VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1677076
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: SARS-CoV-2 antibody test; Result Unstructured Data: Antibodies level was a 14.

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: ANTIBODY LEVEL OF 14; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. 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: Unknown, Expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, patient's antibodies level was a 14 with the SARS-Cov-2 semi-quantitative total antibody. Patient stated that she was immunocompromised. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antibody level of 14 was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as this record states the patient antibody level. there is no product quality issue reported. approval to void this record due to no PQC identified.) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210904072-COVID-19 VACCINE AD26.COV2.S- antibody level of 14. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1677077
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
Hospital: Y

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

Lab Data: Test Date: 202108; Test Name: White blood cells; Result Unstructured Data: Increased

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: BRIGHT RED BLOOD IN STOOL; ABDOMINAL PAIN; INCREASED WHITE BLOOD CELLS; POSSIBLE BLOOD CLOT; RECTAL BLEEDING; This spontaneous report received from a patient concerned a 40 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, and rectal bleeding, and had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 01-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Humira (adalimumab) started on 27-Jul-2021 for moderate to severe ulcerative colitis. On AUG-2021, the patient experienced possible blood clot, rectal bleeding, and white blood cells was increased. On 25-AUG-2021, the patient experienced bright red blood in stool, and abdominal pain. On the same day she visited emergency room (ER) on early hours, and was admitted for increased white cell count, rectal bleeding and possible blood clot. She was hospitalized for 1 day and discharged late on 26-AUG-2021. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased white blood cells, possible blood clot, rectal bleeding, bright red blood in stool, and abdominal pain. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210904116-COVID-19 VACCINE AD26.COV2.S -Possible blood clot, Increased white blood cells. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210904116-COVID-19 VACCINE AD26.COV2.S - Rectal bleeding, Bright red blood in stool, Abdominal pain. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE

Other Meds: ADALIMUMAB

Current Illness: Rectal bleeding; Ulcerative colitis

ID: 1677078
Sex: M
Age:
State: OK

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
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: OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a male of unspecified age. 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: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced incorrect product storage. On 30-AUG-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210906607.

Other Meds:

Current Illness:

ID: 1677079
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 08/27/2021
Rec V Date: 09/07/2021
Hospital: Y

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

Lab Data: Test Date: 20210827; Test Name: MRI; Result Unstructured Data: did not find anything initially.

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: BLOOD CLOTS; ISCHEMIC STROKE; This spontaneous report received from a consumer concerned a 60 year old white and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included: stroke, which occurred on 16-OCT-2020. At that time, the patient was found on the floor in the morning at 06:30 and the stroke took out patient's left side and the bleed took out the right frontal lobe. The patient needed to relearn how to do everything from putting on clothes to brushing teeth. Concurrent conditions included: penicillin allergy, hay fever, abstains from alcohol, and non-smoker. The patient had no history drug abuse or illicit drug usage. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination on right arm. Concomitant medications included daily consumption of acetylsalicylic acid, apixaban, atorvastatin calcium, baclofen, diltiazem, escitalopram oxalate, and methylphenidate hydrochloride (not daily, depending on the day). On 27-AUG-2021, the patient experienced ischemic stroke and blood clots. The patient went to the emergency room on 27-AUG-2021 and did not initially find anything on the Magnetic resonance imaging but was called back on 28-AUG-2021 and then the patient was hospitalized and was released on 30-AUG-2021. The patient was hospitalized for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ischemic stroke, and had not recovered from blood clots. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210905634- covid-19 vaccine ad26.cov2.s-Ischemic stroke . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210905634- covid-19 vaccine ad26.cov2.s-Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: Lipitor; Baclofen; Lexapro; Cardizem [Diltiazem]; Eliquis; Ritalin; Baby Aspirin

Current Illness: Abstains from alcohol; Hay fever; Non-smoker; Penicillin allergy.

ID: 1677080
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: HEART ATTACK; This spontaneous report, a hearsay case, received from a consumer from a recording concerned a 7 decade old male of unknown ethnicity. The patient's height, and weight were not reported. The patient was epileptic. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, atorvastatin, carbamazepine, cetirizine, clopidogrel bisulfate, ezetimibe, metoprolol, phenytoin, and piroxicam. On an unspecified date, the patient experienced heart attack and It was not clear if it was before or after patient received the covid-19 vaccine. Consumer stated that patient had a conversation with his neurologist in AUG-2021. The action taken with covid-19 vaccine was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210905680-COVID-19 VACCINE.-Heart attack. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds: DILANTIN [PHENYTOIN]; TEGRETOL; PAXIL [PIROXICAM]; METOPROLOL; ATORVASTATIN; PLAVIX; ZETIA; ASPIRIN; CETIRIZINE

Current Illness: Epilepsy

ID: 1677081
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 07/30/2021
Rec V Date: 09/07/2021
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: FELT PARALYZED FROM THE NECK UP PHYSICALLY (NOT NEUROLOGICALLY); RESUMPTION OF FACIAL PAIN; RESUMPTION OF FACIAL SEIZURES; This spontaneous report received from a patient via a company representative concerned an adult male of unspecified race and ethnic origin. Initial information was processed with additional information received on 03-SEP-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: trigeminal neuralgia, and environmental allergies, and other pre-existing medical conditions included: The patient had no other significant history reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was diagnosed with trigeminal neuralgia, facial pain and facial seizures 10 years ago, which has been well controlled by medication until 30-JUL-2021. The patient previously reported symptoms (facial pain) present only during very bad allergy seasons. On 30-JUL-2021, the patient experienced resumption of facial seizures and resumption of facial pain. On AUG-2021, the patient felt paralyzed from the neck up physically (not neurologically). The patient was assessed by their physician and it was determined that a blood vessel and nerve were touching, causing the facial pain and seizure/paralysis. According to the patient's physician, severe inflammation triggered by the vaccine was the cause for the return of the patient's symptoms (facial seizures and facial pain).The patient is receiving ongoing medical care to handle chronic pain symptoms. The patient may require surgical correction for relief. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from resumption of facial seizures, felt paralyzed from the neck up physically (not neurologically), and resumption of facial pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210905749-COVID-19 VACCINE AD26.COV2.S-Resumption Of Facial Seizures. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY

Other Meds:

Current Illness: Environmental allergy (trigger symptoms associated with trigeminal neuralgia); Trigeminal neuralgia (controlled by medication from 10 years).

ID: 1677082
Sex: F
Age:
State: WI

Vax Date:
Onset Date: 09/02/2021
Rec V Date: 09/07/2021
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: ADMINISTRATION OF VACCINE 33 MINUTES AFTER THE RECOMMENDED STORAGE TIME; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: 29-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced administration of vaccine 33 minutes after the recommended storage time. On 02-SEP-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine 33 minutes after the recommended storage time and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905816 and 20210906551.

Other Meds:

Current Illness:

ID: 1677083
Sex: M
Age:
State: WI

Vax Date:
Onset Date: 09/02/2021
Rec V Date: 09/07/2021
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: ADMINISTRATION OF JANSSEN COVID-19 VACCINE AFTER THE RECOMMENDED STORAGE TIME (45 MINUTES); This spontaneous report received from a health care professional concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have known drug allergies and had not reported any symptoms. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816027, and expiry: 29-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced administration of janssen covid-19 vaccine after the recommended storage time (45 minutes). The action taken with covid-19 vaccine was not applicable. The outcome of administration of janssen covid-19 vaccine after the recommended storage time (45 minutes) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905756 and 20210906551.

Other Meds:

Current Illness:

ID: 1677084
Sex: F
Age:
State: MA

Vax Date:
Onset Date: 08/24/2021
Rec V Date: 09/07/2021
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: Body temperature; Result Unstructured Data: 99.5 F

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: ARM PAIN AROUND THE INJECTION SITE; FEELING TIRED; TEMPERATURE OF 99.5 FAHRENHEIT; LYMPH NODES SWOLLEN AND HURT; UNABLE TO WALK; COULD NOT MOVE; COULD NOT BEND; BAD LOWER BACK PAIN RADIATING TO LEGS; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid disorder, asthma, sulfa allergy, levaquin allergy, seafood/shellfish allergy, penicillin allergy, non-alcohol user, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 07-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced unable to walk. On 24-AUG-2021, the patient experienced could not move. On 24-AUG-2021, the patient experienced could not bend. On 24-AUG-2021, the patient experienced bad lower back pain radiating to legs. On 25-AUG-2021, the patient experienced lymph nodes swollen and hurt. On an unspecified date, the patient experienced arm pain around the injection site, feeling tired, and temperature of 99.5 fahrenheit. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move, and could not bend on 27-AUG-2021, and temperature of 99.5 fahrenheit, was recovering from bad lower back pain radiating to legs, had not recovered from lymph nodes swollen and hurt, and the outcome of feeling tired, arm pain around the injection site and unable to walk was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Allergic reaction to antibiotics; Asthma; Non-smoker; Penicillin allergy; Seafood allergy; Thyroid disorder

ID: 1677085
Sex: F
Age:
State: WA

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: VACCINE WAS ADMINISTERED 17 YEARS OLD PATIENT; This spontaneous report received from a health care professional concerned a 17 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: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced vaccine was administered 17 years old patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was administered 17 years old patient was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677086
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data: Test Name: CAT scan; Result Unstructured Data: Right occipital neuralgia; Comments: Right occipital neuralgia (nothing was pressing on the nerve); Test Name: Blood test; Result Unstructured Data: Unknown; Comments: Unknown; Test Name: Platelet count; Result Unstructured Data: 139; Test Name: MRI; Result Unstructured Data: Right occipital neuralgia; Comments: Right occipital neuralgia (nothing was pressing on the nerve)

Allergies:

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

Symptoms: MAJOR DIZZINESS; RIGHT OCCIPITAL NEURALGIA (HEADACHE, TINGLING IN THE HEAD); This spontaneous report received from a consumer concerned a 78 year old male. The patient's weight was 165 pounds, and height was 73 inches. The patient's concurrent conditions included: thrombocytopenia, and low level of platelets. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: gabapentin ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for right occipital neuralgia. No concomitant medications were reported. On 12-APR-2021, the patient experienced right occipital neuralgia (headache, tingling in the head). On an unspecified date, the patient experienced major dizziness. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, CAT scan (NR: not provided) Right occipital neuralgia, MRI (NR: not provided) Right occipital neuralgia, and Platelet count (NR: not provided) 139. The action taken with covid-19 vaccine ad26.cov2.s, and gabapentin was not applicable. The patient was recovering from right occipital neuralgia (headache, tingling in the head), and the outcome of major dizziness was not reported. This report was non-serious.

Other Meds:

Current Illness: Platelet count low; Thrombocytopenia (10 years ago)

ID: 1677087
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 08/31/2021
Rec V Date: 09/07/2021
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: VERY TIRED FOR THE NEXT 24 HOURS; FEVER; DISORIENTED FEELING; CHILLS; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 250 pounds, and height was 70 inches. The patient's concurrent conditions included: alcohol user, and cigarette smoker, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol. On 31-AUG-2021, the patient experienced disoriented feeling. On 31-AUG-2021, the patient experienced chills. On 31-AUG-2021, the patient experienced fever. On 01-SEP-2021, the patient experienced very tired for the next 24 hours. The action taken with covid-19 vaccine was not applicable. The patient recovered from disoriented feeling, chills, and fever on 31-AUG-2021, and very tired for the next 24 hours on 01-SEP-2021. This report was non-serious.

Other Meds: VITAMIN D [ERGOCALCIFEROL]

Current Illness: Alcohol use (socially); Cigarette smoker (once a week or so.)

ID: 1677088
Sex: U
Age:
State: CA

Vax Date:
Onset Date: 09/02/2021
Rec V Date: 09/07/2021
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: VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned an infant of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/biotin/minerals nos/nicotinic acid/retinol/tocopherol/vitamin b nos/vitamin d nos for drug used for unknown indication. On 02-SEP-2021, the patient experienced vaccine exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure via breast milk was not reported. This report was non-serious.

Other Meds: PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS

Current Illness:

ID: 1677089
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: TERRIBLE CHILLS; TERRIBLE FEVER; 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. The patient's pre-existing medical conditions included: Patient reported of not been sick like this in many years. The patient received covid-19 vaccine (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 an unspecified date, the patient experienced terrible chills, and terrible fever. The action taken with covid-19 vaccine was not applicable. The outcome of the terrible fever and terrible chills was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677090
Sex: F
Age:
State: CT

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

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

Lab Data:

Allergies:

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

Symptoms: LOST ALL FEELING IN FINGERS; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unknown) dose, start therapy date were not reported 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 an unspecified date, the patient experienced lost all feeling in fingers. The action taken with covid-19 vaccine was not applicable. The outcome of lost all feeling in fingers was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677091
Sex: M
Age:
State: VA

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

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

Lab Data: Test Date: 20210812; Test Name: COVID-19; Result Unstructured Data: Normal

Allergies:

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

Symptoms: RASH UNDER HIS ARMS/NEAR ARMPITS/SWOLLEN RED BUMPS THAT LEFT DRY PATCHES OF SKIN AFTER WENT AWAY; PARASTHESIA IN FINGERS/TOES/FINGERS AND TOES STARTED HAVING PINS NEEDLES/NUMBNESS/FEELING OF NEEDLES AND PAIN IN THE VEINS OF MY WRISTS; SHARP PAINS IN VEINS OF WRISTS; HEADACHES; INTERMITTENT NAUSEA; CHEST/HEART STABBING PAIN; LEFT FOREARM SWELLING; RIGHT SIDED ABDOMINAL PAIN NEAR THE APPENDIX AREA; SHARP STOMACH PAINS; FEELING OFF, NOT 100 PERCENT; CONCUSSION-LIKE SYMPTOMS OF CONFUSION/SWOLLEN HEAD; WEIRD FEELING IN CHEST/HEART; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight was 235 pounds, and height was 76 inches. The patient's past medical history included: covid-19, and hpv, and concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021, the patient experienced chest/heart stabbing pain. On 11-AUG-2021, the patient experienced left forearm swelling. On 11-AUG-2021, the patient experienced right sided abdominal pain near the appendix area. On 11-AUG-2021, the patient experienced sharp stomach pains. On 11-AUG-2021, the patient experienced feeling off, not 100 percent. On 11-AUG-2021, the patient experienced concussion-like symptoms of confusion/swollen head. On 11-AUG-2021, the patient experienced weird feeling in chest/heart. On 11-AUG-2021, the patient experienced sharp pains in veins of wrists. On 11-AUG-2021, the patient experienced headaches. On 11-AUG-2021, the patient experienced intermittent nausea. On 12-AUG-2021, Laboratory data included: COVID-19 (NR: not provided) Normal. On 27-AUG-2021, the patient experienced parasthesia in fingers/toes/fingers and toes started having pins needles/numbness/feeling of needles and pain in the veins of my wrists. On 01-SEP-2021, the patient experienced rash under his arms/near armpits/swollen red bumps that left dry patches of skin after went away. The action taken with covid-19 vaccine was not applicable. The patient recovered with sequelae from rash under his arms/near armpits/swollen red bumps that left dry patches of skin after went away on 03-SEP-2021, had not recovered from chest/heart stabbing pain, feeling off, not 100 percent, and intermittent nausea, and the outcome of sharp pains in veins of wrists, left forearm swelling, right sided abdominal pain near the appendix area, headaches, concussion-like symptoms of confusion/swollen head, parasthesia in fingers/toes/fingers and toes started having pins needles/numbness/feeling of needles and pain in the veins of my wrists, weird feeling in chest/heart and sharp stomach pains was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (Socially); Non-smoker

ID: 1677092
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: Body temperature; Result Unstructured Data: 38.30 C

Allergies:

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

Symptoms: THROAT IS STARTING TO GET SCRATCHY A BIT; CAN'T SLEEP; ENTIRE BODY IS NUMB; 38.30?C OF FEVER; 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: Unknown) dose, start therapy date were not reported 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 an unspecified date, the patient experienced throat is starting to get scratchy a bit, can't sleep, entire body is numb, and 38.30?c of fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 38.30 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the entire body is numb, can't sleep, throat is starting to get scratchy a bit and 38.30?c of fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677093
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: CHEST PAIN; SWOLLEN LYMPH NODES; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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, start therapy date were not reported 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 an unspecified date, the patient experienced chest pain, and swollen lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain and swollen lymph nodes was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677094
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 08/18/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data: Test Date: 20210818; Test Name: Heart rate; Result Unstructured Data: 108-111 bpm; Test Date: 20210818; Test Name: Blood pressure; Result Unstructured Data: 120/80 mmHg; Test Date: 20210824; Test Name: Heart rate; Result Unstructured Data: 97-111bpm; Test Date: 20210825; Test Name: Heart rate; Result Unstructured Data: 97-111bpm

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: BRUISING ARMS AND LEGS; SHE COULD NOT GO TO WORK OR DRIVE HER CAR; CHILLS; RASH ON RIGHT ARM; NAUSEATED; HEADACHE; FEVER; BALANCE DISTURBANCES ("FELT OFF BALANCE, KIND OF LIKE BEING DRUNK"); DIZZY; HEART RATE WAS GOING UP; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid, pollen seasonal allergies, non alcoholic, and non-smoker, and other pre-existing medical conditions included: The patient not had any drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. Concomitant medications included thyroid for thyroid. On 18-AUG-2021, the patient experienced dizzy. On 18-AUG-2021, the patient experienced heart rate was going up. On 18-AUG-2021, the patient experienced balance disturbances ("felt off balance, kind of like being drunk"). On 18-AUG-2021, the patient experienced chills. On 18-AUG-2021, the patient experienced rash on right arm. On 18-AUG-2021, the patient experienced nauseated. On 18-AUG-2021, the patient experienced headache. On 18-AUG-2021, the patient experienced fever. Laboratory data included: Blood pressure (NR: not provided) 120/80 mmHg, and Heart rate (NR: not provided) 108-111 bpm. Treatment medications included: paracetamol. On 19-AUG-2021, the patient experienced bruising arms and legs. On 19-AUG-2021, the patient experienced she could not go to work or drive her car. On 24-AUG-2021, Laboratory data included: Heart rate (NR: not provided) 97-111bpm. On 25-AUG-2021, Laboratory data included: Heart rate (NR: not provided) 97-111bpm. The action taken with covid-19 vaccine was not applicable. The patient recovered from dizzy, she could not go to work or drive her car, chills, nauseated, and fever on 2021, heart rate was going up, bruising arms and legs on 29-AUG-2021, balance disturbances ("felt off balance, kind of like being drunk") on 21-AUG-2021, rash on right arm on 22-AUG-2021, and headache on 25-AUG-2021. This report was non-serious.

Other Meds: ARMOUR THYROID

Current Illness: Abstains from alcohol; Non-smoker; Pollen allergy; Thyroid disorder

ID: 1677095
Sex: M
Age:
State:

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

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

Lab Data: Test Date: 20210902; Test Name: Body temperature; Result Unstructured Data: 99 degrees and rising

Allergies:

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

Symptoms: DIZZY, ESPECIALLY UPON STANDING/CANNOT STAND WITHOUT ASSISTANCE; BAD FLU; TEMPERATURE WAS "OVER 99 DEGREES AND RISING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetic. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-SEP-2021, the patient experienced dizzy, especially upon standing/cannot stand without assistance. On 02-SEP-2021, the patient experienced bad flu. On 02-SEP-2021, the patient experienced temperature was "over 99 degrees and rising. Laboratory data included: Body temperature (NR: not provided) 99 degrees and rising. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from temperature was "over 99 degrees and rising, dizzy, especially upon standing/cannot stand without assistance, and bad flu. This report was non-serious.

Other Meds:

Current Illness: Type 1 diabetes mellitus

ID: 1677096
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 08/24/2021
Rec V Date: 09/07/2021
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: SENSATION OF INTERMITTENT PINS AND NEEDLES IN FINGERTIPS; EXTREME LIGHT HEADEDNESS INTERMITTENTLY; BRAIN FOG/NOT FEELING LIKE MYSELF; UNABLE TO CONCENTRATE; IT FEELS ALMOST LIKE GOING TO FAINT, BUT DON'T, IT'S NOT DIZZINESS, IT'S WORSE WHEN STAND UP FROM SITTING; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 155 pounds, and height was 64 inches. The patient's concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: Patient has no significant medical history, no known allergies and patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced extreme light headedness intermittently. On 24-AUG-2021, the patient experienced brain fog/not feeling like myself. On 24-AUG-2021, the patient experienced unable to concentrate. On 24-AUG-2021, the patient experienced it feels almost like going to faint, but don't, it's not dizziness, it's worse when stand up from sitting. On 01-SEP-2021, the patient experienced sensation of intermittent pins and needles in fingertips. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from extreme light headedness intermittently, brain fog/not feeling like myself, sensation of intermittent pins and needles in fingertips, and unable to concentrate, and the outcome of it feels almost like going to faint, but don't, it's not dizziness, it's worse when stand up from sitting was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1677097
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: FELT LIKE SHIT; HEADACHE; FATIGUE; 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 (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported 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 an unspecified date, the patient experienced felt like shit, headache, and fatigue. The action taken with covid-19 vaccine was not applicable. The patient was recovering from felt like crap, headache, and fatigue. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677098
Sex: U
Age:
State: IN

Vax Date:
Onset Date: 09/03/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ENTIRE BACK IS ITCHING BUT NO RASH OR HIVES; ACHINESS ALL OVER THE BODY; TINGLING TO LEFT HAND; CHILLS; EXTREME FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had not provided medical history and had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number:1808980,expiry:18-SEP-2021) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, treatment medications included: paracetamol. On 03-SEP-2021, the patient experienced entire back is itching but no rash or hives. On 03-SEP-2021, the patient experienced achiness all over the body. On 03-SEP-2021, the patient experienced tingling to left hand. On 03-SEP-2021, the patient experienced chills. On 03-SEP-2021, the patient experienced extreme fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from entire back is itching but no rash or hives on 04-SEP-2021, was recovering from extreme fatigue, chills, and achiness all over the body, and had not recovered from tingling to left hand. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677099
Sex: M
Age:
State: MN

Vax Date:
Onset Date: 09/02/2021
Rec V Date: 09/07/2021
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: INTERMITTENT NUMBNESS IN THE FINGER TIPS OF THE LEFT HAND; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's past medical history included: sprained neck, and other pre-existing medical conditions included: The patient had no lifestyle changes. The patient had no other issues. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced chills. On 02-SEP-2021, the patient experienced headache. On 03-SEP-2021, the patient experienced intermittent numbness in the finger tips of the left hand. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills on 02-SEP-2021, and headache on 03-SEP-2021, and had not recovered from intermittent numbness in the finger tips of the left hand. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677100
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/28/2021
Rec V Date: 09/07/2021
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: UPPER BACK DISCOMFORT (NEAR SHOULDER BLADES)/ FEELS LIKE PRESSURE IS BEING APPLIED TO UPPER BACK/ MORE OF AN ANNOYANCE THAN OUTRIGHT PAIN; OCCASIONAL JOINT PAIN IN LEGS; This spontaneous report received from a patient concerned a 33 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 (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 28-AUG-2021, the patient experienced upper back discomfort (near shoulder blades) / feels like pressure is being applied to upper back/ more of an annoyance than outright pain. On 28-AUG-2021, the patient experienced occasional joint pain in legs. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient was recovering from upper back discomfort (near shoulder blades)/ feels like pressure is being applied to upper back/ more of an annoyance than outright pain, and occasional joint pain in legs. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677101
Sex: U
Age:
State:

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

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

Lab Data: Test Name: Diagnostic procedure; Result Unstructured Data: acute leukemia

Allergies:

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

Symptoms: ACUTE LEUKEMIA; This spontaneous report received from a patient via a media article 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) dose, start therapy date were not reported, 1 total administered 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 an unspecified date, the patient was diagnosed with acute leukemia after vaccination. Laboratory data included: Diagnostic procedure (NR: not provided) acute leukemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of acute leukemia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210908666-Covid-19 vaccine ad26.cov2.s-Acute leukemia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1677102
Sex: F
Age:
State: NM

Vax Date:
Onset Date: 09/03/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-SEP-2021, the patient experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677103
Sex: M
Age:
State: FL

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

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

Lab Data: Test Date: 202107; Test Name: Heart rate; Result Unstructured Data: 167 bpm; Test Name: CT scan; Result Unstructured Data: normalcy; Test Name: Lab test; Result Unstructured Data: Normal; Test Name: X-ray; Result Unstructured Data: normalcy

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: PAIN IN NECK; PAIN IN FACE; PAIN IN LUNGS WITH SHORTNESS OF BREATH; PAIN IN SHOULDER; TINGLING; NUMBNESS; PAIN IN FEET/ARM; PAIN IN HEAD; SUPRAVENTRICULAR TACHYCARDIA IN HEART; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and other pre-existing medical conditions included: The patient is in excellent health. The patient had no history of pre-existing medical conditions. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the patient experienced supraventricular tachycardia in heart. Laboratory data included: Heart rate (NR: not provided) 167 bpm. On an unspecified date, the patient experienced pain in neck, pain in face, pain in lungs with shortness of breath, pain in shoulder, tingling, numbness, pain in feet/arm, and pain in head. Laboratory data (dates unspecified) included: CT scan (NR: not provided) normalcy, Lab test (NR: not provided) Normal, and X-ray (NR: not provided) normalcy. The action taken with covid-19 vaccine was not applicable. The outcome of the tingling, numbness, pain in feet/arm, pain in head, pain in neck, pain in shoulder, pain in face, supraventricular tachycardia in heart and pain in lungs with shortness of breath was not reported. This report was non-serious.

Other Meds:

Current Illness: Non-smoker

ID: 1677104
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: BRUISES ON LOWER LEFT ARM OR TINY BLOOD SPOTS UNDER SKIN AND EASY BRUISING; EXTREMELY TIRED (COMPARED THIS LEVEL OF TIREDNESS TO BEING PREGNANT); This spontaneous report received from a patient concerned an 85 year old female. The patient's weight was 160 pounds, and height was 61 inches. The patient's past medical history included: stents, and concurrent conditions included: non smoker, and alcohol use, and other pre-existing medical conditions included: patient felt tired prior to receiving the vaccine, The patient had no known drug allergies and and no history of drug abuse or illicit dug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. Concomitant medications included cyanocobalamin for tiredness. On an unspecified date, the patient experienced bruises on lower left arm or tiny blood spots under skin and easy bruising, and extremely tired (compared this level of tiredness to being pregnant). The action taken with covid-19 vaccine was not applicable. The outcome of the extremely tired (compared this level of tiredness to being pregnant) and bruises on lower left arm or tiny blood spots under skin and easy bruising was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908782.

Other Meds: VITAMIN B12 [CYANOCOBALAMIN]

Current Illness: Alcohol use (wine); Non-smoker

ID: 1677105
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 08/26/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data: Test Date: 20210826; Test Name: COVID-19 virus test; Result Unstructured Data: Positive.

Allergies:

Symptom List: Nausea

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 54 year old white and non Hispanic or Latino 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: 1808978, and expiry: 11-SEP-2021) dose was not reported, 1 total, administered on left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-AUG-2021, the patient tested positive for Covid-19 (suspected covid-19 infection and suspected clinical vaccination failure) and was quarantined. Patient lost taste and was fatigued. On 05-SEP-2021, at about midnight and at 15:00, patient went to the bathroom. The patient reported no muscle pain and no bunion pain. The patient had lost taste and smell again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210908708-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1677106
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: WORST HANGOVER HAVE EVER HAD (DON'T KNOW IF DRINK) TIMES IT BY 10; MESSED UP; CHILLS; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the patient experienced worst hangover have ever had (don't know if drink) times it by 10, messed up, and chills. The action taken with covid-19 vaccine was not applicable. The patient recovered from messed up, and the outcome of worst hangover have ever had (don't know if drink) times it by 10 and chills was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677107
Sex: M
Age:
State: MD

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

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

Lab Data:

Allergies:

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

Symptoms: VERY SORE ARM AND ACHINESS IN LEGS WITH SHARP PAINS; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 175 pounds, and height was 68 inches. The patient's pre-existing medical conditions included: The patient had no known allergies and no medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced very sore arm and achiness in legs with sharp pains. The action taken with covid-19 vaccine was not applicable. The patient recovered from very sore arm and achiness in legs with sharp pains on SEP-2021. This report was non-serious. This case, from the same reporter is linked to 20210909059.

Other Meds:

Current Illness:

ID: 1677108
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/07/2021
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: DIFFICULTY IN MOVING EYES; DOUBLE VISION; BEEN INCREASING THE LAST OF 24 HOURS; NORMAL SYMPTOMS; This spontaneous report received from a patient 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-SEP-2021, the patient experienced normal symptoms. On 01-SEP-2021, the patient experienced difficulty in moving eyes. On 01-SEP-2021, the patient experienced double vision. On 01-SEP-2021, the patient experienced been increasing the last of 24 hours. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from normal symptoms, difficulty in moving eyes, double vision, and been increasing the last of 24 hours. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677109
Sex: U
Age:
State: NM

Vax Date:
Onset Date: 09/03/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: SORE ARM; This spontaneous report received from a consumer 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: Unknown) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-SEP-2021, the patients experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908676 and 20210908685.

Other Meds:

Current Illness:

ID: 1677110
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: SWEATS; CHILLS FOR TWO WEEKS; FEVER; This spontaneous report received from a patient via a company representative concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient reported that she might had a very mild case of COVID19 last year and reacted to the shot. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the patient experienced sweats, chills for two weeks, and fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from sweats, chills for two weeks, and fever. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677111
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: UNTIL NOW ITS SO TIGHT; EVERY TIME PUT HANDS UP DON'T HAVE STRENGTH, VERY WEAK; AFTER I HAVE VACCINE IN THAT SPOT THE PAIN IS THERE; 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the patient experienced until now its so tight. On 2021, the patient experienced every time put hands up don't have strength, very weak. On 2021, the patient experienced after i have vaccine in that spot the pain is there. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from until now its so tight, and every time put hands up don't have strength, very weak, and the outcome of after i have vaccine in that spot the pain is there was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1677112
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 09/04/2021
Rec V Date: 09/07/2021
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: RIGHT KNEE SWOLLEN AND ACTING WEIRD; BOTH LEGS SWOLLEN BUT IT MORE ON THE RIGHT ONE; HAS TO WAIT A LITTLE WHEN TRYING TO GET UP FROM SITTING POSITION BECAUSE LEG LIKE FREEZING; UNCOMFORTABLE GETTING IN OR OUT OF THE CAR/THE LEG BOTHERS WHEN TRYING TO EXTEND IT; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, occasional alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, and patient was very healthy. The patient was not on heavy medication except regular over the counter medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-SEP-2021, the patient experienced right knee swollen and acting weird. On 04-SEP-2021, the patient experienced both legs swollen but it more on the right one. On 04-SEP-2021, the patient experienced has to wait a little when trying to get up from sitting position because leg like freezing. On 04-SEP-2021, the patient experienced uncomfortable getting in or out of the car/the leg bothers when trying to extend it. The action taken with covid-19 vaccine was not applicable. The outcome of the uncomfortable getting in or out of the car/the leg bothers when trying to extend it, right knee swollen and acting weird, both legs swollen but it more on the right one and has to wait a little when trying to get up from sitting position because leg like freezing was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (occasionally, one may be less than one); Diabetes; Non-smoker

ID: 1677113
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 09/04/2021
Rec V Date: 09/07/2021
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: ANXIETY; MILD ACHES; FELT LIKE PINCHING IN THE ARMPIT (FURTHER MENTIONED NOT IN THE ARMPIT AND MORE TOWARDS THE TOP PART OF THE SHOULDER ON THE LEFT SIDE); PULSATING FEELING (FELT BLOOD PUMPING FROM PALM UP TO ELBOW AND HIS SHOULDER AND THE CHEST) BUT ONLY ON THE LEFT SIDE; TIGHT MUSCLE FEELING IN THE CHEST, SHOULDER AND THE ARM ON THE LEFT SIDE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, penicillin allergy, seasonal allergies, alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 04-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-SEP-2021, the patient experienced pulsating feeling (felt blood pumping from palm up to elbow and his shoulder and the chest) but only on the left side. On 04-SEP-2021, the patient experienced tight muscle feeling in the chest, shoulder and the arm on the left side. On 04-SEP-2021, the patient experienced mild aches. On 04-SEP-2021, the patient experienced felt like pinching in the armpit (further mentioned not in the armpit and more towards the top part of the shoulder on the left side). On 05-SEP-2021, the patient experienced anxiety. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulsating feeling (felt blood pumping from palm up to elbow and his shoulder and the chest) but only on the left side on 04-SEP-2021, was recovering from mild aches, and had not recovered from tight muscle feeling in the chest, shoulder and the arm on the left side, anxiety, and felt like pinching in the armpit (further mentioned not in the armpit and more towards the top part of the shoulder on the left side). This report was non-serious.

Other Meds:

Current Illness: Alcohol use (Sometimes a glass of wine.); Asthma (Uses inhalers.); Non-smoker; Penicillin allergy (Happened when was a child and did not remember, possibly anaphylactic.); Seasonal allergy.

ID: 1677114
Sex: F
Age:
State: NM

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

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

Lab Data: Test Date: 202109; Test Name: Body temperature; Result Unstructured Data: 103 F

Allergies:

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

Symptoms: GENERAL ACHE; MISERABLE; SORE ARM; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced general ache. On SEP-2021, the patient experienced miserable. On SEP-2021, the patient experienced sore arm. On SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine was not applicable. The outcome of the fever, sore arm, general ache and miserable was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908676, 20210908685 and 20210908729.

Other Meds:

Current Illness:

ID: 1677115
Sex: M
Age:
State: NC

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 09/07/2021
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: LEFT JAW AREA HURTS; CAN'T HEAR WELL; MAKES AN ECHO NOISE; HIGH RINGING IN LEFT EAR; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: congestive heart failure, grand mal seizures, chronic obstructive pulmonary disease, back problem, leg problem, on oxygen, abstains from alcohol, and cigarette smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with phenobarbital. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. Concomitant medications included oxygen. On SEP-2021, the patient experienced left jaw area hurts. On SEP-2021, the patient experienced can't hear well. On SEP-2021, the patient experienced makes an echo noise. On SEP-2021, the patient experienced high ringing in left ear. The action taken with covid-19 vaccine was not applicable. The outcome of the high ringing in left ear, left jaw area hurts, can't hear well and makes an echo noise was not reported. This report was non-serious.

Other Meds: OXYGEN

Current Illness: Abstains from alcohol; Back disorder; Chronic obstructive pulmonary disease; Cigarette smoker (pack a day); Congestive heart failure; Grand mal seizure; Musculoskeletal disorder; Oxygen supplementation

ID: 1677116
Sex: F
Age: 70
State: AZ

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 09/07/2021
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: chills; body aches; A spontaneous report was received from a type concerning a 70-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, body aches. The patient's medical history was not provided. Concomitant medications reported were Acetaminophen for drug use for unknown indication. No relevant lab data was reported by the reporter. On 4 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient experienced chills, body aches. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), chills, body aches was unknown.

Other Meds: ACETAMINOPHEN

Current Illness:

ID: 1677117
Sex: F
Age: 73
State: CA

Vax Date: 02/15/2021
Onset Date: 03/15/2021
Rec V Date: 09/07/2021
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: Red rash on left arm; Nausea; Fatigue; Headache; Fever; Chills; Normal red rash; Usual discomfort at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on left arm), VACCINATION SITE DISCOMFORT (Usual discomfort at injection site), RASH ERYTHEMATOUS (Normal red rash), FATIGUE (Fatigue) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 001M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included AMLODIPINE BESILATE (NORVASC), HYDROCHLOROTHIAZIDE, LEVOTHYROXINE SODIUM (SYNTHROID) and LOSARTAN POTASSIUM (COZAAR) for an unknown indication. On 15-Feb-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE DISCOMFORT (Usual discomfort at injection site). On 16-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Normal red rash). On 16-Mar-2021 at 12:30 PM, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 16-Mar-2021 at 9:00 PM, the patient experienced FATIGUE (Fatigue). On 17-Mar-2021, the patient experienced NAUSEA (Nausea). On 15-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on left arm). The patient was treated with MULTIVITAMINS [VITAMINS NOS] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash on left arm), VACCINATION SITE DISCOMFORT (Usual discomfort at injection site), RASH ERYTHEMATOUS (Normal red rash), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Supplements and vitamins were given as concomitant medications. Patient reported that no medication was taken to relieve the symptoms of 48 hour duration. Patient woke up next morning at 1230am with headache, fever, chills, and nausea beginning at 430am and normal red rash This case was linked to MOD-2021-064379 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: significant follow up contains updated narrative (no treatment taken)

Other Meds: NORVASC; HYDROCHLOROTHIAZIDE; SYNTHROID; COZAAR

Current Illness:

ID: 1677118
Sex: F
Age: 54
State: OH

Vax Date: 06/01/2021
Onset Date: 07/02/2021
Rec V Date: 09/07/2021
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: Breast pain on same side as the shot; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Breast pain on same side as the shot) and PYREXIA (Low grade fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 032B21A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. Concomitant products included METFORMIN and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced BREAST PAIN (Breast pain on same side as the shot) and PYREXIA (Low grade fever). At the time of the report, BREAST PAIN (Breast pain on same side as the shot) had not resolved and PYREXIA (Low grade fever) outcome was unknown. No treatment medication was provided. The patient was waiting to get an appointment with the physician and would follow back when possible. This case was linked to MOD-2021-246443 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: follow up : Breast pain event outcome was updated to not recovered

Other Meds: METFORMIN; SYMBICORT

Current Illness: Asthma

ID: 1677119
Sex: F
Age: 76
State: CT

Vax Date: 01/26/2021
Onset Date: 06/17/2021
Rec V Date: 09/07/2021
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: red rash all over body, it was on her arms, legs, back and groin were all red; Red rash all over face/her face was all bright red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Red rash all over face/her face was all bright red) and RASH ERYTHEMATOUS (red rash all over body, it was on her arms, legs, back and groin were all red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M21A and 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Food allergy since 1950. Concomitant products included VITAMINS NOS, GLUCOSAMINE, CHONDROITIN and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3) for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced ERYTHEMA (Red rash all over face/her face was all bright red). On 25-Jun-2021, the patient experienced RASH ERYTHEMATOUS (red rash all over body, it was on her arms, legs, back and groin were all red). The patient was treated with PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) from 22-Jun-2021 to 30-Jun-2021 for Adverse event, at a dose of 20 milligram once a day. On 24-Jun-2021, ERYTHEMA (Red rash all over face/her face was all bright red) had resolved. On 15-Jul-2021, RASH ERYTHEMATOUS (red rash all over body, it was on her arms, legs, back and groin were all red) had resolved. No information regarding corrective treatment was reported by the patient. This case was linked to MOD-2021-250539 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Significant follow up received on 20-Aug-2021 which includes event outcome, Medical history, concomitant medication, treatment medication date updated.

Other Meds: VITAMINS NOS; GLUCOSAMINE; CHONDROITIN; CALCIUM & VITAMIN D3

Current Illness: Food allergy

ID: 1677120
Sex: F
Age:
State: CA

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/07/2021
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: Bad shakes; Severe pain in the lower part of her body/ a lot of pain/severe pain; Feels like her body has changed/her body has become heightened and it is attacking the weak parts of her body and no medication is working; she states her body is attacking itself; Has urinary tract like symptoms, it keeps reoccurring; Cant sleep; Severe pain in bladder; Severe pain in vagina; Boosted her immune system; Fever; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Bad shakes), PAIN (Severe pain in the lower part of her body/ a lot of pain/severe pain), FEELING ABNORMAL (Feels like her body has changed/her body has become heightened and it is attacking the weak parts of her body and no medication is working; she states her body is attacking itself), URINARY TRACT DISORDER (Has urinary tract like symptoms, it keeps reoccurring) and SLEEP DISORDER (Cant sleep) in a 54-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. The patient's past medical history included Bladder disorder NOS. Concomitant products included TOLTERODINE L-TARTRATE (DETROL) for Bladder disorder NOS. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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 TREMOR (Bad shakes), PAIN (Severe pain in the lower part of her body/ a lot of pain/severe pain), FEELING ABNORMAL (Feels like her body has changed/her body has become heightened and it is attacking the weak parts of her body and no medication is working; she states her body is attacking itself), URINARY TRACT DISORDER (Has urinary tract like symptoms, it keeps reoccurring), SLEEP DISORDER (Cant sleep), BLADDER PAIN (Severe pain in bladder), VULVOVAGINAL PAIN (Severe pain in vagina), THERAPEUTIC RESPONSE UNEXPECTED (Boosted her immune system), PYREXIA (Fever) and CHILLS (Shivers). The patient was treated with ESTROGENS CONJUGATED (PREMARIN) for Adverse event, at an unspecified dose and frequency; ESTRADIOL (YUVAFEM) for Adverse event, at an unspecified dose and frequency; SOLIFENACIN for Adverse event, at an unspecified dose and frequency and TOLTERODINE L-TARTRATE (DETROL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Bad shakes), PAIN (Severe pain in the lower part of her body/ a lot of pain/severe pain), FEELING ABNORMAL (Feels like her body has changed/her body has become heightened and it is attacking the weak parts of her body and no medication is working; she states her body is attacking itself), URINARY TRACT DISORDER (Has urinary tract like symptoms, it keeps reoccurring), SLEEP DISORDER (Cant sleep), BLADDER PAIN (Severe pain in bladder), VULVOVAGINAL PAIN (Severe pain in vagina), THERAPEUTIC RESPONSE UNEXPECTED (Boosted her immune system), PYREXIA (Fever) and CHILLS (Shivers) outcome was unknown. Treatment also included taking antibiotics. This case was linked to MOD-2021-250636 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow-up received on 27 Aug 2021 includes concomitant medication added and treatment medication added in inarrative.

Other Meds: DETROL

Current Illness:

ID: 1677121
Sex: F
Age:
State: NC

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 09/07/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Medical history was not provided. On 01-Feb-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medication were provided. No treatment information was provided. This case was linked to MOD-2021-027888 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received contains non significant information.Patient date of vaccination changed from 02-FEB-2021 to 01FEB-2021 (initial version).

Other Meds:

Current Illness:

ID: 1677122
Sex: F
Age: 72
State: FL

Vax Date: 04/15/2021
Onset Date: 05/12/2021
Rec V Date: 09/07/2021
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: Has not received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). On 09-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment information was provided. This case was linked to MOD-2021-253017 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Email address added.

Other Meds:

Current Illness:

ID: 1677123
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 09/07/2021
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: Test Name: COVID-19 rapid test; Test Result: Negative ; Result Unstructured Data: negative; Test Name: COVID-19 sensitive test; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Got the two shots of the Moderna vaccine, and afterwards got covid-19/breakthrough infection) and DRUG INEFFECTIVE (Lack of efficacy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got the two shots of the Moderna vaccine, and afterwards got covid-19/breakthrough infection) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (Got the two shots of the Moderna vaccine, and afterwards got covid-19/breakthrough infection) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative and positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. It was reported that patient didn't take any medication for COVID-19 Infection. This case was linked to MOD-2021-253192 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up information included event and event outcome. Changed qualification of reporter.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. This is a case of lack of effect assuming the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days). Further information is expected upon follow-up.

Other Meds:

Current Illness:

ID: 1677124
Sex: F
Age: 70
State: NJ

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 09/07/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Horrible leg pain/ horrible pain in the legs), FALL (Falling/ fell/had fallen six times), BALANCE DISORDER (Loss of balance/ she loss balance/ Could not maintain her balance), DYSSTASIA (legs collapsed) and DIZZINESS (Dizzy spells) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Herniated disc (lower). On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-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 (Horrible leg pain/ horrible pain in the legs), FALL (Falling/ fell/had fallen six times), BALANCE DISORDER (Loss of balance/ she loss balance/ Could not maintain her balance), DYSSTASIA (legs collapsed), DIZZINESS (Dizzy spells), GAIT INABILITY (Could not walk without a walker), LIMB DISCOMFORT (Unsteady on her feet), CHILLS (horrible chills), PYREXIA (Fever) and ARTHRALGIA (sharp pains in her knees). At the time of the report, PAIN IN EXTREMITY (Horrible leg pain/ horrible pain in the legs), FALL (Falling/ fell/had fallen six times), BALANCE DISORDER (Loss of balance/ she loss balance/ Could not maintain her balance), DYSSTASIA (legs collapsed), DIZZINESS (Dizzy spells), GAIT INABILITY (Could not walk without a walker), LIMB DISCOMFORT (Unsteady on her feet), CHILLS (horrible chills), PYREXIA (Fever) and ARTHRALGIA (sharp pains in her knees) outcome was unknown. No concomitant product information was provided. No treatment information was provided. Patient reported that She had been to eye, hearing, and orthopedic specialists, and all said they could not find anything and her bloodwork was also fine. The neurologist was scheduled to do magnetic resonance imaging (MRI) scans of her head in Sep/2021. Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Added Patient demographics(date of birth), Medical history, Dose 1 information, Anatomical location for dose 2 and new events(Dizzy spells, pain in her knees, unsteady on her foot, could not walk without a walker). Updated dose 2 batch number and event verbatim (fall, balance disorder). On 25-Aug-2021: Follow up received contains no new information

Other Meds:

Current Illness: Herniated disc (lower)

ID: 1677125
Sex: F
Age: 37
State: OH

Vax Date: 07/14/2021
Onset Date:
Rec V Date: 09/07/2021
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: lower back pain; sore throat; Itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PRURITUS (Itchiness at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower back pain), OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PRURITUS (Itchiness at injection site). At the time of the report, BACK PAIN (lower back pain), OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PRURITUS (Itchiness at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: contains no new information and email id provided by reporter was not correct

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am