VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1653378
Sex: F
Age: 0
State:

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 08/29/2021
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: patient was supposed to receive Prevnar and was given MENACTRA by mistake, no AE; Initial information received on 16-Aug-2021 regarding an unsolicited valid non-serious case received from a physician via Global Media Information (under the reference 00726178). This case involved a 6 months old female patient who was supposed to receive PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR)and was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Menactra) by mistake (wrong product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and HIB VACCINE CONJ (OMPC) (PEDVAXHIB) (lot number and expiration date not reported) via unknown route in an unknown site for prophylactic vaccination. On 16-Aug-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6921AA and expiration date :17-Apr-2022) via intramuscular route in the right thigh for prophylactic vaccination. It was an actual medication error due to wrong vaccine administered (same day latency). It was reported that "nurse supervisor asking if there are any adverse events reported in 6 month olds who are given MENACTRA, and how they should proceed". At time of reporting, 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 by the regulatory authority. 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: PEDIARIX; PEDVAXHIB

Current Illness:

ID: 1653379
Sex: U
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: anaphylactic reaction; Initial information received on 16-Aug-2021 regarding an unsolicited valid serious case from a pharmacist via Agency (Reference number- 00726317). This case involves a patient (unknown demographics) who experienced anaphylactic reaction, while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date (2017-2018), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UI883AB and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date (2017-2018), the patient developed a serious anaphylactic reaction (unknown latency), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was reported as unknown. Information on the batch number was requested.; Sender's Comments: This case involves a patient (unknown demographics) who had anaphylactic reaction, after receiving FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is unknown. 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: 1653380
Sex: F
Age: 3
State: WI

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 08/29/2021
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: The patient was administrated with an expired Act-hib vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via consumer/non-healthcare professional via Global Medical Information (Reference number- 00726333) and transmitted to Sanofi on 16-Aug-2020. This case involves a 3-year-old female patient who was administered an expired HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (Expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 16-Aug-2021, the patient received a first dose of suspect HIB (PRP/T) VACCINE (lot UJ327AAB, expiry: 28-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used (latency same day). It was reported "stated that an expired ACT-HIB was given and wants to know what the recommendations would be on the vaccine. stated that she does not have that information" 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: 1653381
Sex: U
Age:
State: RI

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
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: two patients received ADACEL Adult vaccine which was stored in a fridge that had a temperature excursion that reached 34 degrees Fahrenheit (or 1.11 degrees Celsius) over the weekend/ No AE; Initial information was received on 17-Aug-2021 regarding an unsolicited valid non-serious case received from an other health care professional via consumer under Global Medical Information Inquiry Number:00727607. This case involves two patients with an unknown age and gender who were administered with a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] that was stored in a fridge that had a temperature excursion that reached 34 degrees Fahrenheit (or 1.11 degrees Celsius) over the weekend (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 patients received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number: U6964AA and expiry date not provided via unknown route in unknown administration site for prophylactic vaccination. It was case of an actual medication error due to incorrect product storage (latency: same day). It was reported" We currently have ADACEL TDAP (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE) Adult vaccine stored in a fridge that had a temperature excursion. The refrigerator reached 34 degrees Fahrenheit (or 1.11 degrees Celsius) over the weekend, we do not know when the excursion began. It was noted yesterday. The refrigerator has since been reset and is at it normal temperature of 40 degrees Fahrenheit (or 4.44 degrees Celsius). The vaccine was administered to two patients. We need to know if the vaccine was safe to use." 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: 1653382
Sex: U
Age:
State: WA

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 08/29/2021
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: An expired dose was given with no reported adverse event; Initial information received on 13-Aug-2021 regarding an unsolicited valid non-serious case from an other health professional and consumer/ non health care professional via Global Media Information (Under reference 00727701). This case involves a patient (unknown age and gender) who received an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) [expired product administered]. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 10-Aug-2021, the patient received a dose of suspect ACT-HIB (lot number: not reported and expiration date: 25-Jul-2021) via unknown route in an unknown administration site for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). It was reported that "We would like to know if there is a significant degradation in potency for the vaccine if it was roughly 2 weeks past its expiration date. Please advise". At time of reporting, the outcome was unknown for the reported event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1653383
Sex: F
Age:
State: OK

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 08/29/2021
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: chills; myalgias; fever; progressively worsening swelling at injection site; Initial information received on 17-Aug-2021 regarding an unsolicited valid non-serious case (under reference number : 00727839) from a physician. This case involves a 34 years old female patient who experienced chills, myalgias (myalgia), fever (pyrexia) and progressively worsening swelling at injection site (vaccination site swelling), after receiving DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC]. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 13-Aug-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Solution for injection, once, total, lot U6831AA and expiration date :08-Oct-2022) via intramuscular route in the left deltoid for prophylactic vaccination. On 13-Aug-2021, the patient developed a non-serious chills, myalgias (myalgia), fever and progressively worsening swelling at injection site (vaccination site swelling), on the same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. It was reported as " Physician reported that a patient received TENIVAC on 13AUG2021. She returned to office on 17AUG2021 with complaints of progressively worsening swelling at injection site, fever, chills, and myalgias. Physician asking if there are any recommendations on how to proceed, and the ingredients of TENIVAC. Physician was unable to provide all information for AE report at time of call. Physician given case number and states he will call back when he has all information to complete AE report. Physician declined to provide email." No laboratory data reported. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for all the reported events.

Other Meds:

Current Illness:

ID: 1653384
Sex: M
Age: 0
State: TX

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 08/29/2021
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: four month old male patient administered QUADRACEL vaccine in the thigh left with no reported AE; Initial information received on 17-Aug-2021 regarding an unsolicited valid non-serious case from a other health care professional via Medical Information (Reference number- 00727886). This case involves a four month old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] at the left thigh (product administered at inappropriate site). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On 16-Aug-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5763AA and expiry date: 26-Aug-2022) (Frequency: once) via an intramuscular route in the left thigh for prophylactic vaccination. It was a case of actual medication error due to Vaccine administered at inappropriate site (latency on same day). 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: PREVNAR 13; ROTAVIRUS VACCINE

Current Illness:

ID: 1653385
Sex: U
Age:
State: VA

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 08/29/2021
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: Flublok was administered outside the 2 day window/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 17-Aug-2021 from a Nurse (Reference number- 00727907) and transmitted on 17-Aug-2021. This case involves a patient (unknown age and gender) who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] outside the two- day window, with no adverse event (Inappropriate schedule of product administration). The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided. On 16-Aug-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination. It was case of an actual medication error due to Inappropriate schedule of product administration (latency was on the same day). It was reported that, "Flublok was received and administered to a patient outside the 2 day window. The nurse practitioner states that the Flublok was received yesterday from facility to the clinic and there was a message left with one of the nurses over the weekend that due to an error it was sent outside of the two day window. She states that when she received the shipment yesterday, she gave one to a patient which was "not good" and "very upsetting" to her that she did that. She said she didn't get the message until today that since it was sent outside of the two-day window that it needed to be quarantined and sent back. She states that nothing looked out of the ordinary. She states that she is confused as to what she needs to do with the patient. She wants to know if she is going to be receiving a return shipping label and if so will it be mailed or e-mailed to her". 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. There will be no information on batch number for this case.

Other Meds:

Current Illness:

ID: 1653386
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
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: patient received 3 doses of Ipol as a baby, but never received the fourth dose with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional and consumer/non-health care professional via Global Medical Information (Reference number- 00727955) and transmitted to Sanofi on 17-Aug-2021. This case involved 15-year-old female patient received 3 doses of IPV (VERO) [IPOL] as a baby, but never received the fourth dose (incomplete course of vaccination) Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On an unknown date, the patient received 3 doses of suspect IPV (VERO) as a baby (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination but never received the fourth dose (incomplete course of vaccination) It was reported that,"Now, should she receive a single dose? Start the series over? or, because of her age, no dose is necessary"? This was an actual medication error due to incomplete course of vaccination (latency: same day) At the time of reporting, no adverse event This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 1653387
Sex: F
Age: 34
State: OK

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 08/29/2021
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: aches and pains; patient has decreased range of motion of left arm; joint stiffness; chills; myalgia; fever; progressively worsening swelling at injection site; patient was positive for 3 centimeter raised injection site reaction that is tender to palpation; patient was positive for 3 centimeter raised injection site reaction that is warm to touch; Initial information received on 17-Aug-2021 regarding an unsolicited valid non-serious case from a physician via Medical Information (Reference number- 00727956). This case involves a 34 year old female patient who experienced myalgia, fever (pyrexia), chills, joint stiffness, aches and pains, (pain), decreased range of motion of left arm (mobility decreased), progressively worsening swelling at injection site (vaccination site swelling), patient was positive for 3 centimeter raised injection site reaction that is tender to palpation and warm to touch (vaccination site pain) and (vaccination site warmth), while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC]. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 13-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6831AA and expiry date: 08-Oct-2022) via an intramuscular route in the left deltoid for prophylactic vaccination. On 13-Aug-2021, the patient developed a non-serious event "She returned to office on 17-Aug-2021 with complaints of progressively worsening swelling at injection site" (vaccination site swelling), myalgia, fever (pyrexia), "physician states on physical exam patient was positive for 3 centimeter raised injection site reaction that is tender to palpation and warm to touch" (vaccination site pain) and (vaccination site warmth), on same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. On an unknown date, the patient developed a non-serious decreased range of motion of left arm (mobility decreased), joint stiffness and aches and pains (pain), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Physician reports patient has no hives or urticaria, no airway compromise, and no shortness of breath. It was reported that "Physician states patient is not pregnant -Last menstrual period: 30-Jul-2021. Due date AE (adverse event) symptoms or no AE. If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food and drug administration) requirement". Details of laboratory data not reported. Physician also states he recommended Ibuprofen, Tylenol (Paracetamol) and rest. At the time of reporting, the patient had not recovered from the all events.

Other Meds:

Current Illness:

ID: 1653388
Sex: U
Age:
State: NE

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
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: 5 patient received Menactra vaccine which was store at minus 8 degrees Celsius for 7 hours and 24 minutes/ No AE; Initial information was received on 17-Aug-2021 regarding an unsolicited valid non-serious case received from another health professional via consumer (under Medical Information Inquiry Number:00727996). This case is linked to case 2021SA275306 (Same reporter). This case involves five patients with an unknown age and gender who were administered dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that had stored at minus eight degrees Celsius for seven hours and 24 minutes (product storage error). The patients medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided. On an unknown date, the patients received dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE Solution lot number: U6921AB, U7087AA and expiry date:17-Apr-2022, 05-Oct-2022 via an unknown route in unknown administration site for prophylactic vaccination respectively. It was case of an actual medication error due to product storage error temperature too low (latency: same day). It was reported "Nurse calling back to ask specifically about MENACTRA and IPOL that was administered yesterday after temperature. Is re-vaccination needed and if so, when should it be given. Caller states they do not think they had a real temperature excursion but had a faulty data logger because none of the other vaccines were frozen. States he provided minus eight degrees Celsius for seven hours and 24 minutes. Caller states 1 patient had received the IPOL. Caller thinks he had 5 patients between the two lots for the Menactra but is looking through his computer now to gather all the information. Product used." 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: 1653389
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data: Test Name: CT scans; Result Unstructured Data: Epstein Barr diagnosis; Test Name: other tests; Result Unstructured Data: Epstein Barr diagnosis

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Epstein Barr diagnosis; experienced some weird neurological symptoms; Initial information regarding an unsolicited valid non serious case was received from a pharmacist via Medical Information (Reference number- 00728247). This case involves an unknown age female patient who had Epstein Barr diagnosis and some weird neurological symptoms (Epstein-Barr virus infection), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date in last year, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious Epstein Barr diagnosis and some weird neurological symptoms (Epstein-Barr virus infection) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported, "pharmacist stated that a female patient received the Fluzone Quadrivalent flu shot last year and is experiencing some weird neurological symptoms and has had CT scans and other tests and the only thing showing is Epstein Barr diagnosis. Pharmacist stated the flu shot was the only thing different the patient had done". Relevant laboratory test results included: Computerized tomogram (CT) scans and other tests and the only thing showed was Epstein Barr diagnosis. 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. There will be no information available on the lot number for this case.

Other Meds:

Current Illness:

ID: 1653390
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
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: patient was given an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 17-Aug-2021 from a Physician via Global Medical Information (GMI) (Reference number- 00728357) and transmitted to Sanofi on 16-Aug-2021. This case involves an 11-year-old male patient who was administered with an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine with no adverse event (Expired product administered). 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 0.5ml (total) (once) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number: U6401AA and expiry date: 26-Jul-2021] via intramuscular route in the left deltoid (also reported as left arm) for prophylactic vaccination. It was reported that, "she gave an expired ADACEL vaccine. She states that the vaccine was expired and she gave it to the patient intramuscularly in the left arm, she asked how soon the patient could be revaccinated". Emergency Room/Dr. visit and date 17Aug2021. First time product used: No. Still using product : Yes. Was Device Used : No. It was case of an actual medication error due to expired vaccine used (latency was on the same day). 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 by the regulatory authority. 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: 1653391
Sex: F
Age:
State: TX

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 08/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: expired ADACEL was given with no reported adverse event; Initial information received on 17-Aug-2021 regarding an unsolicited valid non-serious case received from a other health professional via Media information (under the reference 00728465). This case involved a 30 years old female patient who was vaccinated with an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication were given to the patient. On 17-Aug-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (suspension for injection, total, 1X(once), 0.5ml, lot U6214AA and expiration date: 14-mar-2021) via intramuscular route in the left arm for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). It was reported, "HCP (Healthcare Professional) stated expired ADACEL was given and wanted to know what needed to be done. Attempted transfer to MIS-No answer. Placed in proxy for a call back. HCP request to be called on the mobile number on file. She would be leaving out the office in the next 25 minutes." At time of reporting, no adverse event was reported and the outcome was unknown for 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: 1653392
Sex: U
Age:
State: CO

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 08/29/2021
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: Patient received expired QUADRACEL with no AE; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Global Medical Information (Reference number- 00728548) and transmitted to Sanofi on 17-Aug-2021. This case involves a patient with unknown gender who received expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 16-Aug-2021, the patient received a dose of expired suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number was not reported and expiry date: 13-Aug-2021) via unknown route at an unknown administration site for prophylactic vaccination (expired product administered). It was a case of actual medication error due to expired vaccine used (latency: on same day). It was reported that "Caller did not have any other AE reporting information to provide and is only inquiring about if this dose is valid or if re-vaccination is needed and if so, how soon?" It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1653393
Sex: M
Age:
State: SC

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 08/29/2021
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: ADACEL expired 2 days ago was administered with no reported adverse event; Initial information was received on 18-Aug-2021 regarding an unsolicited valid non-serious case from a pharmacist and non-healthcare professional via call center via Medical Information (Reference number- 00729455). This case involves an adult male patient in his 30's administered expired vaccine (expired product administered) DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's medical history, past medical treatment, vaccination and family history were not provided. On 17-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported and expiry date: 15-Aug-2021) via an unknown route at an unknown administration site for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency: same day). At the time of reporting, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1653394
Sex: M
Age: 6
State: IA

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 08/29/2021
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: Patient was inadvertently administered an expired dose of Quadracel with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Global Medical Information (GMI) (Reference number- 00729642) and transmitted to Sanofi on 18-Aug-2021.. This case involves a 6-year-old male patient who experienced patient was inadvertently administered an expired dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 17-Aug-2021, the patient received an expired second dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5656AA and expiry date: 13-Aug-2021) via intramuscular route in the right deltoid for prophylactic vaccination (expired product administered). It was a case of actual medication error due to expired vaccine used (latency: on same day). It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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: PROQUAD; HEPATITIS B VACCINE

Current Illness:

ID: 1653395
Sex: U
Age:
State: CA

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 08/29/2021
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: patient did not receive a full dose due to the patient squirming during injection/ no AE; the vaccine did visibly leak down the patient's arm./ no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00730052) and transmitted to Sanofi on 18-Aug-2021. This case involves an unknown age and gender patient while received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] then reported patient did not received a full dose due to the patient squirming during injection (underdose) and the vaccine did visibly leak down the patient's arm (exposure via skin contact). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On 17-Aug-2021, the patient received a 0.5 mL (total) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (solution for injection) [lot U7140AA, expiry date 04-Nov-2022] via unknown route at an unknown administration site for prophylactic vaccination and reported (latency was on same day) patient did not received a full dose due to the patient squirming during injection (underdose) and the vaccine did visibly leak down the patient's arm (exposure via skin contact). Details of laboratory data not reported. It is unknown if the patient experienced any additional symptoms/events. No adverse event was reported. It was not reported if the patient received any corrective treatment. The outcome was unknown for both the events.

Other Meds:

Current Illness:

ID: 1653396
Sex: U
Age:
State: CO

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 08/29/2021
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: Patient received an expired QUADRACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Care Professional via Medical Information (Reference number- 00730061) and transmitted to Sanofi on 18-Aug-2021. This case involves a patient with unknown demography who received a dose of expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 16-Aug-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number was not reported and expiry date: 13-Aug-2021) via unknown route at an unknown administration site for prophylactic vaccination (expired product administered). It was reported that "Medical assistant supervisor asked if patient should be revaccinated or is there a grace period. Medical assistant supervisor does not have the patient's information on hand. She agreed to call us back if she has obtained the patient's information." It was a case of actual medication error due to expired vaccine used (latency: same day). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1653397
Sex: F
Age: 1
State: NV

Vax Date: 07/19/2021
Onset Date: 07/19/2021
Rec V Date: 08/29/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

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

Symptoms: Patient received expired ACT-HIB vaccine/ NO AE; Initial information was received on 18-Aug-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (reference number- 00730100). This case involves a 1-years-old female patient who administered expired vaccine (expired product administered) HIB (PRP/T) VACCINE [ACT-HIB]. The patient's medical history, past medical treatment, vaccination and family history were not provided. On 19-Jul-2021, the patient received a 0.5 ml first dose of suspect HIB (PRP/T) vaccine (frequency: once, strength: standard, lot number: UJ183AA and expiry date: 12-Feb-2021) via an intramuscular route in the right thigh for prophylactic vaccination. It was of actual medication error due to expired vaccine used (latency: same day). It was reported as "patient received an expired ACTHIB vaccine; asking if patient will need to be revaccinated. Event Information -Treatment: patient did not receive treatment for this event ". At the time of reporting, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1653398
Sex: F
Age:
State: PA

Vax Date: 07/20/2021
Onset Date:
Rec V Date: 08/29/2021
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: daughter was given DAPTACEL on Friday, when the vaccine expired on 17Jul2021 with no reported adverse event; Initial information received on 18-Aug-2021 regarding an unsolicited valid non-serious case received from a consumer/ Non-Healthcare Professional (mother). This case involves an unknown age female patient who was expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 20-Jul-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported, expiry date 17-Jul-2021 via unknown route in unknown administration site. It was a case of actual medication error due to expired product administered (latency same day). It was reported that, "The caller stated, I find it unsettling you only provide information to providers. I don't feel safe with the provider who gave this expired vaccine to my child. Why can't you tell me if another dose should be given? I want to file a complaint. It is not good enough to talk to you, how do I file a formal complaint? Will I receive follow-up that something has changed? What is the efficacy of vaccine that is expired by a certain amount of time? Do you have that information? What is the risk of getting more than one dose of the vaccine too close together? (Agent addressed 2nd to last question by saying we do not have studies at all that look at amount of efficacy v of days expired. During hold time for research of the last question, could not reconnect to the caller after hold. Had to disconnect the call. Outbound call at 14:35 and reached voicemail. Left message apologizing for technical difficulties, instructed to call back and ask for MIS III. If I am not available, find out best time for me to call her back)." 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. 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: 1653399
Sex: U
Age: 5
State: PA

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 08/29/2021
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: had inadvertently been administered an expired dose of Daptacel with no reported adverse event; Initial information received on 18-Aug-2021 regarding an unsolicited valid non-serious case received from a other health professional via Consumer/ Non-Healthcare Professional.. This case involves a 5 years old (unknown gender) patient who had inadvertently been administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included POLIO VACCINE (POLIO) for prophylactic vaccination. On 03-Aug-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5643BA, expiry date-17-July-2021 via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of actual medication error due to expired product administered (latency same day). 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. 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: POLIO

Current Illness:

ID: 1653400
Sex: U
Age:
State:

Vax Date: 08/14/2021
Onset Date: 08/14/2021
Rec V Date: 08/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: patient was given expired Menactra/ NO AE; Initial information was received on 18-Aug-2021 regarding an unsolicited valid non-serious case from a physician and non-healthcare professional via call center via Global Medical Information (Reference number- 00730324). This case involves a patient of (unknown demographics) who administered (expired vaccine used) (expired product administered) MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. On 14-Aug-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number not reported and expiry date: 26-Jan-2021) via an unknown route at an unknown administration site for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency: same day). It was reported as "The Physician asks if the Menactra needs to be revaccinated. The Physician had to get off the phone, however the Physician or a medical assistant (MA) will be calling back to provide the Pasteur adverse event (AE) questions". At the time of reporting, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1653401
Sex: M
Age: 17
State: IL

Vax Date: 08/14/2021
Onset Date: 08/14/2021
Rec V Date: 08/29/2021
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: medical assistant provided expired MENACTRA vaccine to a patient/no AE; Initial information was received on 18-Aug-2021 regarding an unsolicited valid non-serious case received from a Physician via (Medical Information-00730396). This case involves a 17 years 3 months old male patient who was vaccinated with expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (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-Aug-2021, the patient received 0.5 mL (total; standard) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6521AB and expiry date 26-Jan-2021) via an intramuscular route at the left deltoid for prophylactic vaccination. It was reported "HCP called back to provide AE information from previous call that he had to disconnect from. Doctor reports that medical assistant provided expired MENACTRA vaccine to a patient on 14Aug2021.Doctor also asked about the most common side effects that may occur with an expired dose of MENACTRA but was unable to hold for a MIS transfer. Caller was advised on previous call that vaccine was not valid. MA got the expiration date confused and mixed up the year with the date 26-Jan-21. She thought it expired in 2026". 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:

ID: 1653402
Sex: U
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
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: practice had given 2 vaccines the MENACTRA and the TDAP that had been expired for 3 month/no AE; Initial information regarding an unsolicited valid non-serious case was received from the physician assistant via medical information (Reference number- 00730400) and transmitted to Sanofi on 18-Aug-2021. This case involves two patients (of an unknown demographics) to whom practice had given 2 vaccines the MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE that had been expired for 3 months (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patients received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) that had been expired for three months (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (same day). It was reported, "calling to report their practice had given 2 vaccines the MENACTRA and the TDAP That had been expired for 3 months. She wants to know from a healthcare standpoint should they be on the watch for anything and does the patient need to be re-vaccinated. physicians assistant states the expired MENACTRA was given to 2 patients and she doesn't know what brand of Tdap was used". 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: 1653403
Sex: U
Age:
State: OH

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 08/29/2021
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: patient received expired quadracel with no adverse event reported; Initial information received on 18-Aug-2021 regarding an unsolicited valid non-serious case received from a consumer/ Non-Healthcare Professional via other health professional. This case involves a patient with unknown demographics who received expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL]. Medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Aug-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported, expiry date 13-Aug-2021 via unknown route in unknown administration site for prophylactic vaccination. It was a case of actual medication error due to expired product administered (latency same day). 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 by the regulatory authority. 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: 1653404
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
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: Patient received a yellow fever vaccine intramuscular instead of subcutaneous with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional. This case involves patient with unknown demography who received YELLOW FEVER VACCINE - US [YF-VAX] intramuscular instead of subcutaneous (incorrect route of product administration). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - US (lot UJ386AA and expiry date was not reported) via intramuscular route at an unknown administration site instead of subcutaneous route for prophylactic vaccination (incorrect route of product administration). It was reported "Caller asked what, if anything, needed to be done". It was an actual medication error case due to inappropriate route of vaccination (latency: same day). At the time of reporting, the patient experienced no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 1653405
Sex: M
Age: 2
State: TX

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 08/29/2021
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: Expired Act-Hib was administered without any reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number- 00732188) and transmitted to Sanofi on 19-Aug-2021. This case was linked to case - 2021SA279788. This case involves a two year old male patient who was administered an expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) and MEASLES VACCINE LIVE, MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination. On 09-Aug-2021, the patient received a dose 3 (0.5 ml) of suspect HIB (PRP/T) VACCINE (lot number: UJ398AA; expiry date: 06-Aug-2021) via intramuscular route in the right thigh for prophylactic vaccination. It was case of actual medication error due to expired vaccine used (latency: same day). It was reported, "Expired Act-Hib was administered, and she wants to know how to follow up? Expired ActHIB was given to 2 patients. Event Information o Treatment--none at this time o Dose # if series-3rd o List concomitant or "no other vaccines"- Kinrix, ProQuad o Pregnancy--NA Last menstrual period Due date AE symptoms or no AE." No adverse events were reported at the time of this report. The outcome of the event was unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: KINRIX; PROQUAD

Current Illness:

ID: 1653406
Sex: F
Age: 5
State: TX

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 08/29/2021
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: :Expired Act-Hib was administered without any reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number-00732218) and transmitted to Sanofi on 19-Aug-2021. This case is linked to case 2021SA279787(CLUSTER). This case involves a five-year-old female patient who was administered an expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) and MEASLES VACCINE LIVE , MUMPS VACCINE LIVE , RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination. On 09-Aug-2021, the patient received a second dose (0.5 ml) of suspect HIB (PRP/T) VACCINE (lot number: UJ398AA; expiry date: 06-Aug-2021) via intramuscular route in the right thigh for prophylactic vaccination. It was case of actual medication error due to expired vaccine used (latency: same day). It was reported, "Expired Act-Hib was administered, and she wants to know how to follow up? Expired ActHIB was given to 2 patients. Event Information o Treatment--none at this time o Dose # if series-3rd o List concomitant or "no other vaccines"- Kinrix, ProQuad o Pregnancy?NA. Last menstrual period. Due date. AE symptoms or no AE." No adverse events were reported at the time of this report. The outcome of the event was unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: KINRIX; PROQUAD

Current Illness:

ID: 1653407
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: patient received a expired dose of menactra vaccine with no reported adverse event; Initial information received on 19-Aug-2021 regarding an unsolicited valid non-serious case from a consumer via Medical Information (Reference number- 00732275) in the United States. This case involves a patient (unknown demographics) who was vaccinated with the expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered). Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number not reported and expiry date: 30-Jul-2021) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency on same day). It was reported "caller wanted to know if there was any information if this is harmful and when is the soonest they can receive a non-expired Menactra vaccine and to report an AE (adverse event)". 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. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1653408
Sex: F
Age: 55
State:

Vax Date: 03/15/2020
Onset Date:
Rec V Date: 08/29/2021
Hospital:

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

Lab Data: Test Date: 2020; Test Name: EEG; Result Unstructured Data: no abnormalities shown; Test Date: 202107; Test Name: EEG; Result Unstructured Data: no findings in brain; Test Date: 202009; Test Name: spinal tap; Result Unstructured Data: ruled out brain infection; Test Date: 2020; Test Name: MRI; Result Unstructured Data: no abnormalities shown; Test Date: 20200630; Test Name: MRI; Result Unstructured Data: done; Test Date: 202104; Test Name: MRI of brain; Result Unstructured Data: done; Test Date: 20200616; Test Name: eye test; Result Unstructured Data: retina and vitreous were normal; Test Date: 2021; Test Name: Thyroid test; Result Unstructured Data: done

Allergies:

Symptom List: Injection site pain

Symptoms: became depressed and sucidal; became depressed and sucidal; started having visual disturbances and seeing light and objects which increased in numbers over time; eye ache; pain spreading throughout body; weakness in limbs; headache in forehead area and top of head; Initial information regarding an unsolicited valid serious case was received consumer/non- health care professional via Agency (Reference number- 00732293) and transmitted to Sanofi on 19-Aug-2021. This case involves a 55 year old female patient who became depressed and sucidal [(suicidal ideation) and(depressed mood)], disturbances and seeing light and objects which increased in numbers over time (visual impairment), eye ache (eye pain), pain spreading throughout body (pain), weakness in limbs (muscular weakness), and headache in forehead area and top of head (headache) after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. However, the patient had no pre-existing conditions prior to the FLUZONE vaccine. On 15-Mar-2020, the patient received a first event dose (0.5 ml) of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UJ273AB; expiry date: not reported) via intramuscular route in the left forearm for prophylactic vaccination. On an unknown date in 2020, two weeks after receiving the vaccine, the patient developed a non-serious event reported as started having visual disturbances and seeing light and objects which increased in numbers over time (visual impairment), weakness in limbs (muscular weakness) and headache in forehead area and top of head (headache) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date in 2020, the patient developed a non-serious eye ache (eye pain) and pain spreading throughout body (pain) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported, the patient began experiencing side effects from the vaccine approximately 2 weeks after receiving it. The patient had experienced many side effects which had progressed and required many doctor's visits and hospitalizations due to the adverse reaction to the FLUZONE vaccine. Further the reporter detailed that two weeks after receiving the vaccine the patient started having visual disturbances and seeing light and objects which increased in numbers over time. The patient began to have a headache in forehead area and top of head with weakness in limbs. The weakness was rated as 4 on a scale of 1-10 in limbs. On 05-May-2020, the patient visited, the optometrist and the patient was given an eyedrop (not specified in this report). On 16-Jun-2020, the patient visited a retina specialist the patient. Relevant laboratory test on 16-Jun-2020: Ophthalmological examination (eye test): [retina and vitreous were normal]. On 29-Jun-2020, again the patient visited a retina specialist, and everything looked normal. On 30-Jun-2020, the patient's symptoms were so bad that the patient went to ER (emergency room). Relevant laboratory test on 30-Jun-2020: Magnetic resonance imaging (MRI): [done (results not reported)]. On 04-Jul-2020, the patient visited the ER again. It was reported the patient had headache in forehead and top of head and eye ache. It was not migraine related. They could not determine cause. On 02-AUG-2020, the patient visited a neurologist, the patient as referred to neuro-ophthalmologist. On 28-AUG-2020, the patient visited the neurologist who ordered MRI (Magnetic resonance imaging) and ECG (Electroencephalogram). Relevant laboratory test included: Electroencephalogram in 2020: [no abnormalities shown] Magnetic resonance imaging: in 2020: [no abnormalities shown] On 10-SEP-2020, the patient visited a neuro-ophthalmologist who originally thought it started in brain, but original diagnosis was incorrect. Relevant laboratory test in Sep-2020: Lumbar puncture (spinal tap): [ruled out brain infection]. In 2020, the patient developed a serious event reported as became depressed and sucidal [(suicidal ideation) and depressed mood)] (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The event suicidal ideation was assessed as medically significant. It was reported, the patient became depressed and suicidal from symptoms and pain spreading throughout body. The patient was submitted to the psychiatric care on 20-DEC-2020. On 07-Jan-2021, the patient had second psychiatric visit. On 08-Feb-2021, the patient had third psychiatric visit. On 05-Mar-2021, the patient visited psychiatrist. On an unknown date in Apr-2021, the patient had a visit to a primary care physician. Relevant laboratory test included: Magnetic resonance imaging head: Magnetic resonance imaging head - in April 2021: [done (results not reported)]. Also, the patient was ordered thyroid tests. Relevant laboratory test included: Thyroid function test (thyroid test) - in 2021: [done (results not reported)]. On 01-Jun-2021, the patient had visit to the neurologist. On an unknown date in Jul-2021, the patient visited neurologist again. Relevant laboratory test included: Electroencephalogram - In July 2021: [no findings in brain] Magnetic resonance imaging- In July 2021: [no findings in brain] An unknown corrective treatment was received for the event visual impairment. It was not reported if the patient received any corrective treatment for the other events. At the time of this report the outcome of the event was unknown.; Sender's Comments: This case concerns a 55-year-old female patient who had suicidal ideation, depressed mood, visual impairment, eye pain, pain, muscular weakness, and headache after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible for the events- visual impairment, muscular weakness and headache. Time to onset is unknown for the events- suicidal ideation, depressed mood, eye pain and pain. The patient had no pre-existing conditions prior to the vaccination. Additional information regarding medical history, other lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1653409
Sex: M
Age: 11
State: CA

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 08/29/2021
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: an 11 year old was given Daptacel instead of Adacel with no adverse event; an 11 year old was given Daptacel instead of Adacel with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00732363). This case involves a 11-year-old male patient who was administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age). The patient's medical history, past medical treatment(s), vaccination(s), and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA). On 18-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5743AA and expiry date: 06-Jun-2022) via an intramuscular route in the left deltoid for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age). It was reported that "the child received Daptacel instead of Adacel and they knows "there is more in there" but wanted to know what to look for and if they should do anything?" This was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (latency same day). At time of reporting, no adverse events were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: GARDASIL; MENACTRA

Current Illness:

ID: 1653410
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
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: The vaccine was leaking out of the hole the needle made to pierce the septum/ no AE; only able to get 0.7 ml out of the single dose vial initially and She was unable to give the patient her dose/ no AE; Initial information regarding an unsolicited valid non-serious case was received from Nurse via Medical Information (Reference number- 00733317) and transmitted to Sanofi on 20-Aug-2021. It was reported that a 30-year-old female patient while receiving RABIES (HDC) VACCINE [IMOVAX RABIES] (powder and solvent for suspension for injection) third 1 mL dose [lot T1B813M, expiry date 27-Dec-2021] via unknown route at an unknown administration site prophylactic vaccination then the vaccine was leaking out of the hole the needle made to pierce the septum (product leakage) and nurse only able to get 0.7 ml out of the single dose vial initially and was unable to give the patient her dose (product dose omission issue). Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided. It was a case of potential medication error due to missed dose (latency was on same day). It was reported "Caller state that she has a patient there to receive their 3rd rabies vaccine and she only able to draw up .7 ml of the vaccine instead of 1 ml of the vaccine. Caller stated that she did use sterile diluent." 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: 1653411
Sex: F
Age: 0
State: TX

Vax Date: 08/04/2021
Onset Date: 08/20/2021
Rec V Date: 08/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: patient inadvertently received a dose of PENTACEL after having already received a dose of Pediarix, with no reported adverse event; Initial information received on 20-Aug-2021 regarding an unsolicited valid non-serious case from an other health professional and consumer/ non healthcare professional via Media information (under reference 00733710). This case involves a 6 months old female patient who inadvertently received a dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL [VERO]) after having already received a dose of DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) [extra dose administered]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration for prophylactic vaccination. On 04-Aug-2021, the patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On 20-Aug-2021, the patient received a 0.5 ml dose of suspect PENTACEL (lot UJ458AA and expiration date: 21-May-2022) via intramuscular route in the left thigh for prophylactic vaccination. It was an actual medication error due to extra dose administered (same day latency). It was reported "Caller states that a patient inadvertently received a dose of PENTACEL on 20-Aug-2021 after having already received a dose of Pediarix on 04-Aug-2021. Caller asked if the patient was at risk for any adverse events because of the close proximity of the two doses and stated that she realized that today's dose would not count as a valid dose in the series". At time of reporting, it was unknown if the patient experienced any adverse event 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: ROTAVIRUS VACCINE; PREVNAR 13

Current Illness:

ID: 1653412
Sex: M
Age:
State: CA

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 08/29/2021
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: 15-month-old male patient had inadvertently received an expired dose of Daptacel, with no reported AE; Initial information received on 20-Aug-2021 regarding an unsolicited valid non-serious case from a nurse via Medical Information (Reference number- 00733906). This case involves a 15 month old male patient who was inadvertently vaccinated with the expired dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination. On 19-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5624AA and expiry date: 10-Jun-2021) (Strength: Standard, Frequency: once) via an unknown route in the left thigh for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency on same day). 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. 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: ACT-HIB; PREVNAR

Current Illness:

ID: 1653413
Sex: U
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
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: patient was administered an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 21-Aug-2021 from a Pharmacist via Medical Information (Reference number- 00734255) and transmitted to Sanofi on 23-Aug-2021. This case involves a patient (unknown age and gender) who administered an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] with no adverse event (expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U6521AB, expiry date 26-Jan-2021] via unknown route in unknown administration site for prophylactic vaccination. It was reported, "A patient was given an expired dose of Menactra". It was a case of actual medication error due to expired vaccine used (latency was on the same day). At the time of reporting, patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1653414
Sex: M
Age: 0
State: PA

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 08/29/2021
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: Expired dose had been administered, no AE; Initial information received on 23-Aug-2021 regarding an unsolicited valid non-serious case from a nurse and physician via Media Information (under the reference 00735979). This case involved a 2 month old male patient who was given an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant medication was given to the patient. On 23-Aug-2021, the patient received a first dose of suspect HIB (PRP/T) VACCINE (0.5 ml, once in total, lot UJ266AA and expiration date: 05-Jun-2021) via intramuscular route in the left thigh for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). It was reported "Nurse called to report that an expired dose of ACTHIB had been administered to a patient. The caller would like to know whether the dose is valid and if it should be repeated." No treatment was required. At time of reporting, it was unknown where 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.

Other Meds:

Current Illness:

ID: 1653415
Sex: M
Age: 2
State: TX

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 08/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: patient received expired powder portion of ACT-HIB/ no AE; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from other health professional and physician via call center via Global Medical Information (GMI) (reference number- 00736119). This case involves a 24 months old male patient who administered expired powder portion of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, past medical treatment, vaccination and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. On 23-Aug-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE (strength: standard, frequency: once) (powder: UJ357AA and expiry date: 26-JUL-2021) (diluent: lot number: U6849AA and expiry date: 22-JAN-2022)) via an intramuscular route in the left vastus lateralis for prophylactic vaccination. It was of actual medication error due to expired vaccine used (latency: same day). It was reported ''Stated that the vaccine was given, but the diluent portion expired on 01/22/2022, powder expired 07/26/2021 and she wants to know what the recommendations are.'' At the time of reporting, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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: PREVNAR 13

Current Illness:

ID: 1653416
Sex: F
Age: 28
State: TX

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 08/29/2021
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: patient was supposed to receive an HPV vaccine but they received an Adacel vaccine that was not ordered for her with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional (nurse) via Medical Information (Reference number- 00736518) and transmitted to Sanofi on 23-Aug-2021. This case involves a 28-year-old female patient who was supposed to receive an HPV (Human papillomavirus) VACCINE but they received an HPV VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine that was not ordered for her (wrong product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Information of concomitant medications was not reported. On 19-Aug-2021, the patient received a dose (0.5ml) of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6927AA; expiry date: 280Aug-2023) via intramuscular route in the left deltoid for prophylactic vaccination instead of suspect HPV VACCINE not produced by Sanofi Pasteur (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination. It was case of actual medication error due to wrong vaccine administered (latency: same day). It was reported, "Nurse needs some safety information as ADACEL was administered to a patient that shouldn't have received it she states. The nurse states that the patient was supposed to receive an HPV vaccine but they received an Adacel vaccine that was not ordered for her." No adverse event was reported at the time of this report. The outcome of the event was reported as unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1653417
Sex: M
Age:
State:

Vax Date: 09/21/2020
Onset Date: 09/21/2020
Rec V Date: 08/29/2021
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: He had an incident and lost blood; He had an incident and lost blood; This spontaneous case was received on 30-Sep-2020 from a pharmacist via Med Communications (reference number: SEQW20-02629) and concerned a 73-year-old, male patient. The patient's concurrent condition included high blood pressure. The patient's concomitant medications included unspecified high blood pressure medications. On 21-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279791, expiry date: 28-May-2021. On the same day, shortly after receiving Fluad Quadrivalent, the patient had an incident and lost blood, however it was not enough for a transfusion. The outcome of events was not reported. The reporter assessed events as not related to Fluad Quadrivalent. The pharmacist said that it was not related to the vaccine. The event of 'blood loss of (NOS)' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. Additional information received on 06-Nov-2020 with additional information received on 12-Nov-2020 (being processed together) from pharmacist: Reference number added and reporter's email address was provided. No changes in the narrative. Case updated on 14-Dec-2020: Correction made to information received on 30-Sep-2020: Typo in company comment amended. Company comment: The patient experienced haemorrhage and accident (reported as 'he had an incident and lost blood') after administration of Fluad Quadrivalent. The patient's concurrent condition included high blood pressure while concomitant medications included unspecified high blood pressure medications. Causality will follow the reporter's causality assessment - not related to vaccine and more likely related to mechanical/physical accident.; Reporter's Comments: The pharmacist said that it was not related to the vaccine.; Sender's Comments: The patient experienced haemorrhage and accident (reported as 'he had an incident and lost blood') after administration of Fluad Quadrivalent. The patient's concurrent condition included high blood pressure while concomitant medications included unspecified high blood pressure medications. Causality will follow the reporter's causality assessment - not related to vaccine and more likely related to mechanical/physical accident.

Other Meds:

Current Illness: Blood pressure high

ID: 1653418
Sex: F
Age:
State:

Vax Date: 11/30/2020
Onset Date: 11/30/2020
Rec V Date: 08/29/2021
Hospital:

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

Lab Data: Test Date: 20201101; Test Name: Cystic fibrosis mutation analysis; Result Unstructured Data: No major congenital malformation noted.; Test Date: 20210429; Test Name: Glucose tolerance test; Result Unstructured Data: No major congenital malformation noted. Patient failed the 1 hour glucose and then passed the 3 hour glucose; meaning no gestational diabetes noted.; Test Date: 20201101; Test Name: Genetic screening; Result Unstructured Data: No major congenital malformation noted.; Test Date: 20210223; Test Name: Anatomy ultrasound; Result Unstructured Data: No major congenital malformation noted.; Test Date: 20201130; Test Name: Ultrasound; Result Unstructured Data: No major congenital malformation noted.; Test Date: 20201211; Test Name: Ultrasound; Result Unstructured Data: No major congenital malformation noted.; Test Date: 20201223; Test Name: Ultrasound; Result Unstructured Data: No major congenital malformation noted.; Test Date: 20210205; Test Name: Ultrasound; Result Unstructured Data: No major congenital malformation noted.; Test Date: 20210429; Test Name: Ultrasound; Result Unstructured Data: No major congenital malformation noted.

Allergies:

Symptom List: Pain in extremity

Symptoms: Maternal postpartum hemorrhage due to retained placenta; Maternal postpartum hemorrhage due to retained placenta; Vaccine exposure during pregnancy; This observational study case , initially received on 30-Apr-2021 from other health professional and concerned a 37-year-old pregnant, female subject of body weight 130 lbs, height 68 inches and body mass index (BMI) 19.8, enrolled in a prospective observational safety study. The subject's concurrent condition included pregnancy with advanced maternal age. The subject's concomitant medications included folic acid and prenatal vitamins (unspecified minerals and vitamins), both used for healthy pregnancy and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) used for vaccination. The subject's obstetrical history included two previous pregnancies with two spontaneous abortions. The subject had no history of offspring with major congenital malformation (MCM). The subject had no paternal or maternal history with MCM. The subject did not use tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period (LMP) date was reported as 03-Oct-2020. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 10-Jul-2021. The type of pregnancy was singleton. On 01-Nov-2020, the genetic screening and cystic fibrosis mutation analysis tests revealed no MCMs. On 30-Nov-2020, at approximately eight weeks of gestation (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for an influenza immunisation. The batch number reported was P100267077. On the same day, the ultrasound test revealed no MCMs. On 11-Dec-2020, 23-Dec-2020 and 05-Feb-2021, the ultrasound tests revealed no MCMs. On 23-Feb-2021, anatomy ultrasound test revealed no MCMs. On 29-Apr-2021, ultrasound test revealed no MCMs. Also, the subject failed the initial glucose tolerance test (one-hour glucose) and then passed the three-hour glucose, meaning no gestational diabetes was noted. At 39.7 weeks of gestation (as reported), the subject delivered female neonate via vaginal method of delivery. Resuscitation at delivery was required and the neonate received positive pressure ventilation for up to 3 minutes following delivery. The neonate's birth weight was 4170 grams, body length: 53.3 centimetres (cm) and head circumference was 35 cm. Appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was five, at five minutes was eight and at ten minutes was not reported. Also, the neonate experienced hyperbilirubinemia and received phototherapy for 24 hours post-delivery. No MCM were identified at delivery. On the same day, the subject experienced postpartum hemorrhage due to retained placenta. The outcome of the event 'postpartum haemorrhage' and retained placenta was not reported. The reporter did not provide causality assessment. The events of 'postpartum hemorrhage' and retained placenta were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. This case is linked to case 202102844 (the corresponding baby case). Case updated on 18-Jun-2021: Correction made to information received on 30-Apr-2021: Company agent causal updated from 'no' to 'yes'. Additional information received on 06-Aug-2021 from physician with additional information received on the same day (being processed together) from other health professional: Additional reporter added. Pregnancy outcome provided. Dates for 'genetic screening' and 'cystic fibrosis mutation analysis' provided. Event 'glucose tolerance test abnormal' deleted from event tab because result for glucose tolerance test provided. Result updated for the test. 'Postpartum haemorrhage' and retained placenta added as new events. Stop date and outcome added for 'Vaccine exposure during pregnancy'. The narrative amended accordingly. Company Comment: A 37-year-old subject was vaccinated at 8 weeks of gestation with the suspect product, Afluria QIV (explicitly coded as 'Vaccine exposure during pregnancy'). Subjects medical history was not reported. The subject's obstetrical history included two previous pregnancies with two spontaneous abortions. On the same day after delivery the subject experienced postpartum haemorrhage due to retained placenta. The subject experienced postpartum haemorrhage due to retained placenta on the same day after delivery. Causality for vaccine exposure during pregnancy is assessed as not related s per company specific guidelines. Causality for postpartum haemorrhage and retained placenta is assessed as not related due to biological implausibility.; Sender's Comments: A 37-year-old subject was vaccinated at 8 weeks of gestation with the suspect product, Afluria QIV (explicitly coded as 'Vaccine exposure during pregnancy'). Subjects medical history was not reported. The subject's obstetrical history included two previous pregnancies with two spontaneous abortions. On the same day after delivery the subject experienced postpartum haemorrhage due to retained placenta. The subject experienced postpartum haemorrhage due to retained placenta on the same day after delivery. Causality for vaccine exposure during pregnancy is assessed as not related s per company specific guidelines. Causality for postpartum haemorrhage and retained placenta is assessed as not related due to biological implausibility.

Other Meds: FOLIC ACID; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; TDAP

Current Illness:

ID: 1653419
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
Hospital: Y

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: Dehydration; This spontaneous case was received on 06-Aug-2021 from other non-health professional (consumer) via Agency (reference number: SEQW21-01546) and concerned a female patient of an unknown age. At the time of initial reporting, the patient was a 45-year-old. The patient's medical history and concomitant medications were not reported. On an unspecified date in the past, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; indication, dose, anatomical location, route of administration: not reported). The batch number was not reported. The patient did not know the name of the vaccine or lot number or expiration date. On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced severe dehydration and was admitted to hospital due to the event. The outcome of the event was not reported. The reporter did not provide a causality assessment. The event of 'dehydration' was assessed as serious due to criterion of hospitalization. This case is linked with case 202102845 (due to the same patient). Company Comment: A female patient developed dehydration after vaccination with the suspect product influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history and related diagnostic findings have not been provided. Due to lack of information regarding the temporal relationship, causality is unassessable.; Sender's Comments: A female patient developed dehydration after vaccination with the suspect product influenza virus vaccine polyvalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history and related diagnostic findings have not been provided. Due to lack of information regarding the temporal relationship, causality is unassessable.

Other Meds:

Current Illness:

ID: 1653421
Sex: F
Age:
State:

Vax Date: 11/30/2020
Onset Date: 07/08/2021
Rec V Date: 08/29/2021
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: Foetal exposure during pregnancy; Hyperbilirubinemia in infant; Resuscitation at delivery; Birthweight of 4170 g; APGAR score 5 at one minute; This observational study case was received from other health professional on 06-Aug-2021 and concerned a female neonate, whose mother was a 37-year-old, pregnant, female subject of body weight 130 lbs, height 68 inches and body mass index (BMI) 19.8, enrolled in a prospective observational safety study. The maternal concurrent conditions included pregnancy with advanced maternal age. The maternal concomitant medications included folic acid and prenatal vitamins (unspecified minerals and vitamins), both used for healthy pregnancy and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) used for vaccination. The maternal obstetrical history included two previous pregnancies with two spontaneous abortions. The neonate's mother had no offspring with major congenital malformations (MCMs). The neonate's mother had no maternal or paternal history with MCMs. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. The last menstrual period (LMP) date was reported as 03-Oct-2020, estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were both reported as 10-Jul-2021. The type of pregnancy was singleton. The paternal age was 38 years. On 01-Nov-2020, the genetic screening and cystic fibrosis mutation analysis tests revealed no MCMs. On 30-Nov-2020, at approximately eight weeks of gestation (calculated per LMP), the neonate's mother was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, anatomical location and route of administration: not reported) (explicitly coded as 'Foetal exposure during pregnancy') for influenza immunisation. The batch number reported was P100267077. On the same day, the ultrasound test revealed no MCMs. On 11-Dec-2020, 23-Dec-2020 and 05-Feb-2021, the ultrasound tests revealed no MCMs. On 23-Feb-2021, anatomy ultrasound test revealed no MCMs. On 29-Apr-2021, ultrasound test revealed no MCMs. The mother failed initial glucose tolerance test (one-hour glucose) and then passed the three-hour glucose, meaning no gestational diabetes was noted. At 39.7 weeks of gestation (as reported), the mother delivered female neonate via vaginal method of delivery. Resuscitation at delivery was required and the neonate received positive pressure ventilation for up to 3 minutes following delivery. The neonate's birth weight was 4170 grams, body length: 53.3 centimetres and head circumference was 35 cm. Appearance, pulse, grimace, activity and respiration (APGAR) scores at one minute was 5, at five minutes was 8 and at ten minutes was not reported. Also, the neonate experienced hyperbilirubinemia and received phototherapy for 24 hours post-delivery. No MCMs were identified at delivery. The neonate's mother experienced postpartum haemorrhage due to retained placenta. On the same day, the neonate recovered from 'apgar score low' and 'resuscitation'. The outcome of the events of 'hyperbilirubinemia newborn', 'large for dates baby' was not reported. The reporter did not provide a causality assessment. The events of 'hyperbilirubinemia newborn', 'large for dates baby', 'apgar score low' and 'resuscitation' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. This case is linked to case 202102377 (the corresponding mother case). Company Comment: A female neonate was born with 4170 grams, 7 months and 8 days after maternal receipt of Afluria QIV (explicitly coded as 'Foetal exposure during pregnancy'). APGAR score was 5 at one minute. Resuscitation at delivery was required and the neonate received positive pressure ventilation for up to 3 minutes following delivery. The neonate required phototherapy for 24 hours post-delivery due to hyperbilirubinemia. No MCMs were identified at delivery. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. Causality for foetal exposure during pregnancy is not related as per company specific guidelines. Causality for all other events is assessed as not related due to biological implausibility.; Sender's Comments: A female neonate was born with 4170 grams, 7 months and 8 days after maternal receipt of Afluria QIV (explicitly coded as 'Foetal exposure during pregnancy'). APGAR score was 5 at one minute. Resuscitation at delivery was required and the neonate received positive pressure ventilation for up to 3 minutes following delivery. The neonate required phototherapy for 24 hours post-delivery due to hyperbilirubinemia. No MCMs were identified at delivery. The mother did not use tobacco, alcohol or illicit drugs during pregnancy. Causality for foetal exposure during pregnancy is not related as per company specific guidelines. Causality for all other events is assessed as not related due to biological implausibility.

Other Meds: Tdap; Folic acid; Prenatal vitamins

Current Illness:

ID: 1653422
Sex: F
Age: 37
State:

Vax Date: 01/10/2014
Onset Date: 01/10/2014
Rec V Date: 08/29/2021
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: Eyes started to itch; Eyes and face were swollen; Eyes and face were swollen; Swelling in face and warmness and red; Swelling in face and warmness and red/face was warm; This spontaneous case was received on 06-Aug-2021 from other non-health professional (consumer) via communications (reference number: SEQW21-01546) and concerned a 37-year-old, female patient. At the time of initial reporting, the patient was a 45-year-old. The patient's concurrent conditions included allergy to Neosporin (gramicidin, neomycin sulfate, polymyxin b sulfate). The patient's past medical history included two high risk pregnancies and blood clots. The patient's historical drug included Neosporin (gramicidin, neomycin sulfate, polymyxin b sulfate) after which the patient had face swelling and developed high allergy to this drug. The patient's historical vaccine included flu vaccine after which the patient was admitted to hospital for severe dehydration (refer to case 202102826). The patient was not taking any concomitant medications. On 10-Jan-2014, the patient was vaccinated with Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine; dose: 0.5 ml, route of administration and anatomical location: not reported) as an immunisation against influenza. The batch number reported was 1309501 and expiry date was Apr-2014. On the same day, after receiving Fluvirin, the patient went home and noticed that her eyes started to itch. After she looked in the mirror the patient noticed that her eyes and face were swollen, and her face was warm and red. The patient went to emergency room (ER) and received steroids and Benadryl (diphenhydramine hydrochloride). The patient reported that she might have received Pepcid (famotidine), but she was not sure. They observed her for a few hours and let her go home. On an unspecified date, the patient recovered from events. It was reported that it took several days and lots of Benadryl (diphenhydramine hydrochloride) before the symptoms subsided. The reporter assessed the events as related. As reported, the patient stated that she experienced adverse events for Fluvirin. It was also reported that the patient was working with her allergist and they were trying to determine what ingredients she was allergic to and if she should get the Covid vaccine. The case was assessed as non-serious. This case is linked with case 202102826 (due to the same patient). Company comment: A female patient developed eye pruritus, eye and face swelling, facial erythema and she was feeling facial warmth on the same day after vaccination with the suspect product Fluvirin. Patient visited emergency room however related diagnostic findings have not been provided. Patient has a history of allergic reactions, however at time of event she was not taking any concomitant medications. Based on suggestive time relationship, causality for the reported events is assessed as possibly related.; Reporter's Comments: Consumer states she experience an adverse event for FLUVIRIN on 10JAN2014. Patient stated she is working with a allergist and she is trying to determine what ingredients she are allergic to. She would like to know the ingredients in the Fluvirin vaccine 2013-1014 season. They are trying to determine if she should get the Covid vaccine. She also mentioned that she is highly allergic to Neosporin and had a similar reaction with face swelling.; Sender's Comments: A female patient developed eye pruritus, eye and face swelling, facial erythema and she was feeling facial warmth on the same day after vaccination with the suspect product Fluvirin. Patient visited emergency room however related diagnostic findings have not been provided. Patient has a history of allergic reactions, however at time of event she was not taking any concomitant medications. Based on suggestive time relationship, causality for the reported events is assessed as possibly related.

Other Meds:

Current Illness: Allergy to antibiotic

ID: 1653423
Sex: F
Age:
State:

Vax Date: 10/03/2020
Onset Date: 03/14/2021
Rec V Date: 08/29/2021
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: Spontaneous abortion at 11 weeks of gestation; This spontaneous case was received on 10-Aug-2021 from other health professional and concerned a 42-year-old female patient, of body weight: 108 lbs, height: 61 inches and body mass index (BMI): 20.4. The patient had no relevant medical history. The patient's concomitant medications included Vitafol One (ascorbic acid, betacarotene, colecalciferol, cupric oxide, cyanocobalamin, folic acid, iron polysaccharide complex, magnesium oxide, nicotinamide, omega-3 fatty acids, potassium iodide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) for healthy pregnancy. The patient's obstetrical history included two previous pregnancies, with one elective abortion and one ectopic pregnancy. The patient had no history of offspring with major congenital malformation (MCM) and no maternal or paternal history with MCMs. The patient did not use tobacco, alcohol or illicit drugs during pregnancy. The patient's last menstrual period (LMP) date was reported as 27-Dec-2020. The type of pregnancy was singleton. The estimated delivery date (EDD) was reported as 03-Oct-2021 and corrected estimated date of delivery (CEDD) was not reported. On 03-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose, indication, route of administration and anatomical location: not reported). The batch number reported was P100239705. No pregnancy complications were noted, and no prenatal tests were performed. On 14-Mar-2021, five months and 11 days after receiving Afluria Quadrivalent, at 11 weeks of gestation, the patient had spontaneous abortion. The outcome of the event spontaneous abortion was not reported. The reporter did not provide a causality assessment to Afluria Quadrivalent. The event of 'spontaneous abortion' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. Company Comment: Spontaneous abortion was reported in a 42-year-old female patient five months after vaccination with the suspect product Afluria Quadrivalent. No pregnancy complications were noted, and no prenatal tests were performed. Information regarding autopsy and possible aetiology for the reported event have not been provided. Patients age confounds causality since the risk of spontaneous abortions significantly increases by age. Based on implausible temporal relationship and presented confounder, causality is assessed as not related.; Sender's Comments: Spontaneous abortion was reported in a 42-year-old female patient five months after vaccination with the suspect product Afluria Quadrivalent. No pregnancy complications were noted, and no prenatal tests were performed. Information regarding autopsy and possible aetiology for the reported event have not been provided. Patients age confounds causality since the risk of spontaneous abortions significantly increases by age. Based on implausible temporal relationship and presented confounder, causality is assessed as not related.

Other Meds: Vitafol one

Current Illness:

ID: 1653424
Sex: F
Age:
State:

Vax Date: 11/01/2014
Onset Date: 11/01/2014
Rec V Date: 08/29/2021
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: Heart feeling as out of rhythm; Coughing so much that she felt as though she had ripped a muscle in her chest; Coughing so much that she felt as though she had ripped a muscle in her chest; Respiratory flu-like symptoms; She felt as though she was going to vomit or experience diarrhea; Feel extremely weak, characterizing it as "wavy weirdness''; Feel extremely weak, characterizing it as 'wavy weirdness'/ weakness; Fearing that she was going to pass out/felt as though she was going to pass out while in the car; Stabbing pain in her stomach; She felt as though she was going to vomit or experience diarrhea; This spontaneous case was received on 11-Aug-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-01582) with additional information received on 13-Aug-2021 (being processed together) via Med Communications (reference number: SEQW21-01582) and concerned an adult, female patient. At the time of initial reporting, the patient was a 62-year-old. The patient's concurrent conditions included Graves' disease, blood pressure abnormal, history of heart arrythmia and several allergies to other medications. The patient's concomitant medications included unspecified blood pressure medication for blood pressure abnormal. The patient's historical medications included Augmentin (amoxicillin) after which she felt as her skin was on fire and "shot with poison", codeine after which she felt like her blood pressure was increased and "hyped up", unspecified blood pressure medicine from different manufacturer after which she had adverse reaction. If she had not taken any, she kept getting weaker with crazy blood pressure and heart rate spikes and once she got the one from the manufacturer she had been on, the symptoms straightened out within two days and she felt better with the first dose. In addition, the patient reported that she can take amoxicillin only not brand name Augmentin. On an unspecified date in Nov-2014, the patient was vaccinated with Afluria Trivalent (influenza vaccine; dose, anatomical location, route of administration: not reported) as protection against seasonal influenza. The batch number was not reported. The patient waited the 15-minute period after receiving the injection in case she developed an allergic reaction, which she did not. On the same day, after receiving Afluria Quadrivalent, the patient went and ran errands and she spent 10 - 15 minutes in one store with no issues. Then she went to store and after about 15 - 20 minutes of shopping, the patient began to feel extremely week, characterizing it as "wavy weirdness". The patient left the store as quick as she could, fearing that she was going to pass out. Patient stated that she felt as though she was going to pass out while in the car and had to distract herself to make sure she remained conscious while she drove home. This weakness lasted about three days and was accompanied by stabbing pain in her stomach, where she felt as though she was going to vomit or experience diarrhea. On an unspecified date in 2014, about three days from onset, the patient recovered from the event of 'feelings of weakness'. On an unspecified date, reported as 'after this time period', the patient began to experience respiratory flu-like symptoms including coughing so much that she felt as she had ripped a muscle in her chest. The patient reported that during this time, she also experienced heart feeling as though it was out of rhythm. The patient stated that it took her about three weeks to "pull herself together" and longer to be able to return back to work. On an unspecified date, about two months from onset, the patient recovered from the events of 'flu-like symptoms', 'coughing' and 'chest discomfort'. On an unspecified date, the patient recovered from the events of 'arrhythmia cardiac (NOS)' 'pre-syncope', 'weird feeling', 'stomach pain', 'nausea' and 'abdominal discomfort'. The reporter assessed all events as related to Afluria Trivalent. As reported, the patient received AFLURIA Influenza Vaccine 2014-2015 formulation and had a bad reaction to it. She has been worried ever since to get any other vaccine due to that experience. The event of 'arrhythmia cardiac (NOS)' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. Company Comment: An adult female patient developed weakness (characterized as wavy weirdness), presyncope, stomach pain, nausea and abdominal discomfort after vaccination with the suspect product Afluria Trivalent. An unknown amount of time after vaccination the patient developed flu-like symptoms, cough accompanied by chest discomfort and non-specified cardiac arrhythmia. Patients medical history is significant for heart arrythmias and several allergies to other medications. Based on plausible time relationship causality for the events asthenia, weird feeling, presyncope, abdominal discomfort, nausea and stomach pain is assessed as possibly related. Causality for all other events is unassessable due to unclear temporal relationship.; Reporter's Comments: As reported, the patient received AFLURIA Influenza Vaccine 2014-2015 formulation and had a bad reaction to it. She has been worried ever since to get any other vaccine due to that experience.; Sender's Comments: An adult female patient developed weakness (characterized as wavy weirdness), presyncope, stomach pain, nausea and abdominal discomfort after vaccination with the suspect product Afluria Trivalent. An unknown amount of time after vaccination the patient developed flu-like symptoms, cough accompanied by chest discomfort and non-specified cardiac arrhythmia. Patients medical history is significant for heart arrythmias and several allergies to other medications. Based on plausible time relationship causality for the events asthenia, weird feeling, presyncope, abdominal discomfort, nausea and stomach pain is assessed as possibly related. Causality for all other events is unassessable due to unclear temporal relationship.

Other Meds:

Current Illness: Blood pressure abnormal; Drug allergy; Graves' disease

ID: 1653425
Sex: F
Age: 15
State:

Vax Date: 10/17/2020
Onset Date: 10/19/2020
Rec V Date: 08/29/2021
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: Began to hit herself with her arms uncontrollably/abnormal body movements and neurological problems; Anxiety; OCD symptoms; Motor and vocal tics; Orthostatic hypotension; Intolerance to cold; Hallucination; Having problems holding her phone and couldn't pick up food; This spontaneous case was received on 12-Aug-2021 from physician via Agency (reference number: SEQW21-01593) and concerned a 15-year old female patient. The patient had no relevant medical history and was not taking any concomitant medications. The patient was healthy and never had any problems before and had always stayed up to date on her vaccines. The patient's historical vaccine included Gardasil vaccine (HPV vaccine VLP rL1 4v (yeast)). On 17-Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported) for an influenza prophylaxis. The batch number reported was 279827 and expiration date was 18-Jun-2021. On 19-Oct-2020, two days after receiving Flucelvax Quadrivalent, the patient started having problems holding her phone and could not pick up food. On an unknown date, the patient began to hit herself with her arms uncontrollably and a vest was purchased to prevent that. The patient also experienced severe anxiety, obsessive-compulsive disorder (OCD) symptoms, motor and vocal tics (reported as ticks), hallucinations, orthostatic hypotension and intolerance to cold. The patient saw her pediatrician, pediatric neurologist, five different neurologists and was seeing her rheumatologist, however further details were not provided. On an unknown date, the patient started treatment with guanfacine for tics and with unspecified selective serotonin reuptake inhibitors (SSRI) for anxiety. At the time of initial reporting on 12-Aug-2021, the patient had not recovered from the events. The reporter assessed the events as related to Flucelvax Quadrivalent. It was reported that a reporter's daughter received Flucelvax Quadrivalent last year and had an adverse reaction. The event of hallucination was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. Company comment: A 15-year old female patient was vaccinated with the suspect product Flucelvax Quadrivalent. After two days patient experienced decreased mobility. An unknown amount of time after vaccination the patient experienced anxiety, symptoms of obsessive-compulsive disorder, ticks, hallucinations, orthostatic hypotension and intolerance to cold. Information regarding related diagnostic findings have not been provided, although patient visited paediatricians and neurologist. Insufficient information provided precludes a proper causality assessment.; Reporter's Comments: Reporter's daughter received Flucelvax Quadrivalent last year and had an adverse reaction.; Sender's Comments: A 15-year old female patient was vaccinated with the suspect product Flucelvax Quadrivalent. After two days patient experienced decreased mobility. An unknown amount of time after vaccination the patient experienced anxiety, symptoms of obsessive-compulsive disorder, ticks, hallucinations, orthostatic hypotension and intolerance to cold. Information regarding related diagnostic findings have not been provided, although patient visited paediatricians and neurologist. Insufficient information provided precludes a proper causality assessment.

Other Meds:

Current Illness:

ID: 1653426
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
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: Had a reaction to it, including swelling in the face and other; Had a reaction to it, including swelling in the face and other; This spontaneous case was received on 14-Aug-2021 from other non-health professional (reference number: NUS2021US122701) and concerned a female patient, of an unreported age. The patient's concurrent conditions and concomitant medications were not reported. The patient had another side effect to unspecified product prior to Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine) which resulted with the hospitalization. On an unknown date in 2014, the patient was vaccinated with Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine; dose, route of administration, indication and anatomical location: not reported). The batch number reported was 1309501. On an unknown date, unknown amount of time after receiving Fluvirin, the patient had a reaction to it, including swelling in the face and other. The outcome of the events was not reported. The reporter assessed all events as related to Fluvirin. The patient had a reaction to it. Company Comment: A female patient experienced adverse reaction and swelling of face after vaccination with the suspect product Fluvirin. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to limited information causality is unassessable.; Sender's Comments: A female patient experienced adverse reaction and swelling of face after vaccination with the suspect product Fluvirin. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to limited information causality is unassessable.

Other Meds:

Current Illness:

ID: 1653427
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
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: Bruising reaction; Muscular issue in my left arm; Muscular pain; Drs suggested there may be a protein in them that I may be allergict to; This spontaneous case was received on 16-Aug-2021 via Med Communications (reference number: SEQW21-01609) from other non-health professional (consumer) and concerned a female patient of an unreported age. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included unspecified vaccine (not a flu vaccine) after which the patient experienced muscular pain and bruising reaction that lasted far longer than the 'typical' timelines listed as side effects. On an unknown date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration, dose, anatomical location and indication: not reported). The batch number was not reported. This was the first flu vaccine the patient had ever gotten. On an unknown date, unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced severe muscular pain/bruising reaction, that also lasted far longer than the 'typical' timelines listed as side effects. Doctors suggested there may be a protein in them that patient may be allergic to. The patient also experienced a muscular issue in her left arm. The outcome of the events was unknown. The reporter did not provide causality assessment. Company comment: A female patient experienced allergic reaction with severe muscular pain and bruising reaction Flucelvax Quadrivalent. The patient also experienced a muscular issue in her left arm. Information regarding the related diagnostic findings have not been provided. Due to limited information regarding the temporal relationship, causality is unassessable.; Sender's Comments: A female patient experienced allergic reaction with severe muscular pain and bruising reaction Flucelvax Quadrivalent. The patient also experienced a muscular issue in her left arm. Information regarding the related diagnostic findings have not been provided. Due to limited information regarding the temporal relationship, causality is unassessable.

Other Meds:

Current Illness:

ID: 1653428
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/29/2021
Hospital:

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

Lab Data: Test Name: Lesional skin biopsy; Result Unstructured Data: Demonstrated a subepidermal blister with numerous eosinophils; Test Name: Eosinophils; Result Unstructured Data: Peripheral eosinophilia - eosinophils 24%.; Test Name: BP180 ELISA; Result Unstructured Data: BP180 >100; Test Name: DIF of perilesional skin; Result Unstructured Data: Linear deposition of IgG and C3 along the dermoepidermal junction; Test Name: WBC; Result Unstructured Data: Leukocytosis - WBC 30.5 cells/mm3

Allergies:

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

Symptoms: Bullous pemphigoid of infancy; This literature case was received on 16-Aug-2021 and concerned a 5-month-old, female patient. The aim of this conference abstract was to highlight clinical presentation, diagnosis, and management of bullous pemphigoid (BP), a rare disease in infancy. The patient had no relevant medical history and was healthy. The patient's concomitant medications were not reported. On an unspecified date, reported as recently prior to presentation, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for influenza vaccination. The batch number was not reported. On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient presented with five-day history of pruritic vesicles and bullae on the trunk, extremities, palms and soles. Laboratory work-up revealed a leukocytosis with peripheral eosinophilia (white blood cell count (WBC) was 30.5 cells/mm3 and eosinophils 24%) Lesional skin biopsy demonstrated a subepidermal blister with numerous eosinophils. Direct immunofluorescence (DIF) of perilesional skin revealed linear deposition of immunoglobulin G (IgG) and complement 3 (C3) along the dermoepidermal junction. Enzyme-linked immunosorbent assay (ELISA) was positive for BP (BP180 >100) and the patient was diagnosed with BP of infancy. On an unspecified date, the patient commenced treatment with systemic steroids (prednisolone at a dose of 2 mg/kg/day). Skin findings significantly improved within two days. At the time of initial reporting, the patient was recovering from the event. The patient remained in remission while tapering off prednisolone. The reporter did not provide causality assessment. It was reported that numerous cases have been reported in association with recent vaccinations. Some authors posit vaccines may unmask subclinical BP by inducing a nonspecific immune activation, while others believed the trauma from injection can generate T-helper (Th) 17 cell activation and release of proinflammatory cytokines, leading to bullae formation. The event of 'bullous pemphigoid' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. Company comment: A 5-month-old, female patient developed bullous pemphigoid (BP) an unknown amount of time after vaccination with the suspect product influenza virus vaccine polyvalent. The patient had no relevant medical history and was healthy. The patient's concomitant medications were not reported. Enzyme-linked immunosorbent assay (ELISA) was positive for BP. Due to unclear temporal relationship, causality for the reported event is unassessable.; Sender's Comments: A 5-month-old, female patient developed bullous pemphigoid (BP) an unknown amount of time after vaccination with the suspect product influenza virus vaccine polyvalent. The patient had no relevant medical history and was healthy. The patient's concomitant medications were not reported. Enzyme-linked immunosorbent assay (ELISA) was positive for BP. Due to unclear temporal relationship, causality for the reported event is unassessable.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am