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: 1730579
Sex: F
Age:
State: SC

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 09/24/2021
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: severe pain; rashes; pain in back; pain in the back and shoulder down to arm; pain in the back and shoulder down to arm; This is a spontaneous report from a contactable consumer from the Pfizer-sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 Vaccine on 05Mar2021 and after two hours, the patient had pain in the back and shoulder down to arm. Then in the morning of 08Mar2021, rashes showed up from the top of the shoulder down to the elbow. She also experienced severe pain on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1730580
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: fatigue a lot; constipation; little pain in my joints - knees and heels; arm pain; a little fever; feel a little bad; This is a spontaneous report from a contactable healthcare professional. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 52-year-old via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She got the Pfizer vaccine and reports having experienced arm pain, "a little fever" and "feel a little bad" for one day after the vaccine. She still experiences "fatigue a lot" as well as constipation and "little pain in my joints-knees and heels". The outcome of the events arm pain, "a little fever" and "feel a little bad" was unknown, and not recovered for the rest of the events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1730581
Sex: F
Age:
State: IL

Vax Date: 02/21/2021
Onset Date: 02/21/2021
Rec V Date: 09/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Burning, itching rash all over body that began the night of the vaccine; Burning, itching rash all over body that began the night of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 45-year-old, via an unspecified route of administration, administered in left arm on 21Feb2021 08:30 (Lot Number: EL9269) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced burning, itching rash all over body that began the night of the vaccine on 21Feb2021 20:00 and progressively spread all over 3 days later. The patient did not receive any treatment for the events. The outcome of the events was recovered on 28Feb2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1730582
Sex: M
Age:
State: MA

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 09/24/2021
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: muscle soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 27Jan2021 at 14:00 (at the age of 34-years-old) (Lot Number: EL3247) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (strength: 600 mg) and vitamin D3. The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination. On 28Jan2021, the patient experienced muscle soreness at injection site. No treatment was received for the event. The outcome of the event recovered on 31Jan2021. No follow-up attempts are needed. No further information is expected.

Other Meds: IBUPROFEN; VITAMIN D3

Current Illness:

ID: 1730583
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
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: I'm not million percent sure if the little bit local itching wasn't; my immune system is already so low that it doesn't over react easily; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included psoriatic arthropathy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date the patient experienced I'm not million percent sure if the little bit local itching wasn't, my immune system is already so low that it doesn't overreact easily, I don't know if it was super easy because my immune system is already so low that it doesn't overreact easily but. following information was not provided during the call: Patient gender The outcome of the events pruritus decreased immune responsiveness was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: event "off label use" deleted. This follow-up report is being submitted to allow appropriate reporting to health authorities.

Other Meds:

Current Illness:

ID: 1730584
Sex: M
Age:
State: CA

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 09/24/2021
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: I had like allergic reaction like itching; I had like allergic reaction like itching; I feel hydrated too and I am tired; I feel dehydrated too and I am tired'; This is a spontaneous report from a contactable consumer or other non hcp. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EP7534), dose 2 via an unspecified route of administration on 16Mar2021 (Vaccination at the age of 60 years) as DOSE 2, SINGLE for covid-19 immunisation. NDC number and UPC number of COVID Vaccine: Unknown. The patient's medical history and concomitant medications were not reported. Patient previously took bnt162b2 (LOT#: Consumer stated, "EN62, looks like 31 or 51.") on 23Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient had like allergic reaction like itching (hypersensitivity) (pruritus), felt dehydrated too and was tired (fatigue) (dehydration) on an unspecified date. Outcome of the event like allergic reaction like itching (hypersensitivity) was not recovered and other events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1730585
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
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: This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A female patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection; batch/lot# and expiration date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously vaccinated with flu shot for influenza immunization on an unspecified date. With the COVID-19 vaccine, patient experienced muscle spasms and soreness in her arm on an unspecified date. Reportedly, it felt like when she gets a flu shot. The outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021206222 Same reporter and product, similar event; different patient.

Other Meds:

Current Illness:

ID: 1730586
Sex: F
Age:
State: NY

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/24/2021
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: she had very blood shot eyes. Both of them were very red; Chills, freezing, shivering; Very, very, dehydrated; Chills/Chills, freezing, shivering; Low grade fever; little bit of body ache; Tired; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot # EP7533) via unknown route of administration received on the upper left arm on 01Apr2021 9: 20 AM (age at vaccination: 65 years) as dose 2, single dose for COVID-19 immunization. Medical history included high blood pressure and cholesterol; both ongoing from an unknown date. The concomitant medications included unspecified high blood pressure pills and unknown cholesterol medication from an unknown date and ongoing and had no reactions. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot # EN6199) received on upper left arm on 11Mar2021, at 9:45 AM, in the upper left arm as a single dose for COVID-19 immunization; and flu shot for past 2 years and has had no reactions. Patient reported that, "I had gotten the Pfizer vaccine, the second shot on April 1. I had a little bit of a reaction to it, the first night I had severe chills, low grade fever, little bit of body aches and tired that lasted a day. By the next day on Friday afternoon I felt better. Then that same night on 02Apr2021, she had very blood shot eyes. Both of them were very red. No itching or burning like an eye infections. She followed up with her eye doctor on Monday on 05Apr2021 who stated she had inflammation from the vaccine. They prescribed an eye lubricant as needed and they also prescribed her eye drops to take for 5 days. She stated she has taken the eye drops all week. Tomorrow is her last day for the eye drops. There has not been a change, maybe a slight change with her eyes. She stated her blood shot eyes are ongoing. She planned to follow up with her eye doctor on 13Apr2021. It was also reported that she got her shot around 9:20 AM on 01Apr2021. By 9:30 PM or 10 PM at night she was freezing shivering like she could not believe. During night she felt she had low grade fever, but did not get up to take her temperature. She was also very very dehydrated. She stated she is not a big water drinker but she had her husband keep bringing her glasses of water after water after water to keep hydrated. By the next day 3:00 PM her symptoms were gone except her very red eyes. She is still using her drops. She has one more day of them. She uses them 4 times a day. Patient received treatment for eyes with Tobramycin-Dexameth Ophth Susp, NDC # 61314-647-05, Expiry Jul2022, 1 drop, for both eyes, 4 times a day, for 5 days for her very red now blood shot eyes. She has taken this medication for 05Apr2021-08Apr2021, and tomorrow will be the 5th day. She also was given sample boxes and has used an eye lubricant named Systame, Lot # 1073U, Expiry Mar2021, # on bottom states 9017639-0619, as needed, for dry eyes. patient stated she used the lubricant for the first 2 days and once yesterday but she does not feel dryness in her eyes so she is not using it unless she has to. The outcome of the events ocular hyperaemia was not resolved, and the outcome of other events was resolved on 02Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Blood cholesterol abnormal; Blood pressure

ID: 1730587
Sex: F
Age:
State: MA

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 09/24/2021
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: 20210330; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: feeling like I couldn't cool off enough; extremely nauseated; Tons of diarrhea; fever; hot flashes; tons of vomiting/thrown up; Some itchiness, esp. on backs of hands and legs; my throat / tongue-in-pharynx tingled and slowly, slightly swelled up; my throat / tongue-in-pharynx tingled and slowly, slightly swelled up; my throat / tongue-in-pharynx tingled and slowly, slightly swelled up; my throat / tongue-in-pharynx tingled and slowly, slightly swelled up; This is a spontaneous report from a contactable consumer. A 38-years-old non-pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 13Apr2021 14:00 (Batch/Lot number was not reported) (age at vaccination: 38 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included severe apnea all night and day, cardiovascular issues, fibromyalgia, possible cushing's syndrome, autism, depression, PTSD, anxiety and crohn's in remission. The patient did not take other vaccine in four weeks. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); diphenhydramine hydrochloride (BENADRYL); senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]); melatonin (MELATONIN); omeprazole (OMEPRAZOLE). The patient previously took sulfa [sulfadiazine], macrobid [clarithromycin], abilify discmelt, geodon [ziprasidone hydrochloride] and Prozac, cloxapen [ampicillin trihydrate;cloxacillin sodium], and Lorazepam; all experienced drug hypersensitivity. On 13Apr2021, the patient experienced some itchiness, esp. on backs of hands and legs, my throat / tongue-in-pharynx tingled and slowly, slightly swelled up. On 14Apr2021 02:00, the patient experienced, feeling like i couldn't cool off enough, extremely nauseated, tons of diarrhea, fever, hot flashes, and tons of vomiting/thrown up. Clinical course included: on 13Apr2021, the patient experienced within 5 min of vaccination, her throat / tongue-in-pharynx tingled and slowly, slightly swelled up. She ended up staying a little more than an hour to make sure it wouldn't just keep on swelling more and more. Some itchiness, esp. on backs of hands and legs. Later in the evening, around 2am, she got extremely nauseated. Tons of diarrhea, fever and hot flashes, tons of vomiting, and felt like she couldn't cool off enough, even in a cold bath and with cold showers, sipping seltzer, etc. She felt a little better now that she thrown up and cooled off her body, but she was worried it will happen again or get worse. The patient was not tested positive for covid prior vaccination. The patient was tested positive for covid post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 30Mar2021. Therapeutic measures were taken as a result of some itchiness, especially on backs of hands and legs, my throat / tongue-in-pharynx tingled and slowly, slightly swelled up, feeling like i couldn't cool off enough, extremely nauseated, tons of diarrhea, fever, hot flashes, and tons of vomiting/thrown up with Benadryl x3 (1 just after vaccine, 2 at 2am). The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected

Other Meds: EFFEXOR; BENADRYL; SENNA [SENNA ALEXANDRINA LEAF]; MELATONIN; OMEPRAZOLE

Current Illness:

ID: 1730588
Sex: F
Age:
State: GA

Vax Date: 04/13/2021
Onset Date: 04/14/2021
Rec V Date: 09/24/2021
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: Golf ball sized, painful lymph node in bend of left arm. Right at elbow; Golf ball sized, painful lymph node in bend of left arm. Right at elbow; Mild diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EW0162), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 13:00 (Vaccination at the age of 53 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity (Known allergies: Sulfa) from an unknown date. There were no concomitant medications. The patient previously took acetaminophen and experienced drug hypersensitivity, bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: ER7833), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 14:30 (Vaccination at the age of 53 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced golf ball sized, painful lymph node in bend of left arm. Right at elbow and mild diarrhea on 14Apr2021 08:30. Patient didn't took other vaccine in four weeks, didn't had covid prior vaccination and not tested covid post vaccination. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1730589
Sex: F
Age:
State: CA

Vax Date: 03/14/2021
Onset Date: 03/14/2021
Rec V Date: 09/24/2021
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: Headache; exhaustion; sinus pressure; fever; chills; sweats; dizzy; nausea; stomach aches; diarrhea; brain fog; sleep issues; Due to nausea & brain fog unable to work as bookkeeper; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Mar2021 (Batch/Lot Number: EP7534) as DOSE 1, SINGLE for covid-19 immunisation (57-years at the age of vaccination).Medical history included asthma from an unknown date and unknown if ongoing , hypersensitivity from an unknown date and unknown if ongoing , allergy to animal from an unknown date and unknown if ongoing. Concomitant medication included clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported. The patient experienced headache, exhaustion, sinus pressure, fever, chills, sweats, dizzy, nausea, stomach aches, diarrhea , brain fog, sleep issues, due to nausea & brain fog unable to work as bookkeeper on 14Mar2021. Therapeutic measures were taken as a result of all events. The outcome of the events Headache, exhaustion, nausea, stomach aches, brain fog, sleep issues and Due to nausea & brain fog unable to work as bookkeeper was not resolved and other events was resolved on 2021. No follow-up attempts are possible. No further information is expected.

Other Meds: CLARITIN [CLARITHROMYCIN]

Current Illness:

ID: 1730590
Sex: F
Age:
State: CA

Vax Date: 03/15/2021
Onset Date: 03/01/2021
Rec V Date: 09/24/2021
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: Laryngeal spasm; panicked; sore arm; This is a spontaneous report from a contactable Nurse/patient (reported for herself). A 52-years-old non-pregnant female patient started to receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6208) via intramuscularly administered on left arm on 15Mar2021 10:30 AM (age at vaccination: 51 years old) as a dose 1, single for covid-19 immunisation. Medical history included allergy to latex (latex allergy with prolonged exposure such as wearing latex gloves daily). Patient had no covid prior vaccination. Patient has not been tested for covid post vaccination. The concomitant medications included vitamin B NOS (VITAMIN B) drops, ergocalciferol (VITAMIN D) drops and "unknown calcium supplement". On an unknown date in 15Mar2021 3:30 PM, patient had laryngeal spasm which occurred about 5 hours after the vaccination. My airway started to feel like it was closing up and started to have difficulty breathing. It lasted maybe about a minute or less, but left me panicked. I called my husband who is an ENT physician who considered it a laryngeal spasm. Patient also had sore arm on an unknown date in Mar2021 at vaccinated arm. The patient did not receive any treatment for the events. The outcome of the event sore arm was unknown and other events was resolved on 15Mar2021. No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.

Other Meds: VITAMIN B [VITAMIN B NOS]; VITAMIN D [ERGOCALCIFEROL.]

Current Illness:

ID: 1730591
Sex: F
Age:
State: NC

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 09/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Injection site pain; Severe fatigue; Severe Urinary incontinence; Headaches; This is a spontaneous report from a contactable consumer (patient) reported herself. A 51-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EW0151), via an unknown route of administration in left arm on 17Apr2021 (at the age of 51-years-old) as dose 2, single for COVID-19 immunization at public health department. The patient's medical history included diabetes II, high blood pressure, reflux, anxiety, obesity and menopause. Concomitant medication was not reported. The patient received morphine, Wellbutrin as past medication and experienced known allergies. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: ER8727), via an unknown route of administration in left arm on 19Mar2021 (at the age of 51-years-old) as historical vaccine as dose 1, single for COVID-19 immunization. No other vaccine in four weeks. On 17Apr2021, the patient experienced injection site pain, severe fatigue, severe urinary incontinence and headaches. Continued on day 3. No COVID prior vaccination. No COVID tested post vaccination. No treatment for event. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1730592
Sex: F
Age:
State: TN

Vax Date: 03/27/2021
Onset Date: 04/17/2021
Rec V Date: 09/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: cut her head; Patients second dose greater than 3 weeks due to fall; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 27Mar2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included ongoing gastroesophageal reflux disease Verbatim: acid relux , ongoing hypertension Verbatim: high blood pressure , ongoing anxiety Verbatim: Anxiety. The patient received tetanus, a week after she fell, not given at hospital went to doctor 4-5 days later she gave her a tetanus shot vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken for gastroesophageal reflux disease, start and stop date were not reported.On 17Apr2021 the patient experienced patient fell trying to get to second vaccine, cut her head, patients second dose greater than 3 weeks due. The outcome of event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: To delete the event Missed dose.

Other Meds: OMEPRAZOLE

Current Illness: Acid reflux (oesophageal) (Verbatim: acid relux); Anxiety (Verbatim: Anxiety); Hypertension (Verbatim: high blood pressure)

ID: 1730593
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
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: had smells of burning and gasoline; This is a spontaneous report from a contactable consumer (patient's sister) received via agency. This consumer reported similar events for two patients. This is the 2nd of two reports. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had smells of burning and gasoline. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187152 same reporter and drug, similar event, different patient

Other Meds:

Current Illness:

ID: 1730594
Sex: F
Age:
State: CT

Vax Date: 04/14/2021
Onset Date: 04/15/2021
Rec V Date: 09/24/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Bloodwork; Result Unstructured Data: Test Result:Unknown result; Test Date: 2021; Test Name: Stool sample; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: Instant and severe diarrhea; White blood cells indicated inflammation.; Heavy legs at night; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number, Expiry date: not reported) via an unspecified route of administration, administered in arm left on 14Apr2021 at 16:00 (age at vaccination 51-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number and Expiry date: not reported) via an unspecified route of administration, administered in arm left on 22Apr2021 at 16:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included birth control from an unknown date and unknown if ongoing (patient received birth control pills other medications in two weeks). The patient had no known allergies. The patient concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 15Apr2021 16:00, the patient had experienced instant and severe diarrhoea started about 24 hours after second injection. It had not stopped for over six weeks. I went to the doctor at four weeks and did bloodwork and provided stool sample. White blood cells indicated inflammation. I also had heavy legs at night which was also new and very scary. The patient did not receive treatment for the adverse event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. On an unspecified date 2021, the patient underwent lab tests and procedures which included blood test: unknown result, stool analysis: unknown result. The outcome of events was not recovered. Follow-up activities closed. Batch/lot number not available for [Vaccine BNT162B2].

Other Meds:

Current Illness:

ID: 1730595
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
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: Ongoing Stomach cramps; Nausea; bloating; lethargy; foul smelling gas; This is a spontaneous report from a contactable Consumer. This Consumer reported similar events for herself and 3 patients. This report is for 1st of 3 patient. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single for COVID-19 immunisation at clinic. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination and did not test for COVID post vaccination. On an unspecified date, the patient experienced ongoing stomach cramps, nausea, bloating, lethargy and foul smelling gas. Effecting the ability to work. Three other people the patient know had all been complaining about the same symptoms. The symptoms were not subsiding. The patient did not receive any treatment for the events. Outcome of the events was unknown. The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1730596
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 06/02/2021
Rec V Date: 09/24/2021
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: experiencing shooting pains down my arm where I was vaccinated pain radiates into my shoulder and elbow; experiencing shooting pains down my arm where I was vaccinated pain radiates into my shoulder and elbow, Pain in hand; I feel tingles, burning, itching, and numbness; I feel tingles, burning, itching, and numbness; I feel tingles, burning, itching, and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; This also radiates into my hands and my face on the left side has also experienced some shooting pain and numbness; anxiety; My menstrual cycle was also been delayed for 14 days; pretty uncomfortable for me; This is a spontaneous report from a contactable Consumer or other non-health care professional (Patient). A 22-Years-Old Non-pregnant Female received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/Lot number: not reported) via an unspecified route of administration on an unknown date at the age of 22-years-old as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. No Known allergies were reported. Historical vaccine included patient took bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: not reported) via an unspecified route of administration, administered in left arm on 31Mar2021 03:00 PM (at the age of 22-years-old) as dose 1, single for COVID-19 immunization. Patient did not receive other vaccines within four weeks and No other medications received within two weeks of vaccination. Patient was not diagnosed with covid prior vaccination and not tested post vaccination. On 02Jun2021 at 10:00 AM, 6 weeks post 2nd vaccine patient has been experiencing shooting pains down her arm where she was vaccinated, pain radiates into her shoulder and elbow. She felt tingles, burning, itching, and numbness and also radiates into her hands and her face on the left side has also experienced some shooting pain and numbness. Patient thought some of that could be anxiety-induced but the arm issues are a bit concerning for her. It does come and go but it has been pretty uncomfortable for her. Her menstrual cycle was also been delayed for 14 days. But it did come. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events caused. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1730597
Sex: F
Age:
State: TX

Vax Date: 06/12/2021
Onset Date: 06/14/2021
Rec V Date: 09/24/2021
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: Pain chest; This is a spontaneous report from a contactable consumer. This 15-year-old female contactable consumer(patient) reported that. A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12Jun2021 09:00 as (At the age of 15-years) dose 2, single for covid-19 immunisation. Medical history included back pain from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 22May2021 09:00 AM as (At the age of 15-years) dose 1, single for covid-19 immunisation. It was Unknown if patient had covid prior vaccination. No covid tested post vaccination. No Known allergies ware reported. The patient experienced pain chest on 14Jun2021 08:00. Patient did not receive any treatment for events. The outcome of event was not recovered at the time of report. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected

Other Meds:

Current Illness:

ID: 1730598
Sex: F
Age:
State: IN

Vax Date: 03/03/2021
Onset Date: 05/01/2021
Rec V Date: 09/24/2021
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: Chest pain; shortness of breath; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-years-old non-pregnant female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6708 and Expiration date was unknown) via intramuscular route of administration, administered in left arm on 03Mar2021 at 18:00 hours as dose 1, single for Covid-19 immunization. The patient medical history was not reported. Patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient received unspecified medications as concomitant medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 01May2021 at 00:00 hours, patient experienced chest pain, shortness of breath and headache. Patient did not receive any treatment for the events. The outcome of all the events was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1730599
Sex: F
Age: 29
State: PA

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 09/24/2021
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: Fluzone taken on 15-sep-2021, estimated date of delivery: 09-Oct-2021, with nno reported advere event; Initial information was received on 15-Sep-2021 regarding an unsolicited valid non-serious case from other health professional. This case involves a 29 years old female patient who was exposed to vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] on 15-sep-2021, estimated date of delivery: 09-oct-2021 at unknown gestation period (exposure during pregnancy). Data regarding this pregnancy were received prospectively. The date of last menstrual period was reported as 2021. The estimated due date is 09-Oct-2021. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. The patient had no previous pregnancy/ies. On 15-Sep-2021, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (Suspension for injection, lot 4T7325QA and expiry date: 30-Jun-2022) via intramuscular route at an unknown administration site for prophylactic vaccination. It was a case of vaccine exposure during pregnancy (latency: same day). At the time of reporting, no adverse event was reported. Additionally, at time of reporting, the pregnancy is still ongoing and the outcome of the pregnancy was unknown.

Other Meds:

Current Illness:

ID: 1730600
Sex: F
Age: 76
State: MN

Vax Date: 09/14/2021
Onset Date: 09/14/2021
Rec V Date: 09/24/2021
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: leaking syringe while administering FUZONE HD PFS; part of dose leaked out of syringe on to patient's arm when plunger was pushed down, no adverse event; leaking syringe while administering FUZONE HD PFS; part of dose leaked out of syringe on to patient's arm when plunger was pushed down, no adverse event; leaking syringe while administering FUZONE HD PFS; part of dose leaked out of syringe on to patient's arm when plunger was pushed down, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00768655) and transmitted to Sanofi on 14-Sep-2021. This case involves a 76-year-old female patient who experienced leaking syringe while administering INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], part of dose leaked out of syringe on to patient's arm when plunger was pushed down [(incorrect dose administered), (exposure via skin contact) and (syringe issue)]. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Information of concomitant medications was not reported. On 14-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ702AC; expiry date: 30-Jun-2021; form: pre-filled syringe) via intramuscular route in the left deltoid for prophylactic vaccination. It was case of actual medication error due to incomplete dose administered, exposure via skin contact and syringe leak (latency: same day). It was reported "Pharmacist reports leaking syringe while administering FUZONE HD PFS; part of dose leaked out of syringe on to patient's arm when plunger was pushed down, pharmacist paused injection and checked tightness of connector and needle, then pushed plunger down again and a few drops leaked on to his glove" The reporter mentioned, leaking did not come from barrel and it was coming from where it connects with luer adaptor narrowing between luer lock adaptor and barrel. Further the reporter mentioned, less than half the dose leaked, approximately 3 drops on patient's arm, and some drops on caller's glove. There were no signs of damage or tampering with the vial, stopper, flip seal or carton. The reporter had used PFS (pre-filled syringes) from same box on patient's husband just prior and had no issues. Also, the syringe did not look dropped or damaged. The caller checked syringe and needle and it was screwed on correctly. The caller had used same needle tips all day without issue. The reporter requested information on revaccination as he did not know how much vaccine the patient received and would like to know if any other issues had been reported. The reporter stated that the syringe was discarded in sharps container and was not available for the return. The reporter was advised that if the customer states picture(s) were available, ask to send us the picture(s). No adverse events were reported at the time of this report. The outcome of the events was reported as unknown. 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 the 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.

Other Meds:

Current Illness:

ID: 1730602
Sex: U
Age:
State: MA

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 09/24/2021
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: patient was given FLUZONE QIV T instead of FLUZONE HIGH-DOSE QUADRIVALENT with no AE; Initial information regarding an unsolicited valid non-serious was received from other health professional via Medical Information (Reference number- 00770131) and transmitted to Sanofi on 15-Sep-2021. This case involves a 66 years old patient with unknown gender who was given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 15-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ705AA and expiry date: 30-Jun-2022) via unknown route at an unknown administration site for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) (wrong product administered). It was reported "Nurse states that a 66 year old patient was given FLUZONE QIV T instead of FLUZONE HIGH-DOSE QUADRIVALENT and wanted to know if any additional protection was required for the patient. Caller asked if the patient needed an additional 0.2 ml since the FLUZONE HIGH-DOSE QUADRIVALENT contains 0.7ml per vaccine. Caller states that she is in the process of reaching out to the patient and wanted to know if she needed to have them return for a second vaccination." It was a case of actual medication error due to wrong vaccine administered (latency: same day). At the time of reporting, the patient experienced no adverse event. 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 the legal guidelines. 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.

Other Meds:

Current Illness:

ID: 1730603
Sex: M
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
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: Tachycardia; nitial information received on 16-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Media Information (under reference 00772775). This case involves a male patient (over 65years of age) who had tachycardia, after receiving QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV). The patient's past medical history included lung cancer (Lung neoplasm malignant), had a lung tumor removed (Pulmonary resection) with caller did not say when the tumor was removed and Tobacco user with had not smoked in twenty years. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. At the time of the event, the patient was suffering from COPD (Chronic obstructive pulmonary disease). On an unknown date, the patient received a dose of suspect FLUBLOK QIV (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious tachycardia (unknown latency) following the administration of vaccine. It was reported "he is concerned with his HCP wanting to administer FLUBLOCK; caller would rather have FLUZONE HIGH DOSE (522 - FLZ HD HV QIV) and would like to have an HCP agent give him some information regarding if he should ask for the FLUZONE HD caller states that he is trying to be cautious in his choice for a flu vaccine due to the current pandemic number levels and would like the vaccine that is best for his age group and health conditions; at time of call all agents were busy and caller agreed to a call back; caller states it is best to reach him until 12:00pm - 1:00pm. A consumer reporting that he tends to get side effects to allergy meds described as getting tachycardia; that the caller did report in passing that he received the Flublok last year and was told that this is a high dose; that his pharmacist confirmed that the Flublok was not the high dose." No laboratory data were reported. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness: COPD

ID: 1730604
Sex: F
Age: 66
State: OH

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 09/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Nurse was supposed to vaccinate the patient with Adacel, however vaccinated them with Daptacel instead in error with no A/E; Inappropriate age at vaccine administration with no A/E; Initial information was received on 16-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via phone call (under Medical Information Inquiry Number: 00773248). This case is linked to cluster cases 2021SA310131and 2021SA311632. This case involves a 66-years old female patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].(wrong product administered and product administered to patient of inappropriate age). The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On 10-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number: C5687AA and expiry date 09-Dec -2021 via intramuscular route in the deltoid for prophylactic vaccination. It was an actual medication error due to Wrong vaccine administered and inappropriate age at vaccine administration (same day latency). It was reported "Director of Quality stated that a nurse was supposed to vaccinate three patients with Adacel, however vaccinated them with Daptacel instead in error. The caller asked if the patient's should be injected with Adacel now, or if the Daptacel was sufficient. The caller stated that this occurred because the Daptacel and Adacel sound the same. No additional Adverse events were reported as a result of this.Patient two Pasteur adverse event reporting refunds/credits would not be issued due to adverse events." At the time of reporting, no adverse event 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 the 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.

Other Meds:

Current Illness:

ID: 1730606
Sex: M
Age: 62
State: TX

Vax Date: 08/17/2021
Onset Date: 08/01/2021
Rec V Date: 09/24/2021
Hospital:

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

Lab Data: Test Date: 20210820; Test Name: Biopsy skin; Result Unstructured Data: Results consistent with allergic reaction

Allergies:

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

Symptoms: Erythema on his upper back/extended to his buttocks, thighs and legs; Biopsy skin consistent with allergic reaction; Itch on his upper back/extended to his buttocks, thighs and legs; Urticaria on his upper back/extended to his buttocks, thighs and legs; Some spots that open up and come back on his upper arm, axilla, parts of his back; This spontaneous case was received on 14-Sep-2021 from physician (anesthesiologist) (reference number: 202101127869), with additional information (being processed together) received on the same day (reference numbers: SEQW21-02231 and SEQW21-02242) and concerned a 62-year-old, male patient. The patient's concurrent conditions included osteoarthritis (since 2001), acid reflux/gastrooesophageal reflux disease (GERD) and penicillin allergy, developed when he was 12 years old. The patient's concomitant medications included Aspirin (acetylsalicylic acid) for stroke prevention, Pepcid (famotidine) and Zegerid (omeprazole) (reported as over the counter Prilosec (omeprazole) plus bicarbonate), both for antireflux/heartburn, vitamin B12 (cyanocobalamin), vitamin D3 (colecalciferol), multivitamin (unspecified vitamins), Lutein (xantofyl), Omega-3 (docosahexaenoic acid, eicosapentaenoic acid), Osteo bi-flex (chondroitin sulfate, glucosamine hydrochloride) and Red Yeast Rice tablets (monascus purpureus), all used for an unreported indication. The patient had a planned elective shoulder replacement surgery on 02-Aug-2021. The patient's historical drug included penicillin, at the age of twelve when it caused a non-significant rash. The patient had taken cephalosporins with no problems and Ancef (cefazolin) which patient took before his shoulder surgery. On 19-Dec-2020 and 09-Jan-2021 the patient was vaccinated with first dose and second dose of non-company Pfizer Biontech COVID-19 vaccine (COVID-19 mRNA vaccine) to prevent getting COVID. On 17-Aug-2021, eight months after the patient's last shot, the patient was vaccinated with third dose of non-company, co-suspect Pfizer Biontech COVID-19 vaccine (COVID-19 mRNA vaccine; anatomical location: left upper arm, dose and route of administration: not reported) to prevent getting COVID. The batch number reported was FC3181. On the same day, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose, route of administration and anatomical location: not reported) to prevent the flu. The batch number reported was P100344370. On 18-Aug-2021, when he woke up the next day at 7 am, the patient experienced severe itch, erythema and urticaria on his upper back. The patient stated that over the next 24 hours (also reported as 48 hours) it extended to his buttocks, thighs and legs. The patient spoke to the dermatologist but was not taken seriously at first, so he also took pictures. The dermatologist thought it could be contact dermatitis. On 20-Aug-2021, reported as Friday, the patient went to see the dermatologist and the doctor thought it could be many things. The patient was given high dose steroids, prednisone taper, Zyrtec (cetirizine hydrochloride), Benadryl (diphenhydramine hydrochloride) and clobetasol. On the same date, the dermatologist took a biopsy and results were consistent with allergic reaction. On an unspecified date in Aug-2021, reported as Saturday, the patient tapered down his prednisone dose and finished the treatment. On an unspecified date in Aug-2021, the patient developed some spots that opened up and came back on his upper arm, axilla and different parts of his back. The patient stated his dermatologist could not offer anything else to him. The patient visited an allergist, but doctor did not know what caused this. He was still taking antihistamines as the lesions started to show up. At the time of initial reporting, the patient was recovering from all the events as they improved significantly with steroids, except for 'spot-like rash'. The patient stated that treatment medications had some good effect. The patient had not recovered from the event of 'spot-like rash' and he was still taking antihistamines. The reporter assessed the events as possibly related to Afluria Quadrivalent. The reporter stated he could not say if it was from the vaccine with certainty, but timing of events led him to believe it was the COVID-19 or flu vaccine. He took them together and nothing else had changed. The reporter assessed all events as serious due to seriousness criteria of medical significance and disability. Company comment: A 62-year-old patient was vaccinated with Afluria Quadrivalent. One the same date, the patient was vaccinated with third dose of non-company, co-suspect COVID-19 vaccine. One day later, the patient experienced severe itch, erythema and urticaria on his upper back. It extended to his buttocks, thighs and legs. Two days later, the patient went to see the dermatologist. The doctor took a biopsy and results were consistent with allergic reaction. Causality was highly confounded by co-suspect COVID-19 vaccine. However, causal role of the suspect vaccine is assessed as possibly related, considering biological and chronological plausibility.; Reporter's Comments: The reporter assessed the events as possibly related to Alfuria Quadrivalent. The reporter stated he could not say if it was from the vaccine with certainty, but timing of events lead him to believe it was the COVID-19 or Flu vaccine. He took them together and nothing else had changed.; Sender's Comments: A 62-year-old patient was vaccinated with Afluria Quadrivalent. One the same date, the patient was vaccinated with third dose of non-company, co-suspect COVID-19 vaccine. One day later, the patient experienced severe itch, erythema and urticaria on his upper back. It extended to his buttocks, thighs and legs. Two days later, the patient went to see the dermatologist. The doctor took a biopsy and results were consistent with allergic reaction. Causality was highly confounded by co-suspect COVID-19 vaccine. However, causal role of the suspect vaccine is assessed as possibly related, considering biological and chronological plausibility.

Other Meds: Aspirin; Pepcid; Zegerid; Vitamin b12; Vitamin d3; Multivitamin; Lutein; Omega-3; Osteo bi-flex; Red Yeast Rice

Current Illness: GERD (Start date reported as '40 years'.); Osteoarthritis

ID: 1730689
Sex: F
Age: 42
State:

Vax Date: 01/15/2021
Onset Date: 01/20/2021
Rec V Date: 09/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Numbness on right side of my face; Numbness on tongue; Inappropriate route of vaccination; Olfactory (smelling smoke) hallucinations; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Olfactory (smelling smoke) hallucinations), HYPOAESTHESIA (Numbness on right side of my face), HYPOAESTHESIA ORAL (Numbness on tongue) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination ) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The patient's past medical history included Migraine. Concurrent medical conditions included Environmental allergy. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced HALLUCINATION (Olfactory (smelling smoke) hallucinations). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness on right side of my face), HYPOAESTHESIA ORAL (Numbness on tongue) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination ). At the time of the report, HALLUCINATION (Olfactory (smelling smoke) hallucinations) had not resolved, HYPOAESTHESIA (Numbness on right side of my face) and HYPOAESTHESIA ORAL (Numbness on tongue) outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination ) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous), the reporter did not provide any causality assessments. No concomitant medical information were reported. No treatment information was reported.; Sender's Comments: This case concerns a 42 year-old, female subject, with medical history of environmental allergies and migraine, who experienced the unexpected event of Hallucination. The event occurred approximately 6 days after the first dose of Spikevax. The rechallenge was not applicable as the event happened after the first dose. The medical history of environmental allergies and migraine remain confounders. The benefit-risk relationship of Spikevax is not affected by this report. The event was captured as serious as per IME list, however, reporter and the company physician consider the reported event as non-serious.

Other Meds:

Current Illness: Environmental allergy

ID: 1730697
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
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: get the shingles even with the shot/ shingle shot, came down with the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The reporter stated that the shingles were not prevented and one could still get the shingles even with the shot. The patient had the Shingles shot and a few years later, she came down with the shingles. The reporter saw them, as did her doctor. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1730698
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
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: got the shingles shot and then got the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient got the shingles shot and then right afterwards got the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1730703
Sex: M
Age:
State: KY

Vax Date:
Onset Date: 09/22/2021
Rec V Date: 09/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210943895.

Other Meds:

Current Illness:

ID: 1730704
Sex: U
Age:
State: OR

Vax Date:
Onset Date: 09/22/2021
Rec V Date: 09/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1730705
Sex: F
Age:
State: LA

Vax Date: 07/27/2021
Onset Date:
Rec V Date: 09/24/2021
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: Redness from the top of the leg to the arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness from the top of the leg to the arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced ERYTHEMA (Redness from the top of the leg to the arm). On 28-Jul-2021, ERYTHEMA (Redness from the top of the leg to the arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up information received :Outcome of the event updated

Other Meds:

Current Illness:

ID: 1730706
Sex: F
Age: 85
State: VA

Vax Date: 06/22/2021
Onset Date: 06/23/2021
Rec V Date: 09/24/2021
Hospital:

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

Lab Data: Test Name: Antibody test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: more than 36 days since the first dose and she did not get the second; arm was red from the vaccination site to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm was red from the vaccination site to the elbow) and PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose and she did not get the second) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. Treatment medications was not reported. The patient's past medical history included COVID-19 in November 2020. Concomitant products included WARFARIN, METOPROLOL, PRAVASTATIN and EZETIMIBE (ZETIA) for an unknown indication. On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was red from the vaccination site to the elbow). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose and she did not get the second). At the time of the report, VACCINATION SITE ERYTHEMA (arm was red from the vaccination site to the elbow) and PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose and she did not get the second) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications was not reported Reporter did not allow further contact

Other Meds: WARFARIN; METOPROLOL; PRAVASTATIN; ZETIA

Current Illness:

ID: 1730707
Sex: F
Age: 57
State: MO

Vax Date: 08/06/2021
Onset Date:
Rec V Date: 09/24/2021
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: Covid arm after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid arm after 1st shot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 06-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 VACCINATION COMPLICATION (Covid arm after 1st shot). At the time of the report, VACCINATION COMPLICATION (Covid arm after 1st shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication and treatment medications reported. This case was linked to MOD-2021-317570 (Patient Link).

Other Meds:

Current Illness:

ID: 1730708
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 09/14/2021
Rec V Date: 09/24/2021
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: I was taking an antibiotic so I couldn't get the dose; I was taking an antibiotic so I couldn't get the dose when it was due; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (I was taking an antibiotic so I couldn't get the dose) and PRODUCT DOSE OMISSION ISSUE (I was taking an antibiotic so I couldn't get the dose when it was due) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I was taking an antibiotic so I couldn't get the dose when it was due). On an unknown date, the patient experienced ADVERSE EVENT (I was taking an antibiotic so I couldn't get the dose). On 14-Sep-2021, PRODUCT DOSE OMISSION ISSUE (I was taking an antibiotic so I couldn't get the dose when it was due) had resolved. At the time of the report, ADVERSE EVENT (I was taking an antibiotic so I couldn't get the dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment information was provided. On 23-Aug-2021, Original 2nd dose was due. On 03-Sep-2021, patient completed antibiotic therapy.

Other Meds:

Current Illness:

ID: 1730709
Sex: F
Age:
State: KY

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 09/24/2021
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: I am anxious about my sinus allergies; Arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (I am anxious about my sinus allergies) and INJECTION SITE PAIN (Arm tenderness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. Concurrent medical conditions included Allergic sinusitis (just stuffy nose and a bit of drainage). On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced INJECTION SITE PAIN (Arm tenderness). On an unknown date, the patient experienced ANXIETY (I am anxious about my sinus allergies). At the time of the report, ANXIETY (I am anxious about my sinus allergies) outcome was unknown and INJECTION SITE PAIN (Arm tenderness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 6 hours after the vaccination Patient experienced tenderness in the arm.No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness: Allergic sinusitis (just stuffy nose and a bit of drainage)

ID: 1730710
Sex: M
Age:
State: IL

Vax Date: 06/10/2021
Onset Date:
Rec V Date: 09/24/2021
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: Pain in arm/ Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm/ Sore arm) and HEADACHE (Headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 022B21A) for COVID-19 vaccination. The patient's past medical history included Liver transplantation in February 2021. Concurrent medical conditions included Spleen disorder NOS (A blood clot that burst in spleen.) since 05-Aug-2021 and Pancreatic insufficiency (Exocrine pancreatic insufficiency(EPI)). Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) and TACROLIMUS for an unknown indication. On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-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 (Pain in arm/ Sore arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in arm/ Sore arm) and HEADACHE (Headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On unknown date patient had CT Scan and the result was not provided. The concomitant medications include other antirejection medications No treatment information provided. This case was linked to MOD-2021-320594 (Patient Link).

Other Meds: MYCOPHENOLATE; TACROLIMUS

Current Illness: Pancreatic insufficiency (Exocrine pancreatic insufficiency(EPI)); Spleen disorder NOS (A blood clot that burst in spleen.)

ID: 1730711
Sex: F
Age: 57
State: IL

Vax Date: 06/10/2021
Onset Date:
Rec V Date: 09/24/2021
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: splenic infarctions; Disorder spleen; Radiating pain; some issues with her pancreas; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of SPLENIC INFARCTION (splenic infarctions) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) and TACROLIMUS for an unknown indication. On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-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 SPLENIC INFARCTION (splenic infarctions) (seriousness criterion medically significant), SPLEEN DISORDER (Disorder spleen), PAIN (Radiating pain), PANCREATIC DISORDER (some issues with her pancreas) and MYALGIA (Myalgia). At the time of the report, SPLENIC INFARCTION (splenic infarctions), SPLEEN DISORDER (Disorder spleen), PAIN (Radiating pain), PANCREATIC DISORDER (some issues with her pancreas) and MYALGIA (Myalgia) outcome was unknown. No treatment information reported. Company Comment: This case refers to a 57-year-old female patient with no specified medical history who experienced the unexpected events of Splenic Infarction, Spleen Disorder, Myalgia, Pain and Pancreatic Disorder on an unspecified date after the administration of COVID-19 Vaccine Moderna. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report. This case was linked to MOD-2021-320491 (Patient Link).; Sender's Comments: This case refers to a 57-year-old female patient with no specified medical history who experienced the unexpected events of Splenic Infarction, Spleen Disorder, Myalgia, Pain and Pancreatic Disorder on an unspecified date after the administration of COVID-19 Vaccine Moderna. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds: MYCOPHENOLATE; TACROLIMUS

Current Illness:

ID: 1730712
Sex: M
Age: 70
State: IL

Vax Date: 02/02/2021
Onset Date: 08/14/2021
Rec V Date: 09/24/2021
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: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown. Concomitant product details was not reported. Treatment details was not reported .

Other Meds:

Current Illness: Immunocompromised

ID: 1730713
Sex: F
Age:
State: IN

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/24/2021
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: Sometimes it's fine but like last night it woke the patient up 5-6 times; Between the shoulder blade and elbow, it itches and burns/injection area itches and burns; Injection area seems swollen at times; Between the shoulder blade and elbow, it itches and burns/injection area itches and burns; When the patient puts the hand on the arm, it feels very hot/injection area very hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (When the patient puts the hand on the arm, it feels very hot/injection area very hot), INSOMNIA (Sometimes it's fine but like last night it woke the patient up 5-6 times), VACCINATION SITE PAIN (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns), VACCINATION SITE SWELLING (Injection area seems swollen at times) and VACCINATION SITE PRURITUS (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 August 2021, the patient experienced VACCINATION SITE WARMTH (When the patient puts the hand on the arm, it feels very hot/injection area very hot), VACCINATION SITE PAIN (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns), VACCINATION SITE SWELLING (Injection area seems swollen at times) and VACCINATION SITE PRURITUS (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns). On 15-Sep-2021, the patient experienced INSOMNIA (Sometimes it's fine but like last night it woke the patient up 5-6 times). At the time of the report, VACCINATION SITE WARMTH (When the patient puts the hand on the arm, it feels very hot/injection area very hot), INSOMNIA (Sometimes it's fine but like last night it woke the patient up 5-6 times), VACCINATION SITE PAIN (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns), VACCINATION SITE SWELLING (Injection area seems swollen at times) and VACCINATION SITE PRURITUS (Between the shoulder blade and elbow, it itches and burns/injection area itches and burns) outcome was unknown. No concomitant medications reported. No treatment information was provided. The itching was not a rash or red in color but was most prominent at one area and was annoying to the patient.

Other Meds:

Current Illness:

ID: 1730714
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
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: did not receive their second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive their second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive their second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive their second dose) 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 were reported. No treatment medication were reported. It was reported that, patient who had received first dose of Moderna vaccine more than 35 days ago without getting second dose.

Other Meds:

Current Illness:

ID: 1730715
Sex: M
Age: 70
State: NM

Vax Date: 09/15/2021
Onset Date: 09/16/2021
Rec V Date: 09/24/2021
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: feels a fever coming on/fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feels a fever coming on/fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced PYREXIA (feels a fever coming on/fever). At the time of the report, PYREXIA (feels a fever coming on/fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were provided. No treatment medications were provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow up received on 16 Sep 2021 contains updated consent information.

Other Meds:

Current Illness:

ID: 1730716
Sex: M
Age:
State: NC

Vax Date: 09/13/2021
Onset Date: 09/13/2021
Rec V Date: 09/24/2021
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: Previously received a complete series of a non-WHO approved vaccine; Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021) and INTERCHANGE OF VACCINE PRODUCTS (Previously received a complete series of a non-WHO approved vaccine in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. Co-suspect product included non-company product COVID-19 VACCINE INACT W.VIRION NIV-2020-770 ([COVID-19 VACCINE INACT W.VIRION NIV-2020-770]) for COVID-19 vaccination. No Medical History information was reported. On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE INACT W.VIRION NIV-2020-770 ([COVID-19 VACCINE INACT W.VIRION NIV-2020-770]) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Previously received a complete series of a non-WHO approved vaccine ()). On 13-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Previously received a complete series of a non-WHO approved vaccine had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported. The date of manufacture of vaccine was reported as 12-Mar-2021. The date that the vial was 30 days in the refrigerator was 05-Sep-2021. This case was linked to MOD-2021-320340, MOD-2021-320812, MOD-2021-320833, MOD-2021-320902, MOD-2021-321000, MOD-2021-321030, MOD-2021-321058, MOD-2021-321061, MOD-2021-321072, MOD-2021-321076, MOD-2021-321086, MOD-2021-321106 (Patient Link).

Other Meds:

Current Illness:

ID: 1730717
Sex: U
Age:
State:

Vax Date: 09/01/2021
Onset Date: 09/16/2021
Rec V Date: 09/24/2021
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: joint pain; muscle pain; 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 ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown. No concomitant drug information was provided, No Treatment drug information was provided,

Other Meds:

Current Illness:

ID: 1730718
Sex: M
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
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: experienced soreness at the injection and states that "if I push on it, it is still there"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experienced soreness at the injection and states that "if I push on it, it is still there") 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (experienced soreness at the injection and states that "if I push on it, it is still there"). At the time of the report, VACCINATION SITE PAIN (experienced soreness at the injection and states that "if I push on it, it is still there") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.

Other Meds:

Current Illness:

ID: 1730719
Sex: F
Age: 33
State: CA

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 09/24/2021
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: appendix was rotting really quickly / It was super inflammed but getting to the point of bursting; She was in bed for a week; Crying; couldn't stand up straight; I was getting extreme pain in the lower right quadrant of my stomach; tried to sleep and ignore the pain but it got worse/it was hard to lay on the side/was hard to lay down; her arm was a little sore; there was a bump in it; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (appendix was rotting really quickly / It was super inflammed but getting to the point of bursting) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Appendectomy (Patient appendix was rotting really quickly, so underwent emergency surgery.). Concomitant products included ZINC, VITAMIN D NOS, VITAMIN B12 NOS, VITAMIN C [ASCORBIC ACID] and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced VACCINATION SITE PAIN (her arm was a little sore) and VACCINATION SITE SWELLING (there was a bump in it). On 21-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (I was getting extreme pain in the lower right quadrant of my stomach) and PAIN (tried to sleep and ignore the pain but it got worse/it was hard to lay on the side/was hard to lay down). On 22-Aug-2021, the patient experienced DYSSTASIA (couldn't stand up straight) and CRYING (Crying). On an unknown date, the patient experienced APPENDICITIS (appendix was rotting really quickly / It was super inflammed but getting to the point of bursting) (seriousness criteria hospitalization prolonged and medically significant) and BEDRIDDEN (She was in bed for a week). At the time of the report, APPENDICITIS (appendix was rotting really quickly / It was super inflammed but getting to the point of bursting), ABDOMINAL PAIN UPPER (I was getting extreme pain in the lower right quadrant of my stomach), PAIN (tried to sleep and ignore the pain but it got worse/it was hard to lay on the side/was hard to lay down), DYSSTASIA (couldn't stand up straight) and CRYING (Crying) had resolved and VACCINATION SITE PAIN (her arm was a little sore), VACCINATION SITE SWELLING (there was a bump in it) and BEDRIDDEN (She was in bed for a week) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication information was mentioned by reporter. Her physician doesn't think appendicitis was related to the vaccine. Company Comment: This case concers a 34 year old female patient with no medical history reported, who experience the unexpected event of appendicitis after firs dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The event was considered not related to the product as per her physician. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concers a 34 year old female patient with no medical history reported, who experience the unexpected event of appendicitis after firs dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The event was considered not related to the product as per her physician. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds: ZINC; VITAMIN D NOS; VITAMIN B12 NOS; VITAMIN C [ASCORBIC ACID]; ALLEGRA

Current Illness:

ID: 1730720
Sex: F
Age: 51
State: FL

Vax Date: 04/02/2021
Onset Date: 04/01/2021
Rec V Date: 09/24/2021
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: spotting consisting of dark brown discharge; extreme dryness when she attempted to insert a tampon; hot, hot sweating at night; flashes/hot, hot sweating at night; constant peeing; did not get her monthly period; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (did not get her monthly period), NIGHT SWEATS (hot, hot sweating at night), HOT FLUSH (flashes/hot, hot sweating at night), POLLAKIURIA (constant peeing) and INTERMENSTRUAL BLEEDING (spotting consisting of dark brown discharge) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder NOS. On 02-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 April 2021, the patient experienced MENSTRUATION DELAYED (did not get her monthly period). In May 2021, the patient experienced NIGHT SWEATS (hot, hot sweating at night), HOT FLUSH (flashes/hot, hot sweating at night) and POLLAKIURIA (constant peeing). In August 2021, the patient experienced INTERMENSTRUAL BLEEDING (spotting consisting of dark brown discharge) and VULVOVAGINAL DRYNESS (extreme dryness when she attempted to insert a tampon). At the time of the report, MENSTRUATION DELAYED (did not get her monthly period) was resolving and NIGHT SWEATS (hot, hot sweating at night), HOT FLUSH (flashes/hot, hot sweating at night), POLLAKIURIA (constant peeing), INTERMENSTRUAL BLEEDING (spotting consisting of dark brown discharge) and VULVOVAGINAL DRYNESS (extreme dryness when she attempted to insert a tampon) outcome was unknown. No concomitant medications were reported. No treatment information was provided

Other Meds:

Current Illness: Thyroid disorder NOS

ID: 1730721
Sex: U
Age:
State:

Vax Date: 09/15/2021
Onset Date: 09/01/2021
Rec V Date: 09/24/2021
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: my arm where I got the vaccine is hard and painful to the touch; my arm where I got the vaccine is hard and painful to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (my arm where I got the vaccine is hard and painful to the touch) and VACCINATION SITE PAIN (my arm where I got the vaccine is hard and painful to the touch) 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 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE INDURATION (my arm where I got the vaccine is hard and painful to the touch) and VACCINATION SITE PAIN (my arm where I got the vaccine is hard and painful to the touch). At the time of the report, VACCINATION SITE INDURATION (my arm where I got the vaccine is hard and painful to the touch) and VACCINATION SITE PAIN (my arm where I got the vaccine is hard and painful to the touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medication was reported. Treatment information were not provided.

Other Meds:

Current Illness:

ID: 1730722
Sex: M
Age: 85
State: OR

Vax Date: 09/15/2021
Onset Date: 09/16/2021
Rec V Date: 09/24/2021
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: patient received a third Moderna dose of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a third Moderna dose of an expired vaccine) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021 at 10:31 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021 at 10:31 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a third Moderna dose of an expired vaccine). On 16-Sep-2021 at 10:31 AM, EXPIRED PRODUCT ADMINISTERED (patient received a third Moderna dose of an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Medication was provided. No treatment was provided. On 16/Sep/2021, a nursing supervisor reported that the vial had been punctured at 10:41 AM on 15/Sep/2021 and stored in refrigerator for the interim administered at 10:31 AM, 16/Sep/2021. A punctured vial was administered just under 12 hours past expiration.

Other Meds:

Current Illness:

ID: 1730723
Sex: F
Age: 22
State: FL

Vax Date: 08/18/2021
Onset Date: 09/15/2021
Rec V Date: 09/24/2021
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: Hands are still cold and numb,feet have remained ice cold,[feet] feel a little cold; Really hurts to walk; Pins and needles; she was really cold; Feet and hands went numb; They were a little blue and purplish hasn't gotten better,[hands] turning a little blue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (she was really cold), HYPOAESTHESIA (Feet and hands went numb), SKIN DISCOLOURATION (They were a little blue and purplish hasn't gotten better,[hands] turning a little blue), PERIPHERAL COLDNESS (Hands are still cold and numb,feet have remained ice cold,[feet] feel a little cold) and GAIT DISTURBANCE (Really hurts to walk) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0481217 and 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021 at 6:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced FEELING COLD (she was really cold), HYPOAESTHESIA (Feet and hands went numb) and SKIN DISCOLOURATION (They were a little blue and purplish hasn't gotten better,[hands] turning a little blue). On 16-Sep-2021, the patient experienced PERIPHERAL COLDNESS (Hands are still cold and numb,feet have remained ice cold,[feet] feel a little cold) and PARAESTHESIA (Pins and needles). 16-Sep-2021, the patient experienced GAIT DISTURBANCE (Really hurts to walk). At the time of the report, FEELING COLD (she was really cold), HYPOAESTHESIA (Feet and hands went numb), SKIN DISCOLOURATION (They were a little blue and purplish hasn't gotten better,[hands] turning a little blue), PERIPHERAL COLDNESS (Hands are still cold and numb,feet have remained ice cold,[feet] feel a little cold), GAIT DISTURBANCE (Really hurts to walk) and PARAESTHESIA (Pins and needles) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am