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: 1793434
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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 a Half a dozen last week, with no adverse event; Initial information received on 08-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional. This case involves adult and unknown gender patient who got a half a dozen last week (extra dose administered) while receiving INFLUENZA VACCINE. The patient medical history, medical treatment(s), vaccination(s), 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 in unknown administration site for prophylactic vaccination. It was case of actual medication error due to extra dose administered [Latency: on the same day]. Details of laboratory data not reported. At the time of report no adverse event was reported. 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. 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. 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: 1793435
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Arm is sore; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Agency (under reference number - US-SA-SAC20211011001392). This case involves adult patient of unknown age and gender patient who experienced arm is sore (pain in extremity), after receiving vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), concomitant therapy, 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. On an unknown date, the patient developed a non-serious arm is sore (pain in extremity) (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: 1793436
Sex: U
Age:
State:

Vax Date: 10/06/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sore arm; Initial information was received on 07-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 and unknown gender patient who experienced sore arm (pain in extremity) while receiving INFLUENZA VACCINE and COVID-19 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 in last week, the patient received booster dose of suspect COVID-19 VACCINE not produced (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On 06-Oct-2021 (yesterday), 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 sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 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. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1793437
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Almost died; Initial information was received on 09-Oct-2020 regarding an unsolicited non-valid non-serious case received from a consumer or non-healthcare professional (patient) via public post on the flu shot campaign. This was an non-valid case as adverse event not specified. This case involves patient who after receiving flu shot was almost died, while he/she received vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications 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 unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious adverse event as after flu shot patient was almost died (unevaluable event) on an unknown latency following the administration of INFLUENZA VACCINE. Details of laboratory data were not reported. It was not reported if the patient received a corrective treatment. The outcome was unknown for the unevaluable event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1793438
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: flu both times; Initial information received on 09-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.. This case involves adult patient (unknown age and gender) who experienced flu both times (influenza), while receiving vaccine INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. The patient's medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a two doses 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 flu both times (influenza) (unknown latency) following the administration two doses of INFLUENZA VACCINE. It was reported "I have had the flu shot twice and got the flu both times. No amount of convincing will get me to take it again". 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 unknown for the reported event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1793439
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital: Y

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 mine in August and in the hospital with pneumonia; flu; Initial information received on 09-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consumer (under reference number: US-SA-SAC20211012000320). This case involves a patient with an unknown demographics who experienced serious events got mine in August and in the hospital with pneumonia (pneumonia) and flu (influenza) after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided. It was unknown if the patient had any concomitant disease or risk factor. On an unknown date, in the month of August, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed serious events got mine in august and in the hospital with pneumonia (pneumonia) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. On an unknown date, the patient developed a serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event. It was unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available. An unknown corrective treatment was received for the events. At time of reporting, the outcome of events was reported as unknown. It was unknown if patient's physician provided consent to be contacted.; Sender's Comments: This case involves a patient with an unknown demographics who experienced serious events pneumonia and influenza (unknown latency) after receiving INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown with the role of the vaccine. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of suspect vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1793440
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: slight sore arm; Initial information received on 09-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional. This case involves adult patient (unknown age and gender) who experienced slight 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's 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 slight sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Got mine yesterday. Love the expression Flu shot Friday. Not a regular for flu vaccine, but feel this is the time to start. Just a slight sore arm". It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1793441
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: little fatigue; sore arms; Initial information was received on 07-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media. This case involves a (unknown demographic) patient who experienced little fatigue (fatigue) and sore arms (pain in extremity) when received vaccine INFLUENZA VACCINE. The patient's past medical treatments, vaccinations, 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 (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 little fatigue (fatigue) and sore arms (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "I initially went in to get my flu shot and to schedule my booster shot for the following week. My pharmacist said I could get both at the same time so I went for it. Other than a little fatigue and sore arms, I was fine." 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 events. The event outcome was unknown for both the events. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1793442
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: flu; Initial information was received on 09-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.. This case involves adult patient of unknown gender who had flu (influenza), after receiving INFLUENZA VACCINE. The patient had no 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 flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "the following potential adverse event has been found on a public post on a social media page. I took flu shots twice and both times ended up with the flu! When I started taking Vitamin D3, I stopped getting colds and flus!" It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available The patient was treated with VITAMIN D3 for Influenza. 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: 1793443
Sex: M
Age: 65
State: NJ

Vax Date: 10/07/2021
Onset Date: 10/08/2021
Rec V Date: 10/16/2021
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: all over body pain; fatigue; injection site is very painful; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional. This case involves a 65-year-old male patient who had all over body pain (pain), fatigue and injection site is very painful (vaccination site pain), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. 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 07-Oct-2021, the patient received a dose of 0.7mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once, injection, lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On 08-Oct-2021, the patient developed non-serious all over body pain (pain), fatigue and injection site is very painful (vaccination site pain) (one day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported "next day after receiving shot woke up with all over body pain and fatigue. Also, injection site is very painful. Could not sleep on the arm." 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 any corrective treatment for the events. At time of this report, the patient was recovering from all the reported events. There will be no information available on the lot number for this case.

Other Meds:

Current Illness:

ID: 1793444
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Name: body temperature; Test Result: 102 {DF}; Test Name: body temperature; Test Result: 105 {DF}

Allergies:

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

Symptoms: The two times I did get the flu shot, within half an hour I had a fever of 102?F and had COVID19 in Jan & Feb-2020.First week:sore throat,then fever; had COVID19 in Jan & Feb-2020.First week; had COVID19 in Jan & Feb-2020.First week:sore throat; had COVID19 in Jan & Feb-2020.First week:sore throat,then fever,then ok for 2 days,then felt really bad off,on the rest of the 3 1/2 weeks,much like the flu,but a longer time.Still have numb spots on fingertips and some areas on the soles of my feet; had COVID19 in Jan & Feb-2020.First week:sore throat,then fever,then ok for 2 days,then felt really bad off,on the rest of the 3 1/2 weeks,much like the flu,but a longer time.Still have numb spots on fingertips and some areas on the soles of my feet; had COVID19 in Jan & Feb-2020.First week:sore throat,then fever,then ok for 2 days,then felt really bad off,on the rest of the 3 1/2 weeks,much like the flu,but a longer time.Still have numb spots on fingertips and some areas on the soles of my feet; Initial information received on 07-Oct-2021 regarding an unsolicited valid serious case received from a via Consumer Non-Healthcare Professional under reference number: US-SA-SAC20211012000793. This case involves Adult and unknown gender patient who was experienced the two times i did get the flu shot, within half an hour i had a fever of 102? had COVID19 in Jan & Feb-2020.First week: sore throat, then fever, then ok for 2 days, then felt really bad off, on the rest of the 3 1/2 weeks, much like the flu, but a longer time. Still have numb spots on fingertips and some areas on the soles of my feet fever (pyrexia, COVID-19, oropharyngeal pain, Feeling abnormal, Influenza like illness and Hypoaesthesia) after receiving INFLUENZA VACCINE. The patient's medical history, medical treatments, vaccinations, concomitant medications 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 unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a serious event the two times i did get the flu shot, within half an hour i had a fever of 102?f and had covid19 in Jan & feb-2020.first week: sore throat, then fever (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event. On an unknown date the patient developed a non-serious events had COVID19 in Jan & Feb-2020.First week: sore throat, then fever, then ok for 2 days, then felt really bad off, on the rest of the 3 1/2 weeks, much like the flu, but a longer time. Still have numb spots on fingertips and some areas on the soles of my feet fever (covid-19, oropharyngeal pain, feeling abnormal, influenza like illness, hypoaesthesia) (unknown latency) following the administration of INFLUENZA VACCINE. Relevant laboratory test results included: On an unknown date Body temperature 102 F. It is unknown if the patient experienced any additional symptoms/ event. It is 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 patient outcome was Unknown from the events. There was be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1793445
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: arm got infected; Initial information received on 07-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional. This case involves a patient (unknown age and gender) who had arm infected (localised infection) after receiving INFLUENZA VACCINE. The patient's medical treatment(s), vaccination(s), concomitant medication(s) 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 (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date the patient's arm got infected (localised infection, non-serious) (unknown latency) following the administration of vaccine. It was unknown if the patient experienced any additional symptoms/events. No laboratory data reported. It was reported "Got my flu shot last year arm got infected had to take antibiotics for seven days no thanks I will pass." It was reported that the patient received antibiotics for a seven days as corrective treatment. At time of reporting, the outcome was unknown for the reported event.

Other Meds:

Current Illness:

ID: 1793446
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Flu; Initial information was received on 08-Oct-2021 regarding an unsolicited valid serious case received from social media from consumer/non-health care professional via regulatory authority (under reference number - US-SA-SAC20211012000839). This case involves adult patient of unknown age and gender patient who experienced flu (influenza), after receiving vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), concomitant therapy, 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 flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event. 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 adult patient of unknown age and gender patient who experienced flu (influenza), after vaccination with INFLUENZA VACCINE. The time to onset is compatible with the role of the vaccine. However, patient's medical condition at time of vaccination, Lab data and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the individual vaccines cannot be assessed.

Other Meds:

Current Illness:

ID: 1793447
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: flu like symptoms; runny nose; cough; Initial information received on 10-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer Non-Healthcare Professional (under reference number: US-SA-SAC20211012001046). This case involves Adult female patient who was experienced flu like symptoms, runny nose and cough (influenza like illness and rhinorrhoea) while receiving INFLUENZA VACCINE. The patient's medical history, past medical treatments, vaccinations, 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 not reported. On an unknown date the patient developed a non-serious events flu like symptoms, runny nose and cough (influenza like illness and rhinorrhoea) (unknown latency) following the administration of INFLUENZA VACCINE. It is unknown if the patient experienced any additional symptoms/ event. It is unknown if there were lab data/results available It was not reported if the patient received a corrective treatment from the events. At time of reporting, the patient outcome was Unknown for the events.

Other Meds:

Current Illness:

ID: 1793448
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: it makes me sick; Initial information was received on 09-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional. This case involves adult patient of unknown gender who had "it makes me sick" (illness), after receiving INFLUENZA VACCINE. The patient had no 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 "it makes me sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "the following potential adverse event has been found on a public post on a social media page. I cannot take the flu shot it makes me sick but I did get my 2 (Corona Virus Disease) COVID shots." 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 any corrective treatment for the event. At time of this report, 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: 1793449
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Patient was inadvertently administered the Fluzone High-Dose Quadrivalent vaccine, rather than the Fluzone Quadrivalent vaccine with no reported adverse event; FLUZONE HIGH DOSE QUADRIVALENT was given to a consumer under 65, with no adverse event; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist via agency (under reference- 00791171 ). This case is linked to case 2021SA326103 (CLUSTER). This case involves a 19 years old female patient who was inadvertently administered the QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), rather than the QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) [wrong product administered and 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 an unknown date, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ733AA, expiry date-30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination. It was an actual medication error due to wrong product administered and product administered to patient of inappropriate age. (latency: same day). It was reported "HCP (Healthcare Professional) stated FLUZONE HIGH DOSE QUADRIVALENT was given to a consumer under 65 and wanted to know if there was any data? Pharmacist stated that two patients under age 65 had inadvertently been administered the Fluzone High-Dose Quadrivalent vaccine". 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: 1793451
Sex: M
Age: 69
State: KY

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/16/2021
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: received a vaccination of fluzone high-dose quadrivalent after the physician was informed that it was no longer suitable for use/ no AE; Initial information was received on 01-OCT-2021 regarding an unsolicited valid non-serious case received from a Physician (Reference number- 00794512) and transmitted to Sanofi on 01-OCT-2021. This case involves a 69-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] after the physician was informed that it was no longer suitable for use with no adverse event (Product administration error). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 27-Sep-2021, the patient received a 0.7 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ748AA and expiry date 30-Jun-2022] via unknown route in unknown administration site for prophylactic vaccination. It was reported "Caller states that a patient received a vaccination of FLUZONE HIGH-DOSE QUADRIVALENT on 27SEP2021 after the physician was informed that it was no longer suitable for use." It was a case of actual medication error due to Drug administration error (latency was on same day). At the time of reporting, patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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: 1793452
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 10/02/2021
Rec V Date: 10/16/2021
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: fever; rash on his face; throwing up; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case received from a Consumer via Regulatory authority (Reference number- 00796584) and transmitted to Sanofi on 04-Oct-2021. This case involves an 18-year-old male patient who experienced fever (pyrexia), rash on his face (rash) and throwing up (vomiting) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date the patient received dose (once) of suspect INFLUENZA QUADRIVAL A-B VACCINE (Solution for injection in pre-filled syringe) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination. On 02-OCT-2021 the patient developed a non-serious fever (pyrexia), rash on his face (rash) and throwing up (vomiting) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. He went to HCP on 03OCT2021 and had urine test, COVID test and was given a steroid which was not filled yet. Product used: Used. First time product used: No. It was not reported if the patient received any corrective treatment. At the time of report, the outcome of event was unknown. There will be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 1793453
Sex: M
Age: 59
State: IL

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
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: multiple excurion occured during shiping time with no adverse event; Initial information received on 04-Oct-2021 regarding an unsolicited valid non-serious case received from a nurse and non-healthcare profession and non-healthcare professional via [Regulatory authority (reference -00797286]. This case involves a 59 years old male patient who vaccinated INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] which went on multiple temperature excursions (product storage error). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On 04-Oct-2021, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number QFAA2121 expiry date 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was reported "Nurse practitioner reports that she received a delivery of FLUBLOK today 04OCT2021; states it was shipped 01OCT2021, and she received a message from Sanofi stating that her product was in shipment for too long and it was not viable for use. Nurse practitioner states that when she received this message, she had already administered FLUBLOK to one patient; asks if there are any recommendations after FLUBLOK is administered post-excursion." It was a case of actual medication error due to incorrect product storage (latency was on same day). At the time of reporting, no adverse event reported. Outcome of event was unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1793456
Sex: F
Age: 73
State: MA

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
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: trouble swallowing her saliva; About 10 minutes after administration, experienced tingling in her tongue, that started at the tip of tongue and then moved back towards middle of tongue, sensation continued to at least half way to the back of her tongue; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/ non health care professional (Reference number- 00798748). This case involves a 73-year-old female patient who experienced about 10 minutes after administration, experienced tingling in her tongue, that started at the tip of tongue and then moved back towards middle of tongue, sensation continued to at least half way to the back of her tongue (paraesthesia oral) and trouble swallowing her saliva (dysphagia) after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 28-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry date: not reported) (Frequency: once) via intramuscular route in the left arm for prophylactic vaccination. On 28-Sep-2021, the patient developed a non-serious about 10 minutes after administration, experienced tingling in her tongue, that started at the tip of tongue and then moved back towards middle of tongue, sensation continued to at least half way to the back of her tongue (paraesthesia oral) and trouble swallowing her saliva (dysphagia) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported "The patient would like to know the difference between the ingredients from this years FLUZONE HD vaccine and the ingredients in the previous FLUZONE HD vaccine from 2019. " Details of laboratory data not reported. The patient was treated with 100 mg BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] (patient took this on her own). At the time of reporting, the outcome of events were reported as unknown. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1793457
Sex: F
Age: 30
State: PA

Vax Date: 10/05/2021
Onset Date: 10/05/2021
Rec V Date: 10/16/2021
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: Product leaked out from the back of the barrel with no adverse event; Product leaked out from the back of the barrel onto her hands and the floor with no adverse event; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case from an other health care professional (under the reference 00798927). This case involves a 30 year old female patient who had INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] leaked out from the back of the barrel (device leakage) and onto her hands and the floor (exposure via skin contact). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 05-Oct-2021, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (lot UJ764AC and expiration date: 30-jun-2022) via unknown route in an unknown administration site for prophylactic vaccination It was an actual medication error due to device leakage and exposure via skin contact (same day latency). At time of reporting, the outcome was unknown for the reported 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 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: 1793460
Sex: M
Age:
State: NM

Vax Date: 10/19/2020
Onset Date: 10/05/2021
Rec V Date: 10/16/2021
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: Patient had 3 other doses of flu vaccines given in the past year / NO AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Regulatory authority (Reference number- 00799351) and transmitted to Sanofi on 05-Oct-2021. This case involves a 73 years old male patient who administered 3 other doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] in the past year (inappropriate schedule of product administration). The patient's past medical treatment, vaccination, concomitant medication and family history were not provided. At the time of the event, the patient had ongoing Memory impairment. On 19-Oct-2020, 06-Feb-2021, 06-Mar-2021, 05-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ764AC and expiry date: 30-JUN-2022) via an intramuscular at an unknown administration site for prophylactic vaccination. It was an actual medication error due to inappropriate schedule of vaccine administered (latency: same day). It was reported "Patient was given FLUZONE HD QIV on 05Oct2021, and practice found out afterwards he has had 3 other doses of flu vaccines administered in the past year. The original dose was given by the practice on 19Oct2020, with the two following on 06Feb2021 and 06Mar2021, which were not administered by the practice." HCP states that patient also received 2 flu vaccines in 2018. At the time of reporting, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness: Memory disturbance

ID: 1793464
Sex: M
Age: 59
State: ME

Vax Date: 10/05/2021
Onset Date: 10/05/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20211005; Test Name: home antigen Covid-19 test; Test Result: Negative

Allergies:

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

Symptoms: severe sweats; Lots of myalgias; headache; Felt febrile; shaking chills; prodrome to a minor respiratory illness; stuffy nose; Initial information was regarding an unsolicited valid non serious case was received from a physician (Reference number- 00800817) and transmitted to Sanofi on 06-Oct-2021. This case involves a 59-years-old male patient who experienced serious prodrome to a minor respiratory illness (respiratory disorder), severe sweats (night sweats), myalgia, headache, felt febrile (pyrexia), shaking chills (tremor), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's past medical treatment included TOZINAMERAN. The patient's past vaccination(s) included INFLUENZA VACCINES and COVID-19 VACCINE. The patient's medical history, concomitant medication and family history were not provided. On 05-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (once, Suspension for injection, lot number and expiry date not reported) via an unknown route in the left deltoid for prophylactic vaccination. On 05-Oct-2021, the patient developed non-serious prodrome to a minor respiratory illness (respiratory disorder) and stuffy nose (nasal congestion) (same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 06-Oct-2021, the patient developed non-serious severe sweats (night sweats), myalgia, headache, felt febrile (pyrexia), shaking chills (tremor) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Relevant laboratory test results included: SARS-CoV-2 test (severe acute respiratory syndrome coronavirus)- On 05-Oct-2021: Negative It was not reported if the patient received any corrective treatment for the events. It was reported "about 6 hours after receiving his flu shot yesterday, he experienced a stuffy nose that seemed like a prodrome to a minor respiratory illness. He went to bed and woke up around 02:00 with severe sweats, shaking chills, lots of myalgias, headache, and felt febrile. He believes the symptoms are related to the flu shot, but it seems very peculiar to him since he has not experienced reactions to flu shots before now. He said, I thought that this seemed like a robust reaction to a flu vaccine. He now feels fine". On an unknown date, the patient was recovered from the events. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1793465
Sex: M
Age: 72
State: PA

Vax Date: 09/17/2021
Onset Date: 10/06/2021
Rec V Date: 10/16/2021
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 received two FLUZONE HIGH DOSE vaccinations within few weeks with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional and consumer/non-health care professional (Reference number- 00800876) and transmitted to Sanofi on 06-Oct-2021. This case involves a 72-year-old male patient who received two vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within few weeks one on 17-Sep-2021 and another on 06-Oct-2021 (extra dose administered). The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On 17-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [via an unknown route at an unknown administration site]. On 06-Oct-2021 he also received a dose of the same vaccine [frequency: once, strength: standard, dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin test(TB) skin test 0.7ml, lot UJ716AB, expiry date: 30-Jun-2022 via an intramuscular route at an the left arm] for prophylactic vaccination. It was an actual medication error case due to extra dose administered (latency: same day). It was reported ''Patient received two FLUZONE HIGH DOSE vaccinations, one on 17Sep2021 and 06Oct2021. Caller states the wife called since he came to the doctor's office by himself and he didn't realize he had already had the vaccine. Caller states he has never had any side effects from the past vaccine and she didn't report any this time.'' 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: 1793467
Sex: M
Age: 78
State:

Vax Date: 10/06/2021
Onset Date: 10/06/2021
Rec V Date: 10/16/2021
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: A patient was received expired FLUZONE HIGH-DOSE QUADRIVALENT with no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via consumer/non-health care professional via Medical Information (Reference number- 00801040) and transmitted on 06-Oct-2021. This case is linked to case 2021SA334081 (same reporter). This case involves a 78-year-old male patient who was received expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 06-Oct-2021, the patient received a first dose (0.7 ml) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ454AB, expiry: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). It was reported "Nurse calling in regards to expired FLUZONE HIGH-DOSE QUADRIVALENT (QIV HD) being administered to two patients. Caller would like to know how to proceed and if there is a safety issue." 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. 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: 1793468
Sex: F
Age: 57
State: MD

Vax Date: 10/01/2021
Onset Date: 10/05/2021
Rec V Date: 10/16/2021
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: COVID; congestion; headache; fever; fatigue; aches; sore throat; Initial information received on 06-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non health care professional via Regulatory Authority (under the reference 00801151). This case involves a 57 years old female patient who had covid (covid-19) [Coronavirus Disease] after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 01-Oct-2021, the patient received a dose of suspect FLUZONE QUADRIVALENT (0.5 ml, lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On 05-OCT-2021 the patient developed a serious covid [Coronavirus Disease] (covid-19), congestion (pulmonary congestion), headache, fever (pyrexia), fatigue, aches (pain) and sore throat (oropharyngeal pain), four days later following the administration of vaccine. This all events was assessed as medically significant. No laboratory data reported. The patient was treated with ACETAMINOPHEN and fluids. At time of reporting, the outcome was unknown for the reported events. It was reported "Caller states that symptoms started 05-oct-2021 and she went in this morning and diagnosed with rapid test she is still waiting on pcr (polymerase chain reaction) test. Caller states that she is vaccinated for covid (Coronavirus Disease)." Batch number requested.; Sender's Comments: This case concerns a 57-year-old female patient who had covid-19 [Coronavirus Disease] after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible. However, patient's medical condition at the time of vaccination 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:

ID: 1793471
Sex: M
Age:
State: CO

Vax Date: 10/03/2021
Onset Date: 10/03/2021
Rec V Date: 10/16/2021
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: a 6 year old patient was given FLUBLOK with no AE; 6 year old inadverntly got the FLUBLOK instead of Fluzone Quadrivalent with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from physician via agency (Reference number- 00802581) and transmitted to Sanofi on 07-Oct-2021. This case involves a 6-year-old male patient who experienced 6 year old inadverntly got the flublok instead of fluzone quadrivalent (wrong product administered and product administered to patient of inappropriate age) while receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient medical history, medical treatment(s), vaccination(s), concomitant medication, 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 an unknown route in unknown administration site for prophylactic vaccination. On 03-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 an intramuscular route in the left deltoid for prophylactic vaccination. It was a case of actual medication error due to wrong product administered (On 03-Oct-2021) and product administered to patient of inappropriate age [Latency: on the same day]. 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. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1793472
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: A 14-year-old patient received a dose of FLUBLOK no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional (Reference number- 00802604) and transmitted to Sanofi on 07-Oct-2021. This case involves a 14-year-old female 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), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. It was a case an actual medication error due to inappropriate age at vaccine administration (latency same day). It was reported "Caller states that FLUBLOK has been administered to a patient under the age of 18; the patient is 14 years of age female; caller would like to know about adverse effects to look out for and if/when the proper flu vaccine can be administered" 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: 1793473
Sex: U
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: refrigerator door was left open. Products were exposed to a maximum of 57.2 degree Fahrenheit for a duration of 12 hours with no adverse event; Initial information received on 07-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves no identifiable patient and it was reported that refrigerator door was left open. products were exposed to a maximum of 57.2 degree Fahrenheit for a duration of 12 hours with no adverse event (product storage error). Product included: Insulin glargine [Toujeo] (batch number and expiry date unknown). On an unknown date (latency unknown), it was reported that a refrigerator door was left open. Products were exposed to a maximum of 57.2 degree Fahrenheit for a duration of 12 hours (product storage error). Action taken with suspect drug was not applicable. No corrective treatment was received. At the time of report, event outcome was unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. There will be no information available on the batch number for this case No further relevant information was reported

Other Meds: LANTUS SOLOSTAR; TOUJEO; LANTUS VIAL

Current Illness:

ID: 1793476
Sex: F
Age: 15
State: TN

Vax Date: 09/25/2021
Onset Date: 09/25/2021
Rec V Date: 10/16/2021
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: FLUBLOK was mistakenly administered to an underage patient with no adverse event; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via consumer via physician via phone (Inquiry Number: 00804698). This case involves a 15-years old female patient who was mistakenly administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] with no adverse event (product administered to patient of inappropriate age). The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On 25-Sep-2021, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number: UJ723AA and expiry date: 30-Jun-2022 via intramuscular route in the right deltoid for prophylactic vaccination. It was of actual medication error due to inappropriate age at vaccine administration (latency: same day). It was reported "FLUBLOK was mistakenly administered to an underage patient, caller would like to know safety and how to proceed." 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: 1793477
Sex: M
Age:
State: FL

Vax Date: 08/21/2021
Onset Date: 08/21/2021
Rec V Date: 10/16/2021
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: Patient received FLUZONE QUADRIVALENT instead of FLUZONE HIGH-DOSE QUADRIVALENT/ no adverse event; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case from non-healthcare professional via call center via agency (Reference number- 00804783). This case involves a 65 years old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered) and (underdose). The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On 21-Aug-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) instead of 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 of actual medication error due to wrong vaccine administered and vaccine underdose (latency: same day). At the time of reporting, no adverse event reported. It was reported "The caller states that since he turned 65 they have given him the high dose flu vaccine every year because it has more of the antigen and there is not any question that the high dose is better. He states that there was a different pharmacist there that did not administer the high dose flu vaccine to him but they were more than willing to give him a second dose but he wanted to check on getting a second dose first." 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: 1793478
Sex: M
Age:
State: MD

Vax Date:
Onset Date: 10/07/2021
Rec V Date: 10/16/2021
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: 4 month old was inadvertently given a FLUZONE QUADRIVALENT with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via (Reference number- 00804995). This case involves a 4-month-old male patient who was inadvertently given a INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (off label use). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ). On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7347NA and expiry date: 30-Jun-2022] strength: standard via an intramuscular route in left thigh for prophylactic vaccination. On 07-Oct-2021, the patient inadvertently received a dose of fluzone quadrivalent(Off label use in unapproved age group) (Latency same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Laboratory details were not reported. 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.

Other Meds: PENTACEL; PREVNAR; ROTATEQ

Current Illness:

ID: 1793481
Sex: F
Age:
State: KS

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: A 7-year-old patient received FLUBLOK QIV vaccine with no AE; The nurse advised that the colors used for Flublok are similar to the colors used for Fluzone Quadrivalent no AE; Flublok are similar to the colors used for Fluzone Quadrivalent no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via consumer/non-health care professional via agency (Reference number- 00805127) and transmitted to Sanofi on 08-Oct-2021. This case is linked to case 2021SA339055 (same reporter). This case involves a 7-year-old female patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age), instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered) as FLUBLOK QIV and FLUZONE QUADRIVALENT are similar to the colors (Product appearance confusion). 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 QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2128, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. It was case of actual medication error due to inappropriate age at vaccine administration, wrong vaccine administered and product appearance confusion (latency same day). It was reported "Two children under the age of 18 years old were administer with Flublok. The nurse (reporter) advised the Sanofi Representative that the colors used for Flublok are similar to the colors used for Fluzone Quadrivalent. It was reported that the children's parents have been notified. Both children were administered a dose from the same lot number." 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: 1793482
Sex: M
Age: 12
State: IA

Vax Date: 09/20/2021
Onset Date: 09/20/2021
Rec V Date: 10/16/2021
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: patient received DAPTACEL instead of ADACEL with no reported AE; 11 year patient received DAPTACEL instead of ADACEL with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from the pharmacist via Medical Information (Reference number- 00805147) and transmitted to Sanofi on 08-Oct-2021. This case involves a 11-year-old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [(wrong product administered) and (product administered to patient of inappropriate age)]. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for prophylactic vaccination. On 20-Sep-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection, lot number: C5743AA, expiry date unknown) via intramuscular route in the left deltoid instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) for prophylactic vaccination. It was case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day). It was reported "patient received DAPTACEL instead of ADACEL patient was 11 years old". At the time of this 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 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: FLUZONE QUADRIVALENT; MMR VACCIN; VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]

Current Illness:

ID: 1793485
Sex: F
Age:
State: GA

Vax Date: 10/06/2021
Onset Date: 10/06/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20211006; Test Name: Blood pressure; Result Unstructured Data: around 170/91; Test Date: 20211006; Test Name: body temperature; Test Result: 100 {DF}

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: strange feeling run up left arm and into neck and lower face, then legs had that same feeling/feeling yucky all over; blood pressure has been elevated; light headed; general malaise; fatigue; had temperature of 100.0 Farad; Initial information was received on 11-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via Regulatory authority (under reference 00806707). This case involves a 69-year-old female patient who had strange feeling run up left arm and into neck and lower face, then legs had that same feeling/feeling yucky all over (feeling abnormal), blood pressure has been elevated (blood pressure increased), light headed (dizziness), general malaise (malaise), fatigue, had temperature of 100.0 farad (pyrexia), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. At the time of the event, the patient had ongoing hypertension. She takes medication for high blood pressure and it runs normally. On 06-Oct-2021, the patient received a dose of 0.7mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once, lot number and expiry date were not reported) via intramuscular route in the left arm for prophylactic vaccination. On 06-Oct-2021, the patient developed non-serious strange feeling run up left arm and into neck and lower face, then legs had that same feeling/feeling yucky all over (feeling abnormal), blood pressure has been elevated (blood pressure increased), light headed (dizziness), general malaise (malaise), fatigue, had temperature of 100.0 farad (pyrexia) (on the same day), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported "the caller stated that she received the FLUZONE HIGH-DOSE QUADRIVALENT vaccine on 6 OCT 2021. The caller stated that she heard a noise coming from the syringe during the injection. The caller stated that she experienced side effects after receiving the injection. The callers stated that immediately after she received her injection she had a strange feeling run up her left arm and into her neck and lower face, then her legs had that same feeling. She could not describe the feeling, she denied pain or numbness. Then she started feeling yucky all over and light headed. That evening she had temperature of 100.0 Farad. They did call her Doctor and was told to take tylenol. Her temperature was normal the next morning but the general malaise/fatigue has continued and the yucky feeling. She wants to know when the symptoms will go away, could the way the vaccination was given cause these symptoms. She said that she always gets flu shots but has never felt this way before. She also said that her blood pressure has been elevated. She takes medication for high blood pressure and it normally runs 130/? but since since the vaccination it has been around 170/91. She also stated that when she was given her injection she also heard a gurgling noise come from the pre-filled syringe." Relevant laboratory test results included: Blood pressure measurement - On 06-Oct-2021: [around 170/91] Body temperature - On 06-Oct-2021: 100 Farad The patient was treated with PARACETAMOL (TYLENOL). On 07-Oct-2021, the patient was recovered from the event pyrexia but the outcome was unknown for the rest of events. There will be no information available on the lot number for this case.

Other Meds:

Current Illness: Blood pressure high (She takes medication for high blood pressure and it normally runs)

ID: 1793486
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: The patient received FLUZONE QUADRIVALENT, but the patient was requesting Fluzone High-Dose quadrivalent no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via agency (Reference number- 00806883) and transmitted to Sanofi on 11-Oct-2021. This case involves a patient (unknown demographics) who was received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], but the patient was requested for INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered). 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 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiry not reported, formulation: solution) via unknown route in unknown administration site for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. It was a case of actual medication error due to wrong vaccine administered (latency same day). It was reported "pharmacist reporting that during a flu clinic the patient received FLUZONE QUADRIVALENT, but the patient was requesting Fluzone High-Dose (HD) quadrivalent. The pharmacist wanted to know if the same composition was in both formulations and if a person could receive more that one Fluzone inoculation to meet the Fluzone HD." No other 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: 1793489
Sex: U
Age:
State: NY

Vax Date: 10/11/2021
Onset Date: 10/11/2021
Rec V Date: 10/16/2021
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: patient had received fluzone quadrivalent instead of fluzone hd, with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a pharmacist via agency(Reference number- 00807239) and transmitted to Sanofi on 11-Oct-2021. This case involves an unknown demographic patient (unknown age and unknown gender) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (wrong product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 11-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B 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 wrong product administered (latency: same day). It was reported patient came in today to receive FLUZONE HD, but received FLUZONE QUADRIVALENT (prefilled syringe) instead. 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: 1793493
Sex: M
Age:
State: MD

Vax Date: 10/08/2021
Onset Date: 10/08/2021
Rec V Date: 10/16/2021
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: Patient was administered an expired vaccine with no reported A/E; Initial information was received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a physician via consumer (Regulatory authority Inquiry Number: 00807266). This case involves a 74- years old male patient who was administered an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (expired product administered). The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided. On 08-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ469AA and expiry date: 2021 via unknown route in unknown administration site for prophylactic vaccination. It was case of an actual medication error due to expired vaccine used (latency: same day). It was reported "There are no side effects but since it's a different formulation, do we advise to give the 21-22 version. How long should we wait. The nurse who administered the vaccine wrote the expiration down and put expired next to it, and then proceeded to administer the vaccine. The physician stated that her facility would be documenting the event as an incident report. The patient is fine." 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: 1793495
Sex: F
Age: 69
State: VA

Vax Date: 09/30/2021
Onset Date: 09/30/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore arm; she felt weak, she felt "off" for the entire rest of the day; she looked a "cooked lobster" (she turned red); metallic taste at the back of her tongue; Initial information was regarding an unsolicited valid non serious case was received from a consumer/non-healthcare professional (Reference number- 00807402) and transmitted to Sanofi on 11-Oct-2021. This case involves a 69-year-old female patient who experienced she looked a cooked lobster (she turned red) (erythema), metallic taste at the back of her tongue (dysgeusia) and she felt weak, she felt off for the entire rest of the day (asthenia) and sore arm (pain in extremity), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 30-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ702AB, expiry date unknown) via an unknown route at an unknown administration site for prophylactic vaccination. On 30-Sep-2021 the patient developed non-serious she looked a cooked lobster (she turned red) (erythema), metallic taste at the back of her tongue (dysgeusia) and she felt weak, she felt off for the entire rest of the day (asthenia) (on the same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. On an unknown date, the patient developed non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Details of laboratory data not reported. It was not reported if the patient received any corrective treatment for the events. It was reported "she received the Fluzone high dose vaccine on 30sep2021.The caller reported a metallic taste at the back of her tongue, that she felt weak, and husband said she looked a cooked lobster (she turned red). The caller reported that the metallic taste lingered for a while and she felt off for the entire rest of the day. Caller states that she had a reaction after getting the flu shot and she has never had a reaction before other than getting a sore arm". At time of reporting, the outcome was unknown for the events.

Other Meds:

Current Illness:

ID: 1793496
Sex: U
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: hives; Initial information was regarding an unsolicited valid serious case was received from a pharmacist (Reference number- 00809510) and transmitted to Sanofi on 12-Oct-2021. This case involves an unknown demographic (unknown age and unknown gender) patient who experienced hives (urticaria), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a 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. On an unknown date, the patient developed non-serious hives (urticaria) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Details of laboratory data not reported. It was not reported if the patient received any corrective treatment for the event. It was reported "his personal physician contacted him to say a patient had hives from the Fluzone High Dose this year and has received the product in years past without any issues". At time of reporting, the patient was unknown for the event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1793497
Sex: F
Age:
State:

Vax Date: 09/27/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Renal Function; Result Unstructured Data: Renal function is fine

Allergies:

Symptom List: Pain in extremity

Symptoms: Periorbital (around both eyes) swelling; This spontaneous case was received on 29-Sep-2021 from a physician (reference number: SEQW21-02925) with additional document (being process together) received on 02-Oct-2021 from a pharmacist (reference number: SEQW21-03183) and concerned a female patient of an unreported age. The patient's medical history and concomitant medications were not reported. On 27-Sep-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; anatomical location: left deltoid, route of administration, indication, dose: not reported). The batch number was not reported. On an unspecified date in Sep-2021, unknown amount of time after receiving Afluria Quadrivalent, the patient developed a periorbital swelling around both eyes. The patient had no fever and no pain to site. On an unspecified date in 2021, the patient visited physician for observation and complete blood count (CBC) and renal function test were performed, and her renal function was fine. The patient was advised that periorbital swelling was most likely not the flu shot but an allergic reaction to mascara or something and the patient was advised to change mascara. At the time of initial reporting on 29-Sep-2021, the patient was recovering from the event, as her swelling was almost resolved. The reporter did not provide a causality assessment. As reported, it was most likely not the flu shot but an allergic reaction to mascara or something. This case is linked with case 202103663 (due to the same reporter). Company comment: On 27-Sep-2021, a patient was vaccinated with Afluria Quadrivalent. On an unspecified date in Sep-2021, unknown amount of time after receiving Afluria Quadrivalent, the patient developed a periorbital swelling around both eyes. The patient visited physician for observation and was advised that periorbital swelling was most likely not the flu shot but an allergic reaction to mascara or something. Causal role of the suspect vaccine cannot be excluded. However, due to unclear temporal relationship and diagnostic findings, causality is unassessable.; Reporter's Comments: As reported, this was most likely not the flu shot but an allergic reaction to mascara or something.; Sender's Comments: On 27-Sep-2021, a patient was vaccinated with Afluria Quadrivalent. On an unspecified date in Sep-2021, unknown amount of time after receiving Afluria Quadrivalent, the patient developed a periorbital swelling around both eyes. The patient visited physician for observation and was advised that periorbital swelling was most likely not the flu shot but an allergic reaction to mascara or something. Causal role of the suspect vaccine cannot be excluded. However, due to unclear temporal relationship and diagnostic findings, causality is unassessable.

Other Meds:

Current Illness:

ID: 1793498
Sex: F
Age: 42
State:

Vax Date: 09/30/2021
Onset Date: 09/30/2021
Rec V Date: 10/16/2021
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: The injection site has a cellulitis reaction, three and half inches long. Redness and hot to the touch. Physician states it hurts a lot; Physician states that when pharmacist pulled out the vaccine it dripped some content out of arm; Physician states that she was given the vaccine subcutaneously or intradermally; This spontaneous case was received on 01-Oct-2021 from a physician via agency (reference number: SEQW21-03131) with additional document (being process together) received on the same date and concerned a 42-year-old, female patient. The patient had no relevant medical history and was not taking any concomitant medications. The patient never had a reaction to flu vaccine. On 30-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: subcutaneous or intradermal, anatomical location: deltoid) (explicitly coded as 'Inappropriate route od administration') for influenza prophylaxis. The batch number reported was 309613 and expiry date 25-Jun-2022. On the same date, after the pharmacist pulled out the vaccine, it dripped some content out of arm. The patient stated she believed the vaccine was given subcutaneously or intradermally instead of intramuscularly. The vaccine was not leaking prior to administration. On the same day, after receiving Flucelvax Quadrivalent, the patient developed a cellulitis reaction on injection site, three and half inches long which was red, hot and to the touch. Additionally, the patient stated that it hurt a lot. The patient was treated with compresses. At the time of initial reporting, it was warm to the touch. The outcome of the events was not reported. The reporter assessed the event of 'vaccination site cellulitis' to be related to Flucelvax Quadrivalent and did not provide causality assessment for the event of 'vaccination site extravasation' The reporter assessed the case as non-serious. Company Comment: A 42-year-old, female patient developed vaccination site cellulitis on the same day after vaccination with the suspect product Flucelvax Quadrivalent. Vaccination site extravasation was also reported. Vaccine was administered subcutaneously or intradermally (explicitly coded as 'Inappropriate route od administration'). Causality for this event is assessed as not related as per company specific guidelines. Causality for the remaining two events is assessed as possibly related, although confounded by inappropriate route od administration.; Sender's Comments: A 42-year-old, female patient developed vaccination site cellulitis on the same day after vaccination with the suspect product Flucelvax Quadrivalent. Vaccination site extravasation was also reported. Vaccine was administered subcutaneously or intradermally (explicitly coded as 'Inappropriate route od administration'). Causality for this event is assessed as not related as per company specific guidelines. Causality for the remaining two events is assessed as possibly related, although confounded by inappropriate route od administration.

Other Meds:

Current Illness:

ID: 1793528
Sex: M
Age: 23
State:

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/16/2021
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: Whole body muscle pain, lymph node swelling and pain, chest pain, difficulty breathing, difficulty sleeping, headache, light sensitivity

Other Meds: Celexa

Current Illness:

ID: 1793529
Sex: F
Age: 41
State: NY

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: none

Allergies: Folic MTHFR

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

Symptoms: extremely heavy bleeding as if there were a miscarriage -- and not at the appropriate time for my period.

Other Meds: None

Current Illness: None

ID: 1793530
Sex: F
Age: 65
State: MI

Vax Date: 09/25/2021
Onset Date: 09/25/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Vomiting

Symptoms: I had a terrible headache which started about an hour after the injection and lasted for 3 days. I had a sore arm for two weeks which was hard to move. I started having a brain fogginess and vertigo (that leads to nausea), and fatigue within 24 hours after the vaccine and it has continued to this day which is 21 days ago. It comes and goes especially when I look up or down/ side to side quickly. I have not seen my doctor yet (appointment upcoming) but I am not planning on getting the second vaccine d/t these reactions.

Other Meds: None

Current Illness: None

ID: 1793531
Sex: F
Age: 63
State: KY

Vax Date: 10/13/2021
Onset Date: 10/14/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: None

Allergies: Pcn

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Swelling, pain snd rash around injection site. Shoulder pain, stiff neck and headaches

Other Meds: Multi vitamins Synthroid Caltrate Zyrtec Cymbalta

Current Illness: None

ID: 1793532
Sex: F
Age: 53
State: PA

Vax Date: 04/17/2021
Onset Date: 04/24/2021
Rec V Date: 10/16/2021
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: Hair loss starting roughly one to two weeks after first injection. The hair loss is evenly distributed over my head. I have probably lost at least 50% of my hair. I continue to shed an unusually large amount of hair daily.

Other Meds: Synthroid, 150 mcg daily

Current Illness:

ID: 1793533
Sex: F
Age: 30
State: NY

Vax Date: 09/11/2021
Onset Date: 10/02/2021
Rec V Date: 10/16/2021
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: PCP visit on 10/7/2021 for chest pain, dizziness, shortness of breath. EKG performed, which showed normal findings. Blood work drawn, showing negative finding. ER visit on 10/11 with all normal finding and lab results for cardiac issues and blood clots.

Allergies: Sudafed, nuts, shellfish

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Series 1 Pfizer vaccine administration date 9/11/2021. Series 2 Pfizer vaccine administration date 10/2/2021. Chest pain, Shortness of breath, Left arm tingling, and left back pain between shoulder Blades occurring 48hrs after 2 dosage of vaccine. Day 6 after vaccine: Brain fog, extreme fatigue, dizziness, SOB, head tension, cognitive defects (confusion, Slower thought process, short term memory loss), jumping eyes Day 10 after vaccine: vertigo, dizziness, nausea, jumping eyes, cognitive defects persist, fatigue, slight joint and, muscle aches.

Other Meds: Multivitamin

Current Illness: None

ID: 1793534
Sex: M
Age: 65
State: NE

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: None

Allergies: Cat scan dye, hornet venom, Celebrex

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

Symptoms: Injection site pain and swelling same day. work to high fever, body aches, chills, injection site pain and swelling, chills

Other Meds: Generic Caduet 10/80, Metroprolol Succinate 200, Allopurinol 300, Quinapril Hal 10, Aleve,Low dose aspirin 81. All in mg once daily dose.

Current Illness: None

ID: 1793535
Sex: F
Age: 51
State: MD

Vax Date: 04/09/2021
Onset Date: 04/10/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Ultrasound- May 2021 Vagina exam- April, May, July, August, September, October Hysteroscopy type procedure and biopsy May in gyecologist Office blood work April, May, June, D&C and Uterine Ablation with Biopsy October 6.2021

Allergies: none

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

Symptoms: Heavy vaginal bleeding with large clots. After 7 days, it wasn't letting up and I was having difficulty breathing. Consulted gynecologist and bloodwork, which revealed the blood loss caused iron deficiency and very low red blood cells. Doctor did testing, including internal exam and ultrasound. Unable to identify why this was happening and had never happened to me in my life. Prescribed Medroxyprgesterine and later norethindrone, progesterone IUD as well to try to slow the blood loss. This lessened blood loss, but I was still bleeding. She later prescribed premarin, which still didn't stop the bleeding. This lasted for 6 MONTHS! I just had a D&C and an ablation procedure - outpatient surgery. The surgery was a little over a week ago. So far bleeding has stopped. Still healing.

Other Meds: Zyrtek Iron Fluoxetine

Current Illness: none

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am