sep-2021: Follow-up received. Reporter denies for further follow-up.

Other Meds: TALTZ; PREDNISONE; OXYCODONE

Current Illness: Psoriatic arthritis (Since 22 years and has been on 9 different biologic medicines)

ID: 1725324
Sex: F
Age:
State: NJ

Vax Date: 04/01/2021
Onset Date: 09/12/2021
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: Very sore at site of injection; extreame fatigue; a little headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore at site of injection), FATIGUE (extreame fatigue) and HEADACHE (a little headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0 21B21A) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy and Psoriatic arthritis (Psoratiac Arthritis) since 01-Jan-1999. Concomitant products included PREDNISONE from 01-Jan-1999 to an unknown date and OXYCODONE from 01-Jan-1999 to an unknown date for Psoriatic arthritis. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced PAIN IN EXTREMITY (Very sore at site of injection), FATIGUE (extreame fatigue) and HEADACHE (a little headache). The patient was treated with IXEKIZUMAB (TALTZ) from 04-Jul-2021 to 07-Jul-2021 for Psoriatic arthritis, at a dose of 1 dosage form. On 13-Sep-2021, PAIN IN EXTREMITY (Very sore at site of injection) and FATIGUE (extreame fatigue) had resolved. On 14-Sep-2021, HEADACHE (a little headache) had resolved. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: The follow-up document received contain ne Information (medical history, concomitant meds) On 17-Sep-2021: Follow- up document received contain significant information - New events added and dosage information updated.

Other Meds: PREDNISONE; OXYCODONE

Current Illness: Psoriatic arthritis (Psoratiac Arthritis); Seasonal allergy

ID: 1725325
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: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Left eyelid is a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Left eyelid is a little swollen) 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 SWELLING OF EYELID (Left eyelid is a little swollen). At the time of the report, SWELLING OF EYELID (Left eyelid is a little swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1725326
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: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Light headed dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed dizzy) 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 DIZZINESS (Light headed dizzy). At the time of the report, DIZZINESS (Light headed dizzy) outcome was unknown. No concomitant medications were mentioned. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1725327
Sex: F
Age: 65
State: FL

Vax Date: 03/23/2021
Onset Date: 03/23/2021
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: stress; headache; Vomiting; Pain; Feeling unwell; Diarrhea; Burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation), PAIN (Pain), MALAISE (Feeling unwell), DIARRHOEA (Diarrhea) and STRESS (stress) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Headache (due to dental issues). Concomitant products included vitamin B12, multivitamin and NICOTINAMIDE (VITAMIN B3) for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation). In April 2021, the patient experienced PAIN (Pain), MALAISE (Feeling unwell), DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On an unknown date, the patient experienced STRESS (stress) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL) at an unspecified dose and frequency and CALCIUM CARBONATE, MAGNESIUM CARBONATE, MAGNESIUM TRISILICATE (TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE;MAGNESIUM TRISILICATE]) at an unspecified dose and frequency. On 05-Apr-2021, BURNING SENSATION (Burning sensation) had resolved. In August 2021, MALAISE (Feeling unwell), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved. At the time of the report, PAIN (Pain), STRESS (stress) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Her left breast was larger than the other. She had thermography that indicated excess heat in the left underarm and left breast lymph nodes. treatment medication include cold packs. She was scheduled for her second dose on 13 Sep 2021.

Other Meds: VITAMIN B12 NOS; MULTIVITAMINS [VITAMINS NOS]; VITAMIN B3

Current Illness:

ID: 1725328
Sex: F
Age: 71
State: CO

Vax Date: 01/14/2021
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:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Slept all day and night; Couldn't see anything - "it shouldn't have been like that dark"; "Explosive diarrhea"; Had "absolutely no energy"; Little bit of fever; Headache "but not a big deal"; Arm got sore; Could not eat anything until Friday night; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Had "absolutely no energy"), PAIN IN EXTREMITY (Arm got sore), SOMNOLENCE (Slept all day and night), VISUAL IMPAIRMENT (Couldn't see anything - "it shouldn't have been like that dark") and DIARRHOEA ("Explosive diarrhea") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 030M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Mastectomy. Concurrent medical conditions included Breast cancer since 2008. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PAIN IN EXTREMITY (Arm got sore) and FEEDING DISORDER (Could not eat anything until Friday night). On 10-Sep-2021, the patient experienced ASTHENIA (Had "absolutely no energy"), SOMNOLENCE (Slept all day and night), VISUAL IMPAIRMENT (Couldn't see anything - "it shouldn't have been like that dark"), DIARRHOEA ("Explosive diarrhea"), PYREXIA (Little bit of fever) and HEADACHE (Headache "but not a big deal"). On 10-Sep-2021, VISUAL IMPAIRMENT (Couldn't see anything - "it shouldn't have been like that dark") had resolved. On 11-Sep-2021, SOMNOLENCE (Slept all day and night) and HEADACHE (Headache "but not a big deal") had resolved. On 12-Sep-2021, DIARRHOEA ("Explosive diarrhea") had resolved. At the time of the report, ASTHENIA (Had "absolutely no energy"), PAIN IN EXTREMITY (Arm got sore) and PYREXIA (Little bit of fever) outcome was unknown and FEEDING DISORDER (Could not eat anything until Friday night) was resolving. Concomitant product use was not provided. Treatment information was not provided. It was reported that patient was not sure whether she was immunocompromised. This case was linked to MOD-2021-318772 (Patient Link).

Other Meds:

Current Illness: Breast cancer

ID: 1725329
Sex: M
Age: 68
State: DC

Vax Date: 09/11/2021
Onset Date: 09/11/2021
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: fever; Chills; Body ache; arm is really sore; fatigue; severe headache triple this time, much worse; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills), MYALGIA (Body ache), PAIN IN EXTREMITY (arm is really sore) and FATIGUE (fatigue) in a 68-year-old male patient 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 was provided by the reporter. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 11-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced PYREXIA (fever), CHILLS (Chills), MYALGIA (Body ache), PAIN IN EXTREMITY (arm is really sore), FATIGUE (fatigue) and HEADACHE (severe headache triple this time, much worse). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for No adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (Chills), MYALGIA (Body ache), PAIN IN EXTREMITY (arm is really sore), FATIGUE (fatigue) and HEADACHE (severe headache triple this time, much worse) outcome was unknown. Patient received first dose on 01-FEB-2021 intramuscularly (batch no: 004M20A) and second dose on 02-MAR-2021 (batch no: 025A21A) Patient's side effects from 3rd dose is much worse than from the 2nd dose.

Other Meds: MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1725330
Sex: F
Age:
State: WV

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: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Did not sleep for 3 nights after first shot; Headache for 3 days after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Did not sleep for 3 nights after first shot) and HEADACHE (Headache for 3 days after the first shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Angioma (Patient suffers from Angioma takes Acetaminophen, Tramadol, and Flexeril.). Concomitant products included PARACETAMOL (ACETAMINOPHEN), TRAMADOL and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication. 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 INSOMNIA (Did not sleep for 3 nights after first shot) and HEADACHE (Headache for 3 days after the first shot). At the time of the report, INSOMNIA (Did not sleep for 3 nights after first shot) outcome was unknown and HEADACHE (Headache for 3 days after the first shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. treatment medications were not reported. This case was linked to MOD-2021-318514, MOD-2021-318515.

Other Meds: ACETAMINOPHEN; TRAMADOL; FLEXERIL [CEFIXIME]

Current Illness: Angioma (Patient suffers from Angioma takes Acetaminophen, Tramadol, and Flexeril.)

ID: 1725331
Sex: F
Age: 63
State: NJ

Vax Date: 01/07/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: swollen lymph nodes after both shots in vaccinated (left) arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes after both shots in vaccinated (left) arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 025L20A) for COVID-19 vaccination. Medical history was not provided. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-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 LYMPHADENOPATHY (swollen lymph nodes after both shots in vaccinated (left) arm). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes after both shots in vaccinated (left) arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On an unknown date, Patient had a biopsy with unknown results. Concomitant medication was not reported. Treatment information was not reported. This case was linked to MOD-2021-132300 (Patient Link).

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am