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: 1813032
Sex: F
Age: 80
State:

Vax Date: 09/22/2021
Onset Date:
Rec V Date: 10/23/2021
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: achy; tired; Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves an 80-year-old female patient who had achy (pain) and tired (fatigue), after receiving INFLUENZA VACCINE and MODERNA COVID-19 VACCINE. The patient's past medical history included feeling abnormal. The patient reported that she had not been feeling good. At the time of the event, the patient had ongoing secondary pulmonary arterial hypertension. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included WARFARIN SODIUM. On 22-Sep-2021, 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 in March and April, the patient received a dose of suspect MODERNA COVID-19 VACCINE not produced by Sanofi Pasteur (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 achy (pain) and tired (fatigue) (unknown latency) following the administration of INFLUENZA VACCINE and MODERNA COVID-19 VACCINE. It was reported "On an unreported date, the patient experienced events of achy (pain) and tired (fatigue). Co-suspect included Moderna COVID vaccine (elasomeran) and Flu shot (influenza vaccine). The patient reported that she had not been feeling good (feeing abnormal previously reported). She received the Moderna COVID vaccine in March and April and the Flu shot on 22 Sep 2021." It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received any corrective treatment for the events. At time of reporting, the outcome was unknown for both the events. There will be no information available on the lot number for this case.

Other Meds: WARFARIN SODIUM

Current Illness: Secondary pulmonary arterial hypertension

ID: 1813033
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: body temperature; Test Result: 99.1 {DF}; Result Unstructured Data: 99.1

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Achy and tummy hurt not sick; I got the flu; headache; chills; very low fever 99.1; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional. This case involves a 65-year-old patient of unknown gender who had achy and tummy hurt not sick (abdominal pain), i got the flu (influenza), headache, chills, very low fever 99.1 (pyrexia), 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 achy and tummy hurt not sick (abdominal pain), i got the flu (influenza), headache, chills, very low fever 99.1 (pyrexia), (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Hello, the following potential adverse event has been found on a public post for Flu Shot Fridays page. Since this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine. I have got the shot every year never got the flu I told my doctor I am not taking it because I think they are going to trick us and give us the one for the virus which I will not get the jab. So he assured me they cannot do that .so I got the flu shot.Sure enough I think I got the flu.I had a headache chills, Achy and tummy hurt not sick, very low fever99.1 nothing then the next day that afternoon I felt fine and the chills was not bad I just could not get warm.I feel asleep.If it was from that it was not bad at all.I have heard this year they are making it stronger for the elderly and I am 65." 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. On an unknown date (the next day) that afternoon, the patient was recovering from chills and was recovered from all other reported events. There will be no information available on the lot number for this case.

Other Meds:

Current Illness:

ID: 1813034
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: flu; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Medical information (under reference number - US-SA-SAC20211019001069). This case involves female patient (unknown age) who experienced flu (influenza), after receiving vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious flu (influenza) (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: 1813035
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Flu vaccination injury; Initial information was received on 15-Oct-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional. This case involves Adult (unknown gender) patient who experienced flu vaccination injury (vaccination complication) when received INFLUENZA VACCINE. The patient's past medical treatments, vaccinations, concomitant medication and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (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 vaccination injury (vaccination complication) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. 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. The event outcome was unknown for the event. There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an adult (unknown gender) patient who experienced vaccination complication (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1813036
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: He gets some what sick; Initial information was received on 17-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via the social media. This case involves male patient of unknown age who got somewhat sick (illness) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided. No concomitant medications were reported. 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 an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious event "gets somewhat sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Flu starts every year with the flu shots. What a coincidence. I have a friend who gets and every time he gets somewhat sick after it and spreads it around so we all get a share." It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were laboratory 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 would be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 1813037
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: I end up with the flu; Initial information received on 17-Oct-2021 regarding an unsolicited valid Social Media non-serious case from consumer/non-healthcare professional via Digital Media. This case involves patient (unknown age and gender) who had flu (influenza), after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination On an unknown date, the patient had flu (influenza, non-serious) (unknown latency) following the administration of vaccine. It was reported "Not getting it period everytime I get it I end up with the flu" It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were laboratory 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: 1813038
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Rash; swollen throat; Arm hurt for months, right arm never did come back to normal; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a Social Media via consumer/non-health care professional. This case involves a patient (unknown demographics) who had rash, swollen throat (pharyngeal swelling) and arm hurt for months, right arm never did come back to normal (pain in extremity) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed non-serious rash, swollen throat (pharyngeal swelling) and arm hurt for months, right arm never did come back to normal (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "I would rather not get a shot that's gonna make my arm hurt for months breaking out in a rash with swollen throat and misery for a month or two. My right arm never did come back to normal. The doctor for. 10 years retired and nobody knows where my records are to prove that I'm allergic." It was unknown if the patient experienced any additional symptoms/events It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the event pain in extremity was not resolved while outcome of other events were unknown. The reporter did not report the causality of events with suspect. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1813039
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: every time he gets some what sick after it; Initial information received on 17-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via Digital Media. This case involves a patient (unknown age and gender) who was sick (illness) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient was sick (illness, non-serious) (unknown latency) following the administration of vaccine. It was reported "Flu starts every year with the flu shots. What a coincidence. I have a fried who gets and every time he gets some what sick after it and spreads it around so we all get a share." It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were laboratory 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: 1813040
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: sickest; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media. This case involved adult patient who experienced sickest (illness) after receiving vaccine INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via unknown route at an unknown administration site for Prophylactic vaccination. On an unknown date the patient developed a non-serious sickest (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "patient had a swine flu shot in 1976, said it would be dire if we didn't, next day sickest I had ever been, none since and no flu either." It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the event sickest. At time of reporting, the outcome was unknown for the event sickest. There would be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1813041
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: No reactions other than a sore arm; Initial information received on 17-Oct-2021 regarding an unsolicited valid Social Media non-serious case received via a consumer/non-health care professional (under reference number: US-SA-SAC20211020001115). This case involves Adult and unknown gender patient who experienced no reactions other than a sore arm (pain in extremity) while 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, 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 non-serious no reaction other than a sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Got mine and covid (coronavirus disease) booster." It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome of event was reported as unknown. There will be no information on lot number for this case.

Other Meds:

Current Illness:

ID: 1813042
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: blind in one eye for almost 2 weeks; Initial information was received on 16-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional under (reference US-SA-SAC20211021000134). This case involves a female patient (unknown age) who experienced blind in one eye for almost 2 weeks (blindness unilateral) after received vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a serious blind in one eye for almost 2 weeks (blindness unilateral) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Social media, reporter's sister-in-law was blind in one eye for almost 2 weeks after the jab. Laboratory details were not reported. It was not reported if the patient received a corrective treatment for the event. On an unknown date, the patient recovered from the event (blindness unilateral). There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a female patient of (unknown age) who experienced blindness unilateral (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1813043
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Covid injection instead of flu shots with no adverse event; Initial information received on 16-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media. This case involved adult patient who received corona virus (covid ) injection instead of INFLUENZA VACCINE (wrong product administered). The patient medical history, 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 unknown route at an unknown administration site for Prophylactic vaccination. It was an actual medication error case due to wrong vaccine administered (latency: same day). It was reported "pharmacy gave a whole family the corona virus (covid) injection instead of flu shots." At the time of reporting, no adverse event was reported. This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error. There would be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1813044
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: never so sick in my life; Initial information received on 16-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via social media. This case involved unknown demographic patient (unknown age and gender) who experienced never so sick in my life (illness), after receiving vaccine INFLUENZA VACCINE. The patient medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious event never so sick in my life (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if there were lab data/results available. It was not reported if the patient received any corrective treatment for the event. It was reported "no flu or colds in 5 years, Google it, Kills viruses, had a flu shot once years ago. Never so sick in my life". 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: 1813045
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital: Y

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

Lab Data: Test Name: Body Temperature; Test Result: 104 {DF}; Result Unstructured Data: 104

Allergies:

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

Symptoms: 104 fever; pneumonia in lungs; so sick; Initial information was received on 18-Oct-2021 regarding an unsolicited valid serious case from a consumer/non-healthcare professional. This case involves a (unknown demographic) patient who experienced 104 fever (pyrexia), pneumonia in lungs (pneumonia) and so sick (illness) after receiving vaccine INFLUENZA VACCINE. The patient's past medical history included COVID-19 (Coronavirus disease 2019) with last year & body pushed it out like a common cold. The patient's past medical treatments, vaccinations, concomitant medication and family history were not provided. It was unknown if the patient had any concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and 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 104 fever (pyrexia), pneumonia in lungs (pneumonia) and so sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for these events. Pneumonia event was assessed as medically significant. It was unknown if the patient experienced any additional symptoms/events. Relevant laboratory test results included: Body temperature - On an unknown date: 104 An unknown corrective treatment was received for the events. The event outcome was unknown for the events. Lot number had been requested.; Sender's Comments: This case concerns a (unknown demographic) patient who experienced pyrexia, pneumonia and illness (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is past medical history included COVID-19 (Coronavirus disease 2019) was reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1813046
Sex: F
Age: 64
State: VA

Vax Date: 10/07/2021
Onset Date: 10/07/2021
Rec V Date: 10/23/2021
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: a 64 year old patient stated she was 65 years old received the FLUZONE HIGH DOSE QUADRIVALENT with no AE; a 64 year old patient stated she was 65 years old received the FLUZONE HIGH DOSE QUADRIVALENT with no AE; Initial information received on 08-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 64-year-old female patient for whom it was reported "64 year old patient stated she was 65 years old received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]" (product administered to patient of inappropriate age and overdose). The patient medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE). On 07-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ750AB, expiry date: 30-Jun-2022] via an intramuscular route in the left deltoid for prophylactic vaccination. It was case of actual medication error due to product administered to patient of inappropriate age and overdose [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.

Other Meds: COVID-19 VACCINE

Current Illness:

ID: 1813048
Sex: F
Age: 79
State: NJ

Vax Date: 10/08/2021
Onset Date: 10/08/2021
Rec V Date: 10/23/2021
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: face drooped; garbled speech; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional (patient's husband) via Medical Information (Reference number- 00806677) and transmitted to Sanofi on 11-Oct-2021. This case involves a 79-year-old female patient who experienced face drooped (facial paralysis) and garbled speech (dysarthria) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On 08-Oct-2021, the patient received 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On 08-Oct-2021 the patient developed a serious very-very, violent reaction as face drooped (facial paralysis) and garbled speech (dysarthria) same day (about an hour later) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. facial paralysis event was assessed as medically significant. Additionally, it was reported that fearing a stroke her husband called ambulance, the admitted her into the hospital and after about 2 hours of observation her stroke signs disappeared and she was discharged, she was instructed to follow up with a neurologist. No relevant laboratory data was provided. It was not reported if the patient received a corrective treatment for the events. Patient was recovered from both events on an unknown date. There will be no information available on the batch number for this case.; Sender's Comments: This case concerns 79-year-old female patient who experienced facial paralysis and dysarthria after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible with the role of the vaccine. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1813049
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Fluzone Quad was administered to a patient instead of the Fluzone HD with no AE; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender patient who administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered). 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 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination. 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 in unknown administration site for prophylactic vaccination. It was case of actual medication error due to wrong product administered [Latency: on the same day]. It was reported "caller stated that a nurse was supposed to administer FLUZONE HD to a patient, but instead administered FLUZONE QUAD". Details of laboratory data 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. At the time of report no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good 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: 1813050
Sex: U
Age:
State: KS

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: they were suppose to giving a HD, but gave a regular strength instead with no adverse event; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non healthcare professional via Media Information (under reference 00807032). This case involves a patient (unknown age and gender) who were suppose to receive a QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), but received a regular strength of QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) instead (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 dose of suspect FLUZONE QUADRIVALENT (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. It was an actual medication error due to wrong vaccine administered (same day latency). 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: 1813051
Sex: M
Age:
State: KS

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: A 10-year-old patient received FLUBLOK QIV with no AE; The nurse advised that the colors used for Flublok are similar to the colors used for Fluzone Quadrivalent no AE; Flubloks 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- 00807209) and transmitted to Sanofi on 11-Oct-2021. This case is linked to case 2021SA337747 (same reporter). This case involves a 10-year-old male 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 were 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: 1813052
Sex: M
Age: 66
State: GA

Vax Date: 10/05/2021
Onset Date: 10/01/2021
Rec V Date: 10/23/2021
Hospital: Y

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: blood pressure was also affected; difficulty with heart rate; cant think clearly; fatigue; head discomfort; nausea; diarrhea; get dizzy that night; headache; Initial information received on 11-Oct-2021 regarding an unsolicited valid serious case from a physician via non-healthcare professional/consumer via Regulatory authority (Reference number- 00807496). This case involves a 66 year old male patient who experienced get dizzy that night (dizziness), diarrhea (diarrhoea), difficulty with heart rate (heart rate abnormal), blood pressure was also affected (blood pressure abnormal), nausea, head discomfort, headache, fatigue and cant think clearly (mental impairment), after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's medical treatment included three weeks ago, the patient's doctors believed that the patient overdosed on Caffeine. However, he had fully recovered and that's why he was approved to get FLUZONE HD. The patient's past vaccination included COVID (coronavirus disease)-19 VACCINE in APR-2021. The patient's medical history, concomitant medication and family history were not provided. On 05-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: not reported) (Frequency: once) via an intramuscular route in the left arm for prophylactic vaccination. On 05-Oct-2021 (night), the patient developed a serious get dizzy (dizziness), on same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The next day, the dizziness became worse. The patient was hospitalized for this event. On 06-Oct-2021, the patient developed a serious diarrhea (diarrhoea), difficulty with heart rate (heart rate abnormal) and blood pressure was also affected (blood pressure abnormal), one day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient was hospitalized for these events. On 07-Oct-2021 (Thursday), the patient went to the hospital. He was given electrolytes and was released. On 09-Oct-2021 (Saturday), the patient developed a serious nausea and head discomfort, four days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient was hospitalized for these events. In Oct-2021, the patient developed a serious headache and fatigue, few days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient was hospitalized for these events. In Oct-2021, the patient developed a serious cant think clearly (mental impairment), few days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. He was discharged today. The patient has followed up with multiple doctors in his primary care office. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported events. Information on the batch number was requested.; Sender's Comments: This case involves a 66 year old male patient who had dizziness, diarrhoea, heart rate abnormal, blood pressure abnormal, nausea, head discomfort, headache, fatigue and mental impairment, after receiving FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. Medical treatment included the patient overdosed on Caffeine. The patient's past vaccination included COVID-19 VACCINE. Additional information regarding patient's medical history, condition at the time of the events, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of a vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1813054
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: A 5 month old patient received FLUZONE QIV vaccine no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via a consumer/non-health care professional via Medical Information (Reference number- 00808894) and transmitted to Sanofi on 12-Oct-2021. This case involves a 5 month old patient (unknown gender) who was received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE 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 QUADRIVAL A-B VACCINE (batch number and expiry not reported, formulation: pre-filled syringe) via unknown route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day). It was reported "Nurse manager calling in regard to FLUZONE quadrivalent (QIV) pre-filled syringe (PFS). Nurse would like to know if there are any studies or information available for administration to patients less than 6 months of age? Caller states they may have administered a dose to a 5 month old that is turning 6 months in 2 weeks, but they are unsure if it happened. Caller states they wanted preliminary information just in case it was administered. Caller also stated they do not have any patient or visit related information at this time." 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: 1813056
Sex: F
Age: 86
State: VA

Vax Date: 10/11/2021
Onset Date: 10/11/2021
Rec V Date: 10/23/2021
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: A patient who received a FLUZONE HIGH-DOSE QUADRIVALENT vaccine had already received a flu vaccine this season no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via consumer/non-health care professional via Regulatory Authority (Reference number- 00809130) and transmitted to Sanofi on 12-Oct-2021. This case involves an 86-year-old female patient who received a INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] had already received a flu vaccine this season [extra dose administered]. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included coronavirus disease-2019 (COVID-19) VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE) for prophylactic vaccination. On 11-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ747AC, expiry: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination. It was a case of an actual medication error due to extra dose administered (latency same day). It was reported "Pharmacist states that a patient who received a FLUZONE HIGH-DOSE QUADRIVALENT vaccination in her pharmacy may have already received a flu vaccine this season, according to the patient's daughter. Pharmacist asked if there was any information available on how to proceed if the patient did receive a second flu vaccine in 2021. Pharmacist states that her pharmacy only has records of the FLUZONE HIGH-DOSE QUADRIVALENT that was given to the patient on 11Oct2021, and that the patient may have received the other flu vaccine at a different location." 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: MODERNA COVID-19 VACCINE

Current Illness:

ID: 1813059
Sex: F
Age:
State: MS

Vax Date: 10/12/2021
Onset Date: 10/12/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: child moved her arm and a small amount of the liquid came out of injection site; Initial information regarding an unsolicited valid non-serious case was received from pharmacist and physician via Medical Information (Reference number- 00809341) and transmitted to Sanofi on 12-Oct-2021. This case involves a 5-year-old female child patient moved her arm and a small amount of the liquid came out of injection site (injection site extravasation) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On 12-Oct-2021, the patient received 0.5ml (total) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UT7330MA and expiry date: 30-Jun-2022) (Frequency = once) (Strength = standard) via intramuscular route in the left arm for prophylactic vaccination. On 12-Oct-2021 the child patient moved her arm, and a small amount of the liquid came out of injection site (injection site extravasation) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported "Caller (PharmD) (Doctor of pharmacy) requesting information regarding re-administration of FLUZONE QUADRIVALENT (Prefilled); caller states the facility administered a dose to a child (age 5/female) and as the injection was being done. Caller states that the guardian of the patient does not think that re-administration/re-vaccination is in order, but PharmD would like verification; all demographics obtained by MIA (manufacturing and importation authorization)". No relevant laboratory data was provided. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was not resolved for the event.

Other Meds:

Current Illness:

ID: 1813061
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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 got a partial dose of Fluzone HD with no adverse event; syringe leaked on her arm with no advese event; Initial information received on 13-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Agency (under the reference 00810589). This case involves a 67 years old female patient who got a partial dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (underdose) but syringe leaked on her arm (syringe issue). 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 FLUZONE HIGH-DOSE QUADRIVALENT (0.6 ml, lot UJ747AA and expiration date: 30-jun-2022) via unknown route in an unknown administration site for prophylactic vaccination. It was actual an medication error due to vaccine underose and syring leak (same day latency). It was reported "Consumer states that she just received the HD FLU vaccine 0.7 mL but when it was injected, the syringe leaked on her arm. The nurse thought it was a little bit but the consumer felt it was more than a little. she got a partial dose of Fluzone HD. She states the HCP said she felt she got 0.6 ml of the dose. The vaccine came out of the syringe and ran down her arm." 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 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: 1813063
Sex: F
Age:
State:

Vax Date: 10/07/2021
Onset Date: 10/07/2021
Rec V Date: 10/23/2021
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: patient was accidentally inoculated with Fluzone High Dose; patient was accidentally inoculated with Fluzone High Dose;Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from consumer/non-healthcare professional via call center via Medical Information (Reference number- 00810818). This case involves a 13-month-old female patient who accidentally inoculated INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose). The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided. On 07-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency: same day). It was reported "Is there any thing I should be concerned about? What should I monitor?" 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. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1813064
Sex: F
Age: 54
State: TX

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/23/2021
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: female patient age 54 was given FLUZONE HIGH DOSE with no reported adverse event; female patient inadvertently was administered Fluzone High-Dose Quadrivalent vaccine rather than Fluzone Quadrivalent vaccine with no reported adverse event; Initial information received on 13-Oct-2021 regarding an unsolicited valid non-serious case from other health professional and physician via Agency(under reference 00810932). This case involves a 54 years old female patient who inadvertently was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] rather than INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age and wrong product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient received no concomitant vaccines. On 28-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ690AB and expiration date: 30-Jun-2022) via unknown route in the arm for prophylactic vaccination. It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (same day latency). It was reported "Caller states on 28SEP2021, a female patient age 54 was given FLUZONE HIGH DOSE; caller would like to report the incident and obtain information regarding re-vaccination and adverse effects to look out for; caller asked for any efficacy and safety information on Fluzone High-Dose administered to patients younger than 65 years of age, and any comparison information on the Fluzone High-Dose and Fluzone vaccines. Reporter was unsure whether it was administered in the left arm or right arm." 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: 1813066
Sex: M
Age:
State: PA

Vax Date: 10/12/2021
Onset Date: 10/12/2021
Rec V Date: 10/23/2021
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 patient asked for B12 shot and received the flu vaccine no AE; The patient received a flu vaccine had a flu vaccine a month ago no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Regulatory authority (Reference number- 00811126) and transmitted to Sanofi on 13-Oct-2021. This case is linked to case 2021SA343570 (same reporter). This case involves a 70-year-old male patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and had a flu vaccine a month ago too (extra dose administered) instead of CYANOCOBALAMIN [B12 shot] (wrong product administered). The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 12-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ7725AA, expiry: 30-Jun-2022) via intramuscular route in the right arm for prophylactic vaccination instead of CYANOCOBALAMIN [b12 shot]. It was a case of an actual medication error due to wrong vaccine administered and extra dose administered (latency same day). It was reported "Medical assistant reports two patients who are husband and wife came in for B12 shot and received the flu vaccine. They both had the flu vaccine a month ago. She asks for appropriate follow-up. She asks what specifically to monitor for and also any information regarding one patient has history of renal transplant." 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: CYANOCOBALAMIN

Current Illness:

ID: 1813067
Sex: F
Age:
State: PA

Vax Date: 10/12/2021
Onset Date: 10/12/2021
Rec V Date: 10/23/2021
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 patient asked for B12 shot and received the flu vaccine/ no AE; The patient received a flu vaccine had a flu vaccine a month ago too/ no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00811175) and transmitted to Sanofi on 13-Oct-2021. This case is linked to case 2021SA342362 (same reporter). This case involves a 64-year-old female patient who received a 0.5 mL (once) dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ7725AA, expiry date 30-Jun-2022) via intramuscular route in the right arm on 12-Oct-2021 for prophylactic vaccination instead of CYANOCOBALAMIN [B12 shot] (wrong product administered) and she had a flu vaccine a month ago too (extra dose administered). The patient's medical history included Renal transplant. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was a case of an actual medication error due to wrong vaccine administered and extra dose administered (latency was on same day). It was reported "Medical assistant reports two patients who are husband and wife came in for B12 shot and received the flu vaccine. They both had the flu vaccine a month ago. She asks for appropriate follow-up." 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: CYANOCOBALAMIN

Current Illness:

ID: 1813069
Sex: M
Age: 14
State: GA

Vax Date: 10/12/2021
Onset Date: 10/12/2021
Rec V Date: 10/23/2021
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: administered FLUBLOK to a 14 year old patient/ no AE; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-healthcare professional and physician via call center via Medical Information (Reference number- 00811402). This case involves a 14-year-old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age). The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided. On 12-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: UJ724AA and expiry date: 30-Jun-2022) via an intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day). It was reported "Clinical supervisor reports that one of their staff administered FLUBLOK to a 14 year old patient." 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: 1813070
Sex: F
Age: 49
State: CA

Vax Date: 10/13/2021
Onset Date: 10/13/2021
Rec V Date: 10/23/2021
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: A 49 years old patient received a dose of FLUZONE HIGH-DOSE QUADRIVALENT/ No AE; A 49 years old patient received a dose of FLUZONE HIGH-DOSE QUADRIVALENT/ No AE; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a other health care professional via consumer via phone via regulatory authority: 00812423. This case is linked to cases 2021SA343492, 2021SA343828 and 2021SA343988 (same reporter). This case involves a 49 years old female patient who received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose). The patient's medical history, past medical treatments, vaccinations and family history were not provided. No concomitant vaccines given to patient. On 13-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ769AC, expiry date: 30-Jun-2022, frequency/ drug interval dosage: once, strength: standard via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose (latency: same day for both the events). It was reported "Caller reported last night a family of four who are all under the age of 65 were giving the FLUZONE HIGH DOSE VACCINE. Caller reported there are no adverse events at this time but wanted to make sure there was nothing to expect and what they should do from here." Emergency room/ Doctor visit on 13-Oct-2021. Product used: Used and Still using product: No. 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: 1813071
Sex: F
Age:
State: WI

Vax Date: 10/13/2021
Onset Date: 10/13/2021
Rec V Date: 10/23/2021
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: 11 year old was administered Flublok with no reported adverse event; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (under the reference 00812454). This case involves a 11 years old female patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age). The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided. Patient had no other vaccines. On 13-Oct-2021, the patient received a dose of suspect FLUBLOK QIV (0.5 ml, total, injection, lot QFAA2108 and expiration date: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination. It was an actual medication error due to Inappropriate age at vaccine administration (same day latency). At time of reporting, the outcome was unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1813072
Sex: M
Age: 12
State: CA

Vax Date: 10/13/2021
Onset Date: 10/13/2021
Rec V Date: 10/23/2021
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: patient under age 65 were given the Fluzone HD Quad with no reported adverse event; patient under age 65 were given the Fluzone HD Quad with no reported adverse event; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2021SA342449(same reporter). This case involves a 12-year-old male patient who was under age 65 were given INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose). The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 13-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ769AC and expiry date: not reported] via an intramuscular route in right deltoid administration site prophylactic vaccination. It was a case of actual medication error due to product administered to patient of inappropriate age and overdose [Latency: on the same day]. It was reported "the caller was the director of clinical services. 4 members of the same family, under age 65 were given the Fluzone HD Quad, all the same lot and expiry date". 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: 1813073
Sex: M
Age: 13
State: CA

Vax Date: 10/13/2021
Onset Date: 10/13/2021
Rec V Date: 10/23/2021
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: Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a other health care professional via consumer via phone via Agency number: 00812470. This case is linked to cases 2021SA343449, 2021SA343828 and 2021SA343988 (same reporter). This case involves a 13 year-old male patient who received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose). The patient's medical history, past medical treatments, vaccinations and family history were not provided. No concomitant vaccines given to patient. On 13-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Injection; lot number: UJ769AC, expiry date: 30-Jun-2022, frequency/ drug interval dosage: once, strength: standard) via an intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose (latency: same day for both the events). It was reported "Caller reported last night a family of four who are all under the age of 65 were giving the FLUZONE HIGH DOSE VACCINE. Caller reported there are no adverse events at this time but wanted to make sure there was nothing to expect and what they should do from here." Emergency room/ Doctor visit on 13-Oct-2021. Product used: Used and Still using product: No. 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: 1813074
Sex: F
Age:
State: WI

Vax Date: 10/13/2021
Onset Date: 10/13/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Fluzone high dose was administered to a 60 year old patient with no adverse event; Fluzone high dose was administered to a 60 year old patient with no adverse event; Initial information regarding an unsolicited valid non serious case was received from pharmacist and consumer or non-health professional via Agency Information (Reference number: 00812522) and transmitted to Sanofi on 14-Oct-2021. This case involved a 60-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose). Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided. On 13-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Influenza Quadrival A-B High Dose Hv, frequency: once, dose: 0.7mL, Strength: standard, lot UJ733AC, expiry date: 30-Jun-2022] via an intramuscular route in the left arm for prophylactic vaccination. This was actual medication error case due to Inappropriate age at vaccine administration and vaccine overdose. It was reporter "Pharmacist reports fluzone high dose (HD) was administered to a 60-year-old. Patient states it was not worried about repeating because of immunogenicity, however, asks for safety information." no other vaccines. At the time of this report the patient was fine and had no adverse events after the vaccination. This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error. .

Other Meds:

Current Illness:

ID: 1813076
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: staff member noticed that it looked slightly frozen with no reported adverse event; Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received via a nurse via Agency, Inquiry Number: 00812622). This case was considered as valid case due to patient involvement. This case involves an unknown age female patient who experienced was administered slightly frozen INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (product storage error). The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided. On an unknown date, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ768AC and expiry date: 30-Jun-2022 via intramuscular route in the deltoid for prophylactic vaccination. It was reported "Nurse states that one of their staff members took home FLUZONE HIGH DOSE to administer to their mother, states the FLUZONE HIGH DOSE was placed directly on an ice pack in a Styrofoam cooler, states she is unable to report an exact temperature for temperature excursion because there was no temperature tag in the cooler; states it was there for 15-20 minutes. Nurse states when staff member took out the FLUZONE HIGH DOSE to administer, staff member noticed that it looked slightly frozen. Staff member thawed product by placing it against her skin then administered the product to her mother. Nurse states she thinks it was given 07OCT2021. Nurse does not know if it was the right or left deltoid Nurse asks if the product that was administered was still viable for use since it had appeared frozen, asks if the staff member's mother should be re-vaccinated. Agent provided nurse with stability data per Stability and Storage document, informed nurse we are unable to provide accurate suitability without a worst-case scenario temperature, agent informed nurse, per Stability and Storage document, vaccine should be discarded if it has been frozen. nurse states patient did not receive any treatment after receiving FLUZONE HIGH DOSE.nurse states patient was not pregnant at time of FLUZONE HIGH DOSE administration." 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: 1813077
Sex: M
Age: 67
State: OH

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/23/2021
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 had requested Fluzone HD Quad and instead received the Fluzone Quad with no reported adverse event; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional, consumer/non health care professional and physician via media Information (under reference 00812641). This case involves a 67 years old male patient who requested INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and instead received the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered). The patient had no other vaccines. The patient's medical history, medical treatment(s), concomitant medication(s) and family history were not provided. 14-Oct-2021, the patient received a 0.5 mL dose of suspect FLUZONE QUADRIVALENT (Solution for injection, Total, lot number: UT7317LA and expiration date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination. It was an actual medication error due to wrong vaccine administered (same day latency). It was reported "Pharmacy intern is asking how to go about giving a patient the FLUZONE HD when they received the FLUZONE QUAD yesterday?" 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: 1813078
Sex: M
Age:
State: TN

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/23/2021
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: 80 year old man received two doses of the FLUZONE HD within few weeks with no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer or non-healthcare professional and consumer/non-health care professional via Agency (Reference number- 00812846) and transmitted to Sanofi on 14-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). This case involves a 80-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 27-Sep-2021 and another on 14-Oct-2021 (extra dose administered). The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On 14-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [influenza quadrival a-b high dose hv vaccine strength: high dose, drug structure dosage : 0.7ml drug interval dosage : once drug treatment duration: once, 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 case due to extra dose administered (latency: same day). It was reported " 80 year old man received two doses of the FLUZONE HD. Patient received the first dose on 27-Sep-2021 and the second dose on 14-Oct-2021." 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. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1813079
Sex: F
Age: 69
State: TX

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/23/2021
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: needle was not properly on the syringe and some of the vaccine leaked out; needle was not properly on the syringe and some of the vaccine leaked out; Initial information received on 14-Oct-2021 regarding an unsolicited valid non-serious case from a Pharmacist via Regulatory authority (Reference number- 00812910). This case involves a 69-year-old female patient who was vaccinated with suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] experienced needle was not properly on the syringe and some of the vaccine leaked out (underdose and syringe issue). Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 14-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA and expiry date: 30-Jun-2022) (Frequency = once) (Solution for injection in pre-filled syringe) via intramuscular route in unknown administration site for prophylactic vaccination. It was an actual medication error case due to vaccine underdose and syringe issue. (latency on same day). It was reported "Caller is asking if the patient will need another injection." At time of reporting, no adverse event was reported.

Other Meds:

Current Illness:

ID: 1813080
Sex: M
Age: 74
State: PA

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/23/2021
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: was given the fluzone high dose quadrivalent with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Agency (Reference number- 00813036) and transmitted to Sanofi on 14-Oct-2021. This case involves a 74-year-old male patient who received FLUZONE HIGH-DOSE QUADRIVALENT (extra dose administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 14-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ730AB, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to extra dose administered. (latency: same day). It was reported "a patient was given the FLUZONE HIGH DOSE QUADRIVALENT on 07-Oct-2021 and then 14-Oct-2021 in error". At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good 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: 1813081
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: her doctor gave her the Flublok when she requested the Fluzone; Initial information was regarding an unsolicited valid non serious case was received from a consumer/non-healthcare professional via Agency (Reference number- 00813054) and transmitted to Sanofi on 14-Oct-2021. This case involves a 60-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered). The patient's medical history included immunodeficiency, non-tobacco user, pneumonia with was in the hospital for pneumonia in the past and had complications and clostridium difficile infection. At the time of the event, the patient had ongoing Diabetes mellitus and Chronic respiratory disease. The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT 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 "she is very upset that her doctor gave her the Flublok when she requested the Fluzone. She is 60 years old and is immunocompromised, she states she has had the pneumonia vaccine many times as well as booster shots, she stated that she was in the hospital for pneumonia in the past and had complications, C-Diff and nearly died, she stated she got her Flu vaccine in September 2021 and though it was the high-dose, she states the sales representative should inform the staff about the high-dose because most of the patients are over the age of 65, she is left being very skeptical and angry. She is a force of nature and demanded to see the vaccine inventory and noted there was no high dose, she states that she paid $65.00 for a flu shot, she questioned when she could receive the Fluzone High-Dose and was told that it's not recommended to take multiple flu vaccines during one season, she blames the sales reps for not giving comprehensive education to the staff when the practice is mostly elderly people. She states she was in her bunker last year and did not get the flu, she states she wears a mask and gloves even before the pandemic, she states that specific area is a cesspool and that we are only getting half of the information. She wants to report the practice for not providing the Fluzone High-Dose Quadrivalent, she states she is a diabetic, does not smoke, but has chronic lung issues". 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: Chronic lung disease; Diabetic

ID: 1813083
Sex: F
Age: 56
State: GA

Vax Date: 10/11/2021
Onset Date: 10/11/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: patient accidentally received FLUZONE QUADRIVALENT after an excursion with no adverse event; Initial information was regarding an unsolicited valid non serious case was received from a nurse via Medical Information (Reference number- 00813179) and transmitted to Sanofi on 14-Oct-2021. This case involves a 56-year-old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that was reported in a past excursion was accidently used (product storage error). The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On 11-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (once, suspension for injection, lot UT7315JA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to product storage error (latency: same day). It was reported "FLUZONE QIV that was reported in a past excursion case was accidently used on two patients even though they were no longer suitable for use". 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: 1813085
Sex: F
Age:
State: TX

Vax Date: 10/12/2021
Onset Date: 10/12/2021
Rec V Date: 10/23/2021
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: swelling the size of a golf ball at injection site; redness at injection site that went down to elbow; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Agency (Reference number- 00813290) and transmitted to Sanofi on 14-Oct-2021. This case involves a 62-year-old female patient who experienced swelling the size of a golf ball at injection site (vaccination site swelling) and redness at injection site that went down to elbow (erythema), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 12-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2117 and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. On 12-Oct-2021, the patient developed non-serious swelling the size of a golf ball at injection site (vaccination site swelling) and serious redness at injection site that went down to elbow (erythema) (on the same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Details of laboratory data reported. It was not reported if the patient received any corrective treatment for the events. It was reported "patient reports swelling the size of a golf ball at injection site, redness at injection site that went down to elbow". At time of reporting, the outcome was unknown for the event.

Other Meds:

Current Illness:

ID: 1813086
Sex: F
Age: 65
State: NJ

Vax Date: 10/14/2021
Onset Date: 10/15/2021
Rec V Date: 10/23/2021
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: Severe body ache the entire night; Severe headache; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a physician and non-healthcare professional via Regulatory authority (under reference: 00814214). This case involves a 65 years old female patient who experienced severe headache (headache) and severe body ache the entire night (pain) when received vaccines COVID-19 VACCINE and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On 14-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (injection, 0.7 mL, once, total, lot number and expiry date not reported) via an unknown route in the left arm for prophylactic vaccination. On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On 15-OCT-2021 the patient developed a non-serious severe headache (headache), severe body ache the entire night (pain) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and (unknown latency) following the administration of COVID-19 VACCINE. It was reported "The caller's wife turned 65 within this past year and yesterday received FLUZONE HIGH DOSE QUADRIVALENT for the first time in her life. When the caller woke up this morning, his wife informed that she had a severe headache and severe body ache the entire night. She seems to be improving, as she had an appointment this morning and was able to leave the home to keep her appointment. The caller was unsure of which arm his wife received the injection, but believes it is likely that it was the left arm. He mentions that he and his wife both received Covid-19 vaccinations with the same brand. He had no side effects from the Covid-19 vaccine, but his wife had similar side effects that she is now having with after Fluzone High-Dose Quadrivalent." Laboratory details were not reported. It was not reported if the patient received a corrective treatment for the events. The patient was recovering from the events (headache, pain) at the time of reporting. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1813087
Sex: F
Age: 60
State: PA

Vax Date: 10/11/2021
Onset Date: 10/10/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: product storage error due to refrigerator malfunction at lowest temperature of negative 26 degree celsius, no AE; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from other health care professional and consumer/non- health care professional via Agency (Under reference number 00814299). This case involves a 60 years old female patient who was administered with the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] that had a product storage error due to refrigerator malfunction at lowest temperature of negative 26 degree celsius (Product storage error). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was given to patient. On 11-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Total, once, lot UJ725AA and expiry date 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of actual medication error due to product storage error temperature too low. Details of laboratory data were not provided. It was reported "Practice Administrator calling in a temperature excursion for FLUBLOK. Excursion started on 10-Oct-2021 and ended on 11-Oct-2021, dose of the FLUBLOK was administered. Caller is inquiring if the products are still suitable for use and if not should they revaccinate?' At time of reporting, no adverse event was reported, and the outcome was unknown for the reported event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1813088
Sex: F
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Allergic reaction; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Agency (Reference number- 00814371) and transmitted to Sanofi on 15-Oct-2021. This case involves a female patient (unknown age) who had allergic reaction (hypersensitivity) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. 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 QUADRIVAL A-B VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported "Caller would like to know the ingredients in FLUZONE QUAD from 2020. She states she had an allergic reaction to it. Suggested that the call go to the website My Daily Med. The caller was calling from work and in a hurry. Was not able to obtain template info." No laboratory data was reported. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome of the event was unknown. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1813090
Sex: M
Age: 13
State: KY

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Received expired Fluzone QIV with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional and physician via regulatory authority number: 00814427. This case involves a 13 years old male patient who was administered an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered). The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided. On 14-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7108MA and expiry date: 30-Jun-2021 via intramuscular route in unknown administration site prophylactic vaccination. It was case of an actual medication error due to expired vaccine used (latency: same day). At the time of reporting, no adverse event was reported. This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error 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: 1813091
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: Patient received an expired FLUBLOK QIV with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional via Media information (under the reference 00814428). This case is linked to case 2021SA345109 (CLUSTER). This case involves a patient of (unknown demographics) who received an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product used). The patient's medical history, past medical treatment, vaccination, 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 at an unknown administration site for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day). It was reported "There were 15 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info." At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event. 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: 1813092
Sex: M
Age: 14
State: KY

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/23/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: patient received expired vaccine of FLUZONE QUADRIVALENT with no adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional, physician, non-healthcare professional via Media Information (under reference: 00814496). This case is linked to cases 2021SA344343, 2021SA344107 and 2021SA345249(CLUSTER). This case involves a 14 years old male patient who received expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered). The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On 14-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5mL, once, total, lot UT7108MA, expiry date: 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination. It was an actual case of medication error due to expired vaccine used (latency: same day). It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine." At time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1813094
Sex: M
Age: 14
State: KY

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: patient received expired vaccine of FLUZONE QUADRIVALENT with no adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional, physician, non-healthcare professional via regulatory authority (under reference: 00814513). This case is linked to cases 2021SA344343, 2021SA344107 and 2021SA345249 (CLUSTER). This case involves a 14 years old male patient who received expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered). The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On 14-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5mL, once, total, lot UT7108MA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual case of medication error due to expired vaccine used (latency: same day). It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine." At time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1813095
Sex: F
Age: 13
State: KY

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: received expired FLUZONE QIV NP with no reported adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from other health professional and physician via (Medical Information- 00814531). This case involves a 13-year old female patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (Expired product administered). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccines were not provided. On 14-Oct-2021, the patient received a first 0.5ml dose of expired suspect INFLUENZA QUADRIVAL A-B VACCINE (FLUZONE QIV) (lot number UT7108MA and expiry date 30-Jun-2022 was reported) via intramuscular route in the left deltoid for prophylactic vaccination. It was reported "if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine. This information is regarding the fourth of 12 patients that received expired FLUZONE QIV NP." It was a case of an actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event reported. 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 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:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am