VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.







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: 1713122
Sex: F
Age:
State: ID

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: A1C; Result Unstructured Data: Test Result:5.8

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Tuesday the pain was intense and scheduled a appoint with my doctors office they scheduled a ultra sound and blood work no findings of a blood clot; The pain is not as intense but she is still limping around and in pain.; I had severe leg cramping and body cramping; The next day my leg hurt behind the knee in the calf and the thigh. I could hardly walk by Sunday and went to urgent care they check my leg over could not see a reason for my pain.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 51-year-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN620A and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 01Apr2021 (at the age of 51 years) as single for covid-19 immunization. Medical history included ITP and diabetes from an unknown date and unknown if ongoing. Patient also had Penicillin Allergy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6204 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm right on 11Mar2021 11.00 as single for covid-19 immunization. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and medications in two weeks. On 02Apr2021 the patient experienced leg hurt behind the knee in the calf and the thigh. she could hardly walk by Sunday and went to urgent care they check my leg over could not see a reason for my pain. They didn't visually see a blood clot and sent me home. she had severe leg cramping and body cramping. Tuesday the pain was intense and scheduled a appoint with my doctors office they scheduled a ultra sound and blood work no findings of a blood clot. she also scheduled an appointment with a chiropractor and had no indication of back or knee injuries. she had severe pain for over two month in leg knee lower leg and thighs. The pain is not as intense but she is still limping around. The patient underwent lab tests and procedures which included glycosylated haemoglobin found to be 5.8 on unspecified date. The outcome the events was recovering.

Other Meds:

Current Illness:

ID: 1713123
Sex: F
Age:
State: FL

Vax Date: 04/14/2021
Onset Date: 05/05/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:steadily went up; Test Name: blood pressure; Result Unstructured Data: Test Result:went down; Test Name: bloodwork; Result Unstructured Data: Test Result:Unknown results; Test Name: chest X-ray; Result Unstructured Data: Test Result:Unknown results; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown results; Comments: with & without contrast

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: an allergic reaction; she had trouble moving her tongue to speak; increases thirst within 5 minutes of shot; awareness of throat; creeping headache starting at the base of the neck across the entire head; along with lowering blood pressure; I started feeling floaty; my motor skills decreased; I had trouble standing up; I had trouble standing up & walking; I had trouble speaking forming the words & sentences; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech covid-19 vaccine, Solution for injection, Lot number: EW0153), via an unspecified route in the right arm on 14Apr2021 at 12:45 (age at vaccination: 42-year-old), as a single dose for covid-19 immunization. Medical history included covid prior to vaccination. Known allergies included Biaxin and penicillin. Concomitant medications included Vitamin D and Iron. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient was tested for covid post vaccination. On 05May2021 at 00:45, after the first shot, patient experienced increases thirst within 5 minutes of shot, awareness of throat, creeping headache starting at the base of the neck across the entire head. The throat/headache, along with lowering blood pressure was how she react during an allergic reaction, so she asked the nurse to check her blood pressure. She checked every 15 minutes. Instead of going down, it steadily went up. At this time, she started feeling floaty, her motor skills decreased (She couldn't aim her hand in my bag, she had trouble standing up & walking, and she had trouble moving her tongue to speak), and she had trouble speaking forming the words & sentences. When her blood pressure got to a certain level, the nurse called the paramedics. She was brought to the ER. The patient underwent lab tests and procedures which included blood pressure: it steadily went up and went down, bloodwork, a chest Xray & a CT scan with & without contrast. Patient blood pressure went down as she waited & the results of all tests taken didn't have anything that were of concern to the doctors, so she went home. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: IRON; VITAMIN D NOS

Current Illness:

ID: 1713124
Sex: F
Age:
State: FL

Vax Date: 04/02/2021
Onset Date: 04/09/2021
Rec V Date: 09/18/2021
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: Test Date: 20210415; Test Name: Antibiotics; Result Unstructured Data: Test Result:Pain; Comments: To treat pain w/ urination, Clear antibiotics for pain in lower pelvic region; Test Date: 2021; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown; Comments: received an ultrasound and CT scan to find what was causing the issue; Test Date: 2021; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown; Comments: received an ultrasound and CT scan to find what was causing the issue; Test Date: 20210421; Test Name: Vaginal Ultrasound; Result Unstructured Data: Test Result:Multiple cyst; Test Date: 20210420; Test Name: Urine analysis; Result Unstructured Data: Test Result:Urine culture

Allergies:

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

Symptoms: Multiple cysts; severe lower abdominal pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Right on 02Apr2021 at 10:45 am (Batch/Lot Number: ER8735) as dose 1, single for covid-19 immunization (at the age of 43-years-old). The patient medical history was none. There were no concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19 Since the vaccination, the patient has not been tested for COVID-19. It was reported by the patient that after receiving the first shot of vaccine within one week on 09Apr2021 at 12:00 pm she experienced severe lower abdominal pain in which she visited her doctor, emergency care doctors, received an ultrasound and CT scan to find what was causing the issue but have still not received a diagnosis. She stated that every month since receiving the vaccine she has had extreme lower abdomen pain for at least a week prior to and during her menstrual cycle that also bothers her intermittently all month long and stated that there is a definite link between the vaccine date and the beginning of this pain/issue. She also stated that on 21Apr2021 the vaginal ultrasound showed a multiple cyst. The adverse events resulted in the doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 27Apr2021 gastroenterologist suggested that need to get colonoscopy endoscopy. The patient underwent lab tests and procedures which included antibiotic level which showed pain (to treat pain w/ urination, clear antibiotics for pain in lower pelvic region) on 15Apr2021, urine analysis showed urine culture on 20Apr2021, ultrasound scan vagina showed multiple cysts on 21Apr2021, CT scan (computerised tomogram) and ultrasound abdomen (received an ultrasound and CT scan to find what was causing the issue) which results was unknown on an unspecified date in 2021. The patient was treated with antibiotics and birth control and dicyclomine and ultrasound to monitor cysts 3 months later and need to get colonoscopy and endoscopy. Patient received second dose of BNT162B2 via intramuscular route of administration on 02Apr2021 at 11:15 am (Batch/Lot Number: EW0161) as dose 2, single for covid-19 immunization. The patient was not recovered from the events. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1713125
Sex: M
Age:
State: CA

Vax Date: 06/09/2021
Onset Date: 06/14/2021
Rec V Date: 09/18/2021
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: I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; I had a severe shingles outbreak which I believe was related to Pfizer covid vaccine. I had 3 quite large patches with blisters: on my chest, back, and shoulder. In addition, I had severe headaches fo; This is a spontaneous report from a contactable consumer (patient himself). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186), via an unspecified route of administration, administered in Arm Left on 09Jun2021 (at the age of 38-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included chickenpox (likely had chickenpox in his childhood). The patient's concomitant medications were not reported. It was reported that, he did not have no known allergies. He did not take any other vaccine in four weeks prior COVID vaccine. He was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On 14Jun2021, it was reported that, the patient experienced severe shingles outbreak which he believes was related to Pfizer COVID vaccine. He had 3 quite large patches with blisters: on his chest, back, and shoulder. In addition, he had severe headaches. Now 2 weeks later the rash looks much better however he still feel annoying burning. Patient visited physician's office as a result of events. Therapeutic measures were taken as a result of events include an urgent care nurse prescribed him Acyclovir 800mg tablets 5 times a day and Triamcinolone 0.1% cream 2-4 times a day. The outcome of the events was recovering. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1713126
Sex: M
Age:
State: NY

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: temp; Result Unstructured Data: Test Result:Result unknown

Allergies:

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

Symptoms: cold symptoms; rash; itch; pain near site; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269) via intramuscular on 10Feb2021 (at the age of 80 years old) as dose 2, single for COVID-19 immunisation. Medical history included ongoing thyroid disorder, ongoing cholesterol, and gastrooesophageal reflux disease. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for cholesterol, and famotidine (PEPCID [FAMOTIDINE]) taken for gastrooesophageal reflux disease. The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247) via intramuscular on 20Jan2021 as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced cold symptoms, rash, itch, pain near site. The vaccination facility type was reported as hospital. Prior vaccination (within 4 weeks) was reported as none. The outcome of pain near site was unknown; outcome of all the other events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

Other Meds: CRESTOR; PEPCID [FAMOTIDINE]

Current Illness: Cholesterol; GERD; Thyroid disorder

ID: 1713127
Sex: F
Age:
State: AZ

Vax Date: 03/31/2021
Onset Date: 05/19/2021
Rec V Date: 09/18/2021
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: Post Menopausal full menstration days 21-28 after first dose; This is a spontaneous report from a Non-contactable consumer (Patient reported for herself). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, in left arm on 31Mar2021 (at the age of 53-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient had not taken other vaccine in four weeks and no other medication in two weeks. Patient had no known allergies and no other medical history. Patient had no COVID prior to vaccination and not tested post COVID vaccination. On19May2021 the patient experienced post-menopausal full menstruation days 21-28 after first dose. Patient does not receive any treatment for the reported event. Outcome for the reported event was unknown. No follow-up attempts are possible: information about lot/batch number/expiry date cannot be obtained.

Other Meds:

Current Illness:

ID: 1713128
Sex: F
Age:
State: NY

Vax Date: 04/27/2021
Onset Date: 07/06/2021
Rec V Date: 09/18/2021
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: Shingles; Pain on skin on backside; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. Historical Vaccine first Dose: Date Administered: 06Apr2021; Lot Number: EP6955; Anatomical Location: Caller reported that she doesn't remember, but probably her left arm for covid-19 immunisation. on 06Jul2021 20:00 Caller reported that she went to her health care provider today because she had a pain on her skin on her backside. 07Jul2021 20:00 Caller reported that she was diagnosed with shingles and the health care provider asked if the caller had gotten the Covid-19 vaccine. Outcome of the event back pain was not recovered, for the event shingles was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1713129
Sex: F
Age:
State: CA

Vax Date: 07/07/2021
Onset Date: 07/09/2021
Rec V Date: 09/18/2021
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: I cannot stand up or walk; Severe vertigo; nausea; dizziness; I cannot stand up or walk; This is a spontaneous report from a contactable Consumer (Patient). A 56-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EW0178), via an unspecified route of administration On 07Jul2021 at 12:00 pm (at the age of 56-years-old) administered in Arm Right as a single dose for COVID-19 immunisation. The patient had received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EW0191), via an unspecified route of administration On 16Jun2021 at 12:15 pm administered in Arm Right as a single dose for COVID-19 immunisation. Medical history included non-hodgkin's lymphoma, hyperthyroidism (all from an unknown date and unknown if ongoing). Concomitant medication(s) included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient previously took mycin [benzathine benzylpenicillin] and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 09Jul2021 at 03:00 AM, the patient experienced Severe vertigo, nausea and dizziness. cannot stand up or walk. No treatment was given for the events. The outcome of the events was not recovered. Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1713130
Sex: M
Age:
State: MI

Vax Date: 06/01/2021
Onset Date: 06/02/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:Abnormal; Comments: My son's blood work is abnormal; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Unknown results; Test Name: Liver enzymes; Result Unstructured Data: Test Result:High; Comments: His liver enzymes are high; Test Date: 20210726; Test Name: Liver MRI; Result Unstructured Data: Test Result:Several were abnormal; Comments: Abnormal labs on file with or. matte; Test Date: 20210625; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative; Comments: I had the rapid and the regular nasal.; Test Name: white blood cell count; Result Unstructured Data: Test Result:18,000; Comments: his white blood cell count was like 18,000.

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: He ended up with URI; Rash; thrush; strawberry tongue; Flu like symptoms; . Diarrhea; chills; fever; weird taste; weird smell; thrush; lesions in my mouth; Persistent cough; Dizziness; Nausea; Runny nose; extreme fatigue; upper abdominal pain; liver enzymes are high; same issues but also heart involvement; This is a spontaneous report from a contactable consumer. A female consumer (patient's mother) reported for an 18-year-old male patient (her son) that who received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0186 expiry date was unknown) dose 1 via an unspecified route of administration arm left on 01Jun2021 16:30 (age at the time of vaccination was not reported) as a DOSE 1, SINGLE for covid-19 immunisation. The medical history included multicystic dysplastic kidney (he was born with multicystic dysplastic kidney disease./ His left kidney was removed) from 31Dec2002 to Oct2003, splenomegaly (His spleen kept growing. Two were removed) from 2016 to Aug2017, asthma from 2003 and ongoing (Receives Xolair injections bi-weekly), juvenile idiopathic arthritis from 2020 and ongoing (Juvenile Rheumatoid Arthristis), glaucoma from 2004 and ongoing, autoimmune disease (he has possible unknown autoimmune disease/has possible unknown autoimmune disease), He had to Spleen removed and his left kidney (Kidney biopsy), spleen operation/ Spleen removed from an unknown date and unknown if ongoing, POTS (Postural orthostatic tachycardia syndrome) from an unknown date and unknown if ongoing. The concomitant medication included azithromycin (Z-PAK) via oral, taken for upper respiratory disorder from 21Apr2021 to 26Apr2021; nystatin via oral taken for Mouth Lesions from 14Jul2021 to 21Jul2021. The patient had past drug events as, known allergies to PCN (Penicillin allergy), Topamax, Imitrex, Vancomycin, and Benzoyl peroxide. The patient was advised not to receive the second dose. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient had been tested for COVID-19 with Nasal Swab method on 25Jun2021 which was found to be negative, had the rapid and the regular nasal and the doctor ordered to be retested yesterday as well. The patient had flu like symptoms, diarrhoea, chills, fever, weird taste, weird smell, thrush, lesions in mouth, persistent cough, dizziness, nausea, runny nose and extreme fatigue all on 02Jun2021 at 10:00AM. The adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient dealing with this for 6 weeks now. The liver enzymes were high as well on 02Jun2021 at 10:00AM. The patient had lot of upper abdominal pain on 02Jun2021 at 10:00AM. The patient's blood work was abnormal as well in his liver enzymes are high as well and his white blood cell count was like 18,000. The reporter's son was 18-year-old and has been having the same issues but also heart involvement on 02Jun2021 at 10:00AM. The reporter stated she would not be filling out another long form and said feel free to call. The patient was tested on the same day as the reporter was for covid and was found to be negative. He received his vaccine the same day at the same location. And he has a very involved health history as well. He had to spleen removed and his left kidney and he has possible unknown autoimmune disease, and he has juvenile rheumatoid arthritis. And he was born with multicystic dysplastic kidney disease. The patient again had fatigue and flu like symptoms on 11Jun2021 and received treatment as testing and medications and was recovering. He ended up with URI, strawberry tongue, rash and thrush on an unspecified date. He had Covid test done. Sent to see an ENT, Labs were abnormal. WBC over 18,000 sent for an Echocardiogram which shows changes from last year. He was still dealing with fatigue. We were trying to find a GI and liver doctor near us. Whatever this was his body/immune system was under attack. The patient underwent lab tests and procedures which included blood test: abnormal on his son's blood work was abnormal, echocardiogram: unknown results on an unspecified date, hepatic enzyme: high on His liver enzymes are high, magnetic resonance imaging hepatobiliary: several were abnormal on 26Jul2021 Abnormal labs on file with or. matte, sars-cov-2 test: negative, on 25Jun2021 he had the rapid and the regular nasal, white blood cell count: 18,000 on his white blood cell count was like 18,000. The outcome of the events URI, strawberry tongue, rash and thrush was unknown. The outcome of the event flu like symptoms was recovering, while for other events it was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: Z-PAK; NYSTATIN

Current Illness: Asthma (Receives Xolair injections bi-weekly); Glaucoma; Juvenile rheumatoid arthritis (Juvenile Rheumatoid Arthristis)

ID: 1713131
Sex: M
Age:
State: CA

Vax Date: 02/01/2021
Onset Date: 03/12/2021
Rec V Date: 09/18/2021
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: probably had a sinus infection; overly fatigued; He keeps having extreme epistaxis after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on Feb2021 as dose 2, single for covid-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on Jan2021 for covid-19 immunization. Patient had no known allergies. The patient had relevant medical history of multiple Sclerosis and trigeminal neuralgia. The patient concomitant medications were not reported. Both got the vaccine first dose in Jan and the second dose at the end of Feb. He had extreme epistaxis after receiving the vaccine, with the first episode occurring 12Mar2021 and then 2 times in Apr, once in May and 2 in Jun with the last episode on 22Jun2021. She states he was in the ER for over 6 hours during the first episode and they had a problem getting it stopped. He never had a nose bleed in his life. It was not a normal nose bleed, its like turning on a faucet and projectile out of his nostrils, a significant amount of blood. He saw the ENT in Apr was told he probably had a sinus infection and was given Augmentin, Afrin and nasal rinses. Their was no help and he went back to the ENT. He had two more scopes done. He was already scheduled for an MRI due to be overly fatigued from his MS and no tumors or an increase of plaques were seen. He had been given Augmentin 3 times in total and has also been given Astelin nasal spray. The ENT did not figure out what was causing it. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1713132
Sex: F
Age:
State: NY

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 09/18/2021
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: right arm pain; tremendous pain that went down to her elbow; shingles; can't walk; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 23Mar2021 12:00 (Batch/Lot Number: EP7534) at the age of 62 years as single dose for covid-19 immunisation. Medical history included fibromyalgia on the left side from a previous stroke, diagnosed about 5 years ago, stroke diagnosed 8 year ago and pulmonary hypertension from 03Oct2007. Patient had no family medical history relevant to AE. Historical vaccine included a shingles shot 8 to 10 years ago and it didn't protect her from the shingles this time. Unknown lot, NDC, and expiration date for the shingles vaccine. Patient had no concomitant medications. Patient had no additional vaccines administered on same date of the Pfizer Suspect, had no previous immunization with the Pfizer vaccine considered as suspect. Patient reported shingles post first dose and confirmed shingles outbreak started post second vaccination. Patient experienced first shot: right arm pain. The first shot the patient got in the right arm and it was still killing her when she went to get the second dose. Patient right arm had tremendous pain that went down to her elbow and woke her up because that was how bad it was. The pain the patient's arm happened the day of the first shot day or a couple of days later, she can't remember. The shingles pain was so bad she had been in bed and can't walk. Patient had no relevant tests. Outcome of events were not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1713133
Sex: F
Age:
State:

Vax Date: 04/15/2021
Onset Date: 04/17/2021
Rec V Date: 09/18/2021
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: Significant change in menstrual period. On cycle, Significant increase in bleeding, new (large) clotting; Significant change in menstrual period. On cycle, Significant increase in bleeding, new (large) clotting; Significant change in menstrual period. On cycle, Significant increase in bleeding, new (large) clotting; stronger pain and discomfort; stronger pain and discomfort; This is a spontaneous report from a non-contactable consumer (patient). A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: ER8729) at age of 44-years-old as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not pregnant. The patient experienced significant change in menstrual period. on cycle, significant increase in bleeding, new (large) clotting, stronger pain and discomfort, all on 17Apr2021 with outcome of unknown. No COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1713134
Sex: F
Age: 26
State: PA

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/18/2021
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: pregnant female patient received vaccine/no AE; Initial information was received on 01-Sep-2021 regarding an unsolicited valid non-serious case from physician. This case involves a 25-year-old pregnant female patient who was exposed to INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (exposure during pregnancy) during third pregnancy trimester. Data regarding this pregnancy were received prospectively. The gestation period at onset was 26 weeks. The date of last menstrual period was reported as 26-Feb-2021. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The patient had unknown previous pregnancies. On 01-Sep-2021, the patient received first dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (suspension for injection, lot GT73255A and expiry date 30-Jun-2022) via an intramuscular route at an unknown administration site for prophylactic vaccination. It was a case of vaccine exposure during pregnancy (latency-same day). At the time of report, no adverse event was reported. The estimated due date is 03-Dec-2021. Details of laboratory data was not reported. Additionally, at time of reporting, the outcome of the pregnancy was unknown.

Other Meds:

Current Illness:

ID: 1713135
Sex: F
Age: 26
State: PA

Vax Date: 01/09/2021
Onset Date:
Rec V Date: 09/18/2021
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: patient was administered FLUZONE QUADRIVALENT before she got pregnant, with no reported adverse event; Initial information was received on 01-Sep-2021 regarding an unsolicited valid non-serious case from other health professional. This case is linked to cases 2021SA294755, 2021SA293704, and 2021SA293706(CLUSTER). This case involves a 26-year-old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] before she got pregnant (maternal exposure before pregnancy). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was 30-Apr-2021 The estimated due date is 04-feb-2022. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) concomitant medications and family history were not provided. On 09-Jan-2021, the patient received a dose 1 of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7325JA; expiry date: 30-Jun-2022; form: suspension for injection) via intramuscular route in unknown administration site for prophylactic vaccination. It was the case of vaccine exposure before pregnancy (same day latency). It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were laboratory data/results available. At time of reporting, the outcome was unknown for the reported event. Additionally, at time of reporting, the outcome of the pregnancy was unknown.

Other Meds:

Current Illness:

ID: 1713136
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: swollen lymph nodes; anaphylactic reaction; tongue swelling; Initial information was received on 01-Sep-2021 regarding an unsolicited valid serious case from a consumer/non-healthcare professional. This case involves male patient (unknown age) who experienced tongue swelling (swollen tongue), anaphylactic reaction and swollen lymph nodes (lymphadenopathy) after receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE]. The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date in 2017, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (suspension for injection, lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date in 2017, the patient developed serious anaphylactic reaction (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date in 2017, the patient developed non-serious tongue swelling (swollen tongue), swollen lymph nodes (lymphadenopathy) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Details of laboratory data was not reported. It was not reported if the patient received any corrective treatment for the events. At time of reporting, the outcome was unknown for all the events. There will be no information on the batch number.; Sender's Comments: This case involves an unknown age male patient who had swollen tongue, anaphylactic reaction and lymphadenopathy after vaccination with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE]. The time to onset is unknown. There is no further information regarding patient's medical condition at time of vaccination, history and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of a vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1713139
Sex: U
Age:
State: IA

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: head-to-toe rash with hives; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Medical Information (Reference number- 00752389) and transmitted to Sanofi on 02-Sep-2021. This case involves an unknown age and gender patient who experienced head-to-toe rash with hives (urticaria) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious head-to-toe rash with hives (urticaria) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported "The caller does not have patient specifics regarding the event. She says she assumes that her business partner would have reported the event at the time. The patient was tested for allergies after the event and the only allergy that came back positive was to thimerosal." It was not reported if the patient received any corrective treatment for the event. On an unknown date, the patient recovered from the event. There will be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 1713141
Sex: M
Age: 11
State: PA

Vax Date: 09/04/2021
Onset Date: 09/04/2021
Rec V Date: 09/18/2021
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: general Malaise all day on Sunday; sore arm; nausea; Initial information was received on 07-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-Healthcare professional via Medical Information (Reference number-00757082). This case involves a 11-year-old male patient who experienced sore arm (pain in extremity), nausea, general malaise (malaise), 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 04-Sep-2021, the patient received a dose of 0.5 mL suspect INFLUENZA QUADRIVAL A-B VACCINE (suspension for injection, lot UJ685AA and expiry date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On 04-SEP-2021 the patient developed non-serious nausea and sore arm (pain in extremity) (same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 05-SEP-2021, the patient developed non-serious general malaise all day on Sunday (malaise) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported " Caller reporting an adverse event that her son experienced after receiving a Fluzone Quadrivalent injection on Saturday. "Why did he experience a reaction this time and he has never had a reaction in the previous years? What is different? What can I do about his sore arm? Do it have anything to do with him receiving the vaccine at the clinic and not the pediatrician office? Are the flu shots the same? This is the first time ever he had such a reaction. He experienced nausea and next morning the nausea was gone. Plus his arm has been sore since Saturday and it is getting better now. He also experienced general Malaise all day on Sunday. Caller states that she used children's Tylenol Saturday and part of Sunday." Details of laboratory data were not reported. The patient received children's Tylenol for the events. On 05-Sep-2021, the patient was recovered for the event nausea. At time of reporting, the patient was recovering for the event sore arm, the outcome was unknown for the event general malaise.

Other Meds:

Current Illness:

ID: 1713142
Sex: M
Age:
State: NV

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: his throat started swelling; he had hives/a rash about 1-2 hours; he had hives/a rash about 1-2 hours; had an allergic reaction; Initial information was received on 07-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional. This case involves a 52-year-old male patient who experienced his throat started swelling (pharyngeal swelling), he had hives/a rash about 1-2 hours (urticaria and rash) and an allergic reaction (hypersensitivity), 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 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date in 2020, the patient developed non-serious his throat started swelling (pharyngeal swelling), he had hives/a rash about 1-2 hours (urticaria and rash) and an allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported, "consumer wants to know the ingredients in FLUZONE QUADRIVALENT. He states that last year he took the vaccine and had an allergic reaction and is trying to find out if he can get the Covid-19 vaccination. He is not even sure what brand of "flu shot he had". He wants to receive a Covid-19 vaccine but since he had a reaction to another vaccine his Doctor wanted him to do "research" on the flu vaccines he might have received. He stated that he had hives/a rash about 1-2 hours after receiving the flu vaccination and he was given BENEDRYL by urgent care. Shortly after he started seeing the hives/rash his throat started swelling. Urgent care gave him another "BENEDRYL like medicine". He thinks this occurred in October or November of 2020. Both conditions resolved shortly after each medicine was administered". Details of laboratory data were not reported. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL). At time of reporting, the patient was recovered from the events. There will be no information available on the lot number for this case.

Other Meds:

Current Illness:

ID: 1713143
Sex: F
Age: 35
State: SC

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/18/2021
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 expired fluzone; Initial information was received on 08-Sep-2021 regarding an unsolicited valid non-serious case from a physician and non-healthcare professional via call center via Medical Information (Reference number- 00759516). This case involves a 35 years old female patient who administered expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered). The patient's medical history, past medical treatment, vaccination and family history were not provided. On 07-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7073LA and expiry date: 30-Jun-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination. It was an 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.

Other Meds:

Current Illness:

ID: 1713144
Sex: F
Age: 23
State: SC

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/18/2021
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 given expired fluzone with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Medical Information (Reference number- 00759590) and transmitted to Sanofi on 08-Sep-2021. This case involves 23-year-old female patient given expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered). Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On 07-Sep-2021, the patient received 0.5ml (total, 1X(once)] dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UT7073LA and expiry date: 30-Jun-2021) (Frequency = once) (Strength = standard) via intramuscular route in unknown administration site for prophylactic vaccination (expired product administered). It was reported,"Caller stated that she needs guidance on if they need to revaccinate a patient, If so, what is the time frame she needs to wait?" 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.

Other Meds:

Current Illness:

ID: 1713145
Sex: F
Age: 39
State: SC

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/18/2021
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: given expired FLUZONE, with no AE; Initial information was received on 08-Sep-2021 regarding an unsolicited valid non-serious case from a physician. This case involves a 39-year-old female patient given expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 07-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7073LA, expiry date unknown) via an intramuscular route in unknown administration site for prophylactic vaccination. It was a case of actual medication error expired vaccine used (same day). It was reported, "caller stated that she needs guidance on if they need to revaccinate a patient that was given EXPIRED FLUZONE on 07Sep2021". 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: 1713146
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: mouth and throat were itchy and swollen; mouth and throat were itchy and swollen; mouth and throat were itchy and swollen; Initial information regarding an unsolicited valid non-serious case was received from consumer (patient) via Medical Information (Reference number- 00759668) and transmitted to Sanofi on 08-Sep-2021. This case involves an unknown age female patient who experienced mouth and throat were itchy and swollen (mouth swelling, pharyngeal swelling and pruritus) after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]. The patient's medical history included COVID-19. The patient's past medical treatment(s), vaccination(s) and family history were not provided. In 2005, the patient received a dose (once) of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (Injection) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious mouth and throat were itchy and swollen (mouth swelling, pharyngeal swelling and pruritus) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE. It was reported "she went to the emergency room. The doctors told her that she had reacted to something in the vaccine, so she should not get any more flu vaccines, which she has not. But now, she wants a COVID19 vaccine. She states that she had COVID last spring, and she cannot handle having it again. Her physician is telling her that she shouldn't get the vaccine, as she may react to it, as well. She is trying to get a copy of the PI for the flu vaccine that she received, so she and her doctor can compare ingredients with current COVID vaccines." Details of laboratory data not reported. It was not reported if the patient received any corrective treatment for the events. On an unknown date, the patient recovered from all the events. There will be no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 1713147
Sex: M
Age: 80
State: TN

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/18/2021
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: 80 year old male patient administered expired dose of Fluzone High Dose, with no reported adverse event; Initial information received on 08-Sep-2021 regarding an unsolicited valid non-serious case from a physician via other health professional via Medical Information (Reference number- 00759809). This case involves 80-year-old male patient who was vaccinated with the expired dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered). Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 07-Sep-2021, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ567AA and expiry date: 30-Jun-2021) (Frequency: Once) via intramuscular route in the right deltoid for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency on same day). It was reported "they administered expired FLUZONE HIGH DOSE to a patient. what are the proper steps for the patient after this situation?" At time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1713148
Sex: F
Age:
State: CA

Vax Date: 09/05/2021
Onset Date: 09/05/2021
Rec V Date: 09/18/2021
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: the site where the vaccine was given is swollen; site where the vaccine was given is swollen and discolored/describe a purple mark 2 to 3 inches long; That night, when she was getting undressed, she began to feel itchy; took off her clothes, she was covered in hives horrible hives on the front and back of her arms and legs; worried because her ankles were also swollen; Initial information was received on 08-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (Medical Information (GMI) Inquiry Number 00759870). This case involves a 84 years old female patient who experienced non serious events that night, when she was getting undressed, she began to feel itchy(pruritus), took off her clothes, she was covered in hives horrible hives on the front and back of her arms and legs(urticaria), worried because her ankles were also swollen(Joint swelling), the site where the vaccine was given is swollen (Vaccination site swelling) and discolored/describe a purple mark 2 to 3 inches long (vaccination site discoloration) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The patient's medical history, past medical treatments, vaccinations and family history were not provided. Concomitant medications included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]). On 05-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number and expiry date not provided via unknown route in unknown administration site for prophylactic vaccination. On 05-Sep-2021 the patient developed non-serious events that night, when she was getting undressed, she began to feel itchy (pruritus), took off her clothes, she was covered in hives horrible hives on the front and back of her arms and legs (urticaria), worried because her ankles were also swollen (joint swelling) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. On 06-Sep-2021 the patient developed non-serious events the site where the vaccine was given is swollen (vaccination site swelling) and discolored/describe a purple mark 2 to 3 inches long (vaccination site discolouration) one day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported "Patient had FLUZONE HIGH DOSE vaccine on Sunday. She had a reaction for the first time with the vaccine, even though she gets it yearly. Had vaccine at 11am and that evening had onset of side effects including itching. Patient was trying to go to her doctor today in hopes of getting prednisone or something. Wanted to know more about what was in it that could make her have this reaction. She also wanted to report this adverse event. She did not notice anything wrong for the rest of the day. She stated that she shopped, then sat on a chair and watched the gardener because she doesn't get around that well. She did not have trouble breathing. She self-medicated with four benadryll and went to sleep. They also stated that the area is swollen "like a huge cyst" daughter stated that the swollen area is the size of a baseball. Daughter stateed that she looks as if she was beaten." No lab data was provided. It was not reported if the patient received a corrective treatment for the events At time of reporting, the outcome of events was reported as unknown. Dosage interval - once.

Other Meds: BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness:

ID: 1713149
Sex: M
Age: 43
State: MI

Vax Date: 09/08/2021
Onset Date: 09/08/2021
Rec V Date: 09/18/2021
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: FLUZONE HIGH-DOSE QUADRIVALENT was given to a 43 years old adult male patient/ no AE; Initial information was received on 08-Sep-2021 regarding an unsolicited valid non-serious case from other healthcare professional and non-healthcare professional via call center via Information (Reference number- 00759924). This case involves a 43 years old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event (product administered to patient of inappropriate age). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. On 08-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (frequency: once, strength: standard, lot number: UJ715AA and expiry date: 30-JUN-2023) via an intramuscular route in the left deltoid for prophylactic vaccination. It was of actual medication error due to inappropriate age at vaccine administration (latency: same day). At the time of reporting, no adverse event reported. It was reported "caller would like further information regarding adverse effects on individuals under 65 years of age". This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1713151
Sex: F
Age: 74
State: IL

Vax Date: 09/08/2021
Onset Date: 09/08/2021
Rec V Date: 09/18/2021
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: administered the vaccine before realizing that the vaccine had expired/ no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00760288). This case involves a 74-year-old female patient who vaccinated with a 0.7 mL (once) dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ549AB and expiry date 30-Jun-2021) via intramuscular route in the left deltoid on 08-Sep-2021 for prophylactic vaccination while nurse administered the vaccine before realizing that the vaccine had expired (expired product administered). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was a case of actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. 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: 1713152
Sex: F
Age:
State: UT

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: allergic reaction; Initial information regarding an unsolicited valid non-serious case was received from a nurse via consumer/non-health care professional via Medical Information (Reference number- 00760331). This case involves a female patient (age unspecified) who had an allergic reaction (hypersensitivity) after receiving INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE]. Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date in 2009, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE (lot U3366AA, expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. It was reported, "The caller (nurse) states that a patient received FLUZONE QUADRIVALENT (from MULTI-DOSE VIAL) in 2009 Lot # U3366AA. The patient had an allergic reaction after receiving the vaccine and she would like to know if the vaccine was a swine flu (H1N1) vaccine or regular flu vaccine. The caller also would like ingredients of the 2009 Fluzone Quadrivalent Multi-dose Vials. The nurse states that the client is working with an allergist so that she can get the Coronavirus Disease (COVID vaccine) and she is the middleman." No laboratory data was reported. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1713154
Sex: F
Age:
State: NY

Vax Date: 09/08/2021
Onset Date: 09/08/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: a cellulitic patch around the right deltoid muscle; completely swollen right arm; vaccination site inflammation; irregular red ring shape around the whole deltoid muscle.; Caller also states that the pharmacy representatives did not have a cooler for the vaccines and that they appeared out at room temperature when she saw them; Initial information was received on 09-Sep-2021 regarding an unsolicited valid non-serious case received from an other health care professional via consumer via phone call (under Medical Information Inquiry Number: 00761956). This case is linked to cluster case Id: 2021SA302683. This case involves a 55-years old female patient who experienced a cellulitic patch around the right deltoid muscle (vaccination site cellulitis), completely swollen right arm (extensive swelling of vaccinated limb), vaccination site inflammation and irregular red ring shape around the whole deltoid muscle. (vaccination site erythema) and Caller also states that the representatives did not have a cooler for the vaccines and that they appeared out at room temperature when she saw them (Incorrect product storage) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. The patient's medical history, medical treatments, concomitant medications, vaccinations and family history were not provided. On 08-Sep-2021, the patient received a first 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number: UT7319LA and expiry: 30-Jun-2022 via intramuscular route in the right deltoid for prophylactic vaccination. On 08-Sep-2021, the patient developed a non-serious cellulitic patch around the right deltoid muscle (vaccination site cellulitis), completely swollen right arm (extensive swelling of vaccinated limb), vaccination site inflammation and serious irregular red ring shape around the whole deltoid muscle. (vaccination site erythema) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported "Caller asked for information regarding the product composition of FLUZONE QIV NP Prefilled syringes. Caller stated that representatives from pharmacy administered FLUZONE QIV NP vaccines at her facility on 08-Sep-2021 and that 3 co-workers had adverse reactions to the vaccine. She asked if patients were having more site reactions this year and asked if anything was added to the vaccine. She stated that switching from the prefilled syringe to the Multi Dose Vial (MDV) containing preservative (FLUZONE QIV T) had relieved site reactions in the past. Caller provided information on 2 of 3 co-workers that experienced adverse reactions and stated that she would contact Medical Information when she obtaines information on the third co-worker. Caller stated that she could be contacted by Sanofi Safety if further information was needed and asked for the direct phone number for Medical Information. She also stated that the representatives did not had a cooler for the vaccines and that they appeared out at room temperature when she saw them." This case was an actual medication error due to Incorrect product storage. No lab data was provided. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome of events 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: 1713155
Sex: F
Age:
State: NY

Vax Date: 09/08/2021
Onset Date:
Rec V Date: 09/18/2021
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: body aches; pain in left arm; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional via Medical Information (Reference number- 00762056) and transmitted to Sanofi on 09-Sep-2021. This case is linked to case 2021SA300941 (same reporter). This case involves a 48-year-old female patient who had body aches (pain) and pain in left arm (pain in extremity) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. Medical history, past vaccination, medical treatment(s), and family history were not provided. The patient had no other concomitant vaccines. On 08-Sep-2021, the patient received a 0.5 ml first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7319LA, expiry: 30-Jun-2022 and form: prefilled syringe) via intramuscular route in the left deltoid for prophylactic vaccination. On an unknown date the patient developed a non-serious body aches (pain) and pain in left arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The intensity of events was moderate to severe It was reported "Caller asked for information regarding the product composition of FLUZONE QIV NP Prefilled syringes. Caller states that representatives from pharmacy administered FLUZONE QIV NP vaccines at her facility on 08SEP2021 and that 3 coworkers had adverse reactions to the vaccine. Caller asked if patients were having more site reactions this year and asked if anything was added to the vaccine. Caller states that switching from the prefilled syringe to the multi dose vial (MDV) containing preservative (FLUZONE QIV T) had relieved site reactions in the past. Caller provided information on 2 of 3 coworkers that experienced adverse reactions and stated that she would contact Medical Information when she obtained information on the third coworker. Caller states that she can be contacted by Sanofi Safety if further information is needed and asked for the direct phone number for Medical Information. This information is regarding the second of two reported patients that experienced an adverse reaction to FLUZONE QIV NP on 08SEP2021. Caller states that there was a third patient who experienced adverse reactions but that she does not have the information at this time and would call back. Caller states that a representative from pharmacy came to her facility on 08SEP2021 to administer FLUZONE QIV NP vaccines and that this patient experienced moderate to severe pain in left arm as well as moderate to severe body aches compared to past reactions. This patient was sent home to rest" Caller also states that the representatives did not have a cooler for the vaccines and that they appeared out at room temperature when she saw them No laboratory data was reported. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1713161
Sex: U
Age:
State: ME

Vax Date: 09/08/2021
Onset Date:
Rec V Date: 09/18/2021
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: leaked from the syringe where it connects to the needle and they did not receive the full amount of vaccine with no reported adverse event; leaked from the syringe where it connects to the needle and they did not receive the full amount of vaccine 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 Medical Information (Reference number- 00764055) and transmitted to Sanofi on 10-Sep-2021. This case involved an unknown (age and gender) patient received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] leaked from the syringe where it connects to the needle and they did not receive the full amount of vaccine (underdose) and their symptom (syringe issue) Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On 08-Sep-2021, the patient received first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot: UJ704AA and expiry date: 30-Jun-2022) (Frequency = once) via intramuscular route in the left deltoid for prophylactic vaccination leaked from the syringe where it connects to the needle and they did not receive the full amount of vaccine (underdose) and their symptom (syringe issue) It was reported"Caller asked how to proceed in this situation. Caller states that a nursing student prepared and administered the vaccine from a prefilled syringe and that the needle was not twisted on tight enough. The nurse that was present stated that "the vaccine leaked out where the needle connects to the syringe". Caller states that the cause of the leak was due to human error and that there have been no other issues with FLUZONE HIGH-DOSE QUADRIVALENT prefilled syringes. Caller states that she can be contacted if additional patient information is needed. Caller did not wish to provide specific patient information at this time. Caller states that she may be contacted in the future if it is necessary". This case was vaccine underdose and syringe leak (latency: same day) At the time of reporting, no adverse event

Other Meds:

Current Illness:

ID: 1713162
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: vaccine were exposed to 19.8 Fahrenheit and were out of range for 2 hour and 16 minutes/no ae; Initial information received on 10-Sep-2021 regarding an unsolicited valid non-serious case received from a other health care professional via under Medical Information Inquiry Number: 00764523. This case is linked to case US-SA-2021SA303376(CLUSTER). This case was considered as non-valid due to no involvement of patient. This case involved vaccines IPV (VERO) (lot number: R1F973M and expiry date: 10-MAR-2021), (lot number: T1E871M and expiry date: 10-OCT-2022), (lot number: T1D482M and expiry date: 25-FEB-2022), (lot number: R1F97 and expiry date: 10-MAR-2021), (lot number: T1E87 and expiry date: 10-OCT-2022) HIB (PRP/T) VACCINE (lot number: UJ661AAA and expiry date: 05-JUN-2022), (lot number: UJ526AAA and expiry date: 06-MAR-2022), (lot number: CC5788BA and expiry date: 14-OCT-2022) DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number C5829BA and expiry date: 03-JAN-2031) DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ528AAA and expiry date: 07-OCT-2022), (lot number: UJ435AAA and expiry date: 17-MAY-2022), (lot number: UJ421AAA and expiry date: 03-AUG-2022) DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: CC5788BA and expiry date: 07-OCT-2022) MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6951AA and expiry date: 06-JUN-2022) that were exposed to negative 19.8 degrees Fahrenheit degree for an undetermined period (product storage error). It was potential medication error case due to product storage error temperature too low. It was reported "Caller stated they had a temperature excursion of unknown cause". 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: 1713163
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: really sore arm; pregnant wife received an ADACEL vaccination; Initial information received on 13-Sep-2021 regarding an unsolicited valid non-serious case from a non-health care professional (patient's husband) in the via Media information (reference number 00765855). This case involves female pregnant patient (unknown age) who had really sore arm (pain in extremity), after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (exposure during pregnancy). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported events occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past vaccination(s) included boostrix (other dosing details not reported). The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided. The patient had one previous pregnancy and this was her second. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. It was a case of vaccine exposure during pregnancy (same day latency). On an unknown date, the patient developed a non-serious really sore arm (pain in extremity) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported "Caller states that his pregnant wife received an ADACEL vaccination and wanted to report it to the registry. Caller also states that his wife is pregnant for the second time and that she had received Boostrix in the past. Caller states that his wife developed a "really sore arm" after receiving the ADACEL vaccination. Caller asked if there was any information regarding ADACEL and pregnancy. Caller was placed on hold by agent and was not available after agent returned. Agent placed outbound call on 13-Sep-2021 at 9:59AM and left contact phone number for Medical Information on caller's answering machine. Agent had not provided any medical information or obtained details regarding AE (adverse event) report yet." No laboratory data reported. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported event. Additionally, at time of reporting, the outcome of the pregnancy was unknown. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1713165
Sex: F
Age: 59
State: IL

Vax Date: 09/09/2021
Onset Date: 09/09/2021
Rec V Date: 09/18/2021
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: vaccine was exposed to 76-degree Fahrenheit for 5 days/ no AE; Initial information was received on 13-Sep-2021 regarding an unsolicited valid non-serious case received from a Pharmacist via Medical Information (Reference number- 00766806) and transmitted to Sanofi on 13-Sep-2021. This case involves a 60-year-old female patient reported that INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] was exposed to 76-degree Fahrenheit for 5 days with no adverse event (Product storage error). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 09-Sep-2021, the patient received a 0.5 mL (once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7319LA and expiry date 30-Jun-2022] via unknown route in left deltoid for prophylactic vaccination. It was reported, "Caller states they had a temperature excursion, in which a box of unopened pre-filled syringes of FLUZONE QIV were left out on the counter for 5 days, reaching room temperature of 76 degrees Fahrenheit. He then states nine of these doses were used on patients." It was a case of actual medication error due to incorrect product storage (latency was on same day). At the time of reporting, patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1713168
Sex: U
Age:
State: ID

Vax Date: 09/01/2017
Onset Date: 09/01/2017
Rec V Date: 09/18/2021
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: Arthritis in my hands; Joint pain and joint cramping/The pain and stiffness totally gone; Joint pain and joint cramping/The pain and stiffness totally gone; This spontaneous case was received on 11-Sep-2021 via Med Communications (reference number: SEQW21-02146) from other non-health professional (consumer) and concerned a patient, of an unreported age and gender. The patient's concurrent conditions included deathly allergy to peanuts and all peanut products. The patient's concomitant medications were not reported. The patient had gotten a flu vaccine each year and did not have any reactions at all. On an unspecified date in Sep-2017, the patient was vaccinated with Seqirus influenza virus vaccine polyvalent (brand not specified; route of administration, dose, indication and anatomical location: not reported). The batch number was not reported. On the same day, within a couple of hours after receiving influenza virus vaccine polyvalent, the patient developed severe joint pain and joint cramping. The severity lasted several weeks and then milder pain for the next four months. On an unspecified date, the patient went to doctor and she tested the patient for several illnesses, but nothing appeared to be the problem. On an unspecified date in 2018, after about five months, the pain and stiffness were totally gone, but the patient started having arthritis in hands, which the patient did not have before. The outcome of the event 'arthritis' was not reported. The reporter did not provide causality assessment. The case was assessed as non-serious. Company comment: A patient of an unreported age was vaccinated with influenza virus vaccine polyvalent. On the same day, within a couple of hours after receiving influenza virus vaccine polyvalent, the patient developed severe joint pain and joint cramping. The severity lasted several weeks and then milder pain for the next four months. After about five months, the pain and stiffness were totally gone, but the patient started having arthritis in hands, which the patient did not have before. With information available at the moment, causality is assessed as possibly related for all events.; Sender's Comments: A patient of an unreported age was vaccinated with influenza virus vaccine polyvalent. On the same day, within a couple of hours after receiving influenza virus vaccine polyvalent, the patient developed severe joint pain and joint cramping. The severity lasted several weeks and then milder pain for the next four months. After about five months, the pain and stiffness were totally gone, but the patient started having arthritis in hands, which the patient did not have before. With information available at the moment, causality is assessed as possibly related for all events.

Other Meds:

Current Illness: Peanut allergy

ID: 1713192
Sex: F
Age: 52
State:

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: None ? didn?t seek medical attention

Allergies: Wheat????

Symptom List: Erythema, Pruritus

Symptoms: Had trouble urinating ? had to go, but very little came out ? continued for a couple days and then it seemed to resolve

Other Meds: Lisinopril, fish oil, collagen, turmeric aspirin, probiotic, multi-vitamin, alpha lipic acid, b-12, biotin and chromium

Current Illness: Diabetes?type II ? controlling with diet and exercise, high blood pressure

ID: 1713193
Sex: M
Age: 57
State: GA

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/18/2021
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: Error: Improper storage/temperature.

Other Meds:

Current Illness:

ID: 1713194
Sex: F
Age: 74
State: RI

Vax Date: 09/16/2021
Onset Date: 09/16/2021
Rec V Date: 09/18/2021
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: Error: Improper Storage (temperature)-

Other Meds:

Current Illness:

ID: 1713195
Sex: F
Age: 63
State: RI

Vax Date: 09/16/2021
Onset Date: 09/16/2021
Rec V Date: 09/18/2021
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: Error: Improper storage/temperature.

Other Meds:

Current Illness:

ID: 1713196
Sex: F
Age: 43
State: NY

Vax Date: 09/01/2021
Onset Date: 09/13/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: 9/15 Cat scan Mri Chest xray Blood work Ekg

Allergies: Nsaids, iodine, reglan

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

Symptoms: 9/13 rash left arm still present and spreading 9/15 urgent care and then er - headache, fatigue, weakness, dizzy, tachycardia- taken from urgent care to er for elevated blood pressure - medicine given for head ache - imaging done to rule out clots which was ok bloodwork was ok Still dealing with weakness, headache, tachycardia, and elevated blood pressure

Other Meds: Hydroxine, buspar, lyrica, concentyxx, singulair, melatonon, famotidine, junel, tylenol, metropolol

Current Illness: Gi care for stomach issues - anxiety mood issues around period

ID: 1713197
Sex: F
Age: 67
State: FL

Vax Date: 01/01/2021
Onset Date: 01/20/2021
Rec V Date: 09/18/2021
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: doctors visit with cortisone injection

Allergies: penicillin, aspirin

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

Symptoms: painful persistent spasms in right medial tendon in foot/leg/ankle

Other Meds: vit D; Fish oil; levothyroxine

Current Illness:

ID: 1713198
Sex: F
Age: 15
State: NJ

Vax Date: 09/13/2021
Onset Date: 09/13/2021
Rec V Date: 09/18/2021
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: Site: Pain at Injection Site-Medium, Additional Details: arm pain from shoulder to elbow

Other Meds:

Current Illness:

ID: 1713199
Sex: F
Age: 12
State: GA

Vax Date: 09/17/2021
Onset Date: 09/17/2021
Rec V Date: 09/18/2021
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: Error: Improper Storage (temperature)-

Other Meds:

Current Illness:

ID: 1713200
Sex: F
Age: 55
State: GA

Vax Date: 08/22/2021
Onset Date: 08/22/2021
Rec V Date: 09/18/2021
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: Error: Improper storage/temperature.

Other Meds:

Current Illness:

ID: 1713201
Sex: M
Age: 43
State: GA

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/18/2021
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: Error: Improper Storage (temperature)-

Other Meds:

Current Illness:

ID: 1713202
Sex: M
Age: 57
State: GA

Vax Date: 08/22/2021
Onset Date: 08/22/2021
Rec V Date: 09/18/2021
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: Error: Improper Storage (temperature)-

Other Meds:

Current Illness:

ID: 1713204
Sex: F
Age: 26
State: TX

Vax Date: 09/16/2021
Onset Date: 09/17/2021
Rec V Date: 09/18/2021
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: Employee calling to report a reaction after receiving a COVID-19 vaccine. Vaccine Name - Pfizer Vaccine Date - ? 09/16/2021 Is this your first or second dose- 1st Date of symptom onset - ? 09/17/2021 Symptoms - ? Employee stated have a knot under skin at injection site, swelling, redness " a little bigger than a quarter", and the area is warm to the touch. Last day of work and shift - 09/17/2021 ? Home remedies- Employee stated that she is taking Ibuprofen to help with the pain and swelling Any improvement- Employee stated it is helping the pain a little. Recommendation- Advised employee to continue taking Ibuprofen per package instructions as needed for pain and swelling, and to apply a cold compress for 20 minutes at a time every couple of hours. Also advised employee if symptoms persist or new symptoms develop to follow up with PCP. Employee voiced understanding. Employee voiced understanding Employee of information ? Yes Employee voiced any concerns ? No Employee?s questions answered to employee?s satisfaction -Yes

Other Meds:

Current Illness:

ID: 1713205
Sex: M
Age: 45
State: GA

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 09/18/2021
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: Error: Improper Storage (temperature)-

Other Meds:

Current Illness:

ID: 1713206
Sex: M
Age: 66
State: PA

Vax Date: 05/18/2021
Onset Date: 05/20/2021
Rec V Date: 09/18/2021
Hospital: Y

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

Lab Data: ENT doctor confirmed left paralyzed vocal fold and right vocal fold not moving normally as viewed through laryngeal scoping in the hospital in July 2021 and confirmed again in September 2021.

Allergies: None

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Loss of voice occurred 48 hours after 2nd covid injection followed by aspiration pneumonia resulting in hospital admittance for over 3 weeks. ENT doctor confirmed paralyzed left vocal fold and right vocal fold not moving normally. Doctor injected hyaluronic acid gel into paralyzed left vocal fold to help the paralyzed vocal cord close the glottis.

Other Meds: Vitamins D and C, Magnesium, multivitamin, Calcium Phosphate, Losartan, Creon, Imodium

Current Illness: Crohns disease, Stage 3 kidney disease, Ankylosing Spondylitis

ID: 1713207
Sex: F
Age: 52
State: GA

Vax Date: 08/21/2021
Onset Date: 08/21/2021
Rec V Date: 09/18/2021
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: Error: Improper Storage (temperature)-

Other Meds:

Current Illness:

ID: 1713208
Sex: F
Age: 42
State: FL

Vax Date: 02/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: None

Allergies: Aleve

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

Symptoms: Menstrual cycles stopped completely.

Other Meds: metformin 500mg daily, claritin 10mg daily

Current Illness: none

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am