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

Date Died: 07/22/2021

ID: 1757610
Sex: M
Age: 90
State:

Vax Date: 09/24/2020
Onset Date: 11/18/2020
Rec V Date: 10/04/2021
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: Deceased; Toe infection; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Deceased) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ENZALUTAMIDE (ENZALUTAMIDE ASTELLAS) capsule for Prostate cancer. Concurrent medical conditions included Prostate cancer (Received enzalutamide). On 24-Sep-2020, the patient started ENZALUTAMIDE (ENZALUTAMIDE ASTELLAS) (Oral) 160 mg once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2020, the patient experienced LOCALISED INFECTION (Toe infection). The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, LOCALISED INFECTION (Toe infection) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. This case concerns a 90 year-old male patient with history of prostate cancer, who experienced the unexpected serious event of Death (unknown cause) and the unexpected non-serious event of Localised infection. The events occurred an unknown number of days after the first and second doses of mRNA-1273 vaccine. The history of prostate cancer with unknown onset may have contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness of criteria of Medically significant was overridden for the event of Localised infection based on medical judgement and review of source document that does not include information supporting seriousness criteria.; Sender's Comments: This case concerns a 90 year-old male patient with history of prostate cancer, who experienced the unexpected serious event of Death (unknown cause) and the unexpected non-serious event of Localised infection. The events occurred an unknown number of days after the first and second doses of mRNA-1273 vaccine. The history of prostate cancer with unknown onset may have contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness of criteria of Medically significant was overridden for the event of Localised infection based on medical judgement and review of source document that does not include information supporting seriousness criteria.; Reported Cause(s) of Death: Deceased

Other Meds:

Current Illness: Prostate cancer (Received enzalutamide)

ID: 1757611
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: gotten sicker; Initial information received on 27-Sep-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non healthcare professional. This case involves a patient (unknown age and gender) who had gotten sicker (illness), after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient had gotten sicker (illness, non-serious) (unknown latency) following the administration of vaccine. It was reported "I didn't think the flu existed anymore. No one seemed to get it last year. Only Covid. So weird. I don't get the flu shot. Every time I have, I've gotten sicker than a dog. Stopped about 10 years ago despite teaching and being around all the germs. And seriously flu was down 99% last year." It was unknown if the patient experienced any additional symptoms/events. There were no laboratory data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1757613
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: Sick; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious received from a consumer/non-healthcare professional. This case involves a patient (unknown age and gender) who was sick (illness), after receiving INFLUENZA VACCINE. The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious sick (illness) [unknown latency] following the administration of vaccine. It was reported "Had a flu shot 30 years ago. Sick for about a year. Had the flu ONCE about 25 years ago. Never had it since nor do I take the vaccine. My immune system has done me well." It was unknown if the patient experienced any additional symptoms/events. There were no laboratory data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1757614
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: get a flu shot twice. Both years I caught the flu a few months later.; Initial information was received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media. This case involved an unknown age and gender patient who experienced get a flu shot twice both years i caught the flu a few months later (influenza) while receiving INFLUENZA VACCINE. Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious caught the flu (influenza) few months later get a flu shot twice both years following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. It was reported "Hard pass! I wish you'd stick to your old content that was just fun and funny." It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1757615
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: person who gave the shot gave it way too high with no adverse event; Initial information received on 28-Sep-2021 regarding an unsolicited valid Social Media non-serious case received from via other health professional (under reference number: US-SA-SAC20211001000464). This case involves Adult and unknown gender patient who was administered INFLUENZA VACCINE (product administration error). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. It is unknown if the patient experienced any additional symptoms/ event. It is unknown if there were lab data/results available. It was case of an actual medication error due to product administration error (latency: same day). At the time of reporting, no adverse event was reported. There will be no further information on the lot number for this case. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1757616
Sex: F
Age: 66
State: NC

Vax Date: 09/13/2021
Onset Date: 09/15/2021
Rec V Date: 10/04/2021
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: shingles on her face/ shingles spreading to her eye.; runny nose; cough; 10 pustules on her forehead and they are crusting over; could hardly walk or move" and could barley do her PT exercises.; severe pain; burning" in her back, and down her right leg to the top of her ankle/ felt like her body was on fire/felt like her body was "inflamed"; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and consumer/non-healthcare professional via call center via Agency (Reference number- 00632994). This case involves a 66-year-old female patient who experienced severe pain (pain), burning in her back, and down her right leg to the top of her ankle/ felt like her body was on fire (burning sensation), shingles on her face/ shingles spreading to her eye (herpes zoster), runny nose (rhinorrhoea), cough, 10 pustules on her forehead and they are crusting over (pustule) and could hardly walk or move and could barley do her pt exercises (gait disturbance) after she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. The patient's medical history, vaccinations, concomitant medication and family history were not provided. Patient has had a knee surgery in the past without further detail. On 13-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination. On 15-SEP-2021 the patient developed a non-serious severe pain (pain), burning in her back, and down her right leg to the top of her ankle/ felt like her body was on fire (burning sensation) and could hardly walk or move and could barley do her pt exercises (gait disturbance) 2 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On 19-SEP-2021 the patient developed a non-serious shingles on her face/ shingles spreading to her eye (herpes zoster), runny nose (rhinorrhoea), cough and 10 pustules on her forehead and they are crusting over (pustule) 6 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported "She went to her regularly scheduled physical therapy appointment (she is post-knee surgery)." Laboratory details were not reported. An anti-viral oral medication and eye drops was received for the events (herpes zoster) as a treatment. It was not reported if the patient received a corrective treatment for the events (Pain, burning sensation, back pain and pain in extremity, rhinorrhoea, cough, pustule, inflammation and gait disturbance). On an unknown date, the patient recovered from rhinorrhoea. At the time of this report, outcome of the event cough was not recovered. The event outcome was unknown for the other events. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1757617
Sex: F
Age: 38
State: AR

Vax Date: 09/26/2021
Onset Date: 09/26/2021
Rec V Date: 10/04/2021
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: plunger would not go down completely and he is not sure of the amount of the dose delivered, no adverse event; plunger would not go down completely and he is not sure of the amount of the dose delivered, no adverse event; Pregnant women was administered FLUBLOK, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via Agency (Reference number- 00786301) and transmitted to Sanofi on 27-Sep-2021. This case involves a 38-year-old pregnant female patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (exposure during pregnancy) and the plunger would not go down completely and the reporter was not sure of the amount of the dose delivered [(underdose) and (syringe issue)]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date was not reported. The gestation period at onset and gestation period at exposure was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication(s) were not reported. On 26-Sep-2021, the patient received a dose (0.5 ml; total) of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA2115; expiry date: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination. It was also case vaccine exposure during pregnancy (latency: same day). The reporter mentioned, for the pregnancy, it was checked as 'YES' to the question: are you breast feeding, pregnant or planning to get pregnant but does not know anything further. It was the case of actual medication error due syringe issue and vaccine underdose (latency: same day). It was reported "Caller said they administered FLUBLOK PFS to patient. Caller said they are not sure if due to needle or syringe, but needle would not go all the way down resulting in the full dose not being administered. Caller asking if they should give patient second full dose. Pharmacist states he wasn't the one that gave the injection, and the product has been placed in the sharps. They do not want a replacement for it. States he doesn't know if it was the needle or the prefilled syringe but when administration was attempted the plunger would not go down completely and he is not sure of the amount of the dose delivered. States the box was not damaged and the needle didn't look bent." Also, the reporter stated that the individual that was vaccinated was not trying to aspirate. The plunger was intact upon opening the carton. They had difficulty pushing the plunger during administration. There was no leakage reported. Number of units affected was one and it was not available for return because it was thrown in the sharps container. No adverse events were reported at the time of this report. At the time of this report, the outcome of the events was unknown. At the time of this report, the outcome of the pregnancy was unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1757618
Sex: M
Age: 0
State: WI

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/04/2021
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: A two month old patient accidentally received two injections of Fluzone QIV NP that were intended for family members instead of 2 month vaccine, no AE; A two month old patient accidentally received two injections of Fluzone QIV NP that were intended for family members instead of 2 month vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via consumer/non-health care professional via Agency (Reference number- 00786864) and transmitted to Sanofi on 27-Sep-2021. This case involves a 2 month old male patient who accidentally received two injections of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that were intended for family members instead of 2 month vaccine (Wrong product administered and Product administered to patient of inappropriate age) Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination. On 27-Sep-2021, the patient received a 0.5 ml (dose 1 and 2) of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7325LA, expiry date: 30-Jun-2022, Solution for injection in pre-filled syringe) via intramuscular route in the left thigh for prophylactic vaccination twice. It was a case of an actual medication error due to Wrong product administered and Inappropriate age at vaccine administration (latency same day). It was reported "Doctor states that a two-month-old patient accidentally received two injections of FLUZONE QIV NP (no preservative) that were intended for his family members instead of his 2 month vaccines that were scheduled on 27SEP2021. Doctor asked if there was any information regarding FLUZONE QIV NP in patients of this age and also asked if she should report this to the Vaccine Adverse Event Reporting System (VAERS) as well. Doctor asked if she should hold off on the patient's intended vaccinations so that it could be determined if the FLUZONE QIV NP were responsible if the patient developed any adverse events. Doctor states that patient is still in her office and has not experienced any adverse events thus far" 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: ROTATEQ

Current Illness:

ID: 1757619
Sex: U
Age:
State: WI

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/04/2021
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: inadvertently received a two dose of FLUZONE QUADRIVALENT vaccines instead of PENTACEL (VERO) with no adverse event; Initial information was received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from a physician and non-healthcare professional via Medical information (under reference number - 00786957). This case involves a patient of (unknown demographics) who inadvertently received a two dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] vaccines instead of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (extra dose administered). The patient had no medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medications were not reported. On 27-Sep-2021, the patient received a two dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was case of actual medication error due to extra dose administered. At the time of report, no adverse event was reported. There were no laboratory data/results available. 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 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: 1757620
Sex: U
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: patient never received the 5th dose, with no adverse event; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case from other health professional and consumer/ non-healthcare professional via Media Information (under reference 00787054). This case involves a 7 years old patient (unknown gender) who never received the 5th dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) [product dose omission issue]. The patient had received DAPTACEL for the first four dose in the past. The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DAPTACEL (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to Missed dose (same day latency). It was reported "Is it okay to give them ADACEL for the 5th dose? A clinic wanting to know how to help get a consumer caught up due to having a 7-year old that has not gotten their 5th dose of DAPTACEL. The caller reported that the last dose of DAPTACEL was at the age of 4-years-old." 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 lot number for this case.

Other Meds:

Current Illness:

ID: 1757622
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: administered Fluzone High Dose to a patient who is 58 years old, with no reported adverse event; administered Fluzone High Dose to a patient who is 58 years old, with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from pharmacist and consumer or non-health professional via Information (Reference number: 00789359) and transmitted to Sanofi on 28-Sep-2021. This case involved a 58-year-old patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose). Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported. [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test, strength: 0.5 mL, lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. This was actual medication error case due to Inappropriate age at vaccine administration and vaccine overdose. It was reporter ''pharmacist states that the patient administered FLUZONE HIGH DOSE to a patient who was 58 years old. Pharmacist asks if this was okay and if it would cause any problems. Pharmacist states the patient did not have time to complete an adverse event or safety report at time of call. Pharmacist was given case reference number; stated the patient would try to call back to complete adverse event or safety report at a better time.'' no other vaccines. At the time of this report the patient was fine and had no adverse events after the vaccination. This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1757623
Sex: F
Age: 71
State: NY

Vax Date: 09/23/2021
Onset Date: 09/23/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: chills; low grade fever; cough; aches; Initial information regarding an unsolicited valid non-serious case from the Agency (Reference number- 00790611) was received from a consumer and transmitted to Sanofi on 29-Sep-2021. This case involved a 71-year-old female patient who experienced chills, low grade fever (pyrexia), cough and aches (pain) while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ716AA (expiry date not provided) via intramuscular route in the left deltoid. On 23-SEP-2021 the patient developed a non-serious chills, low grade fever (pyrexia), cough and aches (pain) following the administration of vaccine. No relevant laboratory data was provided. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was resolved for the event chills, low grade fever, and pain and was not resolved for the event cough.

Other Meds:

Current Illness:

ID: 1757624
Sex: U
Age:
State: MD

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/04/2021
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 administered an expired dose of FLUZONE QIV from last year with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Agency (Reference number- 00791011) and transmitted to Sanofi on 29-Sep-2021. This case involved an unknown age and gender patient was administered an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] from last year (expired product administered) Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On an unknown date in September 2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: not reported and expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination (expired product administered). It was reported "Pharmacy student calling for information regarding the FLUZONE QIV and the caller would like to know if the patient requires revaccination? Caller does not have information on the patient of the event. Caller was unable to provide a lot number, but was able to provide an expiration date for the product". This case was an actual medication error due to expired vaccine used (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: 1757625
Sex: F
Age: 67
State:

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/04/2021
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: FLUZONE QUADRIVALENT vaccine that was given in error with No reported adverse event; Initial information regarding an unsolicited valid non-serious case from United states was received from other health professional via call centre General medical inquiry inbound (reference number-00791319) and transmitted to Sanofi on 29-Sep-2021. This case involved a 67-year old female patient when received fluzone quadrivalent vaccine that was given in error with no reported adverse event (Wrong product administered) while receiving vaccines influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] and influenza quadrival a-b vaccine [Fluzone quadrivalent]. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. At the time of the event, the patient had ongoing immunosuppression. On 28-Sep-2021, the patient received a 0.5 ml of suspect influenza quadrival a-b vaccine (lot number not reported and expiry date-30-Jun-2022) via intramuscular route in the deltoid not otherwise specified for prophylactic vaccination. On an unknown date, the patient received an of suspect influenza quadrival a-b high dose hv vaccine (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On 28-Sep-2021, 1 day following the administration of influenza quadrival a-b vaccine the patient developed a non-serious event "fluzone quadrivalent vaccine that was given in error with no reported adverse event" (Wrong product administered). It was reported "HCP (health care professional) states that a patient, over 65, who is immunosuppressed, requested a fluzone high dose quadrivalent vaccine, however the HCP accidentally pulled the flu vaccine from the wrong box and gave the fluzone quadrivalent vaccine instead. The HCP asks if she can give the patient a fluzone high dose quadrivalent vaccine in addition to the fluzone quadrivalent vaccine since she is over 65 and is immunosuppressed". No relevant laboratory details were provided. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event wrong product administered. This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error. No further information was provided.

Other Meds:

Current Illness: Immunosuppression

ID: 1757634
Sex: F
Age: 72
State: MD

Vax Date: 09/17/2021
Onset Date: 09/25/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: None

Allergies: None

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Moderna COVID-19 Vaccine Rash developed around 7-9 days after shot. Extends from torso to arms and legs, around a pimple/square inch. Some painful, many itchy. Prescribed triamcinolone 0.1% cream - not effective. Antihistamines, standard dose - somewhat helpful. No overall reduction in symptoms at time of reporting (10/4/2021).

Other Meds: Vitamin D supplement, 1500 IUD; Synthroid, 75mcg; Omeprazole, 20mg; Atorvastatin, 10mg; Biotin, 500mcg.

Current Illness: None

Date Died: 10/03/2021

ID: 1757635
Sex: F
Age: 16
State: TX

Vax Date: 10/02/2021
Onset Date: 10/03/2021
Rec V Date: 10/04/2021
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: unknown

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

Symptoms: fatigue then death

Other Meds: unknown

Current Illness: unknown

ID: 1757636
Sex: F
Age: 24
State: IN

Vax Date: 09/25/2021
Onset Date: 09/29/2021
Rec V Date: 10/04/2021
Hospital: Y

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data: Blood work, CT scan, echocardiogram

Allergies: Latex, shellfish

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Developed three pulmonary embolisms and sinus tachycardia

Other Meds: Cymbalta, Norgestimate

Current Illness: None

ID: 1757637
Sex: F
Age: 31
State: MA

Vax Date: 10/01/2021
Onset Date: 10/02/2021
Rec V Date: 10/04/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies: N/A

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Significant arm pain first day after vaccine, followed by large swollen lymph nodes under armpit the next day.

Other Meds: Wellbutrin

Current Illness: N/A

ID: 1757638
Sex: F
Age: 19
State: OK

Vax Date: 10/03/2021
Onset Date: 10/03/2021
Rec V Date: 10/04/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies: None

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Passed out, Puking, Sweating, Shaking

Other Meds: None

Current Illness: None

ID: 1757639
Sex: F
Age: 27
State: IL

Vax Date: 10/01/2021
Onset Date: 10/02/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: None

Allergies: Grass, mold, pollen, hay, dust, fish, seafood, misc. outdoor

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

Symptoms: Within 24 hours of vaccine, injection site is red, swollen, painful, warm to touch, enlarged knot/bump. Rash started to spread on arm. 10/3/21 - injection site swelling and redness is even larger

Other Meds: Sertraline, Adderall, Xanax, Tizanidine, magnesium, Zyrtec, Montelukast

Current Illness: None

ID: 1757640
Sex: F
Age: 33
State: IN

Vax Date: 10/01/2021
Onset Date: 10/02/2021
Rec V Date: 10/04/2021
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: None

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

Symptoms: Shot received 10/01/21. Symptoms of muscle aches started that night. The next day, slight fever, some body aches, and painful swelling of a lymph under my left arm pit. Painful swelling continues.

Other Meds: Pristiq, Ritalin, and Women?s One a Day Multivitamin

Current Illness: None

ID: 1757641
Sex: M
Age: 29
State:

Vax Date: 09/21/2021
Onset Date: 09/22/2021
Rec V Date: 10/04/2021
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: chest pain, headache, soreness, nausea, fatigue, high fever over 101, fuzziness missed 3 days of work went to doctor took painkillers, anti-inflammatories, and antihistamines

Other Meds:

Current Illness:

ID: 1757642
Sex: M
Age: 52
State: CA

Vax Date: 04/01/2021
Onset Date: 06/01/2021
Rec V Date: 10/04/2021
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: Blood test, doctor prescribed prednisone which did not help. I am taking antihistamines for hives now. I still get them daily

Allergies: None

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

Symptoms: Hives all over body about 8 weeks after vaccine.

Other Meds: None

Current Illness: None

ID: 1757643
Sex: F
Age: 42
State: IA

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/04/2021
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: Sulfa drugs, environmental

Symptom List: Injection site pain, Pain

Symptoms: Lump in arm, rash that is growing , swelling of lymph nodes under arm pit, elbow pain, rash happened right away and is continuing to grow

Other Meds: Venlaphaxine 225 mg, Zyrtec 3 tablets, iron supplement, birth control pill

Current Illness: N/A

ID: 1757644
Sex: F
Age: 34
State: OK

Vax Date: 04/01/2021
Onset Date: 05/12/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data:

Allergies: Keflex

Symptom List: Injection site pain, Menorrhagia

Symptoms: Irregular periods each month, experiencing a 3 day period 6 days before my regular 5 day cycle

Other Meds: Turmeric, vitamin d, atentenol

Current Illness: Fibermialya

ID: 1757645
Sex: M
Age: 32
State: GA

Vax Date: 09/13/2021
Onset Date: 10/04/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: None

Allergies: None

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

Symptoms: No issue until 3 weeks later. Sudden pain in chest. Hurts if any pressure is applied. Worse when lay down or take deep breaths. Seems to be worse right behind sternum.

Other Meds: No

Current Illness: None

ID: 1757646
Sex: F
Age: 48
State: NC

Vax Date: 08/21/2021
Onset Date: 08/22/2021
Rec V Date: 10/04/2021
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: none yet, MD asked me to wait and see if symptoms persist

Allergies: none

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Constant humming in Left ear that has not stopped like tinnitus (MD appointment pending ) , headache - constant, joint stiffness in neck, Left eye twitching several times / day

Other Meds: phentermine 18.75 mg daily

Current Illness: none

ID: 1757647
Sex: F
Age: 22
State: MI

Vax Date: 01/22/2021
Onset Date: 01/24/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: MRI blood work Neither Dr would help or belived me and the ER doctors didnt know how to help me. 6 weeks of not being able to care for myself or my kids or work or drive or cook constantly in and out of the ER and it slowly started to go away any my brain felt normal completely after about 3 to 4 months. But they still dont believe me idk why it happened and im scared its not over. It was the scariest 6 weeks of my life and i would like an explanation on what happened to me.

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Severe Memory loss, balance issues, couldnt walk, couldnt feel hot or cold, crazy mood swings, extreme fatigue, rash

Other Meds:

Current Illness:

ID: 1757648
Sex: M
Age: 35
State:

Vax Date: 09/17/2021
Onset Date: 09/17/2021
Rec V Date: 10/04/2021
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: Local mild allergic reaction with immediate induration and redness near injection site; not typical local injection site reaction because of robust induration. No other symptoms; no shortness of breath, chest pain, etc at that time. Later on Sept 29, the patient presented with chest pain that reportedly got worse since having the vaccination; however, workup was completely negative (BNP and Troponin within normal limits).

Other Meds:

Current Illness:

ID: 1757650
Sex: M
Age: 32
State: CA

Vax Date: 09/19/2021
Onset Date: 09/27/2021
Rec V Date: 10/04/2021
Hospital: Y

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

Lab Data: White blood cells were low and was not discharged until they returned to normal.

Allergies: Allergic to fish

Symptom List: Nausea

Symptoms: The first Pfizer vaccine shot was administered on Sunday, September 19, 2021. On Monday, September 27, 2021, I started feeling dizzy and lightheaded at around 4:10 pm. During the next couple of minutes, the symptoms continued to worsen and my complexion changed to very pale. By 4:30 pm, I started suffering from fast heart palpitations; strong pain in nape of my neck; I felt tingling and numbness all over my body; I had slurred speech; and shortness of breath resulting in difficulty breathing. My family called 911. The paramedics arrived and administered oxygen and determined that I needed to be taken to the hospital. During the hospital trip, the tingling and numbness throughout my body persisted along with muscle spasm. Once I was at the hospital, I was placed on an IV and had X-rays and blood drawn 3 times. I was told my white blood cell count was low, hence the reason for multiple bloodwork exams. I was discharged after my white blood cell count returned to normal. Symptoms best described as similar to a stroke or myocarditis. I was advised to follow-up with my primary doctor, which I have contacted and given an appointment for October 13, 2021. I was told to return to the ER if I felt the symptoms returning.

Other Meds: N/A

Current Illness: N/A

ID: 1757651
Sex: F
Age: 50
State: CA

Vax Date: 10/01/2021
Onset Date: 10/02/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data:

Allergies: Penicillin

Symptom List: Injection site pain

Symptoms: Fever up to 102.7, body aches, chills, sweats, myoclonus, and nausea

Other Meds: None

Current Illness: None

ID: 1757652
Sex: F
Age: 55
State: NV

Vax Date: 03/29/2021
Onset Date: 08/06/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: 8/16/2021 Biopsy

Allergies: Lortab and gluten sensitivity

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Breast Cancer

Other Meds: Sertraline, Vyvanse, Ibuprofren, Black Cohosh, Vitex, DHEA

Current Illness: None

ID: 1757653
Sex: F
Age: 35
State: PR

Vax Date: 10/02/2021
Onset Date: 10/03/2021
Rec V Date: 10/04/2021
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: Fever, chills, severe body aches, headache, weakness, disoriented.

Other Meds: Neurontin, Lamictal, Klonopin, Temazpem, Doxepin, Omeprazole

Current Illness:

ID: 1757654
Sex: F
Age: 41
State: CA

Vax Date: 09/30/2021
Onset Date: 09/30/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: none

Allergies: penicillin, asprin, bactrim

Symptom List: Tremor

Symptoms: I received my second dose last Thursday, September 30, 2021. That evening, my arm swelled up and was hot at the injection site. The swelling has gone half way down my arm and is burning hot the touch. Tomorrow will be day 4 since I've gotten the vaccine. My temperature has not been below 101.1, I'm shaky, have chills, headache, and a nosebleed several times. My fever continues to worsen, as does my body aches.

Other Meds: amlodipine, banzapril

Current Illness:

ID: 1757655
Sex: F
Age: 48
State: NV

Vax Date: 10/02/2021
Onset Date: 10/03/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: N/A

Allergies: Fish, Seafood

Symptom List: Erythema, Pruritus

Symptoms: Woke up to rapid heart beat (114 bpm), my normal resting heart rate is between 59-75 bpm. Heart stayed elevated for an hour and continued to be higher than normal throughout the day. Arm was excessively painful and hot, with minor swelling. After 24 hours, a dose of ibuprofen was taken and relieved the pain, heart rate continued to be elevated but lingered around 90 bpm.

Other Meds: Losartan, Famotidine, Nexium

Current Illness:

ID: 1757656
Sex: M
Age: 48
State:

Vax Date: 05/12/2021
Onset Date: 05/13/2021
Rec V Date: 10/04/2021
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: Hospital visit, dialysis required

Allergies: N/A

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: My kidneys failed

Other Meds: N/A

Current Illness: N/A

ID: 1757657
Sex: M
Age: 38
State: HI

Vax Date: 09/02/2021
Onset Date: 09/03/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: None

Allergies: None

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Chronic neck muscle pain and daily recurring headaches. Been over a month and still get them daily

Other Meds: Fiber, vitamin C

Current Illness: None

ID: 1757696
Sex: U
Age: 81
State: NY

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 10/04/2021
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: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Vaccine administered on 11 days after first puncture. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received on 29-Sep-2021 and contains no new information.; Sender's Comments: This is a case of expired product administered for this 81 year-old patient, unknown gender, with no medical history reported, with no associated adverse event reported at this time. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1757709
Sex: F
Age: 61
State: PA

Vax Date: 02/25/2021
Onset Date: 08/01/2021
Rec V Date: 10/04/2021
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: breakout in August 2021/ suspected vaccination failure; breakout in August 2021; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (patient had a breakout in march 2021 refer case US2021AMR203693 and pass 20 years had a shingles breakout each year and have been anxiously awaiting the vaccine refer case US2021AMR203687). On 25th February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In August 2021, between 5 and 7 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional details were reported as follows: The case was reported by the patient. The patient had 2nd Shingrix vaccination, had a breakout in August 2021. No contact details were available. The reporter did not consent to follow up This case was considered as suspected vaccination failure as time to onset and laboratory confirmation were unknown at the time of reporting. This was 1 of 3 case reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR203687:Same patient, possible breakout 2020 post-1st dose US-GLAXOSMITHKLINE-US2021AMR203693:Same patient, 2nd dose and breakout March2021

Other Meds:

Current Illness:

ID: 1757712
Sex: F
Age: 65
State: MI

Vax Date: 02/03/2021
Onset Date: 04/01/2021
Rec V Date: 10/04/2021
Hospital: Y

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: Test Date: 20210509; Test Name: Oxygen saturation; Result Unstructured Data: Low; Test Date: 20210522; Test Name: Oxygen saturation; Result Unstructured Data: 83.

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: COVID; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Rituxan. Concurrent medical conditions included Rheumatoid arthritis since October 2020. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced COVID-19 (COVID) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of drug effect). The patient was hospitalized for 20 days due to COVID-19. The patient was treated with OXYGEN ongoing since an unknown date for Difficulty breathing, at a dose of UNK, one time dose. At the time of the report, COVID-19 (COVID) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Oxygen saturation: low (Low) Low. On 22-May-2021, Oxygen saturation: 83 (Low) 83. The patient said the symptoms started on April 28th with fever, chills, aches, body aches and a slight cough. On 29-Apr-2021, the patient took a test locally on a rite aid and it came back negative. On 09-May2021, patient could not breath, was struggling to breath because oxygen level was really low. The patient was admitted on Mother's day, May 9th, for the first time and was discharged on the 12th of May. The patient was then admitted again on the 22nd of May as the "saturation level was 83 of oxygen". The patient was discharged on June 2nd and was sent home with oxygen. The patient was still using oxygen but only at night. The patient said that it was determined the Rituxan on it's system did not allow the vaccine to act. The Rituxan depletes B and T cells causing to be immunosuppressed. The patient was told this after being there one week and after they run all kind of tests, bloodwork's, immunoglobulins, and COVID-19 Antibodies which it said it was non reactive and that was done several times. Symptoms lasted until first week of August and still has some oxygen loss on aerobic exercising. The patient visited doctor and going through all kind of pulmonary testing's. Other treatment medications included Rendezivir, Monoclonal antibody, unspecified steroids and unspecified antibiotic. Company comment: This case of drug ineffective, concerns a 65-year-old female subject with a history of rheumatoid arthritis, who experienced the serious unexpected event of COVID-19. The event occurred in an unknown date of the following month after the second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report. More information has been requested about patient?s immunocompromise and the possible indication of a third dose.; Sender's Comments: This case of drug ineffective, concerns a 65-year-old female subject with a history of rheumatoid arthritis, who experienced the serious unexpected event of COVID-19. The event occurred in an unknown date of the following month after the second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report. More information has been requested about patient?s immunocompromise and the possible indication of a third dose.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1757713
Sex: F
Age:
State: RI

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: HAIR LOSS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hair loss was not reported. This report was non-serious. This case, from the same reporter is linked to 20211001154.

Other Meds:

Current Illness:

ID: 1757714
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 09/30/2021
Rec V Date: 10/04/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: PUNCTURED VIAL DOSE ADMINISTERED; WRONG TECHNIQUE IN DRUG USAGE PROCESS; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced punctured vial dose administered. On 30-SEP-2021, the patient experienced wrong technique in drug usage process. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial dose administered and wrong technique in drug usage process was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1757715
Sex: M
Age:
State: IN

Vax Date: 05/10/2021
Onset Date: 06/21/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: Test Date: 202006; Test Name: pcr; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: upper respiratory/sinus (non-covid) Cold; Yeast infection of all things on my face/genital area; upper respiratory/sinus (non-covid) Cold; on/off joint pain; This spontaneous case was reported by a patient and describes the occurrence of the second episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold), FUNGAL INFECTION (Yeast infection of all things on my face/genital area), the first episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold) and ARTHRALGIA (on/off joint pain) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033821A) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 08-Jun-2020. Concomitant products included LANSOPRAZOLE and FAMOTIDINE (PEPCID [FAMOTIDINE]) for GERD, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Hypertension. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced the first episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold) and ARTHRALGIA (on/off joint pain). On 21-Jun-2021, the patient experienced FUNGAL INFECTION (Yeast infection of all things on my face/genital area). On 16-Sep-2021, the patient experienced the second episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold). In 2021, last episode of NASOPHARYNGITIS (upper respiratory/sinus (non-covid) Cold) had resolved. At the time of the report, FUNGAL INFECTION (Yeast infection of all things on my face/genital area) and ARTHRALGIA (on/off joint pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, Polymerase chain reaction: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided by the reporter. This case was linked to MOD-2021-331767 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant Follow up-events added

Other Meds: BYSTOLIC; LANSOPRAZOLE; PEPCID [FAMOTIDINE]

Current Illness:

ID: 1757716
Sex: F
Age: 50
State: FL

Vax Date: 01/27/2021
Onset Date:
Rec V Date: 10/04/2021
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: Tested positive for COVID-19; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Patient Stated I have never tested positive. No concomitant medication were reported. No treatment medication was reported. This case was linked to MOD-2021-276367 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Significant followup received contains dose 1 start date,anatomical location; Sender's Comments: This case concerns a 50years-old, female with no relevant medical history, who experienced the unexpected event of SARS-CoV-2 test positive. As per SD The event occurred after being fully vaccinated with mRNA-1273 Moderna vaccine. (date of vaccination was not provided). The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.

Other Meds:

Current Illness:

ID: 1757717
Sex: F
Age: 28
State: VA

Vax Date: 07/11/2021
Onset Date: 08/09/2021
Rec V Date: 10/04/2021
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: doses were administered from one expired vial; Administered improperly stored vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered from one expired vial) and PRODUCT STORAGE ERROR (Administered improperly stored vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered from one expired vial) and PRODUCT STORAGE ERROR (Administered improperly stored vaccine). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (doses were administered from one expired vial) and PRODUCT STORAGE ERROR (Administered improperly stored vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product information was not provided. Treatment information was not provided. This case was linked to MOD21-128181, MOD21-128210 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up includes No New Information. On 09-Aug-2021: Follow up includes No New Information.

Other Meds:

Current Illness:

ID: 1757718
Sex: F
Age: 70
State: FL

Vax Date: 02/14/2021
Onset Date: 09/01/2021
Rec V Date: 10/04/2021
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: Tinnitus; General malaise; Mend nebular nose; Runny nose; Feeling miserable; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), MALAISE (General malaise), NASAL DISCOMFORT (Mend nebular nose), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Feeling miserable) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 031L20A and 048A21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised, Upper respiratory disorder, Hypertension (amlodipine, losartan was used as concomitant) and Diabetes (Tresiba insulin). Concomitant products included INSULIN DEGLUDEC (TRESIBA) for Diabetes, AMLODIPINE and LOSARTAN for Hypertension, ADALIMUMAB (HUMIRA), SERTRALINE HYDROCHLORIDE (ZOLOFT), LORAZEPAM (ATIVAN) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient experienced TINNITUS (Tinnitus), MALAISE (General malaise), NASAL DISCOMFORT (Mend nebular nose), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Feeling miserable). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, TINNITUS (Tinnitus), MALAISE (General malaise), NASAL DISCOMFORT (Mend nebular nose), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Feeling miserable) outcome was unknown. This case was linked to MOD-2021-324030 (Patient Link).

Other Meds: HUMIRA; ZOLOFT; ATIVAN; SEROQUEL; AMLODIPINE; LOSARTAN; TRESIBA

Current Illness:

ID: 1757719
Sex: F
Age:
State: IN

Vax Date: 01/28/2021
Onset Date: 01/31/2021
Rec V Date: 10/04/2021
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: mild pain; Shingles-Severe; Itchy spots around back of L arm and onto chest area/Extended onto back of Left chest to centerline of back/Also extended to cover my Left breast; Spots became red in 1 to 2 days/Color became very red; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (mild pain), HERPES ZOSTER (Shingles-Severe), RASH PRURITIC (Itchy spots around back of L arm and onto chest area/Extended onto back of Left chest to centerline of back/Also extended to cover my Left breast) and ERYTHEMA (Spots became red in 1 to 2 days/Color became very red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient had no known allergies. The patient's past medical history included Sjogren's disease in 2005. Concurrent medical conditions included Rheumatoid arthritis since 1994 and Tachycardia (Fast Heart Rate.). Concomitant products included TOCILIZUMAB (ACTEMRA) from 2019 to June 2021, METHOTREXATE from 1998 to 15-Sep-2021 and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) from 1994 to an unknown date for Rheumatoid arthritis, CICLOSPORIN (RESTASIS) from 2001 to an unknown date for Sjogren's disease, ATENOLOL from 2015 to an unknown date for Tachycardia. On 28-Jan-2021 at 4:52 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021 at 8:00 AM, the patient experienced HERPES ZOSTER (Shingles-Severe). On an unknown date, the patient experienced PAIN (mild pain), RASH PRURITIC (Itchy spots around back of L arm and onto chest area/Extended onto back of Left chest to centerline of back/Also extended to cover my Left breast) and ERYTHEMA (Spots became red in 1 to 2 days/Color became very red). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALCIVIR) for Adverse event, at an unspecified dose and frequency. On 22-Mar-2021, HERPES ZOSTER (Shingles-Severe) had resolved with sequelae. At the time of the report, PAIN (mild pain) outcome was unknown and RASH PRURITIC (Itchy spots around back of L arm and onto chest area/Extended onto back of Left chest to centerline of back/Also extended to cover my Left breast) and ERYTHEMA (Spots became red in 1 to 2 days/Color became very red) had resolved with sequelae. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HERPES ZOSTER (Shingles-Severe) to have an unknown relationship. No further causality assessments were provided for PAIN (mild pain), RASH PRURITIC (Itchy spots around back of L arm and onto chest area/Extended onto back of Left chest to centerline of back/Also extended to cover my Left breast) and ERYTHEMA (Spots became red in 1 to 2 days/Color became very red). The patient also used an unknown lotion with specific medications that was made at. It took about 8 weeks to be mostly gone. The patient still had itches at the area it started, with occasional mild pain. This case was linked to MOD-2021-319198 (Patient Link).

Other Meds: ACTEMRA; METHOTREXATE; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; RESTASIS; ATENOLOL

Current Illness: Rheumatoid arthritis; Tachycardia (Fast Heart Rate.)

ID: 1757720
Sex: F
Age: 62
State: WA

Vax Date: 03/20/2021
Onset Date:
Rec V Date: 10/04/2021
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: lost 3 pounds, she lost weight after her first dose; tates the vaccine helped the fatigue, she felt much better; worried.; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (lost 3 pounds, she lost weight after her first dose), THERAPEUTIC RESPONSE UNEXPECTED (tates the vaccine helped the fatigue, she felt much better) and ANXIETY (worried.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 028A21A) for COVID-19 vaccination. The patient's past medical history included COVID-19. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (lost 3 pounds, she lost weight after her first dose), THERAPEUTIC RESPONSE UNEXPECTED (tates the vaccine helped the fatigue, she felt much better) and ANXIETY (worried.). The patient was treated with LISINOPRIL for Blood pressure high, at an unspecified dose and frequency. At the time of the report, WEIGHT DECREASED (lost 3 pounds, she lost weight after her first dose), THERAPEUTIC RESPONSE UNEXPECTED (tates the vaccine helped the fatigue, she felt much better) and ANXIETY (worried.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-325633 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Nonsignificant followup appended.

Other Meds:

Current Illness:

ID: 1757721
Sex: M
Age:
State: DE

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1757722
Sex: F
Age: 79
State: GA

Vax Date: 07/20/2021
Onset Date: 09/21/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: nauseous/felt like throwing up; Overall felt like she had the flu; flu symptoms; weak/can't get up; couldn't sleep; sneezing a lot; tired; feeling so sick; breathing was affected not as easily as normal; very itchy on face; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling so sick), DYSPNOEA (breathing was affected not as easily as normal), PRURITUS (very itchy on face), NAUSEA (nauseous/felt like throwing up) and INFLUENZA LIKE ILLNESS (Overall felt like she had the flu) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypersensitivity and Asthma. Concomitant products included CEFPODOXIME PROXETIL, CLAVULANATE POTASSIUM (FORENZA) for Allergy, MONTELUKAST for Asthma, IRBESARTAN for Blood pressure management, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Chronic sinusitis and Nasal polyps, BUDESONIDE for Nasal polyp and Chronic sinusitis, PRAVASTATIN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and DENOSUMAB (PROLIA) for an unknown indication. On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced MALAISE (feeling so sick), DYSPNOEA (breathing was affected not as easily as normal) and PRURITUS (very itchy on face). On 22-Sep-2021, the patient experienced NAUSEA (nauseous/felt like throwing up), INFLUENZA LIKE ILLNESS (Overall felt like she had the flu), INFLUENZA (flu symptoms), ASTHENIA (weak/can't get up), POOR QUALITY SLEEP (couldn't sleep), SNEEZING (sneezing a lot) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Stomach ache, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Stomach ache, at an unspecified dose and frequency. At the time of the report, MALAISE (feeling so sick), DYSPNOEA (breathing was affected not as easily as normal), PRURITUS (very itchy on face), NAUSEA (nauseous/felt like throwing up), INFLUENZA LIKE ILLNESS (Overall felt like she had the flu), INFLUENZA (flu symptoms), ASTHENIA (weak/can't get up), POOR QUALITY SLEEP (couldn't sleep), SNEEZING (sneezing a lot) and FATIGUE (tired) outcome was unknown. This case was linked to MOD-2021-328121 (Patient Link).

Other Meds: IRBESARTAN; PRAVASTATIN; MONTELUKAST; ADVAIR; FLONASE [MOMETASONE FUROATE]; BUDESONIDE; FORENZA; PROLIA.

Current Illness: Asthma; Hypersensitivity.

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am