VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1824710
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: got mine last week and it hurt like the dickens for 2w days; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media. This case involved a patient (unknown demographic) who reported that "got mine last week and it hurt like the dickens for 2w days" (pain) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious "got mine last week and it hurt like the dickens for 2w days" (pain) (unknown latency) duration 2 week days following the administration of INFLUENZA VACCINE. It was unknown if there were lab data/results available. It was unknown if the patient experienced any additional symptoms/events. It was not reported if the patient received a corrective treatment for the event of pain. At time of reporting, the outcome was unknown for the event pain. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1824711
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: Guillain barre, Attacked his immune system Neurological disorder; Initial information was received on 18-Oct-2021 regarding an unsolicited valid serious case received from social media from consumer/non-health care professional via Medical information (under reference number - US-SA-SAC20211021001514). This case involves adult male patient (unknown age) who experienced Guillain Barre syndrome, attacked his immune system neurological disorder (Guillain Barre syndrome), after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious Guillain Barre syndrome, attacked his immune system neurological disorder (Guillain barre syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. No additional laboratory data was reported. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event. There will be no information available on batch number for this case.; Sender's Comments: This case involves an adult male patient (unknown age) who presented with Guillain Barre syndrome (unknown latency) after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Moreover, patient's medical condition at time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1824712
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
Hospital: Y

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: Guillain-Barre syndrome; Initial information received on 18-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional. This case involves an unknown age male patient who had guillain-barre syndrome after receiving vaccine INFLUENZA VACCINE. The patient's medical history included Cardiovascular disease, unspecified (Cardiovascular disorder). At the time of the event, the patient had ongoing Diabetes (Diabetes mellitus). The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was unknown if the patient had any concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a serious guillain-barre syndrome (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. It was unknown if the patient experienced any additional symptoms/events. No laboratory data 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 on the batch number for this case.; Sender's Comments: This case concerns an an unknown age male patient who had guillain-barre syndrome after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is compatible. The patient's medical history included Cardiovascular disorder. At the time of the event, the patient had ongoing Diabetes mellitus and other relevant laboratory data were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.

Other Meds:

Current Illness: Diabetes

ID: 1824713
Sex: F
Age:
State: CT

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/28/2021
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: Flu-like symptoms; Initial information was received on 17-Oct-2021 regarding an unsolicited valid non-serious case received from a Consumer. This case involves a 84-year-old female patient who experienced flu-like symptoms (influenza like illness) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 14-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination. On 14-Oct-2021, the patient developed a non-serious flu-like symptoms (influenza like illness) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It is unknown if patient's physician provided consent to be contacted. It is unknown if the patient experienced any additional symptoms/events. Other relevant tests were not reported. It was not reported if the patient received any corrective treatment. On an unknown date, patient had recovered from the event. There will be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 1824714
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: bad cough; Initial information was received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media. This case involves adult and unknown gender patient who experienced bad cough (cough) and is still sick after receiving INFLUENZA VACCINE. Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided. The patient had no medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious bad cough (cough) and was sick (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event cough. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1824715
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: Got reaction first time ever; Initial information received on 19-Oct-2021 regarding an unsolicited non-valid Social Media non-serious case received from a consumer/non-health care professional. This case involves a patient (unknown age and gender) who got reaction first time ever (vaccination complication) after receiving INFLUENZA VACCINE. The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a reaction first time ever (vaccination complication, non-serious) (unknown latency) following the administration of INFLUENZA VACCINE. No laboratory data 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 on the batch number for this case.

Other Meds:

Current Illness:

ID: 1824716
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: fighting for his life; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer via social media. This case involves an unknown age male patient who experienced fighting for his life (unevaluable event) after receiving INFLUENZA VACCINE. Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious fighting for his life (unevaluable event) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "wow good luck! My dad is fighting for his life after getting the vaccine!!!" Details of laboratory data not reported. It was not reported if the patient received any corrective treatment. At the time of report, the event outcome reported as unknown for the event. There will be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 1824717
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: Flu; Initial information was received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.. This case involves adult female patient who experienced flu (influenza) after receiving INFLUENZA VACCINE. Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. It was reported "no flu shot, no flu". It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1824718
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: meningitis; coma; Initial information was received on 20-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media. This case is linked to cases 2021SA352054, 2021SA352053 and 2021SA351848 (same reporter) This case involves adult and unknown gender patient who experienced meningitis and coma while receiving INFLUENZA VACCINE. Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a serious meningitis and coma (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant and life-threatening. The patient was hospitalized for these events. It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was unknown for both events. There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns adult and unknown gender patient who suffered from meningitis and coma after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. However, the rationale or medical condition of the patient leading to consideration of the events as life-threatening or descriptions of the specific nature of events being life threatening was not provided. Based upon the reported information the role of the vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1824719
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media. This case involves Adult and unknown gender patient who experienced been not feeling well (malaise) after receiving vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expire date: not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious been not feeling well (malaise) (unknown latency) following the administration of INFLUENZA VACCINE. It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the event. At the time of reporting, the outcome of events was reported as unknown. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1824720
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: sore arm; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media. This case involved adult patient who experienced sore arm (pain in extremity) after receiving vaccine INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if there were lab data/results available. It was reported "Got my flu shot last week. I had no side effects at all. I didn't even have a sore arm this time." It was unknown if the patient experienced any additional symptoms/events. It was not reported if the patient received a corrective treatment for the event. 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:

ID: 1824721
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional. This case involves a patient (unknown demographics) who had got bad infection last year (infection), after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed non-serious got bad infection last year (infection) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "The case received from Social media. Since this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine. Got bad infection last year antibiotics for seven days never again." It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the event. There will be no information available on the lot number for this case.

Other Meds:

Current Illness:

ID: 1824722
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
Hospital: Y

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: I was so sick; almost killed me; Initial information received on 21-Oct-2021 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media. This case involves a patient (unknown demographic) was so sick (illness) and almost killed me (unevaluable event) after receiving vaccine INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a serious had so sick (illness) (unknown latency) and almost killed me (unevaluable event) 2 days following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event illness at 5 day. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was unknown for the reported events. There will be no information available on the batch number for this case.; Sender's Comments: This case involves a patient (unknown demographic) who had illness and unevaluable event after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown for illness and compatible for unevaluable event.The patient was hospitalized for this event illness at 5 day.Additional information regarding patient's lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1824723
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: usually get sick; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Medical information (under reference number - US-SA-SAC20211026000316). This case involves an unknown age and unknown gender patient who experienced usually get sick (illness), after receiving vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious usually get sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. No additional laboratory data was reported. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event. There will be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 1824724
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: Arm was terribly sore; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care professional. This case involves a patient (unknown demographics) who had arm was terribly sore (pain in extremity) after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious arm was terribly sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome of event was unknown. The reporter did not report the causality of event with suspect. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

Date Died:

ID: 1824725
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: felt miserable for days; Initial information received on 21-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional. This case involves an 83 year old male patient who experienced felt miserable for days (feeling abnormal) after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. The patient's vaccination included Influenza Vaccine (He got a flu shot from this late 60 year to when he turned 80 year). The patient's medical treatment, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. In 2010, patient said he was no longer going to get the flu shot because he always felt miserable for days (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE. This event was leading to death. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was fatal for the reported event. It is unknown if an autopsy was done. The cause of death was reported as Feeling abnormal. Information on the batch number to be requested.; Sender's Comments: This poorly documented social media case concerns an 83 year old male patient who had feeling abnormal and died, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. It was unknown if an autopsy was done. Further information regarding patient's past medical condition, previous vaccination tolerance and other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of a suspect vaccine cannot be assessed.; Reported Cause(s) of Death: felt miserable for days

Other Meds:

Current Illness:

ID: 1824726
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: severe dehydration; Initial information was received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a Social Media via consumer/non-health care professional. This case is linked to cases 2021SA350364 and 2021SA355220 (same reporter). This case involves a patient (unknown demographics) who had severe dehydration (dehydration) after receiving INFLUENZA VACCINE. The patient's past vaccination(s) included influenza vaccine (two times) for prophylactic vaccination and the patient had flu (influenza) as a reaction to the vaccine. The patient's other past medical history, medical treatment(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a third dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious severe dehydration (dehydration) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "every time I have gotten the flu shot I ended up in the hospital that week from severe dehydration. Not everyone's bodies are the same! My brother gets it and does well! Swears by it keeping him from getting flu bad! So people do end up in the hospital from the flu vaccine. No one should be pressured to make medical decisions for themselves! The first two times I had the flu vaccine I thought it was coincidence that I ended up with the flu that bad same week. After the third time I ended up in the hospital after I said to myself never again! I have not had the flu bad like that since. Same for my kids. They got sick bad every year after getting it. Have gone a couple of years now without getting it! No 105 fevers, No throwing up, no diarrhea bad at the same time! I have triplets so when they all get bad sick like that and I do too it is exhausting! Never again! They had to go to the emergency room also because their fevers were so high and kept going up after flu shot! One of my triplets has peanut tree nut allergies so not taking chances anymore." It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, outcome of the event was unknown. The reporter did not report the causality of event with suspect. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1824727
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: sore arms; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case received from a Social Media via consumer/non-health care professional. This case involves a adult patient (unknown gender) who had sore arms (pain in extremity) after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received two doses of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious sore arms (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "I got both shots on the same day. I am glad I got them. But, don't recommend doing them together 2 sore arms!" It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, outcome of event was unknown. The reporter did not report the causality of event with suspect. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1824728
Sex: F
Age: 45
State: TX

Vax Date: 09/27/2021
Onset Date: 10/12/2021
Rec V Date: 10/28/2021
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: spasms of the opposite arm; rapid increase of blood pressure; extra dose of FLUZONE QIV MDV being administered to a patient; Initial information received on 13-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via agency (under the reference 00810876). This case involves a 45 years old female patient had spasms of the opposite arm (muscle spasms) and rapid increase of blood pressure (blood pressure increased) after receiving extra dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (extra dose administered). The patient's past vaccination(s) included FLUZONE QUADRIVALENT with once had a previous dose on 27-SEP-2021 (0.5 ml, total) for prophylactic vaccination. The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided. On 12-Oct-2021, the patient received a second dose of suspect FLUZONE (0.5 ml, total, once, lot UJ705AB and expiration date not provided) via intramuscular route in the left deltoid for prophylactic vaccination. On 12-OCT-2021 the patient developed a non-serious spasms of the opposite arm (muscle spasms) and rapid increase of blood pressure (blood pressure increased), same day following the administration of vaccine. It was an actual medication error due to extra dose administered (same day latency) No laboratory data reported. It was reported "Nurse calling in regards to a extra dose of FLUZONE QIV MDV being administered to a patient. Nurse would like to know which adverse events to look out for in the patient? Patient received a second dose of the flu vaccine at a doctors office, patient did seem to exhibit adverse reactions and was transported to the ER (emergency room) where they were treated and discharged" An unknown corrective treatment was received for the events. At time of reporting, the outcome was Unknown for the events. 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: 1824729
Sex: M
Age: 56
State: CA

Vax Date: 10/13/2021
Onset Date: 10/13/2021
Rec V Date: 10/28/2021
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: administered Fluzone High Dose to a patient who is 56 years old, with no reported adverse event; administered Fluzone High Dose to a patient who is 56 years old, with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from other health professional and consumer or non-health professional via Medical Information (Reference number: 00812383) and transmitted to Sanofi on 14-Oct-2021. This case involved a 56-year-old patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose). Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided. On 13-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Solution for injection in pre-filled syringe, frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test 0.7ML, Strength: standard except for fluzone HD, lot UJ769AC, expiry date: 30-Jun-2022] via an intramuscular route in the right deltoid for prophylactic vaccination. This was actual medication error case due to Inappropriate age at vaccine administration and vaccine overdose. It was reporter "caller reported last night a family of 4 who are all under the age of 65 were giving the FLUZONE HIGH-DOSE VACCINE. Caller reported there are no AE's at this time, but wanted to make sure there was nothing to expect and what they should do from here." no other vaccines. At the time of this report the patient was fine and had no adverse events after the vaccination. This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1824730
Sex: F
Age:
State: TX

Vax Date: 10/13/2021
Onset Date: 10/13/2021
Rec V Date: 10/28/2021
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: A medical assistant inadvertently administered a dose of Fluzone Quadrivalent High-Dose to a 63-year-old patient/no AE; A medical assistant inadvertently administered a dose of Fluzone Quadrivalent High-Dose to a 63-year-old patient/no AE; Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a Physician and non-health care professional via Global Medical Information (GMI) - 00812680 in the United States. This case is linked to case 2021SA344205 (same reporter). This case involves a 63 year-old female patient who inadvertently received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Product administered to patient of inappropriate age and overdose) The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given On 13-Oct-2021, the patient received 0.7 mL (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported; frequency-once; strength- High Dose) via an intramuscular route at the deltoid for prophylactic vaccination. It was reported "Administrative agent reported that two patients under the age of 65 received a dose of Fluzone Quadrivalent High-Dose. She requested information on the use of the vaccine for this population." It was an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose (latency: same day for both the events). 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 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. There will be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 1824731
Sex: F
Age:
State:

Vax Date: 10/12/2021
Onset Date: 10/13/2021
Rec V Date: 10/28/2021
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: swelling in her left armpit, Swollen lymph nodes; The injection site was slightly achey; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (Reference number- 00812694) and transmitted on 14-Oct-2021. This case involves a 65-year-old female patient who had swelling in her left armpit, swollen lymph nodes (lymphadenopathy) and the injection site was slightly achey (vaccination site pain) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and coronavirus disease of 2019 (COVID-19) VACCINE. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines. On 12-Oct-2021, the patient received a 0.5 mL first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and expiry not reported, formulation: solution for injection) via intramuscular route in the left arm for prophylactic vaccination. On an unknown date, the patient received a dose of suspect COVID-19 VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. On 13-Oct-2021 the patient developed non-serious swelling in her left armpit, swollen lymph nodes (lymphadenopathy) and injection site was slightly achey (vaccination site pain) 1 day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and (unknown latency) COVID-19 VACCINE. It was reported "Caller has questions about possible side effects of FLUBLOK QUADRIVALENT. Caller states that she received the FLUBLOK QUADRIVALENT vaccine. The injection site is fine; slightly achey, but there is a swelling in her left armpit. She noticed the swelling about 30 hours after getting the vaccine; she believes that it is a swollen lymph node. She states that she feels fine, she is having no other side effects. She has spoken with multiple pharmacists and her doctor, who have given her different answers about whether the swollen lymph node could be related to receiving the vaccine. Caller states that her arm was really bad after receiving the Covid vaccine." No laboratory data was reported. The patient was treated with NAPROXEN SODIUM (ALEVE) for Lymphadenopathy and vaccination site pain. At time of reporting, the outcome of the event was unknown. The reporter did not report the causality of events with FLUBLOK QIV. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1824733
Sex: F
Age: 68
State: PR

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/28/2021
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: syringe was leaking at the connection of the needle and syringe/ NO AE; syringe was leaking at the connection of the needle and syringe/ NO AE; Initial information regarding an unsolicited valid serious case was received from a pharmacist via Medical Information (Reference number- 00812927) and transmitted to Sanofi on 14-Oct-2021. This case was linked to case 2021SA342449 (CLUSTER). This case involves a 68-year-old female patient who experienced syringe was leaking at the connection of the needle and syringe (device leakage)(Vaccine underdose), while received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Medical history, concomitant medication, past medical treatment, vaccination and family history were not provided. On 14-Oct-2021, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [frequency: once, Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test, Strength: standard except for Fluzone HD ,lot UJ743AA, expiry date: 30-Jun-2022] via an unknown route at an unknown administration site for prophylactic vaccination. On 14-Oct-2021, the patient developed a non-serious syringe was leaking at the connection of the needle and syringe(device leakage)(Vaccine underdose), on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported"Caller requesting information regarding FLUZONE high dose (HD). Caller stated that when she went to administer the vaccine, the liquid came out around the place where you attached the needle. Caller stated that part of the liquid was still in the syringe, but she was not sure if any was entered into the patient. Caller wanted to know what to do. Agent warm transferred to MIS. Additional Description of event Adverse events: The caller stated that when she gave the vaccination of Fluzone HD Quad, some of the product leaked out of the patient's skin and a lot of it got on her pants. The syringe was leaking at the connection of the needle and syringe." Details of laboratory data not reported. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was unknown for the events.

Other Meds:

Current Illness:

ID: 1824734
Sex: F
Age: 62
State: GA

Vax Date: 10/11/2021
Onset Date: 10/11/2021
Rec V Date: 10/28/2021
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: Patient excursion case was accidently used on two patients even though they were no longer suitable for use / no AE; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional, physician and nurse via call center via Medical Information (Reference number- 00813237) in a specific country. This case involves a 62-year-old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that was reported in a past excursion was accidently used (product storage error). The patient medical history, medical treatments, vaccinations, concomitant medication, and family history were not provided. On 11-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7315JA and expiry date: 30-Jun-2022] via an intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to product storage error due [Latency: on the same day]. It was reported "nurse states the FLUZONE QIV that was reported in a past excursion case was accidently used on two patients even though they were no longer suitable for use. Nurse was looking for information regarding if they need to re-vaccinate the patients and any possible adverse effects." 2 separate patients accidentally received FLUZONE QUADRIVALENT after an excursion that were aware that they were not supposed to use the FLUZONE QUADRIVALENT. At 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: 1824736
Sex: F
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: This case involves a 25-year-old female patient who had severe burning (burning sensation) and welts on arms (urticaria), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2127, expiry date: 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed non-serious severe burning (burning sensation) and welts on arms (urticaria) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported "Nurse reports they received 50 doses of Flublok. They administered 6 so far and stopped using the product. She reports for 4 of the 6 administered to staff they have complained of severe burning and were even "jumping" with the injection. Two of the employees have had rashes and welts on arms at injection site the size of a baseball. The welts were hot to touch and raised." Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment for the events. At time of reporting, the outcome was unknown for both the events.

Other Meds:

Current Illness:

ID: 1824739
Sex: F
Age:
State: ID

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fluzone High-Dose Quadrivalent was given to a 61-year-old patient with no adverse event; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via Medical Information (Reference number- 00816733) and transmitted to Sanofi on 18-Oct-2021 in a specific country. This case involves a 61-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 14-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error due to product administered to patient of inappropriate age (latency: same day). At 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. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1824740
Sex: M
Age: 64
State: CA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/28/2021
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: FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT with no AE; FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT with no AE; FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT with no AE; Initial information was received on 18-Oct-2021 regarding an unsolicited valid non-serious case from other healthcare professional, consumer/non-healthcare professional and physician via call center via agency (Reference number- 00816964). This case involves a 64-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (wrong product administered, overdose and Product administered to patient of inappropriate age). The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided. On 28-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ747AB and expiry date: 30-Jun-2022) via an intramuscular route in the left deltoid for prophylactic vaccination instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported). It was an actual medication error case due to wrong vaccine administered (latency: same day). It was reported "Caller/Office Manager would like to know side effects of administering FLUZONE HIGH DOSE QUADRIVALENT instead of FLUBLOK QUADRIVALENT. Caller reports that FLUZONE HIGH DOSE QUADRIVALENT was administered to 3 patients instead of FLUBLOK QUADRIVALENT." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1824741
Sex: M
Age: 17
State: OH

Vax Date: 09/25/2021
Onset Date: 09/25/2021
Rec V Date: 10/28/2021
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: 17 year-old patient received FLUBLOK QIV vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received from Nurse (Reference number- 00817095) and transmitted to Sanofi on 18-Oct-2021. This case involves a 17-year-old male patient who received a 0.5 mL (once) dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2108 and expiry date 30-May-2022) via intramuscular route in the left deltoid on 25-Sep-2021 for prophylactic vaccination (product administered to patient of inappropriate age). Medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication included MENINGOCOCCAL VACCINE for prophylactic vaccination. It was a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day). At the time of report, 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. 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: MENINGOCOCCAL VACCINE

Current Illness:

ID: 1824742
Sex: F
Age:
State: KS

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: prescription for FLUZONE HIGH DOSE but she is only 62 years old, with no reported AE; prescription for a patient that is immunocompromised (stage 3 kidney disease), with no AE; they did give it to her last year, with no reported AE; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (Reference number- 00817250).. This case involves a 62-year-old female patient who is immunocompromised for whom the prescription of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was provided and gave it to her last year (Product prescribing issue, Contraindicated product prescribed and product administered to patient of inappropriate age). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Renal disorder and Immunodeficiency. It was reported "her doctor has prescribed her to get the Fluzone High Dose which they plan to give her but are calling to get information that it is OK to do so. Caller states they did give it to her last year but they want information this time. States the consumer has Stage 3 kidney disease." It was a case of potential medication error due Product prescribing issue, Contraindicated product prescribed and product administered to patient of inappropriate age. At time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: Immunocompromised; Renal disorder

ID: 1824743
Sex: F
Age: 48
State: TX

Vax Date: 09/24/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
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: patient receiving an extra dose of Fluzone Quadrivalent with no reported adverse event; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via Global Medical Information (GMI) (Reference number- 00817290). This case involves a 48-year-old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], which was double dose of the vaccine (extra dose administered). Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 18-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ705AB and expiry date: not reported) (Frequency twice) via intramuscular route in the left deltoid for prophylactic vaccination. On 24-Sep-2021, the patient received another dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ694AA and expiry date: not reported) (Frequency twice) via intramuscular route in the left arm for prophylactic vaccination. It was a case of actual medication error due to extra dose administered (latency on same day). It was reported "he nurse was looking for any potential AE information in regards to a patient receiving an extra dose of Fluzone Quadrivalent." At the time of report no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good 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: 1824744
Sex: F
Age: 16
State: IA

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
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: 16 year old patient received FLUBLOK with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via agency (Reference number- 00817382) and transmitted to Sanofi on 18-Oct-2021. This case involves a 16-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [Product administered to patient of inappropriate age]. The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 18-Oct-2021, the patient received a 0.5 mL first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QSAA2136, expiry: 30-Jun-2022, formulation: Solution for injection in pre-filled syringe) via intramuscular route in the right deltoid for prophylactic vaccination. It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day). It was reported "Certified Medical Assistant (CMA) calling in regards to FLUBLOK. Caller would like safety information for FLUBLOK given to patients under 18 years of age. Caller would like to know if there are any adverse reactions/safety issues." No other adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 1824745
Sex: F
Age: 71
State: MI

Vax Date: 10/17/2021
Onset Date: 10/17/2021
Rec V Date: 10/28/2021
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: when she administered the product the medication leaked out/ no adverse event; medication leaked out on consumer's arm/ no adverse event; she only received about 0.1 ml dose of FLUZONE HIGH-DOSE QUADRIVALENT/ no adverse event; Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a other healthcare professional and physician via Media Information (under reference: 00818407) in a specific country. This case involves a 71 years old female patient who when administered the product the medication leaked out on consumer's arm, that she only received about 0.1 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (syringe issue, exposure via skin contact, underdose). The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications included COVID-19 VACCINE for prophylactic vaccination. On 17-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (total, once, lot number: UJ764AC and expiry date: 30-JUN-2022) via an intramuscular route in the right deltoid for prophylactic vaccination. This case was a special situation due to (syringe leak, exposure via skin contact, vaccine underdose) (latency: same day). It was reported "Caller stated that when she administered the product the medication leaked out on consumer's arm. She believes it came out of the glass part. She stated that she only saw about 0.1 ml was actually administered into the patient. Caller wanted to know if there was any data on if the consumer should be revaccinated." At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.

Other Meds: COVID-19 VACCINE

Current Illness:

ID: 1824749
Sex: M
Age: 64
State: PA

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: administered Fluzone High Dose to a patient who is 64 years old, with no reported adverse event; administered Fluzone High Dose to a patient who is 64 years old, with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from other health professional and physician via Medical Information (Reference number: 00812383) and transmitted to Sanofi on 19-Oct-2021 in the . This case involved a 64-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose). Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided. On 18-Oct-2021, the patient received a 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test 0.7ML, Strength: standard except for fluzone HD, lot UJ759AD, expiry date: 30-Jun-2022] via an intramuscular route in the left deltoid for prophylactic vaccination This was actual medication error case due to Inappropriate age at vaccine administration and vaccine overdose. It was reporter " Doctor calling to find out what side effects could occur from the FLUZONE HIGH DOSE QUADRIVALENT. Caller stated that he accidentally gave the vaccine to a patient that was 64 years old. Caller wanting to know comparison of flu vaccines as well." No other vaccines. At the time of this report the patient was fine and had no adverse events after the vaccination. This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1824750
Sex: F
Age: 0
State: NY

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/28/2021
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: FLUZONE HIGH-DOSE QUADRIVALENT was administered to a 9 month old with no reported adverse event; FLUZONE HIGH-DOSE QUADRIVALENT was administered to a 9 month old with no reported adverse event; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional in the . This case involves a 9-month-old and a 3-year-old female patient who administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] to a 9-month-old and a 3 year old [Product administered to patient of inappropriate age]. The patient medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for Prophylactic vaccination. On 19-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Suspension for injection, lot UJ751AA and expiry date: 30-Jun-2022] via an intramuscular route in the left thigh for prophylactic vaccination. The patient visit on 19-oct-2021. It was a case of actual medication error due to product administered to patient of inappropriate age and overdose [Latency: on the same day]. It was reported "MD (Doctor of Medicine) and reviewed standard on children under 18 years. MD had question on what if the children experienced an adverse reaction do the parents contact Sanofi or contact them as the provider". Details of laboratory data not reported. It was not reported if the patient received any corrective treatment for the events. At time of reporting, the outcome was unknown for the events. 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: HEPATITIS B [HEPATITIS B VACCINE]

Current Illness:

ID: 1824752
Sex: F
Age: 3
State: NY

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/28/2021
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: FLUZONE HIGH-DOSE QUADRIVALENT administered to a 3 year old with no reported AE; FLUZONE HIGH-DOSE QUADRIVALENT administered to a 3 year old with no reported AE; Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a nurse. This case involves a three-year-old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (overdose, product administered to patient of inappropriate age). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 19-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (0.7mL, lot UJ751AA, expiry date 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination. It was a case of actual medication error due to overdose and Inappropriate age at vaccine administration (latency: same day). At time of reporting, the outcome was unknown for the 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: 00819055:

Other Meds:

Current Illness:

ID: 1824757
Sex: F
Age: 18
State: IL

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/28/2021
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: during administration, half of the medication appeared to be running down her arm with no A/E; during administration, half of the medication appeared to be running down her arm with no A/E; Initial information was received on 19-Oct-2021 regarding an unsolicited valid non-serious case received via a pharmacist via consumer (under Medical Information Inquiry Number: 00819363) in a specific country. This case involves an 18 years old female patient, while administering INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] half of the medication appeared to be running down her arm (underdose) and during administration, half of the medication appeared to be running down her arm (exposure via skin contact) with no reported adverse event. The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided. On 19-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination. It was case of an actual medication error due to vaccine underdose and exposure via skin contact (latency: same day). It was reported "However, the patient reported to the pharmacist that during administration, half of the medication appeared to be running down her arm and was not administered correctly. The Pharmacist would like to know if the dose should be counted as valid or if it should be repeated." At the time of reporting, no adverse event was reported. There will be no information on lot number for this case. 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: 1824758
Sex: F
Age:
State: WI

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/28/2021
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: A 59 year old patient received Fluzone HD with no reported adverse event; A 59 year old patient received Fluzone HD with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via a consumer/non-health care professional via Medical Information (GMI) (Reference number- 00819379) and transmitted to Sanofi on 19-Oct-2021 in . This case involves a 59 year old female patient who was received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose). The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 04-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to inappropriate age at vaccine administration and overdose (latency same day). It was reported "The sales representative is reporting potential adverse event (AE) information she was made aware of by the Certified Medical Assistant (CMA) lead. The sales representative would like to know if there is a form she can e-mail in or is this the appropriate way to report a potential AE. The sales representative is reporting that the CMA lead reported to her that a 59-year-old female patient received Fluzone high dose (HD) on 04Oct2021. She states that she was asked a couple questions that she didn't answer but these are all the facts she was given." No other adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1824759
Sex: U
Age:
State: SD

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: 8 month old receiving a dose of Flublok vaccine, no adverse event; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional and consumer/non-health care professional via media Information (under reference number 00820516) in a specific country. This case involves a 8 months old, unknown gender patient who was administered with the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age) . The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to inappropriate age at vaccine administration (same day latency). It was reported "Voicemail received on 19Oct2021 at 6:55 PM. More information in the Event Information field. Placed in proxy. Hi my name is I I am calling from . Wondering um what the safety risk are for receiving a dose of Flublok vaccine. If you could call me back, again my number is . Thank You." At time of reporting, no adverse event was reported and the outcome was unknown for the reported 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 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. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1824761
Sex: F
Age:
State: TX

Vax Date: 10/20/2021
Onset Date: 10/20/2021
Rec V Date: 10/28/2021
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: FLUBLOK leaked out around the hub of the needle where it is attached to the syringe/ no adverse event; FLUBLOK leaked out and patient received incomplete dose/ no adverse event; Initial information received on 20-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and physician via Regulatory authority (under the reference 00821115). This case involves a 62 years old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] which leaked out around the hub of the needle where it is attached to the syringe and received incomplete dose (syringe issue, underdose). The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On 20-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (once, total, lot number: QFAA2110 and expiry date: 01-JUN-2022) via an intramuscular route in the left deltoid for prophylactic vaccination. This case was a special situation due to (syringe leak, vaccine underdose) (latency: same day). It was reported "While administering the vaccination, the FLUBLOK leaked out around the hub of the needle where it is attached to the syringe. The Pharmacist is unsure exactly how much of the FLUBLOK was received. The Pharmacist asks if the dose was valid or if she needs to be revaccinated. The needle was a twist on." At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.

Other Meds:

Current Illness:

ID: 1824762
Sex: M
Age: 0
State:

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/28/2021
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: A 8 months old patient received FLUBLOCK with no reported adverse event.; Initial information regarding an unsolicited valid non-serious case was received from Other Health Care Professional via a consumer/non-health care professional via regulatory authority (Reference number- 00822512) and transmitted to Sanofi on 21-Oct-2021. This case involves an 8-month-old male patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccine. On 19-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ724AA, expiry: 30-Jun-2022, formulation: pre-filled syringe) via intramuscular route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day). It was reported "The caller is asking recommendations for a patient given FLUBLOCK at 8 months old?" No other adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 1824763
Sex: F
Age: 2
State: CO

Vax Date: 10/21/2021
Onset Date: 10/21/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: a family came in together for flu shots, but the children received ADACEL instead with no AE; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious case received via an other health care professional via a physician via phone (under agency Inquiry Number: 00822801). This case is linked to cluster case US-SA-2021SA353235. This case involves a 24 months old female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of INFLUENZA VACCINE with no reported adverse event (wrong product administered). The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided. On 21-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U7055BA and expiry date: 30-Jun-2023) via unknown route in the right thigh for prophylactic vaccination. It was a case of an actual medication error due to wrong vaccine administered (Latency: same day). It was reported "Caller states that a family came in together for flu shots, but the children received ADACEL instead of the flu shot. Caller would like to know if there is any safety issue and how will this affect their dosing schedule." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 1824764
Sex: M
Age: 5
State: CO

Vax Date: 10/21/2021
Onset Date: 10/21/2021
Rec V Date: 10/28/2021
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: family came in to receive flu shots but the children received ADACEL instead with no AE; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 5-year-old male patient whom it was reported "family came in to receive flu shots [INFLUENZA VACCINE] but the children received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead (wrong product administered)". The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 21-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U7055BA and expiry date: 03-Jun-2023] via an unknown route in the right arm for prophylactic vaccination. It was a case of actual medication error due to wrong product administered [Latency: on the same day]. At time of reporting, the outcome was unknown for the 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 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: 1824766
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: CIDP; Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy; This literature case was received on 18-Oct-2021 and concerned an elderly, male patient who was 87-year-old at the time of the reporting. The patient's concurrent conditions and concomitant medications were not provided. On an unknown date in 2017, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported. On an unspecified date in 2017, shortly after receiving influenza virus vaccine polyvalent, the patient had symptoms, laboratory, and electrophysiological features of Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy (GBS/AIDP). Thyroid function tests, haemoglobin A1c, serum protein electrophoresis, syphilis and lyme titers were unremarkable. The patient had incomplete resolution of symptoms with a course of five plasma exchange treatments. On an unspecified date in 2017, one month after initial diagnosis and treatment, it was determined that the patient's condition had evolved to chronic inflammatory demyelinating polyneuropathy (CIDP), for which he received ongoing plasmapheresis, on every two weeks basis. At the time of this literature report, the patient was recovering from the events of GBS/AIDP and CIDP, with symptom improvement but not normalization. The authors did not provide causality assessment. Company comment: An elderly patient was vaccinated with influenza virus vaccine polyvalent. On an unspecified date in 2017, shortly after receiving influenza virus vaccine polyvalent, the patient had symptoms, laboratory, and electrophysiological features of Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy (GBS/AIDP). One month after initial diagnosis and treatment, it was determined that the patient's condition had evolved to chronic inflammatory demyelinating polyneuropathy (CIDP). Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship. Brighton Collaboration criteria could not be assessed due to insufficient information about diagnostic findings.; Sender's Comments: An elderly patient was vaccinated with influenza virus vaccine polyvalent. On an unspecified date in 2017, shortly after receiving influenza virus vaccine polyvalent, the patient had symptoms, laboratory, and electrophysiological features of Guillain-Barre syndrome/acute inflammatory demyelinating polyneuropathy (GBS/AIDP). One month after initial diagnosis and treatment, it was determined that the patient's condition had evolved to chronic inflammatory demyelinating polyneuropathy (CIDP). Causal role of the suspect vaccine is unassessable, due to unclear temporal relationship. Brighton Collaboration criteria could not be assessed due to insufficient information about diagnostic findings.

Other Meds:

Current Illness:

Date Died:

ID: 1824822
Sex: U
Age:
State: RI

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
Hospital: Y

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

Lab Data: Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Positive

Allergies:

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

Symptoms: CONFIRMED COVID-19 INFECTION; This spontaneous report was received from literature. This report concerned multiple patients (3 females and 5 male) of above 18 year's age and unspecified race and ethnicity. The objective of this study was to describe the vaccine breakthrough cases and their outcomes compared to unvaccinated COVID-19 cases, we analyzed and compared all consecutive patients, with or without prior vaccination, who were admitted to our hospital network due to COVID-19 from JAN-2021 to APR-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: congestive heart failure, cardiac arrhythmias, hypertension, chronic pulmonary disease, diabetes, renal failure, liver disease, obesity, and metastatic cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, after vaccination, 8 patients with reverse transcription polymerase chain reaction (RT-PCR) test positive and primary diagnosis of covid-19 (confirmed covid-19 infection) were admitted into a hospital. All the patients had oxygen requirement upon admission. The patients had also used dexamethasone and remdesivir. Among the 8 patients 1 patient had tested positive within 1-7 days, 6 patients were tested positive between 8-14 days and 1 patient had tested positive between 15-21 days after vaccination. In the patients who tested positive within the first two weeks (1-14 days) after vaccination one patient was admitted in Intensive care unit (ICU), one patient required mechanical ventilation, one patient had death or discharged to hospice and one patient had died on unspecified date. It was unknown if an autopsy was performed. The outcome of ICU admission, mechanical ventilation, death, death or discharged to hospice was not reported in the remaining three patients who were tested positive between 1-14 days after vaccination and in the patient who had tested positive between 15-21 days after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients were died of covid-19 on an unspecified date. The author concluded that even a single dose of vaccination was associated with decreased risk of death. As of AUG-2021, 72% of the adult population has received at least one dose of the COVID vaccine, while more than 1.7 billion vaccine doses have been administered worldwide. The need for ongoing mass vaccination efforts is still of utmost importance, while vaccination in middle and low-income countries should remain an absolute priority. The outcome of covid-19 was death on an unspecified date. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20211046629-covid-19 vaccine ad26.cov2.s-confirmed covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COVID-19

Other Meds:

Current Illness: Cardiac arrhythmia; Chronic lung disease; Congestive heart failure; Diabetes; Hepatic disease; Hypertension; Metastatic carcinoma; Obesity; Renal failure

ID: 1824823
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 10/07/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 20211007; Test Name: Antibody test; Result Unstructured Data: Negative

Allergies:

Symptom List: Vomiting

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 49 year old white female of unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: 25-MAY-2021) dose was not reported, 1 total administered on left arm on 09-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 07-OCT-2021, the patient went through an antibody test and result was negative (confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211052305-covid-19 vaccine ad26.cov2.s- Confirmed immunological Vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1824824
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: VACCINE GAVE HIM BOOTY WARTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine gave him booty warts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine gave him booty warts was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1824825
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: WHOLE BODY SORE; WEAK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced whole body sore, and weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the whole body sore and weak was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1824826
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: DID NOT REACT GREAT TO THE FIRST SHOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced did not react great to the first shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of did not react great to the first shot was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1824827
Sex: F
Age: 59
State: TX

Vax Date: 07/07/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Name: MRI; Result Unstructured Data: Showed "a tiny bit of arthritis in there"; Test Name: x ray; Test Result: Inconclusive ; Result Unstructured Data: x-rays of her knee which showed no changes; Test Name: x ray; Test Result: Inconclusive ; Result Unstructured Data: x-rays of her knee which showed no changes

Allergies:

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

Symptoms: Knee swelled up; knee pain; She feels crippled by the shot. She feels if she takes a step or moves the wrong way like she has ripped out her knee; My arm hurt / arm pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knee swelled up), ARTHRALGIA (knee pain) and JOINT INJURY (She feels crippled by the shot. She feels if she takes a step or moves the wrong way like she has ripped out her knee) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Knee swelled up) (seriousness criterion disability), ARTHRALGIA (knee pain) (seriousness criterion disability), JOINT INJURY (She feels crippled by the shot. She feels if she takes a step or moves the wrong way like she has ripped out her knee) (seriousness criterion disability) and PAIN IN EXTREMITY (My arm hurt / arm pain). The patient was treated with PREDNISONE (oral) for Adverse event, at a dose of 1 dosage form. At the time of the report, JOINT SWELLING (Knee swelled up), ARTHRALGIA (knee pain), JOINT INJURY (She feels crippled by the shot. She feels if she takes a step or moves the wrong way like she has ripped out her knee) and PAIN IN EXTREMITY (My arm hurt / arm pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: inconclusive (abnormal) Showed "a tiny bit of arthritis in there". On an unknown date, X-ray: inconclusive (Inconclusive) x-rays of her knee which showed no changes and inconclusive (Inconclusive) x-rays of her knee which showed no changes. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. It was reported that the patient also received a methyl-prednisone 40mg and lidocaine injection on 24SEP2021. Talked to 2 doctors and has plans to see a 3rd doctor on Monday. Company Comment: This case concerns a 59-year-old female patient with no relevant medical history, who experienced the unexpected serious events of JOINT SWELLING, ARTHRALGIA and JOINT INJURY. The events occurred approximately 3 weeks after receiving the first dose of Moderna COVID-19 Vaccine. Rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. This case was linked to MOD-2021-353003 (Patient Link).; Sender's Comments: This case concerns a 59-year-old female patient with no relevant medical history, who experienced the unexpected serious events of JOINT SWELLING, ARTHRALGIA and JOINT INJURY. The events occurred approximately 3 weeks after receiving the first dose of Moderna COVID-19 Vaccine. Rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness:

ID: 1824828
Sex: F
Age:
State:

Vax Date: 02/22/2021
Onset Date: 03/10/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 202109; Test Name: Bone density test; Result Unstructured Data: seven percent increase in bone

Allergies:

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

Symptoms: Dizziness; sickness; Achiness,pain; fever; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizziness), ILLNESS (sickness), PAIN (Achiness,pain) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product DENOSUMAB (PROLIA) injection for Osteoporosis postmenopausal. The patient's past medical history included Sinus operation (for dilation) on 12-Aug-2020, Stapedectomy (stapes surgery) on 27-Aug-2021 and Arthroscopic surgery (calcified bone removal and an implant was put in and was intubated.). Previously administered products included for Product used for unknown indication: Boniva. Family history included Deafness (Hearing aid user in both ears, no hearing in right ear from 15 years) since an unknown date. Concurrent medical conditions included Hypertension, Blood cholesterol (Blood cholesterol abnormal), Osteoporosis postmenopausal, Carcinoid tumour since 2010 and Hearing aid user (Hearing aid user in both ears). Concomitant products included HYDROCHLOROTHIAZIDE, ZOLPIDEM TARTRATE (AMBIEN), ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), CALCIUM, MONTELUKAST, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ROSUVASTATIN CALCIUM (CRESTOR), METOPROLOL SUCCINATE (TOPROL) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. In 2008, the patient started DENOSUMAB (PROLIA) (Subcutaneous) 60 milligram every six months. On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ILLNESS (sickness), PAIN (Achiness,pain) and PYREXIA (fever). In September 2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) and PAIN (Achiness,pain) was resolving, ILLNESS (sickness) had resolved and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Bone densitometry: high (High) seven percent increase in bone. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was reported. Patient had underwent urine analysis and laboratory test and results were unknown.

Other Meds: HYDROCHLOROTHIAZIDE; AMBIEN; VITAMIN D [ERGOCALCIFEROL]; CALCIUM; MONTELUKAST; FLONASE [FLUTICASONE PROPIONATE]; SYMBICORT; ALLEGRA; CRESTOR; TOPROL; MULTIVITAMIN [VITAMINS NOS]

Current Illness: Blood cholesterol (Blood cholesterol abnormal); Carcinoid tumour; Deafness (Hearing aid user in both ears, no hearing in right ear from 15 years); Hearing aid user (Hearing aid user in both ears); Hypertension; Osteoporosis postmenopausal

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am