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: 1678028
Sex: M
Age:
State: NJ

Vax Date: 06/17/2021
Onset Date: 06/17/2021
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:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: mild tingling in both of his arms and hands; mild numbness; This is a spontaneous report from a contactable consumer. A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 17Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included calcitriol (VITAMIN D) for 8 months, fish oil been taking for many years, zinc been taking it for 8months, multivitamin been taking for 8 months all ongoing. On 17Jun2021 He experienced mild numbness and tingling in arms and hands (both started 5hrs after vaccination) and the symptoms were gone in 48 hours. Outcome of recovered events was recovered on 19Jun2021. Information on the lot/batch number has been requested.

Other Meds: Vitamin D; FISH OIL; ZINC

Current Illness:

ID: 1678029
Sex: M
Age:
State: CA

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

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

Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:no cause found; Comments: no cause found for the stomach issues; Test Name: blood work; Result Unstructured Data: Test Result:nothing abnormal

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: vomiting/throwing up; nausea/nauseous; stomach isn't right; stomach upset; This is a spontaneous report from a contactable consumer (parent). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0182; expiry unknown), via an unspecified route of administration, administered in Arm Left on 07Jun2021 (at the age of 15-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications (other products) and investigation assessment included none. Patient had no other vaccines on the same day as the suspect product. The patient previously took first dose of BNT162B2 vaccine (Lot number: EW0173; expiry unknown) on 17May2021 (at the age of 15-years-old) for covid-19 immunisation. Patient got the vaccine at a provider's office, but not the patient's doctor, but they are part of the network. Caller believed patient got both doses into left arm but was not entirely sure. The patient experienced vomiting/throwing up, nausea/nauseous, stomach wasn't right, stomach upset on an unspecified date. The patient underwent lab tests and procedures which included blood tests: no cause found for the stomach issues, blood work (investigation): nothing abnormal on unspecified date. Therapeutic measures were taken as a result the reported events. The events were stated as not serious. Patient was vaccinated six or seven weeks ago, had begun nausea and vomiting, doctor visits inconclusive, any advice possible due to vaccine, and reported asked to help. Caller stated that, starting about three weeks ago, the patient's stomach wasn't right, the patient was nauseous and throwing up. Caller stated that they took the patient to a doctor two times, and they did blood tests, and there had been no cause found for the stomach issues. Caller stated that the doctors started patient on Omeprazole which was an anti-acid. Caller stated that patient took that medication for two weeks by the time of this report, and he has had one more follow up event and now he had been scheduled for an ultrasound of his stomach, but he did not have it yet. Caller was wondering if Pfizer had any recommendations and data regarding this side effect of the product. Caller statedthat there was nothing else in-patient history that could cause this, but it had been happening since he got the vaccine. Patient started having stomach issues a couple weeks, maybe two or three weeks after getting his second dose of the product. Caller reported that these events were still ongoing, they had gotten a little bit better, but they were not resolved yet. Caller stated that he was hoping his son's side effects will dissipate. Caller stated patient did have blood work done but it showed nothing abnormal. Caller stated that patient had no other medical history and he never had any history of stomach issues in his 14 years of life. AE(s) did not require a visit to Emergency Room. The caller took patient to a walk-in clinic. If the patient was hospitalized was reported as not applicable. Prior Vaccinations (within 4 weeks); relevant tests included none. Caller asked if he could expect the problem to resolve over a period and stated that blood tests were already done but he thought he would reach out to Pfizer to get this information recorded. Clinical outcome of events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1678030
Sex: M
Age:
State: PA

Vax Date: 07/08/2021
Onset Date: 07/08/2021
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: Test Name: Fevers; Result Unstructured Data: Test Result:102 Fahrenheit; Comments: degrees Fahrenheit; Test Name: diagnosis of HIV; Result Unstructured Data: Test Result:HIV diagnosis; Comments: 25 days ago; Test Date: 2020; Test Name: patient was 220 lbs; Result Unstructured Data: Test Result:220 lbs; Comments: lbs Last year, in 2020, patient was 220 lbs

Allergies:

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

Symptoms: nightly fevers up to 102F; This is a spontaneous report from a contactable pharmacist. A 28-years-old male patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Jul2021 (age at vaccination: 28 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. Medical history included HIV infection from an unknown date and unknown if ongoing He has a new diagnosis of HIV 25 days ago, and 7 days ago is when he got the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced nightly fevers up to 102f on 08Jul2021. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on degrees Fahrenheit, HIV test: HIV diagnosis on 25 days ago, weight: 220 lbs on 2020 lbs Last year, on 2020, patient was 220 lbs. Therapeutic measures were taken as a result of nightly fevers up to 102f was Tylenol. The outcome of the event pyrexia was not recovered. Information about lot/batch has been requested. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1678032
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: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: her tongue was swollen; swollen lymph glands; Initial information regarding an unsolicited valid non-serious case was received from consumer via Medical Information (Reference number- 00746458) and transmitted to Sanofi on 30-Aug-2021. This case involves a 60-year-old female patient who experienced her tongue was swollen (swollen tongue) and swollen lymph glands (lymphadenopathy) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious her tongue was swollen (swollen tongue) and swollen lymph glands (lymphadenopathy) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Details of laboratory data not reported. It was not reported if the patient received any corrective treatment for the events. At time of reporting, the outcome was unknown for both the events.

Other Meds:

Current Illness:

ID: 1678034
Sex: F
Age: 3
State: KS

Vax Date: 08/06/2021
Onset Date: 08/06/2021
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 erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: expired daptacel was administered / no AE; Initial information was received on 31-Aug-2021 regarding an unsolicited valid non-serious case from nurse and physician via call center via Medical Information (Reference number- 00748845) This case is linked to 00748869 (same reporter). This case involves a three-year-old female patient who was vaccinated with an expired dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered). The patient's medical history, past medical treatments, vaccinations and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for prophylactic vaccination. On 06-Aug-2021, the patient received a fourth dose of 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5643AA and expiry date: 17-Jul-2021) via an intramuscular route in the right thigh for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency: same day). It was reported "Nurse reports that expired DAPTACEL was administered to 2 patients. Nurse asks if there are any recommendations for when expired DAPTACEL is administered." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2021SA290302:

Other Meds: HEPATITIS A VACCINE

Current Illness:

ID: 1678037
Sex: M
Age:
State:

Vax Date: 08/26/2021
Onset Date: 08/27/2021
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: Bruising at the injection site; This spontaneous case was received on 27-Aug-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-01760) and concerned 41-year-old, male patient. The patient's medical history and concomitant medications were not reported. On 26-Aug-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular, dose: 0.5 ml and anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported. It was administered by the site nurse in the on-site clinic. On 27-Aug-2021 in the morning, one day after receiving Flucelvax Quadrivalent, while getting ready for work the patient realized there was bruising at the injection site. He was not experiencing any other issues. At the time of initial reporting on 27-Aug-2021, the patient had not recovered from the event of 'vaccination site bruising'. The reporter did not provide causality assessment. The reporter assessed the case non-serious. Company comment: A 41-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving the vaccine, the patient realized there was bruising at the injection site. Causal role of the suspect vaccine is assessed as possibly related due to biological and chronological plausibility.; Sender's Comments: A 41-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving the vaccine, the patient realized there was bruising at the injection site. Causal role of the suspect vaccine is assessed as possibly related due to biological and chronological plausibility.

Other Meds:

Current Illness:

ID: 1678123
Sex: U
Age:
State: CA

Vax Date: 07/30/2021
Onset Date: 08/12/2021
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: No other AE reported; received the second dose of GARDASIL 9 on 30-JUL-2021/received the third dose of GARDASIL 9 on 12-AUG-2021; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided. On 30-JUL-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On 12-AUG-2021, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T028583, expiration date 04-MAR-2023; strength, dose, route of administration and anatomical location were not reported) for prophylaxis, which was given too soon after the second dose (inappropriate schedule of product administration). No other adverse event was reported. No product quality complaint (PQC) was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T028583; expirationdate: 04-MAR-2023; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1678124
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:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: stroke; This case was reported by a consumer via media and described the occurrence of stroke in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown. It was unknown if the reporter considered the stroke to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. A patient got shingles shot and less than a week later she had a stroke. The reporter showed her an article warning of risk of strokes. When the patient confronted, the physician admitted the risk which he had not mentioned to her. But he said there was no way to prove the stroke was from the shot. The reporter said that the patient said could you blame for wondering. No contact details were available.

Other Meds:

Current Illness:

ID: 1678125
Sex: F
Age:
State: PA

Vax Date: 08/18/2021
Onset Date: 08/20/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: Vertigo has not resolved; This case was reported by a consumer and described the occurrence of vertigo in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 18th August 2021, the patient received Shingrix (intramuscular). On 20th August 2021, 2 days after receiving Shingrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was not recovered/not resolved. It was unknown if the reporter considered the vertigo to be related to Shingrix. Additional details were provided as follows: The case was reported by the GlaxoSmithKline employee for a friend. The age at vaccination was not reported. The patient's DOB (date of birth) was unknown by the reporter. The patient received the dose of Shingrix in unknown arm and 2 days after the vaccination the patient experienced vertigo. The reporter and patient gave permission to be contact by GlaxoSmithKline. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1678126
Sex: M
Age: 74
State: MN

Vax Date: 08/19/2021
Onset Date: 08/23/2021
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: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 19th August 2021, the patient received the 1st dose of Shingrix. On 23rd August 2021, 4 days after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The patient received the 1st dose of Shingrix in left arm and 4 days after the vaccination the patient developed shingles on his left arm. The HCP (health care professional) started patient on valacyclovir and confirmed shingles diagnosis. The patient stated that he was about half way through taking the medication prescribed by HCP (health care professional) and he did not want to get the second Shingrix dose. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1678127
Sex: U
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: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and 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 incorrect product storage. On 02-SEP-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1678128
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: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: ABDOMINAL ANEURYSM; This spontaneous report received from a patient via a company representative concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient did not had any drug abuse, or illicit drug usage. The patient did not had any drug consumption and did not had any histories of anything related to this. Patient was healthy women. The Patient did exercise often. 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, the patient experienced abdominal aneurysm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of abdominal aneurysm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210907837-covid-19 vaccine ad26.cov2.s-abdominal aneurysm. This event(s) is considered unassessable. The event(s) 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(s).

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1678129
Sex: F
Age:
State: IL

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: Test Date: 20210902; Test Name: COVID-19 antibody test; Result Unstructured Data: Negative

Allergies:

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

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 63 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 and expiry: unknown) dose was not reported, frequency time 1 total administered at left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient had done blood test for antibodies which was found to be negative (confirmed immunological vaccination failure). She had no side effects from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000192172.; Sender's Comments: V0: 20210907895-COVID-19 VACCINE AD26.COV2.S-confirmed immunological 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: 1678130
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: Test Name: Body temperature; Result Unstructured Data: 102 fever

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; 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 and expiry: Unknown) dose was not reported, 1 total administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient got the corona virus after the vaccine and the only reason patient know was because patient thought that patient caught the sniffles from patient's grandchild (suspected covid-19 infection). Patient's symptoms had been mild 102 fever for one night then feeling normal most of the day until 16:00. Patient did get tired early. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 fever. Patient was 7 days in and patient feels that patient has been 95 % back to normal but not taste. Lost taste on day 4. Patient had zero initial side effects after vaccination, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192284; Sender's Comments: V0: 20210908721-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: 1678131
Sex: F
Age:
State: NC

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: LA

Lab Data:

Allergies:

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

Symptoms: DIFFICULTY BREATHING; HEADACHES (NOT THAT BAD); This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic back pain, non-alcohol user, cigarette smoker, liver problem, chronic obstructive pulmonary disease (copd), and sulfa allergy, and other pre-existing medical conditions included: Patient has no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced headaches (not that bad). On 04-SEP-2021, the patient experienced difficulty breathing. The action taken with covid-19 vaccine was not applicable. The outcome of the difficulty breathing and headaches (not that bad) was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Chronic back pain; Chronic obstructive pulmonary disease; Cigarette smoker (Pack to a pack and half a day); Liver disorder; Sulfonamide allergy

ID: 1678132
Sex: F
Age: 60
State: MD

Vax Date: 05/25/2021
Onset Date: 06/23/2021
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 Name: WBC; Result Unstructured Data: Low

Allergies:

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

Symptoms: after the vaccine she has started to remember her dreams in detail now; now suffering from depression / she never had before (depression) / depressed only because she is dealing with this; diminished appetite may be due to stress / doctors thinks it might be stress/ look like she has mental issues; did not have any appetite, lost her appetite and that is very unusual/has been eating 1 meal a day, does not feel like eating, does not feel hungry / she had a complete loss of appetite/ going to end up anorexic; Patient was down for 24 hours; little bit of night sweats for few days; her arm swell up really tight; chills; headache; Temperature; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (little bit of night sweats for few days), DECREASED APPETITE (did not have any appetite, lost her appetite and that is very unusual/has been eating 1 meal a day, does not feel like eating, does not feel hungry / she had a complete loss of appetite/ going to end up anorexic), VACCINATION COMPLICATION (Patient was down for 24 hours), ABNORMAL DREAMS (after the vaccine she has started to remember her dreams in detail now) and DEPRESSION (now suffering from depression / she never had before (depression) / depressed only because she is dealing with this) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jun-2021, the patient experienced NIGHT SWEATS (little bit of night sweats for few days), VACCINATION COMPLICATION (Patient was down for 24 hours), VACCINATION SITE SWELLING (her arm swell up really tight), CHILLS (chills), HEADACHE (headache) and PYREXIA (Temperature). On 26-Jun-2021, the patient experienced DECREASED APPETITE (did not have any appetite, lost her appetite and that is very unusual/has been eating 1 meal a day, does not feel like eating, does not feel hungry / she had a complete loss of appetite/ going to end up anorexic), DEPRESSION (now suffering from depression / she never had before (depression) / depressed only because she is dealing with this) and STRESS (diminished appetite may be due to stress / doctors thinks it might be stress/ look like she has mental issues). On an unknown date, the patient experienced ABNORMAL DREAMS (after the vaccine she has started to remember her dreams in detail now). At the time of the report, NIGHT SWEATS (little bit of night sweats for few days), ABNORMAL DREAMS (after the vaccine she has started to remember her dreams in detail now), CHILLS (chills) and HEADACHE (headache) outcome was unknown, DECREASED APPETITE (did not have any appetite, lost her appetite and that is very unusual/has been eating 1 meal a day, does not feel like eating, does not feel hungry / she had a complete loss of appetite/ going to end up anorexic), DEPRESSION (now suffering from depression / she never had before (depression) / depressed only because she is dealing with this) and STRESS (diminished appetite may be due to stress / doctors thinks it might be stress/ look like she has mental issues) had not resolved and VACCINATION COMPLICATION (Patient was down for 24 hours), VACCINATION SITE SWELLING (her arm swell up really tight) and PYREXIA (Temperature) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) Low. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included medications for cholesterol and Blood Pressure Medicine 10mg. Patient also mentioned having temperature after the vaccine (high or low not mentioned). Patient was going back and forth to the emergency room. Every blood work test was normal. Patient was now suffering from depression, which she never had before. Patient was now taking depression medicine and therapy. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment. Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up information contains patient's current medical conditions, laboratory details, concomitant medications. New events Peripheral swelling, Depression and Stress were added. Events related information and treatment information were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.

Other Meds: ASPIRIN 81

Current Illness: Blood cholesterol abnormal; Blood pressure abnormal

ID: 1678133
Sex: M
Age:
State: IL

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:

Allergies:

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

Symptoms: battle between Antibodies in patient body and vaccine antibody; Mini-COVID for 24 hours; This spontaneous case was reported by a physician and describes the occurrence of SUSPECTED COVID-19 (Mini-COVID for 24 hours) and VACCINATION COMPLICATION (battle between Antibodies in patient body and vaccine antibody) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 in January 2020. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (battle between Antibodies in patient body and vaccine antibody). On an unknown date, the patient experienced SUSPECTED COVID-19 (Mini-COVID for 24 hours). At the time of the report, SUSPECTED COVID-19 (Mini-COVID for 24 hours) and VACCINATION COMPLICATION (battle between Antibodies in patient body and vaccine antibody) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. HCP described as vaccination reaction as a modified reaction of COVID-19. Concomitant medications were not provided. Treatment medication was not provided. This case was linked to MOD-2021-294336 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Non-significant follow up information included patient demographic details. On 30-Aug-2021: Vaccination reaction Event added

Other Meds:

Current Illness:

ID: 1678134
Sex: F
Age:
State: FL

Vax Date: 05/14/2021
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: The pain in her arm and leg is so great she thought it was thrombosis, but it wasn't/ She's still has a lot of pain; First dose on 14-MAY-2021/ patient didn't receive the 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (The pain in her arm and leg is so great she thought it was thrombosis, but it wasn't/ She's still has a lot of pain) and PRODUCT DOSE OMISSION ISSUE (First dose on 14-MAY-2021/ patient didn't receive the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No Medical History information was reported. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose on 14-MAY-2021/ patient didn't receive the 2nd dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (The pain in her arm and leg is so great she thought it was thrombosis, but it wasn't/ She's still has a lot of pain). At the time of the report, PAIN IN EXTREMITY (The pain in her arm and leg is so great she thought it was thrombosis, but it wasn't/ She's still has a lot of pain) had not resolved and PRODUCT DOSE OMISSION ISSUE (First dose on 14-MAY-2021/ patient didn't receive the 2nd dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not provided. Patient saw a hematologist, the pain in her arm and leg was so great she thought it was thrombosis, but it was not. She is still has a lot of pain. On 29-Sep-2021 she has an appointment with a new GP since hers did not help her and said she should return in 6 months, she is also trying to see a neurologist. she did not receive the 2nd dose. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1678135
Sex: M
Age: 73
State: PA

Vax Date: 01/21/2021
Onset Date: 01/01/2021
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:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included SERTRALINE, ATORVASTATIN, OLANZAPINE, CLONIDINE HYDROCHLORIDE (CLONIDINE [CLONIDINE HYDROCHLORIDE]) and CARVEDILOL for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH (Rash). The patient was treated with ECONAZOLE NITRATE (ECONAZOLE [ECONAZOLE NITRATE]) (topical) for Rash, at an unspecified dose and frequency and FLUOCINONIDE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant medication also included supplements. The patient received second dose of the vaccine in mid February. This case was linked to MOD-2021-294486 (Patient Link).

Other Meds: SERTRALINE; ATORVASTATIN; OLANZAPINE; CLONIDINE [CLONIDINE HYDROCHLORIDE]; CARVEDILOL

Current Illness:

ID: 1678136
Sex: M
Age: 68
State: NJ

Vax Date: 01/09/2021
Onset Date:
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:

Allergies:

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

Symptoms: arm was sore, similar as previous vaccination; minimum swelling; soreness; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (arm was sore, similar as previous vaccination), SWELLING (minimum swelling) and PAIN (soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. No medical history information was reported. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-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 (arm was sore, similar as previous vaccination), SWELLING (minimum swelling) and PAIN (soreness). At the time of the report, PAIN IN EXTREMITY (arm was sore, similar as previous vaccination), SWELLING (minimum swelling) and PAIN (soreness) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The treatment information was not provided. This case was linked to MOD-2021-294360 (Patient Link).

Other Meds: NEXIUM [ESOMEPRAZOLE SODIUM]; BABY ASPIRIN

Current Illness:

ID: 1678137
Sex: M
Age: 47
State: NC

Vax Date: 04/01/2021
Onset Date:
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: shaking for 24 hours; a terrible fever for 24 hours; very tired for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking for 24 hours), PYREXIA (a terrible fever for 24 hours) and FATIGUE (very tired for 24 hours) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Patient says he had Covid on Christmas 2020 for 2 days , It was mild.) on 25-Dec-2020. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (shaking for 24 hours), PYREXIA (a terrible fever for 24 hours) and FATIGUE (very tired for 24 hours). At the time of the report, TREMOR (shaking for 24 hours), PYREXIA (a terrible fever for 24 hours) and FATIGUE (very tired for 24 hours) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided treatment information was not provided This case was linked to MOD-2021-294606 (Patient Link).

Other Meds:

Current Illness:

ID: 1678138
Sex: F
Age: 59
State: NY

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: Unevaluable event

Symptoms: reaction to it was a little soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (reaction to it was a little soreness at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised and Scleroderma. Concomitant products included LOSARTAN POTASSIUM (AVANTAR) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (reaction to it was a little soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (reaction to it was a little soreness at the injection site) outcome was unknown. Treatment medication was not provided by the reporter. This case was linked to MOD-2021-294926, MOD-2021-294965 (Patient Link).

Other Meds: AVANTAR

Current Illness: Immunocompromised; Scleroderma

ID: 1678139
Sex: M
Age: 27
State: AL

Vax Date: 07/26/2021
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: LA

Lab Data:

Allergies:

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

Symptoms: Fever; Chills; Body Aches; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body Aches) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 004C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-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 PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body Aches). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body Aches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product use was provided by the reporter. No treatment medication was provided. No side effects were reported with the first dose of the vaccine.

Other Meds:

Current Illness:

ID: 1678140
Sex: F
Age: 23
State: AL

Vax Date: 07/26/2021
Onset Date: 08/23/2021
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: Nose bleed; Chills; Body aches; Fever; This spontaneous case was reported by a nurse and describes the occurrence of EPISTAXIS (Nose bleed), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 004C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever). On 24-Aug-2021, the patient experienced EPISTAXIS (Nose bleed). At the time of the report, EPISTAXIS (Nose bleed) had resolved and CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medication were not reported. No treatment medication were reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: FU received on 24-AUG-2021 contains No new information

Other Meds:

Current Illness:

ID: 1678141
Sex: M
Age:
State: GA

Vax Date: 07/27/2021
Onset Date: 08/03/2021
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 Date: 20210803; Test Name: SARS CoV-2 test; Test Result: Positive; Result Unstructured Data: Positive

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: tested positive for covid; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for covid) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication details were not provided by the reporter. On 05 Aug 2021, patient received antibodies treatment. He is due for the second dose of the vaccine.

Other Meds:

Current Illness:

ID: 1678142
Sex: F
Age: 28
State: AZ

Vax Date: 08/14/2021
Onset Date: 08/01/2021
Rec V Date: 09/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Excruciating pain; Muscle weakness; Excruciating pain started on her neck; Excruciating pain in back/excruciating pain in multiple spots in her back; Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers; It is so bad she can barely move; Excruciating pain in shoulder; Muscle pain/muscle burning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back) and PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers) in a 28-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. Concurrent medical conditions included Hypertension (High blood pressure), Genital tract inflammation (GTI) and Pain. Concomitant products included LABETALOL for Hypertension. On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back), PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers), MOBILITY DECREASED (It is so bad she can barely move), ARTHRALGIA (Excruciating pain in shoulder) and MYALGIA (Muscle pain/muscle burning). At the time of the report, PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back), PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers), MOBILITY DECREASED (It is so bad she can barely move), ARTHRALGIA (Excruciating pain in shoulder) and MYALGIA (Muscle pain/muscle burning) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication included patient was on antibiotic for GTI and on medication for the pain. It was stated that since the following Monday 16-Aug-2021 or Tuesday 17-Aug-2021 (patient did not remember which day) she has been experiencing excruciating pain, muscle pain and burning and weakness, starting on her neck, shoulder, then her back (multiple spots in her back), legs, hands and fingers. On a scale from 1 to 10 (where 10 was the worst pain a person could feel) she would describe her pain as a 12. It was so bad she could barely move and it was not getting any better.

Other Meds: LABETALOL

Current Illness: Genital tract inflammation (GTI); Hypertension (High blood pressure); Pain

ID: 1678143
Sex: F
Age: 71
State: WV

Vax Date: 03/03/2021
Onset Date: 03/03/2021
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: Test Date: 20210824; Test Name: Skin biopsy; Result Unstructured Data: dermal hypersensitivity reaction by interaction by a drug and due to the timeline of events, dermatologist says it could be caused be the vaccine.; Test Name: blood work; Result Unstructured Data: normal

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: little bit of tingling in the arm; itching in the back, it started really itching mainly in the back,it started really itching in the stomach, it started really itching in the thighs, itching behind knees,down to the chins, top of feet, under the arms, scalp; diagnosed acute eczema; very itchy rash a couple weeks after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (very itchy rash a couple weeks after the first shot), PARAESTHESIA (little bit of tingling in the arm), PRURITUS (itching in the back, it started really itching mainly in the back,it started really itching in the stomach, it started really itching in the thighs, itching behind knees,down to the chins, top of feet, under the arms, scalp) and ECZEMA (diagnosed acute eczema) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The patient's past medical history included Sjogren's disease. Concurrent medical conditions included Eczema acute since 31-Mar-2021. Concomitant products included VITAMINS NOS, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MONTELUKAST SODIUM (SINGULAIR), NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]), CELECOXIB (CELEBREX), PARACETAMOL (TYLENOL) and CALCIUM, COLECALCIFEROL (VITAMIN D3 CALCIUM) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced RASH PRURITIC (very itchy rash a couple weeks after the first shot). On 31-Mar-2021, the patient experienced ECZEMA (diagnosed acute eczema). On an unknown date, the patient experienced PARAESTHESIA (little bit of tingling in the arm) and PRURITUS (itching in the back, it started really itching mainly in the back,it started really itching in the stomach, it started really itching in the thighs, itching behind knees,down to the chins, top of feet, under the arms, scalp). At the time of the report, RASH PRURITIC (very itchy rash a couple weeks after the first shot), PARAESTHESIA (little bit of tingling in the arm), PRURITUS (itching in the back, it started really itching mainly in the back,it started really itching in the stomach, it started really itching in the thighs, itching behind knees,down to the chins, top of feet, under the arms, scalp) and ECZEMA (diagnosed acute eczema) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Biopsy skin: abnormal (abnormal) dermal hypersensitivity reaction by interaction by a drug and due to the timeline of events, dermatologist says it could be caused be the vaccine.. On an unknown date, Blood test: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication was reported by patient. Patient reported that she took the steroid shot (patient thinks it was cortisone) and also a steroid cream on the same day of 2 dose. Patient visited dermatologist blood work was done and nothing was abnormal, biopsy was done on 24 aug 2021. This case was linked to MOD-2021-295518 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: follow up document received on 25-AUG-2021 contains Events added.

Other Meds: VITAMINS NOS; FLONASE [FLUTICASONE PROPIONATE]; SINGULAIR; EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]; CELEBREX; TYLENOL; VITAMIN D3 CALCIUM

Current Illness: Eczema acute

ID: 1678144
Sex: F
Age: 62
State: LA

Vax Date: 02/26/2021
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: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: legs were hurting as if she had restless leg syndrome; legs were hurting as if she had restless leg syndrome; could not get out of bed; sore arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), the second episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), MOBILITY DECREASED (could not get out of bed), MYALGIA (sore arm) and FATIGUE (tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No Concomitant medications were provided by the reporter. On 26-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 the first episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), the second episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), MOBILITY DECREASED (could not get out of bed), MYALGIA (sore arm) and FATIGUE (tiredness). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency and MELOXICAM for Adverse event, at a dose of 15 milligram. At the time of the report, last episode of PAIN IN EXTREMITY (legs were hurting as if she had restless leg syndrome), MOBILITY DECREASED (could not get out of bed), MYALGIA (sore arm) and FATIGUE (tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were not reported. No treatment medications were not provided. This case was linked to MOD-2021-295607, MOD-2021-295431 (Patient Link).

Other Meds:

Current Illness:

ID: 1678145
Sex: M
Age: 41
State: MO

Vax Date: 03/24/2021
Onset Date: 03/24/2021
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: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: my knees swell incredibly; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (my knees swell incredibly) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis, Seasonal allergy and Shellfish allergy. Concomitant products included LISINOPRIL for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced JOINT SWELLING (my knees swell incredibly). The patient was treated with PREDNISONE at a dose of 1 dosage form and NAPROXEN SODIUM (ALEVE) for Pain, at a dose of 1 dosage form. At the time of the report, JOINT SWELLING (my knees swell incredibly) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-295813 (Patient Link).

Other Meds: LISINOPRIL

Current Illness: Rheumatoid arthritis; Seasonal allergy; Shellfish allergy

ID: 1678146
Sex: F
Age:
State: GA

Vax Date: 08/23/2021
Onset Date: 08/23/2021
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 Name: heart rate; Result Unstructured Data: the heart is elevated, but not a whole lot

Allergies:

Symptom List: Nausea

Symptoms: kind of panicking; The heart is elevated, but not a whole lot; Thought that it was anxiety; felt like her heart was beating "really bad/it happened again during the day. And last night, it happened again; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (felt like her heart was beating "really bad/it happened again during the day. And last night, it happened again), HEART RATE INCREASED (The heart is elevated, but not a whole lot), ANXIETY (Thought that it was anxiety) and PANIC ATTACK (kind of panicking) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]), DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]), MAGNESIUM, ZINC and NICOTINIC ACID (B3 NIACIN) for an unknown indication. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced TACHYCARDIA (felt like her heart was beating "really bad/it happened again during the day. And last night, it happened again) and ANXIETY (Thought that it was anxiety). On 24-Aug-2021, the patient experienced HEART RATE INCREASED (The heart is elevated, but not a whole lot). On 25-Aug-2021, the patient experienced PANIC ATTACK (kind of panicking). At the time of the report, TACHYCARDIA (felt like her heart was beating "really bad/it happened again during the day. And last night, it happened again) and HEART RATE INCREASED (The heart is elevated, but not a whole lot) had not resolved and ANXIETY (Thought that it was anxiety) and PANIC ATTACK (kind of panicking) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) the heart is elevated, but not a whole lot. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included Women's multivitamins. No treatment details were reported. It was stated that she has a Whoop band that tracks the heart rate during exercise and every time she felt like her heartbeat was elevated. She was planning on going to the doctor today

Other Meds: ZOLOFT; VERTEX [BETAHISTINE HYDROCHLORIDE]; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]; MAGNESIUM; ZINC; B3 NIACIN

Current Illness:

ID: 1678147
Sex: F
Age: 67
State: FL

Vax Date: 04/06/2021
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: Test Name: blood works; Result Unstructured Data: Pancreas not producing insulin; Test Date: 2021; Test Name: BODY TEMPERATURE; Result Unstructured Data: Her normal temperature is 97

Allergies:

Symptom List: Injection site pain

Symptoms: Sound on her right ear has become unbearable and it never goes away; Productive cough (dark yellow sputum); Making her crazy; Little fever (99 something - her normal temperature is 97); Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (Sound on her right ear has become unbearable and it never goes away), PRODUCTIVE COUGH (Productive cough (dark yellow sputum)), FEELING ABNORMAL (Making her crazy), PYREXIA (Little fever (99 something - her normal temperature is 97)) and MYALGIA (Body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination. The patient's past medical history included Hay fever, Fibromyalgia, Biliary colic (Gallbladder attack) in 2009 and Pancreatitis (For which she was admitted in the ICU). Concurrent medical conditions included Type 1 diabetes mellitus (at 65 years old) since 2019 and Osteoarthritis. Concomitant products included INSULIN for Type 1 diabetes mellitus. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TINNITUS (Sound on her right ear has become unbearable and it never goes away), PRODUCTIVE COUGH (Productive cough (dark yellow sputum)), FEELING ABNORMAL (Making her crazy), PYREXIA (Little fever (99 something - her normal temperature is 97)) and MYALGIA (Body aches). At the time of the report, TINNITUS (Sound on her right ear has become unbearable and it never goes away), PRODUCTIVE COUGH (Productive cough (dark yellow sputum)), FEELING ABNORMAL (Making her crazy), PYREXIA (Little fever (99 something - her normal temperature is 97)) and MYALGIA (Body aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 99 something (High) Her normal temperature is 97. On an unknown date, Blood test: abnormal (abnormal) Pancreas not producing insulin. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked to MOD-2021-295816 (Patient Link).

Other Meds: INSULIN

Current Illness: Osteoarthritis; Type 1 diabetes mellitus (at 65 years old)

ID: 1678148
Sex: U
Age:
State:

Vax Date: 08/05/2021
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: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: back hurts; pee with foam; chest hurts; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back hurts), URINE ABNORMALITY (pee with foam) and CHEST PAIN (chest hurts) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back hurts), URINE ABNORMALITY (pee with foam) and CHEST PAIN (chest hurts). At the time of the report, BACK PAIN (back hurts), URINE ABNORMALITY (pee with foam) and CHEST PAIN (chest hurts) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant drugs provided. Treatment medications was not reported. Requested for follow-up due to incomplete details of the patient.

Other Meds:

Current Illness: Diabetes

ID: 1678149
Sex: U
Age:
State: NM

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: RA

Lab Data:

Allergies:

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

Symptoms: 7 case pairs (more than one person in household) of tinnitus; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (7 case pairs (more than one person in household) of tinnitus) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (7 case pairs (more than one person in household) of tinnitus). At the time of the report, TINNITUS (7 case pairs (more than one person in household) of tinnitus) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: ADR form received- No new information

Other Meds:

Current Illness:

ID: 1678150
Sex: M
Age: 48
State: VA

Vax Date: 07/01/2021
Onset Date:
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: The day after receiving 1st dose, he noticed that his back started hurting.; He hasn't been doing any physical exercise which he had been doing in past because of back pain that started after receiving 1st dose; He feels very limited doing physical activity because of back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (The day after receiving 1st dose, he noticed that his back started hurting.), EXERCISE TOLERANCE DECREASED (He hasn't been doing any physical exercise which he had been doing in past because of back pain that started after receiving 1st dose) and MOBILITY DECREASED (He feels very limited doing physical activity because of back pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BACK PAIN (The day after receiving 1st dose, he noticed that his back started hurting.), EXERCISE TOLERANCE DECREASED (He hasn't been doing any physical exercise which he had been doing in past because of back pain that started after receiving 1st dose) and MOBILITY DECREASED (He feels very limited doing physical activity because of back pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK PAIN (The day after receiving 1st dose, he noticed that his back started hurting.), EXERCISE TOLERANCE DECREASED (He hasn't been doing any physical exercise which he had been doing in past because of back pain that started after receiving 1st dose) and MOBILITY DECREASED (He feels very limited doing physical activity because of back pain) outcome was unknown. No concomitant medication provided. The day after receiving 1st dose, patient started to hurt his back. Patient took 2nd dose on 10Aug2021 on his right arm.

Other Meds:

Current Illness:

ID: 1678151
Sex: M
Age:
State: MO

Vax Date:
Onset Date: 08/25/2021
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: Erythema, Pruritus

Symptoms: Missed second dose, 6 months after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose, 6 months after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose, 6 months after first dose). On 25-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose, 6 months after first dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient received the first dose of Moderna COVID-19 vaccine 6 months ago. Relevant concomitant medications were not provided by the reporter. Treatment medication was not reported.

Other Meds:

Current Illness:

ID: 1678152
Sex: F
Age:
State: TN

Vax Date: 08/25/2021
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: dose administered from a vial at room temperature for greater then 24 hours; dose administered from a vial at room temperature for greater then 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours) and EXPIRED PRODUCT ADMINISTERED (dose administered from a vial at room temperature for greater then 24 hours) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours) and EXPIRED PRODUCT ADMINISTERED (dose administered from a vial at room temperature for greater then 24 hours). At the time of the report, PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (dose administered from a vial at room temperature for greater then 24 hours) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. 2 doses administered. # of doses and vials: 2 doses given from 1 vial Total amount of time vial exposed to room temperature range (8-25 C or 46-77 F): Room temperature for greater then 24 hours. Approximately 24Aug2021 10:30AM to 25Aug2021 12:45pm date and time of dose administration.

Other Meds:

Current Illness:

ID: 1678153
Sex: F
Age: 63
State: OH

Vax Date: 07/25/2021
Onset Date: 08/23/2021
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: painful breathing; fatigue / tired; whole body hurts; can't lift anything; can hardly walk; right arm hurts at injection site; feeling sluggish; light headaches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (painful breathing), FATIGUE (fatigue / tired), PAIN (whole body hurts), MOBILITY DECREASED (can't lift anything) and GAIT DISTURBANCE (can hardly walk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Thyroid disorder. On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced DYSPNOEA (painful breathing), FATIGUE (fatigue / tired), PAIN (whole body hurts), MOBILITY DECREASED (can't lift anything), GAIT DISTURBANCE (can hardly walk), VACCINATION SITE PAIN (right arm hurts at injection site), SLUGGISHNESS (feeling sluggish) and HEADACHE (light headaches). At the time of the report, DYSPNOEA (painful breathing), FATIGUE (fatigue / tired), PAIN (whole body hurts), MOBILITY DECREASED (can't lift anything), GAIT DISTURBANCE (can hardly walk), VACCINATION SITE PAIN (right arm hurts at injection site), SLUGGISHNESS (feeling sluggish) and HEADACHE (light headaches) outcome was unknown. No concomitant medication was mentioned. No treatment medication was mentioned.

Other Meds:

Current Illness: Blood pressure; Thyroid disorder

ID: 1678154
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: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: nausea; vomiting; severely tired; achy joints; This spontaneous case was reported by a pharmacist and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), FATIGUE (severely tired) and ARTHRALGIA (achy joints) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea), VOMITING (vomiting), FATIGUE (severely tired) and ARTHRALGIA (achy joints). At the time of the report, NAUSEA (nausea), VOMITING (vomiting), FATIGUE (severely tired) and ARTHRALGIA (achy joints) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1678155
Sex: M
Age: 41
State:

Vax Date: 08/15/2021
Onset Date: 08/15/2021
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:

Allergies:

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

Symptoms: Sweats; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), CHILLS (Chills) and PYREXIA (Fever) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Relapsing multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced HYPERHIDROSIS (Sweats), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, HYPERHIDROSIS (Sweats), CHILLS (Chills) and PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medications were not reported.

Other Meds: OCREVUS

Current Illness: Relapsing multiple sclerosis

ID: 1678156
Sex: M
Age: 60
State: MO

Vax Date: 03/04/2021
Onset Date: 04/01/2021
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: Got sick for a day; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick for a day), PYREXIA (Fever) and CHILLS (Chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 011A21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ILLNESS (Got sick for a day), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ILLNESS (Got sick for a day), PYREXIA (Fever) and CHILLS (Chills) had resolved. No relevant concomitant medications were reported. The patient took lot of fluids as treatment. This case was linked to US-MODERNATX, INC.-MOD-2021-296473 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-296473:Cross linked case

Other Meds:

Current Illness:

ID: 1678157
Sex: F
Age: 26
State: MA

Vax Date: 03/26/2021
Onset Date: 03/25/2021
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: Pain in extremity

Symptoms: It's been 5 months since my first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It's been 5 months since my first vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (It's been 5 months since my first vaccine). On 25-Mar-2021, PRODUCT DOSE OMISSION ISSUE (It's been 5 months since my first vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Significant follow up appended. Which includes First dose start date added and new event is updated i.e., It's been 5 months since my first vaccine.

Other Meds:

Current Illness:

ID: 1678158
Sex: M
Age: 79
State: NJ

Vax Date: 08/24/2021
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:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: hives around his injection arm; a rash around his injection arm; 12 inches of redness that wraps around his injection arm; rash with hives and redness extension to the other side of body; arm swollen; arm hot; arm red; almost a typical covid arm/It is giving him a little bit of problem; itching; A sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (A sore arm), PERIPHERAL SWELLING (arm swollen), FEELING HOT (arm hot), ERYTHEMA (arm red) and VACCINATION COMPLICATION (almost a typical covid arm/It is giving him a little bit of problem) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 43B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Hypothyroidism, BPH, Sleep apnea, Monoclonal B-cell lymphocytosis (Monoclonal B-cell Leukocytosis (MBL)) and Atrial fibrillation. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), FLECAINIDE, AMLODIPINE BESILATE (NORVASC), TADALAFIL (CIALIS), HYDROCHLOROTHIAZIDE and NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for an unknown indication. On 24-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced PAIN IN EXTREMITY (A sore arm). On 25-Aug-2021, the patient experienced PERIPHERAL SWELLING (arm swollen), FEELING HOT (arm hot), ERYTHEMA (arm red), VACCINATION COMPLICATION (almost a typical covid arm/It is giving him a little bit of problem) and PRURITUS (itching). On 27-Aug-2021, the patient experienced RASH (rash with hives and redness extension to the other side of body). On an unknown date, the patient experienced VACCINATION SITE URTICARIA (hives around his injection arm), VACCINATION SITE RASH (a rash around his injection arm) and VACCINATION SITE ERYTHEMA (12 inches of redness that wraps around his injection arm). The patient was treated with HYDROCORTISONE (topical) for Itching, at an unspecified dose and frequency and ALOE VERA, CANNABIDIOL, MAGNESIUM CHLORIDE, MATRICARIA RECUTITA, MENTHA X PIPERITA OIL (CBD & MAGNESIUM) (topical) for Itching, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (A sore arm) and PRURITUS (itching) was resolving, PERIPHERAL SWELLING (arm swollen), FEELING HOT (arm hot), ERYTHEMA (arm red), VACCINATION COMPLICATION (almost a typical covid arm/It is giving him a little bit of problem), VACCINATION SITE URTICARIA (hives around his injection arm), VACCINATION SITE RASH (a rash around his injection arm) and VACCINATION SITE ERYTHEMA (12 inches of redness that wraps around his injection arm) outcome was unknown and RASH (rash with hives and redness extension to the other side of body) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-297099, MOD-2021-297112 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: follow up document received on 27-AUG-2021 contains Additional information received , includes new events and outcome.

Other Meds: SYNTHROID; ELIQUIS; FLECAINIDE; NORVASC; CIALIS; HYDROCHLOROTHIAZIDE; BYSTOLIC

Current Illness: Atrial fibrillation; Blood pressure high; BPH; Hypothyroidism; Monoclonal B-cell lymphocytosis (Monoclonal B-cell Leukocytosis (MBL)); Sleep apnea

ID: 1678159
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: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: slight rash where I got my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (slight rash where I got my vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (slight rash where I got my vaccine). At the time of the report, VACCINATION SITE RASH (slight rash where I got my vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided by the reporter No treatment medication were provided by the reporter Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1678160
Sex: F
Age: 92
State: MI

Vax Date: 03/13/2021
Onset Date: 08/25/2021
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: has diffuse pruritus on both arms and one leg; local itching pruritus at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (has diffuse pruritus on both arms and one leg) and VACCINATION SITE PRURITUS (local itching pruritus at the injection site) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Hypercholesteraemia. On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (local itching pruritus at the injection site). On 26-Aug-2021, the patient experienced PRURITUS (has diffuse pruritus on both arms and one leg). At the time of the report, PRURITUS (has diffuse pruritus on both arms and one leg) and VACCINATION SITE PRURITUS (local itching pruritus at the injection site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported anti-hypertensive medications as concomitant medication. other treatment medication Claritin 10 mg orally for unknown indication.

Other Meds:

Current Illness: Hypercholesteraemia; Hypertension

ID: 1678161
Sex: M
Age:
State: FL

Vax Date: 04/13/2021
Onset Date: 05/11/2021
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: knots in my bottom lip and top lip; Eyes swelled up; Eyes popped out; Lips swelled up; Throat swelled out; This spontaneous case was reported by a consumer and describes the occurrence of LIP DISORDER (knots in my bottom lip and top lip), EYE SWELLING (Eyes swelled up), EYE DISORDER (Eyes popped out), LIP SWELLING (Lips swelled up) and PHARYNGEAL SWELLING (Throat swelled out) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043D21A and 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced LIP DISORDER (knots in my bottom lip and top lip), EYE SWELLING (Eyes swelled up), EYE DISORDER (Eyes popped out), LIP SWELLING (Lips swelled up) and PHARYNGEAL SWELLING (Throat swelled out). The patient was treated with EPINEPHRINE (intravenous) for Adverse event, at an unspecified dose and frequency. At the time of the report, LIP DISORDER (knots in my bottom lip and top lip), EYE SWELLING (Eyes swelled up), EYE DISORDER (Eyes popped out), LIP SWELLING (Lips swelled up) and PHARYNGEAL SWELLING (Throat swelled out) outcome was unknown. Concomitant product was not provided by the reporter. This case was linked to MOD-2021-297314 (Patient Link).

Other Meds:

Current Illness:

ID: 1678162
Sex: M
Age: 71
State:

Vax Date: 12/21/2020
Onset Date: 12/29/2020
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: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The treatment history was not reported. The concomitant medication was not reported. This case was linked to MOD-2021-297493, MOD-2021-297494 (Patient Link).

Other Meds:

Current Illness:

ID: 1678163
Sex: M
Age: 46
State: CO

Vax Date: 03/10/2021
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: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Dose was given at 13 hours post puncture expiration (vial had been punctured at 10:30 AM on 25/Aug/2021); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given at 13 hours post puncture expiration (vial had been punctured at 10:30 AM on 25/Aug/2021)) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A, 031B21A and 003F21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given at 13 hours post puncture expiration (vial had been punctured at 10:30 AM on 25/Aug/2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given at 13 hours post puncture expiration (vial had been punctured at 10:30 AM on 25/Aug/2021)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were provided by the reporter. No treatment medication were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow-up received and included suspect dose details updated and updated narrative.

Other Meds:

Current Illness:

ID: 1678164
Sex: U
Age:
State: KY

Vax Date: 08/26/2021
Onset Date: 08/26/2021
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:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Vaccinated with the expired vaccine for their 2nd doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with the expired vaccine for their 2nd doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021 at 10:16 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with the expired vaccine for their 2nd doses). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccinated with the expired vaccine for their 2nd doses) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1678165
Sex: F
Age:
State: KS

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:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fatigue, at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. This case was linked to MOD-2021-297796 (Patient Link).

Other Meds:

Current Illness:

ID: 1678166
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: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: soreness in the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness in the injection site). At the time of the report, VACCINATION SITE PAIN (soreness in the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient reported that Adverse Event is getting worse Concomitant product was not provided by the reporter Treatment information was not provided Reporter did not allow further contact

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am