VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1692788
Sex: F
Age:
State: NJ

Vax Date: 05/15/2021
Onset Date: 05/15/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: headache; bloating; mood swings; lethargy; started an abnormal length of spotting (breakthrough bleeding); feel tired; feverish; brought on my period when I haven't had one previously since being on Nexplanon in Jan/ altered menstrual cycle after 2nd dose; I am spotting between my period; Dose Number: 1 # Date of start of drug: 28Apr2021/ Dose Number: 2 # Date of start of drug: 15May2021; anxiety; depression; uncertainty; My cramps ere unusual compared to my normal cycle; This is a spontaneous report from a contactable consumer (Patient). A 29-year-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0173), intramuscular, administered in Arm Left on 15May2021 10:30 (at age of 29 years old) as single dose for COVID-19 immunisation. Medical history included Asthma from 1993 and ongoing, PCOS (Polycystic ovarian syndrome) from Jun2021 and ongoing, Known allergies: Raw Apples, Known allergies: Sulfa drugs. There were no concomitant medications. No other vaccine in four weeks. COVID prior vaccination. No COVID tested post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0170), Intramuscular at left arm on 28Apr2021 01:30 PM (at age of 29 years old) as single dose for COVID-19 immunisation, and The 1st dose made patient feel extremely fatigued with 101 fever & no appetite & head/body aches. The patient had Nexplanon inserted 28Jan2021.The 2nd dose made patient feel tired & feverish, it also brought on patient's period when haven't had one previously since being on Nexplanon in Jan/altered menstrual cycle after 2nd dose (Seriousness criteria: Not Serious). Since my 2nd vaccination, patient was spotting between period. All above events started on 21May2021 07:00 AM. No treatment for above events. Period started a week earlier, lasting a few days longer than normal; start 21May, end 26May. Nine days later (24May2021) started an abnormal length of spotting (breakthrough bleeding). Spotting started on 05Jun and ended 28Jun with a brief day of spotting on 03Jul. During these weeks of spotting patient (Jun2021) experienced headache, bloating, mood swings, and lethargy. In 2021, There were periods of strong anxiety, depression and uncertainty. Patient's cramps were unusual compared to normal cycle. Altered menstrual cycle after 2nd dose had Physician office visit. The outcome of the events feel tired & feverish, spotting between my period was Not recovered, for brought on my period when I haven't had one previously since being on Nexplanon in Jan/altered menstrual cycle after 2nd dose was recovering, for other events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Asthma; Polycystic ovarian syndrome

ID: 1692789
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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 Date: 20210504; Test Name: Skin biopsy; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: red itchy skin rash; red itchy skin rash; This is a spontaneous report from a contactable consumer based on information received by Pfizer from program (manufacturer control number US-AMGEN-USASP2021069724). This case was split from master case 2021537545 for an elderly patient taking bnt162b2 and experienced red itchy skin rash. An elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis with rheumatoid factor, unspecified. Concomitant medication(s) included etanercept (ENBREL) taken for rheumatoid arthritis from Sep2020 and ongoing; allopurinol (ALLOPURINOL); atorvastatin (ATORVASTATIN); fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); ferrous sulfate (FERROUS SULFATE); prednisone (PREDNISONE); valsartan (VALSARTAN). The patient experienced red itchy skin rash on an unspecified date. The patient underwent lab tests and procedures which included biopsy skin: unknown results on 04May2021 to determine cause of rash whose result were not provided. No treatment information was received. Outcome of events was not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: ENBREL; ALLOPURINOL; ATORVASTATIN; BREO ELLIPTA; FERROUS SULFATE; PREDNISONE; VALSARTAN

Current Illness: Rheumatoid arthritis

ID: 1692790
Sex: M
Age:
State: SC

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 09/11/2021
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: 20210610; Test Name: Fever; Result Unstructured Data: Test Result:103.5

Allergies:

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

Symptoms: nauseous; My son started feeling badly 5-6 hours after the 2nd shot./feeling overall very bad; this morning he had 103.5 fever; The patient was less than 12 years old; This is a spontaneous report from a contactable consumer (parent). A 10-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on 09Jun2021 00:30 (at the age of 10-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was allergic to Penicillin's and Sulfa. The patient previously received bnt162b2 (COMIRNATY, solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on 19May2021, 12:00 (at the age of 10-years-old) as dose 1, single for COVID-19 immunisation. There were no other vaccine in four weeks and no other medications in two weeks. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having COVID prior vaccination and has not been COVID tested post vaccination. On 09Jun2021 00:30 The patient who was less than 12 years old took the vaccination and on 10Jun2021 07:30 the patient had 103.5 fever, nauseous and started feeling badly 5-6 hours after the 2nd shot feeling overall very bad. The patient started feeling badly 5-6 hours after the 2nd shot. At 7:30am morning he had 103.5 fever, nauseous and feeling overall very bad. Event treatment included Advil Tylenol swap every 4 hours so far. Laboratory data include fever 103.5. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1692791
Sex: M
Age:
State: MA

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 09/11/2021
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: rash on back from the belt line to under arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8727), via an unspecified route of administration, administered in left arm on 15Apr2021 13:00 (at the age of 65 years old) as dose 1, single for COVID-19 immunisation. Medical history included chronic pain in back and penicillin allergy/cholesterol drugs allergy. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included steroids. The patient experienced rash on back from the belt line to under arm on 16Apr2021 12:00. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of rash on back from the belt line to under arm and included treatment with cream. Outcome of the event was recovered on 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692793
Sex: M
Age:
State: TX

Vax Date: 05/22/2021
Onset Date: 05/26/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: red spots on my chest and overtime they started to spread throughout my body, to my stomach, arms, hands, and now on my thighs; it's an allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22May2021 12:00 (Lot Number: EW0182) as single dose (at the age of 20 years old) for COVID-19 immunisation. The vaccine was administered at Pharmacy or Drug Store. Medical history none. Concomitant medication included vitamin C [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), Vital protein collagen and protein powder, all taken for an unspecified indication, start and stop date were not reported. On 26May2021, the patient experienced: red spots on my chest and overtime they started to spread throughout my body, to my stomach, arms, hands, and now on my thighs; it's an allergic reaction. The outcome of the events was not recovered. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The clinical course was reported as follows: Within 4-5 days after I got the PfizerBioNTech vaccine, I started seeing red spots on my chest and overtime they started to spread throughout my body, to my stomach, arms, hands, and now on my thighs. It does not itch or anything, the most it does is get more red than usual and that happens whenever I am exercising or working out. As of now this is starting to spread more and more and I'm assuming it's an allergic reaction. Follow-up attempts are completed. No further information is expected.

Other Meds: VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1692794
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/17/2021
Rec V Date: 09/11/2021
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: Irregular menstrual cycle; This is a spontaneous report from a contactable Health Care Professional (patient). A 28-year-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), the first dose, on an unspecified date, at single dose, in the left arm and the second dose on an unspecified date (Lot. 59267-1000-03) at single dose, in the left arm, for COVID-19 immunisation. Relevant medical history and concomitant medications were none. The patient had not experienced Covid-19 prior vaccination. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not received any other medications within 2 weeks of vaccination. No known allergies were reported. On 17May2021, the patient had irregular menstrual cycle. No treatment received. Clinical outcome of the adverse event was unknown at time of this report. Post the vaccination, the patient has not been tested for COVID-19. Follow-up attempt have been completed and no further information is expected. The lot number is not available despite follow-up attempts made.

Other Meds:

Current Illness:

ID: 1692795
Sex: M
Age:
State: NC

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 C

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: chills; headache; fever; This is a spontaneous report from a contactable physician (parent). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in arm left on 09Jun2021 07:30 (Batch/Lot Number: EW0186) (at the age of 12-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1, intramuscular (lot number: EW0179) on 18May2021 07:30 AM for COVID-19 immunisation. The patient had no other vaccines within four weeks. The patient had no covid prior vaccination. He had not tested with covid post vaccination. The patient experienced chills, headache and fever on 09Jun2021 19:30 with outcome of recovered on 10Jun2021 14:00. It was reported that 12 hours after receiving the vaccine, the patient started having chills, headache and fever (38.5 degrees Celsius). Ibuprofen 300 mg was taken once. The following morning (June-10) around 9 am another dose of Ibuprofen 300 mg was taken. The events resolved by 2 pm the same day. Therapeutic measures were taken as a result of chills, headache and fever. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1692796
Sex: F
Age:
State:

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 09/11/2021
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: Menstruation abnormal; This is a spontaneous report form a non-contactable consumer (patient). A 43-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Patient did not have COVID-19 prior to vaccination. Patient did not receive other vaccine in four weeks. Concomitant medications included birth control pill, multivitamin. The patient experienced menstruation abnormal (non-serious) on 01Apr2021 with outcome of unknown. The patient reported period cycle changes. First month period did not come. 2nd month lots if cramping and only spotting. Her periods normally were very consistent. Patient was not tested for COVID-19 after vaccination. The lot number for bnt162b2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1692797
Sex: F
Age:
State: OR

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: racy feeling; extreme headache; fatigue; lymph node swelling; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew 0180), via an unspecified route of administration, administered in right arm on 14May2021 at 10:00 (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. Medical history included allergy to medications (some past prescription medications). The patient stated that she was sensitive person and had the uncommon side effects. She had no chronic conditions, no illnesses. She was a healthy person. Concomitant medications included unspecified multivitamins and unspecified magnesium supplements. On 14May2021 in the evening the patient experienced experienced a racy feeling and a bit of needing to take deep breaths. She had an extreme headache for 3 days along with fatigue, along with the lymph node swelling. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not received treatment for events. The patient did not have COVID prior vaccination and she was not tested post vaccination. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692798
Sex: M
Age:
State: PA

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 09/11/2021
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: extreme fatigue; slight fever; cough; This is a spontaneous report from a non-contactable consumer (patient). A 49-year-old male patient received bnt162b2 (BNT162B2, Lot Number: ER8735), dose 1 via an unspecified route of administration, administered in left arm on 20May2021 17:30 (at the age of 49-year-old) as dose 1, single for COVID-19 immunization. Medical history included Covid-19. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. On 20May2021, the patient experienced extreme fatigue, slight fever and cough. The events lasted for about 32 hours. The patient received no treatment for the events. The outcome of the events recovered in May2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1692799
Sex: F
Age:
State: NC

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210609; Test Name: Body Temperature; Result Unstructured Data: Test Result:38.5 Degrees Celsius

Allergies:

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

Symptoms: fever (38.5 degrees Celsius); chills; headache; This is a spontaneous report from a contactable physician (patient's parent). A 12-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), intramuscular, administered in the left arm on 09Jun2021 at 07:30 (Lot Number: EW0186) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient previously received the first dose of BNT162B2 (lot number: EW0179), intramuscular on 18May2021 at 07:30 on the left arm for COVID-19 immunization. On 09Jun2021 at 19:30, 12 hours after receiving the vaccine, the patient started having chills, headache and fever (38.5 degrees Celsius). Ibuprofen 300 mg was taken once. The following morning, 10Jun2021 around 9:00, another dose of Ibuprofen 300 mg was taken. The events resolved 14:00 on 10Jun2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1692800
Sex: F
Age:
State:

Vax Date: 06/06/2021
Onset Date: 06/07/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210607; Test Name: Body Temperature; Result Unstructured Data: Test Result:102 (unspecified units); Comments: 102 fever

Allergies:

Symptom List: Rash, Urticaria

Symptoms: 48 hrs after 2nd shot woke up to lemon size swelling in armpit of arm that was vacinated; 24 hrs after 2nd shot, vomiting; fever (102); This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Jun2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16May2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jun2021 the patient experienced vomiting and 102 fever 24 hrs after 2nd shot, on 08Jun2021, 48 hrs after 2nd shot woke up to lemon size swelling in armpit of arm that was vaccinated. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events vomiting and 102 fever 24 hrs after 2nd shot, on 08Jun2021, 48 hrs after 2nd shot woke up to lemon size swelling in armpit of arm that was vaccinated were not resolved at this time of report. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692802
Sex: F
Age:
State: CA

Vax Date: 06/05/2021
Onset Date: 06/06/2021
Rec V Date: 09/11/2021
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: A week of migraines; many painful acne cysts on face; yeast infections; sore breasts for 2 weeks and counting; multiple periods, 2 week early periods; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 05Jun2021 at 15:45 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 37-years-old). Medical history included patient had known allergies to dilantin and penicillin from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had not received any other vaccine in four weeks and other medications in two weeks. Patient had no covid prior vaccination and not tested for covid post vaccination. It was reported that after receiving the dose of vaccine on 06Jun2021 at 12:00 the patient experienced a week of migraines, many painful acne cysts on face, yeast infections, sore breasts for 2 weeks and counting, multiple periods, 2 week early periods. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient had not received any treatment for the events. The patient was not recovered from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1692803
Sex: U
Age:
State: WI

Vax Date: 05/05/2021
Onset Date: 06/11/2021
Rec V Date: 09/11/2021
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: blood (thick) running from my nose; tongue had splits on it; sight became dark red, swollen and hard; hot flashes; face flushing; itchy neck; Ears ringing; bit wheezy; sight became dark red; sight became dark red, swollen; This is a spontaneous report from a contactable consumer (unspecified relationship with patient) reported for patient. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0164, and Expiration date: Unknown), intramuscular, administered in deltoid left on 05May2021 15:40 as dose 1, single for COVID-19 immunization, at hospital. Medical history included none. There were no concomitant medications. There was no prior vaccination. The patient initially had an itchy neck and a bit wheezy, hot flashes, face flushing. Took a Benadryl, ears ringing, on an unspecified date in 2021. Then after 3 days the sight became dark red, swollen and hard, continued for 1 week. Then on 11Jun2021, while sleeping the patient awoke to "blood (thick) running from my nose (about 2 ounces). The patient's "tongue had splits on it". The outcome of the event "sight became dark red, swollen" (swelling), "sight became dark red" (erythema) and "sight became dark red, swollen and hard" (skin hypertrophy) reported as resolved on an unspecified date in 2021. The investigation assessment was not provided. No relevant tests were performed. The outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692804
Sex: F
Age:
State: MA

Vax Date: 05/29/2021
Onset Date: 05/30/2021
Rec V Date: 09/11/2021
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: Heavier spotting after the second administered dose while still on the pill; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 41 year old non pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 29May2021 (Batch/Lot Number: EW0187) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) taken for an unspecified indication, start and stop date were not reported. The patient previously took oxycodone, albuterol. The patient experienced Light spotting for a week after the first dose administration while still on the contraceptive pill and heavier spotting after the second administered dose while still on the pill for intermenstrual bleeding on 30May2021 with outcome of recovered. Follow-up (23Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: JUNEL FE

Current Illness:

ID: 1692805
Sex: M
Age:
State: CA

Vax Date: 03/17/2021
Onset Date: 04/27/2021
Rec V Date: 09/11/2021
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: Developed chest pain.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Ep6955, Expiry date was not reported) via an unspecified route of administration in arm left (at the age of 37-year-old) on 07Apr2021 10:30 as single dose for COVID-19 immunization. The patient medical history was not reported, no known allergy. Concomitant medication(s) included terbinafine (LAMISIL) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: En6208, Expiry date was not reported) via an unspecified route of administration at arm left (at the age of 37-year-old) on 17Mar2021 10:30 (Lot Number: En6208) as single dose for COVID-19 immunisation. The patient did not have COVID prior vaccination. The patient had not tested COVID post vaccination. On 27Apr2021 the patient experienced developed chest pain. Patient received treatment for the event in the form of pills. The adverse event resulted in consultation in Doctor or other healthcare professional office/clinic visit. The outcome for the event was not recovered. No follow-up attempts are possible. No further information is expected. Follow-up attempts are completed. No further information is expected.

Other Meds: LAMISIL [TERBINAFINE]

Current Illness:

ID: 1692806
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 06/25/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: Body Tempareture; Result Unstructured Data: Test Result:102 F; Test Name: heart rate; Result Unstructured Data: Test Result:around 120 per minute

Allergies:

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

Symptoms: Tired; Starting from around 2:00 pm, I started having high fever, peaking at 102 (then I took some Tylenol pills).; felt very dizzy and weak, having headache and wanting to vomit (but didn't); felt very dizzy and weak, having headache and wanting to vomit (but didn't); wanting to vomit (but didn't).; I realized that my heart beat rate was very high, at around 120 per minute; also felt hard to breath for at least couple of hours; felt very dizzy and weak, having headache and wanting to vomit (but didn't); extremely hard to standup on my feet because of above symptoms; Everything was good on the day when I got the second vaccine shot, except for some pain on my left arm; This is a spontaneous report from a contactable consumer (patient). This 31-year-old non-pregnant female consumer was reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0196, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 25Jun2021 at 15:15 (at the age of 31 years) as dose 2, single for covid-19 immunisation. The patient medical history included known allergy to Cephalosporin. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0187, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 04Jun2021 at 14:30 (at the age of 31 years) as dose 1, single for covid-19 immunisation. Facility type vaccine was pharmacy or drug store. No other vaccine given in four weeks. No other medications in two weeks. No Covid prior and post vaccination. It was reported that everything was good on the day when she got the second vaccine shot, except for some pain on her left arm on 25Jun2021. Things got much worse on the second day (26Jun2021) when she woke at around 11:00 am. She felt very dizzy and weak, had headache and wanting to vomit (but didn't). She realized that her heart beat rate was very high, at around 120 per minute. She also felt hard to breath for at least couple of hours and extremely hard to standup on her feet because of above symptoms. But at that time, there was no fever. Starting from around 2:00 pm, she started having high fever, peaking at 102 (then she took some Tylenol pills). During the whole day, her heart beat was around 120 and felt very dizzy. From the third day to fifth day, heart beat rate became normal but still felt dizzy, headache and tired with low fever. The patient underwent lab tests and procedures which included body temperature: 102 f on 26Jun2021. Therapeutic measures were taken as a result of all events. The outcome of all events was recovered in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1692807
Sex: M
Age:
State: GA

Vax Date: 07/09/2021
Onset Date: 07/10/2021
Rec V Date: 09/11/2021
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: Big knot under shoulder pit; Everything swolled up on the side were got the shot. Shoulder and under shoulder and hurting; Everything swolled up on the side were got the shot. Shoulder and under shoulder and hurting; This is a spontaneous report from a contactable consumer. This 67-year-old male consumer reported for himself that. A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0180), dose 2 via an unspecified route of administration, administered in Arm Right on 09Jul2021 10:00 as (At the age of 67-years) DOSE 2, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis from 2016 and ongoing, hypertension from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium 50mg tablet once a day taken for hypertension from an unspecified start date and ongoing. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186 or EW0180), administered in left shoulder dose 1, single for covid-19 immunisation on 06Jun2021 10:00, and teriflunomide taking 14mg tablet, but he does not take it anymore. He stopped taking a year ago. However, he was informed it stays in system for 2 years. No other Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. No AE following prior vaccinations. No Family Medical History Relevant to AE. It was reported that patient got his second dose on Friday. He had a side effect that was not listed, and he was calling to report on that. He was reading the side effects and he had one that was not listed. He had a big knot under shoulder pit on the side where he got the shot. It all swelled up underneath the arm pit. It was like the size of an orange. He also added he thinks we should know he has multiple sclerosis. Caller explained he had a big knot under shoulder pit, and everything was swollen. His whole shoulder was swollen, and he could not lift it. That whole side was swollen. He had a big red knot underneath arm pit. It was the size of an orange. He noticed the early part of the morning on Saturday his shoulder was bothering him. He woke up from the pain at 3:00 AM. His shoulder and under should was hurting. Now everything is going back down, and he does not really have pain. It is just more soreness and stiffness. He commented he went to the doctor for a checkup, but not due to vaccine. At end of call, he mentioned he was just looking at the side effect list and saw the side effects and symptoms. However, he did not see this event listed with a knot underneath shoulder. He stated, he did have just about half of the symptoms listed after getting the Covid-19 vaccine. Attempted to clarify event details further. However, he did not specify further which events occurred. He only stated it was just about all of them. Patient did not require a visit to Emergency Room or Physician Office. The outcome of events was recovering at the time of report. Follow-up attempts are completed. No further information is expected.

Other Meds: LOSARTAN POTASSIUM

Current Illness: Multiple sclerosis

ID: 1692808
Sex: F
Age:
State:

Vax Date: 07/02/2021
Onset Date: 07/04/2021
Rec V Date: 09/11/2021
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: Shortness of breath (left lung inflammation; side closest to injection site); Shortness of breath (left lung inflammation; side closest to injection site); This is a spontaneous report from a non-contactable other hcp (Patient). A 31-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTEH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 02Jul2021 10:00 as single dose for covid-19 immunization. (Vaccination facility: Hospital). Medical history included allergies to sulfa from an unknown date and unknown if ongoing, patient had Never smoked. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (Lot number= ER8735) in left arm on 11Jun2021 09:00 for covid-19 immunization. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient was not diagnosed with Covid prior vaccination. It was reported that on 04Jul2021 Shortness of breath (left lung inflammation: side closest to injection site), no previous medical concerns with her lungs. Highly physically active individual (especially cardiovascular) consuming a healthy diet. Patient did not receive any treatment for the events. Patient was not tested for covid post vaccination. The outcome for the events was reported as resolving at the time of this report. No follow-up attempts are possible. No further information is expected

Other Meds:

Current Illness:

ID: 1692809
Sex: F
Age:
State: AZ

Vax Date: 04/06/2021
Onset Date: 03/16/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210628; Test Name: Mouth lesion; Result Unstructured Data: Test Result:Non-cancer lichen planus; Test Name: Blood test; Test Result: Negative ; Comments: Don't know

Allergies:

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

Symptoms: Non-cancer Lichen planus; Mouth lesions on lower left, upper left, upper right, lower right and right cheek; This is a spontaneous report from a contactable consumer or other non hcp.A female patient of an 61 year old received BNT162B2 (BioNTech COVID-19 Vaccine,Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 13Mar2021 13:00 as 1stdose, single for covid-19 immunisation (Age at vaccination was 60 years).A female patient of an unspecified age received BNT162B2(CONMINTARY, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 06Apr2021 14:30 as 2nddose, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing High blood pressure, blood cholesterol increased from an unknown date and unknown if ongoing, sleep apnoea syndrome from an unknown date and unknown if ongoing, iodine allergy from an unknown date and unknown if ongoing Known allergies: Iodine scan dye. Concomitant medication(s) included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; linagliptin (TRADJENTA) taken for an unspecified indication, start and stop date were not reported; pioglitazone hydrochloride (PIOGLA) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. The patient experienced mouth lesions on lower left, upper left, upper right, lower right and right cheek on 16Mar2021, non-cancer lichen planus on 28Jun2021 with. The patient underwent lab tests and procedures which included biopsy: non-cancer lichen planus on 28Jun2021, sars-cov-2 test: negative on Don't know. Therapeutic measures were taken as a result of mouth lesions on lower left, upper left, upper right, lower right and right cheek (oral disorder). Upon follow-up 09Aug2021 is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that patient age at time of vaccination was 60 years, Pfizer/BioNTech COVID-19 vaccine details about 1st and 2 nd dose (date, time, anatomical site of injection, batch/Lot number COVID vaccine shot, not available/ provided at time of report completion, relevant tests mouth lesion, Biopsy date 28Jun2021, result non-cancer lichen planus, adverse events seriousness criteria not serious. In narrative it was included patient started feeling a lesion in my lower left area of mouth in front of my lower teeth the day after the 2nd shot of the vaccine 07Apr2021. Went to my dentist, they photographed it thought it was an allergic reaction to vitamin D3 I was taking, but stopped that and it got worse, went to dentist a few weeks later then lesions got larger and there were more. Dental hygienist said they never saw them in my mouth in the 6 years of cleaning my teeth, surgeon suggested a biopsy and they removed a portion from upper right side inside cheek area (6 stitches). Confirmed lichen Planus 'Possibly due to vaccine. Outcome of the events was not recovered. Upon follow-up 09Aug2021 is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that patient age at time of vaccination was 60 years, Pfizer/BioNTech COVID-19 vaccine details about 1st and 2nd dose (date, time, anatomical site of injection, batch/Lot number COVID vaccine shot, not available/ provided at time of report completion, relevant tests mouth lesion, Biopsy date 28Jun2021, result non-cancer lichen planus, adverse events seriousness criteria not serious. In narrative it was included patient started feeling a lesion in my lower left area of mouth in front of my lower teeth the day after the 2nd shot of the vaccine 07Apr2021. Went to my dentist, they photographed it thought it was an allergic reaction to vitamin D3 I was taking, but stopped that and it got worse, went to dentist a few weeks later then lesions got larger and there were more. Dental hygienist said they never saw them in my mouth in the 6 years of cleaning my teeth, surgeon suggested a biopsy and they removed a portion from upper right side inside cheek area (6 stitches). Confirmed lichen Planus 'Possibly due to vaccine. Device Date: 14Jul2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: METFORMIN; SIMVASTATIN; LOSARTAN; TRADJENTA; PIOGLA; VITAMIN D3

Current Illness:

ID: 1692810
Sex: F
Age:
State:

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 09/11/2021
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: runny nose; sore throat; trouble breathing; headaches; This is a spontaneous report from a contactable consumer (Patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) AND dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) both as single dose for covid-19 immunisation. Medical history included ongoing COPD. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced runny nose, sore throat, trouble breathing and headaches. Therapeutic measures were taken as a result of adverse event. Patient received the first dose of the Pfizer COVID-19 vaccine on 03March2021 and the second dose on 23Mar2021 and had recently developed a runny nose, sore throat, trouble breathing and headaches, she does have COPD and was under a doctors care. Stated her doctor/Nurse PR actioner had given her medication and inhalers and would like her to go to the emergency room because of her breathing but she does not want to do that, she was wondering if she can get test of the COVID-19 virus. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.

Other Meds:

Current Illness: COPD

ID: 1692811
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: creatinine Kinase; Test Result: 274 {DF}; Test Name: lactate; Test Result: 2.4 {DF}; Test Name: lumbar puncture protein; Test Result: 45 {DF}; Test Name: Transthoracic echocardiogram; Result Unstructured Data: showed left ventricular ejection fraction (EF) of 20-25% and apical, anterolateral, anteroseptal and inferoseptal wall motion abnormalities.; Test Name: EMG; Result Unstructured Data: suggested an axonal demyelinating polyneuropathy but was not diagnostic; Test Name: EMG; Result Unstructured Data: Repeat electromyogram showed a sensorimotor polyneuropathy with demyelination without myopathic components, confirming acute inflammatory demyelinating polyradiculopathy; Test Name: Complete blood count; Result Unstructured Data: unremarkable; Test Name: Head and spine imaging; Result Unstructured Data: unremarkable; Test Name: autoimmune workup; Test Result: Negative ; Test Name: Cardiac MRI; Result Unstructured Data: with gadolinium revealed diffuse hypokinesis without infarction, scarring, or infiltrate, suggesting potential for functional recovery.; Test Name: BMP; Result Unstructured Data: unremarkable; Test Name: Infectious workup; Test Result: Negative ; Test Name: Physical exam; Result Unstructured Data: diminished vibration and pain in his lower limbs and 0 to 1 plus deep tendon reflexes throughout without myalgias.; Test Name: troponin; Test Result: 0.33 {DF}

Allergies:

Symptom List: Unevaluable event

Symptoms: inability to ambulate; diminished vibration; pain in his lower limbs; diffuse hypokinesis without infarction scarring, or infiltrate; non-ischemic cardiomyopathy; a patient received a double dose influenza vaccine; Guillain-Barre syndrome/ acute inflammatory demyelinating polyradiculopathy; dysphagia; mild dysarthria; proximal muscle weakness; could not lift his arms above his head; Initial information was received on 28-Aug-2021 regarding an unsolicited valid serious case from the other healthcare professional issued in a literature article. This case involves a 79 years old male patient who experienced dysphagia, mild dysarthria (dysarthria), proximal muscle weakness (muscular weakness), inability to ambulate (mobility decreased), could not lift his arms above his head(joint range of motion decreased), diminished vibration (decreased vibratory sense), pain in his lower limbs (pain in extremity), diffuse hypokinesis without infarction scarring, or infiltrate (hypokinesia), non-ischemic cardiomyopathy (cardiomyopathy) and developed Guillain-Barre syndrome/ acute inflammatory demyelinating polyradiculopathy (Guillain-Barre syndrome), after receiving double dose of INFLUENZA VACCINE (extra dose administered). The patient had no medical history or recent illness. The patient's past medical treatments, vaccinations, concomitant medication, and family history were not provided. On an unknown date, the patient received a double dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination respectively. On an unknown date, the patient experienced serious symptoms of dysphagia, mild dysarthria (dysarthria), proximal muscle weakness (muscular weakness), inability to ambulate(mobility decreased), could not lift his arms above his head(joint range of motion decreased), diminished vibration (decreased vibratory sense), pain in his lower limbs (pain in extremity), diffuse hypokinesis without infarction scarring, or infiltrate (hypokinesia), non-ischemic cardiomyopathy (cardiomyopathy) and developed Guillain-Barre syndrome (GBS) / acute inflammatory demyelinating polyradiculopathy (Guillain-Barre syndrome) which was diagnosed (two weeks), following the administration of INFLUENZA VACCINE. These events were assessed as medically significant. Intensity of event dysarthria was mild. It was also a case of an actual medication error due to extra dose administered (latency: same day). Laboratory test results included: Physical exam demonstrated diminished vibration and pain in his lower limbs and 0 to 1 plus deep tendon reflexes throughout without myalgias. Complete blood count (CBC)/ Basic Metabolic Panel (BMP) were unremarkable. Notable labs included creatinine kinase 274 U/L (unit/liter) (30-170 U/L), lactate 2.4 mmol/L (mole/cubic meter) (0.67-1.8 mmol/L), and troponin 0.33 ?g/L (microgram/liter) (0-0.5 ?g/L). Infectious workup was negative. Family was unaffected. A lumbar puncture revealed protein 45 mg/dL (milligrams per deciliter) (15-60 mg/dL). Head and spine imaging were unremarkable. Transthoracic echocardiogram (TTE) showed left ventricular ejection fraction (EF) of 20-25 percent and apical, anterolateral, anteroseptal and inferoseptal wall motion abnormalities. Electromyography (EMG) suggested an axonal demyelinating polyneuropathy but was not diagnostic. Autoimmune workup was negative. Repeat EMG showed a sensorimotor polyneuropathy with demyelination without myopathic components, confirming acute inflammatory demyelinating polyradiculopathy. Cardiac Magnetic resonance imaging (MRI) with gadolinium revealed diffuse hypokinesis without infarction, scarring, or infiltrate, suggesting potential for functional recovery. The patient was treated with two doses of IMMUNOGLOBULINS Intravenous (IVIG) for Guillain-Barre syndrome via intravenous route. Guideline directed medical therapy was initiated for non-ischemic cardiomyopathy with reduced EF. After resuming IVIG for 5 total days of treatment, patient displayed improvement and transferred to inpatient rehabilitation 15 days after symptom onset. Impact/ Discussion: This case illustrates an unusual presentation of GBS and the need to rapidly initiate appropriate treatment. Proximal weakness remains atypical. Rapidly developing profound weakness was also uncharacteristic, as maximum disability typically takes weeks. Mechanism of myocyte injury in rhabdomyolysis from GBS was unclear. Myocardial involvement varies in severity and appears reversible. Cardiomyopathy in GBS appears rare and incidence remains unknown. Proposed mechanisms for GBS-related cardiomyopathy include autonomic and nervous dysfunction from immune-mediated nerve damage. Mainstay of GBS treatment is prompt IVIG infusion. Conclusion: 1. Clinicians should be aware that hyper acute onset of proximal weakness, myositis, and cardiomyopathy are atypical features of GBS. 2. Cardiovascular involvement of GBS may be severe yet reversible with appropriate treatment. The causality of the suspect with the events were reported as GBS and influenza vaccinations have been temporally correlated, but little evidence supports a causal relationship. It is unclear if a double dose vaccination confers greater risk. 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. Information on the batch number was requested for this case.; Sender's Comments: This case involves a 79 years old male patient who experienced Guillain-Barre syndrome, dysphagia, dysarthria, muscular weakness, mobility decreased, joint range of motion decreased, decreased vibratory sense, pain in extremity, hypokinesia, cardiomyopathy two weeks after receiving INFLUENZA VACCINE (unknown manufacturer). Electromyography confirmed acute inflammatory demyelinating polyradiculopathy. The time to onset is compatible. The patient's medical condition at time of vaccination, concomitant medication and other lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1692813
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: hearing impaired; Initial information received on 30-Aug-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional. This case involves an 8-month-old female patient who experienced hearing impaired (hypoacusis) after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient past medical treatment included Noctec. The patient past vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious hearing impaired (hypoacusis) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. Caller states she almost died when she was 8 months from a medication called Adacel. It caused hearing loss as well. It was reported it was spoke from attached document who should not get the vaccine to emphasize the contraindications. Encouraged caller to reach out to HCP (health care professional) with ingredient list for the comimaty vaccine so they can help compare ingredients. It was unknown if there were lab data/results available. It was unknown if the patient experienced any additional symptoms/events. It was not reported if the patient received any corrective treatment for the event (hearing impaired). At time of reporting, the outcome was unknown for the event hearing impaired. Information on the batch number was requested.; Sender's Comments: This case involves an 8-month-old female patient who experienced hypoacusis after vaccination with ADACEL. 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: 1692814
Sex: F
Age: 29
State: PA

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 09/11/2021
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: Fluzone exposure during pregnancy with no adverse event; Initial information received on 01-Sep-2021 regarding an unsolicited valid non-serious case from an other health professional and consumer/non healthcare professional. This case involves a 29 years old female pregnant patient who was vaccinated with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) [exposure during pregnancy]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at 45 weeks of pregnancy and the patient was exposed to QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) at 45 weeks of pregnancy, during unknown pregnancy trimester for the vaccine. The date of last menstrual period was reported as 26-Feb-2020. The estimated delivery due date was 02-Oct-2021. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 09-Jan-2021, the patient received first dose of suspect FLUZONE QUADRIVALENT (suspension for injection, lot UT7325JA and expiration date 30-Jun-2022) via intramuscular route in an unknown administration site for prophylactic vaccination. It was an actual medication error case due to vaccine exposure during 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: 1692815
Sex: F
Age: 24
State: PA

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/11/2021
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: pregnant female patient received FLUZONE vaccine/ NO AE; Initial information received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional and physician. This case involves 24-year-old female pregnant patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (exposure during pregnancy). Data regarding this pregnancy were received prospectively. Patient was exposed to the vaccine at gestation period of 20 weeks. The date of last menstrual period was reported as 20-Apr-2021. The estimated due date is 25-Jan-2022. The patient past medical treatment, family history and concomitant medication were not provided. Patient had any medical history, concomitant disease or risk factor On 01-Sep-2021, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [lot 477325SA, expiry date: 30-Jun-2022] via an intramuscular route at an unknown administration site for prophylactic vaccination. It was the case of vaccine exposure during pregnancy (latency same day). The patient was pregnant when she received FLUZONE vaccine. It was not reported if the patient received a corrective treatment for the events. It was not reported whether patient experienced any adverse reaction after the injection. Pregnancy outcome was unknown at the time of report.

Other Meds:

Current Illness:

ID: 1692816
Sex: F
Age:
State:

Vax Date: 08/14/2020
Onset Date: 08/14/2020
Rec V Date: 09/11/2021
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: other symptoms as well; fainted twice within the first hour; Initial information was received on 31-Aug-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This case involves an adult female patient who fainted twice within the first hour (syncope) and had other symptoms as well (unevaluable event) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Information of concomitant medications was not reported. On 14-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination. On 14-Aug-2020 the patient developed a serious event reported as fainted twice within the first hour (syncope) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant. On an unknown date the patient, developed non-serious other symptoms as well (unevaluable event) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Also, it was reported that sometimes that happens. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the events. At the time of this report, the outcome of both the events was unknown. Information on lot/batch number was requested for this case.; Sender's Comments: This case concerns an adult female patient who had syncope and unevaluable event after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible with the role of the vaccines for the event syncope. The time to onset is unknown for the event unevaluable event. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1692817
Sex: F
Age: 26
State: PA

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 09/11/2021
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: Pregnant woman recieved Fluzone QIV 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 involves a 26-year-old pregnant female patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] on 09-Feb-2021 (exposure during pregnancy). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Pregnant woman received Fluzone QIV with no reported adverse event occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date is 02-Oct-2021. 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-Feb-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 during 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: 1692818
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Expired Fluzone QIV was administered to 4 patients, no AE; The patients received 5 ml of vaccine, no AE; Initial information was received on 07-Sep-2021 regarding an unsolicited valid non-serious case from a physician via other health care professional. This case involves 4 patients (unknown demographics) who were administered an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Expired product administered and overdose). It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patients received a 5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported, Suspension for injection) via unknown route in an unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used and overdose (latency same day). No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will ne no information available on batch number for this case.

Other Meds:

Current Illness:

ID: 1692821
Sex: F
Age: 35
State: MA

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 09/11/2021
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: pregnant patient receive the vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 31-Aug-2021 from a Physician via Medical Information (Reference number- 00748401) and transmitted to Sanofi on 31-Aug-2021. This case involves a 35-year-old female patient who had taken INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] while she was pregnant (Maternal exposure during pregnancy) with no adverse event. Gestation period at onset was not reported. Data regarding this pregnancy were received prospectively for example before pregnancy outcome was unknown. The date of last menstrual period was not reported. The estimated due date is 29-Aug-2021. The medical history, medical treatment, vaccination, family history and concomitant medication were not reported. On 31-Aug-2021, the patient received a 0.5 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ686AA, expiry date 30-Jun-2022] via intramuscular route in the left arm for prophylactic vaccination. It was a case of Maternal exposure during pregnancy as patient was pregnant when she received vaccine (latency on the same day). It is unknown if the patient experienced any additional symptoms/events. Relevant prenatal testing after exposure was not reported. It was not reported if the patient received any corrective treatment. . At the time of report, the outcome of event was unknown.

Other Meds:

Current Illness:

ID: 1692823
Sex: F
Age: 5
State:

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/11/2021
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: expired DAPTACEL was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse and physician via Medical Information (Reference number- 00748869) and transmitted to Sanofi on 31-Aug-2021. This case is linked to case 2021SA290049 (same reporter). This case involved 5-year-old female patient who administered expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered) Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination. On 12-Aug-2021, the patient received second 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot: C5643AA and expiry date: 17-Jul-2021) (Frequency: Once) (Strength: Standard) via intramuscular route in the right thigh for prophylactic vaccination (expired product administered). It was reported,"Nurse asks if there are any recommendations for when expired DAPTACEL is administered". 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: HEPATITIS A VACCINE

Current Illness:

ID: 1692826
Sex: M
Age: 12
State: OH

Vax Date: 07/21/2021
Onset Date: 07/21/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Patient accidentally received DAPTACEL instead of ADACEL in the office; Initial information was received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from physician and other health care professional via Medical information (under reference number - 00750742). This case involves a 12-year-old male patient who was accidentally vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] with no adverse event (Wrong product administered). The patient's past vaccination(s) included DTAP VACCINE with Patient has already received 4 DTAP vaccinations. The patient's past medical treatments, concomitant therapy and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination. On 21-Jul-2021, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number U6628AA and expiry date 04-Apr-2022) via intramuscular route in the deltoid NOS for prophylactic vaccination (Wrong product administered). There were no laboratory data/results available. It was case of an actual medication error due to Wrong vaccine administered (latency was on same day) At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: MENACTRA

Current Illness:

ID: 1692838
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: respiratory illnesses; Patient has an immune disorder for which her immunologist wants her to have the Fluzone High-Dose instead of a vaccine indicated for her age/ recommends Fluzone High Dose and not FluAd; Patient has an immune disorder for which her immunologist wants her to have the Fluzone High-Dose instead of a vaccine indicated for her age/ recommends Fluzone High Dose and not FluAd; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-health care professional via Medical Information (Reference number- 00757759) and transmitted to Sanofi on 07-Sep-2021. This case involves a 63-year-old female patient who experienced respiratory illnesses, patient has an immune disorder for which her immunologist wants her to have the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of a vaccine indicated for her age/ recommends fluzone high dose and not fluad [Off label use and overdose]. The patient medical history included immune disorder (NOS) (not otherwise specified) and respiratory disorder NOS. The patient medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious respiratory illnesses (respiratory disorder) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was a case of actual medication error due to off label use in unapproved age group and overdose [Latency: on the same day]. Caller stated that she was immune compromised and has to get the vaccine. Since in her 40s, she had received high-dose Fluzone as prescribed by her immunologist. She had an immune disorder for which her immunologist wants her to have the Fluzone High-Dose instead of a vaccine indicated for her age. Her doctor specifically recommends Fluzone High Dose and not FluAd. She gets a lot of respiratory illnesses in general. She says she must be vaccinated for the flu in September, or else she would get a bad flu in October. Details of laboratory data not reported. It was not reported if the patient received any corrective treatment for the events. At time of reporting, the outcome was unknown for the events. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1692839
Sex: F
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Name: Cultures of the bursal tissue/culture of the loose bodies; Result Unstructured Data: Negative for bacterial or fungal growth.; Test Name: Histologic analysis of the loose bodies; Result Unstructured Data: Histologic analysis of the loose bodies was revealed to have reactive changes and with areas of tissue necrosis. This was noted to be atypical of synovial or bursal tissue.; Test Name: MRI; Result Unstructured Data: The MRI revealed evidence of severe shoulder bursitis with a large volume of fluid and solid-appearing heterogeneous bodies that extended throughout the subacromial space. There was no evidence of rotator cuff tear.; Test Name: Physical examination; Result Unstructured Data: Significant evidence of shoulder bursitis and shoulder pain with minimal motion especially when attempted overhead. She had limited range of motion as a result of pain; this was most pronounced with attempted forward flexion and/or abduction. Her active elevation, neutral external rotation, and abduction were 90 degree, 25 degree, and 70 degree, respectively. Her external rotation strength was 4/5 and she was neurovascularly intact. No erythema or warmth was noted. She had a positive empty can shoulder test.; Test Name: Physical examination; Result Unstructured Data: Active forward flexion, neutral external rotation, and abduction were 165 degree, 70 degree and 130 degree, respectively. She had no pain with shoulder motion in any plane, and her external rotation strength at neutral was 5/5.

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Fibrinoid necrosis/bursal tissue necrosis; Extensive inflammation in the bursal space; Bursal foreign body reaction/multiple white, hardened caseous-appearing material in the shoulder/hardened, chalklike flakes that represented reactive changes; Shoulder injury related to vaccine administration; Impingement syndrome; Multiple redirections of the needle while injecting the vaccine; Inadvertent injection of influenza vaccine into the subacromial bursa; This literature case was received on 30-Aug-2021 and concerned 51-year-old, female patient. Literature on surgical management of shoulder injury related to vaccine administration (SIRVA) was limited. This case, described a patient who presented with significant rotator cuff bursitis and bursal foreign body reaction 12 weeks after influenza vaccine administration, managed with arthroscopic surgical intervention after failed conservative management. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; anatomical location: right deltoid, dose, route of administration and indication: not reported). The batch number was not reported. The patient described the experience as being traumatic because of multiple redirections of the needle while injecting the vaccine (explicitly coded as 'Product administration error'). Also, it was reported that, likely inadvertent injection of influenza vaccine into the subacromial bursa happened (explicitly coded as 'Vaccine administered at inappropriate site' and 'Inappropriate route of vaccination'). On an unknown date, over 48 hours after receiving influenza virus vaccine polyvalent, the patient developed severe shoulder pain and weakness. The pain was most pronounced with attempted shoulder elevation. On an unknown date, 12 weeks after receiving influenza virus vaccine polyvalent, the patient reported 3 months of severe right shoulder pain, that began after a flu vaccination administered into the right deltoid. The patient was evaluated and diagnosed with rotator cuff bursitis and impingement syndrome. On an unknown date, oral medication consisting of therapeutic doses of nonsteroidal anti-inflammatory drugs were prescribed but did not result in any appreciable benefit. The patient was subsequently treated with a cortisone subacromial injection and referred to physical therapy for rotator cuff-specific exercises. This resulted in only temporary reduction in patient's symptoms, so a magnetic resonance image (MRI) of the shoulder was ordered. The MRI revealed evidence of severe shoulder bursitis with a large volume of fluid and solid-appearing heterogeneous bodies that extended throughout the subacromial space. There was no evidence of rotator cuff tear. On review of the MRI, the patient was sent to the shoulder subspecialty clinic for evaluation. Her physical examination was unchanged from the initial visit. Specifically, the patient had significant evidence of shoulder bursitis and shoulder pain with minimal motion especially when attempted overhead. The patient had limited range of motion as a result of pain; this was most pronounced with attempted forward flexion and/or abduction. Her active elevation, neutral external rotation, and abduction were 90degree, 25 degree and 70 degree, respectively. Patient's external rotation strength was 4/5 and she was neurovascularly intact. No erythema or warmth was noted. The patient had a positive empty can shoulder test. The patient underwent an arthroscopic shoulder debridement, subacromial bursectomy, and intraoperative cultures of the bursal tissue. At the time of surgery, the patient was noted to have extensive inflammation in the bursal space. In addition, the patient had multiple white, hardened caseous-appearing material in the shoulder. This material was distinct from the bursae. These relatively large bodies were evacuated from the shoulder subacromial space and sent for culture and histologic analysis. Next, the rotator cuff was evaluated and noted to be intact. Her glenohumeral joint was evaluated and found to have a normal appearance without any significant abnormality. The patient noted significant relief in her symptoms after surgery. At her 3-month postoperative checkup, her active forward flexion, neutral external rotation, and abduction were 165 degree, 70 degree and 130 degree, respectively. The patient had no pain with shoulder motion in any plane, and her external rotation strength at neutral was 5/5. The patient progressed through physical therapy without significant difficulty. Histologic analysis of the loose bodies was revealed to have reactive changes and with areas of tissue necrosis This was noted to be atypical of synovial or bursal tissue. Cultures were negative for bacterial or fungal growth. Also reported as, our patient had the unique finding of hardened, chalklike flakes that represented reactive changes and fibrinoid necrosis It is likely that this was the resultant effect of inadvertent injection of influenza vaccine into the subacromial bursa. On an unspecified date, the patient recovered from the events of 'soft tissue necrosis', 'bursitis', 'foreign body reaction', 'impingement syndrome' and 'shoulder injury related to vaccine administration'. The reporter assessed the events of 'soft tissue necrosis', 'bursitis', 'foreign body reaction', 'impingement syndrome' and 'shoulder injury related to vaccine administration' as related to influenza virus vaccine polyvalent. It is likely that this was the resultant effect of inadvertent injection of influenza vaccine into the subacromial bursa. The event of 'soft tissue necrosis' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department. In conclusion, SIRVA is an uncommon complication of deltoid vaccine administration that can present with symptoms and imaging that mimic other etiologies of shoulder dysfunction. Failed conservative management could be treated with arthroscopic shoulder debridement of inflamed soft tissue and bone, while obtaining cultures and pathology to rule out infection. In addition, we recommend postoperative physical therapy to achieve functional and symptomatic recovery. Company comment: A 51-year-old patient was vaccinated with influenza virus vaccine polyvalent, inadvertently administered into the subacromial bursa. Reportedly, it was traumatic experience due to multiple redirections of the needle while injecting the vaccine. Over 48 hours after receiving vaccine, the patient developed severe shoulder pain and weakness. On an unknown date, 12 weeks after receiving influenza virus vaccine polyvalent, the patient reported 3 months of severe right shoulder pain. The patient diagnosed with rotator cuff bursitis and impingement syndrome. In addition, the patient had the unique finding of hardened, chalklike flakes that represented reactive changes and fibrinoid necrosis. Causality was highly confounded by inappropriate administration, however causal role of the vaccine cannot be excluded and is assessed as possibly related. Product administration error and Product administered at inappropriate site are assessed as unrelated per company's conventions. (defaults to related in the safety database for reporting purposes).; Reporter's Comments: The reporter assessed the events of 'soft tissue necrosis', 'bursitis', 'foreign body reaction', 'impingement syndrome' and 'shoulder injury related to vaccine administration' as related to influenza virus vaccine polyvalent. It is likely that this was the resultant effect of inadvertent injection of influenza vaccine into the subacromial bursa.; Sender's Comments: A 51-year-old patient was vaccinated with influenza virus vaccine polyvalent, inadvertently administered into the subacromial bursa. Reportedly, it was traumatic experience due to multiple redirections of the needle while injecting the vaccine. Over 48 hours after receiving vaccine, the patient developed severe shoulder pain and weakness. On an unknown date, 12 weeks after receiving influenza virus vaccine

Other Meds:

Current Illness:

ID: 1692840
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: Loss of energy; Loss 15% of body weight; Loss of appetite; Brain fog; This spontaneous case was received on 31-Aug-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-01847) and concerned a male patient of unknown age. The patient's medical history and concomitant medications were not reported. On an unknown date in 2019, the patient was vaccinated with Afluria (TIV) (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported. On an unknown date in 2019, an unknown amount of time after receiving Afluria (TIV), the patient experienced 15% of body weight loss and loss of energy, brain fog and loss of appetite. It was unknown if the patient received any corrective treatment. At the time of initial reporting on 31-Aug-2021, the patient had not recovered from the events as the symptoms were still ongoing. The reporter did not provide a causality assessment. Company comment: A patient of unknown age was vaccinated with Afluria (TIV). On an unknown date in 2019, an unknown amount of time after receiving Afluria (TIV), the patient experienced 15% of body weight loss, loss of energy, brain fog and loss of appetite. The patient's medical history and concomitant medications were not reported. Causality is unassessable for all events, due to lack of information regarding diagnostic findings.; Sender's Comments: A patient of unknown age was vaccinated with Afluria (TIV). On an unknown date in 2019, an unknown amount of time after receiving Afluria (TIV), the patient experienced 15% of body weight loss, loss of energy, brain fog and loss of appetite. The patient's medical history and concomitant medications were not reported. Causality is unassessable for all events, due to lack of information regarding diagnostic findings.

Other Meds:

Current Illness:

ID: 1692841
Sex: F
Age: 66
State:

Vax Date: 08/31/2021
Onset Date: 09/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Pelvic pain; Sore arm; Achy on shoulders and back; Achy on shoulders and back; Feeling like needles were poking her in the left side of her head; This spontaneous case was received on 02-Sep-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-01919) and concerned a 66-year-old female patient. The patient had no relevant medical history and was not taking any concomitant medications. On 31-Aug-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: left deltoid and route of administration: not reported) for influenza prophylaxis. The batch number was not reported. On 01-Sep-2021, one day after receiving Flucelvax Quadrivalent, the patient started feeling like needles were poking her in the left side of her head. In addition, the patient experienced pelvic pain, her arm became sore and the patient felt achy on shoulders and back. The patient did not receive any corrective treatment for the events. At the time of initial reporting on 02-Sep-2021, the patient had not recovered from the events. The reporter did not provide a causality assessment. Company comment: A 66-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving Flucelvax Quadrivalent, the patient started feeling like needles were poking her in the left side of her head. In addition, the patient experienced pelvic pain, her arm became sore and the patient felt achy on shoulders and back. The patient had no relevant medical history and was not taking any concomitant medications. Considering plausible chronology and no alternative aetiology provided, causality is assessed as possibly related for pain in extremity, back pain, pelvic pain, arthralgia and paraesthesia.; Sender's Comments: ompany comment: A 66-year-old patient was vaccinated with Flucelvax Quadrivalent. One day after receiving Flucelvax Quadrivalent, the patient started feeling like needles were poking her in the left side of her head. In addition, the patient experienced pelvic pain, her arm became sore and the patient felt achy on shoulders and back. The patient had no relevant medical history and was not taking any concomitant medications. Considering plausible chronology and no alternative aetiology provided, causality is assessed as possibly related for pain in extremity, back pain, pelvic pain, arthralgia and paraesthesia.

Other Meds:

Current Illness:

ID: 1692856
Sex: F
Age: 43
State: IN

Vax Date: 09/09/2021
Onset Date: 09/09/2021
Rec V Date: 09/11/2021
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: None

Allergies: Eggs, milk, diphenhydramine, latex, bees, horse hair, dogs, mice, mold, shrimp, salmon, multiple trees and plants.

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

Symptoms: Hives, rash

Other Meds: None

Current Illness: None

ID: 1692857
Sex: M
Age: 28
State: AL

Vax Date: 09/10/2021
Onset Date: 09/11/2021
Rec V Date: 09/11/2021
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: Trouble breathing, extreme headache, nausea & pain in abdomen.

Other Meds: Tylenol

Current Illness:

ID: 1692859
Sex: M
Age: 39
State: OH

Vax Date: 04/29/2021
Onset Date: 04/30/2021
Rec V Date: 09/11/2021
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: None

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: I noticed a significant increase in ear ringing (Tinnitus) after the shot (about 1 day after). I spoke with my my ENT about 2.5-3 weeks later to see if it would go away or if it was normal. He stated that multiple patients had similar events, but some resolved after several weeks. Unfortunately, it has been over 4 months and mine has not subsided.

Other Meds: None

Current Illness: None

ID: 1692860
Sex: F
Age: 48
State: OH

Vax Date: 09/08/2021
Onset Date: 09/08/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Not yet. Going next week

Allergies: N/a

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

Symptoms: Left side of face numb, tingling..best way to describe it

Other Meds: Vitamin c, d, b12

Current Illness: No

ID: 1692861
Sex: F
Age: 34
State: GA

Vax Date: 03/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/11/2021
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: Eye exam in may 2021 showed increased optic nerve pressure, referred to ophthalmologist in June 2021 who confirmed swelling and papilladema (right eye) and peripheral vision blind spots (predominantly left eye). Referred to neurologist in august 2021 for possible idiopathic intracranial hypertension. MRI performed and results show possible IIH, sent for lumbar puncture and results show opening pressure of 53.2 confirming diagnosis of IIH.

Allergies: None

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

Symptoms: Increased optic nerve pressure, papilladema, intracranial hypertension First prescribed acetazolamide 250mg 4x/daily for 10 days - could not tolerate medication side effects Dosage dropped to 250mg 2X/daily - side effects lessened but had constant shortness of breath Neurologist switched medication to topiramate 25mg 2X/day - tried for 7 days and could not function effectively with brain fog Now taking Trokendi XR 50mg 1x/daily

Other Meds: Fluoxetine 40 mg/daily Ibuprofen as needed for occasional back pain

Current Illness: None

ID: 1692862
Sex: F
Age: 39
State: KS

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies: amoxicillin

Symptom List: Pain in extremity

Symptoms: Evening of the second shot, swelling to the lips and face and injection site. No difficulty with breathing

Other Meds: prenatal vitamin

Current Illness: congestion/runny nose. kids also sick with similar symptoms and had been tested neg for covid

ID: 1692863
Sex: F
Age: 52
State: WI

Vax Date: 06/17/2021
Onset Date: 06/20/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: None

Allergies: Latex allergy

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

Symptoms: Sunday at 6pm 6/20/21 I has sever pain in my abdomen- demobilization pain all over torso - nothing helped the pain - came on suddenly and lasted thru the night continuously -in the morning it was better - made an appointment with doctor but cancelled it because I could get in for a couple days

Other Meds: Lisinopril 10 mg Acyclovir only as needed for cold sores. None taken prior to shot

Current Illness: None

ID: 1692864
Sex: F
Age: 39
State: CT

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Called primary care over phone on 9/10/21

Allergies: Wheat, eggs, yeast, latex and soy.

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

Symptoms: 10-15 minutes after tingling lips then numb, 10-15 minutes after feet tingling like pins and needs numb then hands too. Called provider within one hour and took two hydroxoxine palmonate 25 mg. One and a half hours later feet snd mouth were still numb but not tingling as much, then developed hives on back and was itching on head, back and legs. It took three hours for itching to stop and then by 7:30pm most symptoms stopped but lips still numb and felt swollen but did not look swollen. Took loratadine over night also per primary care recommendation. Woke up at 7am on 9/11/21, lips still numb feeling, chest is tight and heavy, but no wheezing and arms and back itch slightly.

Other Meds: None

Current Illness: None

ID: 1692865
Sex: M
Age: 72
State: LA

Vax Date: 09/07/2021
Onset Date: 09/08/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Have not gone to a Doctor or Lab. Have put ice pack on arm as often as I can.

Allergies: None

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

Symptoms: Severe arm swelling and redness even after 5 days.

Other Meds: Too many to list....Heart Transplant Patient

Current Illness: None

ID: 1692866
Sex: F
Age: 58
State: KY

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/11/2021
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: I was sick to my stomach for 24 hours. I had the dry heaves. I had COVID-19 2/2021 and getting the vaccine was horrible.

Other Meds:

Current Illness:

ID: 1692867
Sex: M
Age: 74
State: MA

Vax Date: 03/08/2021
Onset Date: 07/13/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Numerous blood tests and evaluations all showing negative to explaining fatigue. Tests can be made available through doctors/hospital.

Allergies: none

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Fatigue. Unexplained fatigue.

Other Meds: Symbicort, Prednisone 3mg, Atoravation, Lisinopril, Proair hfa, Singular, Centrum Silver, vit D3, nicotine lozene

Current Illness: none

ID: 1692868
Sex: F
Age: 41
State: VA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/11/2021
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: Penicillin, dairy, reflex, codine

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: A few hours after the first shot, I had chills, aches and a low fever, then the following day I was hit with complete exhaustion and slept 16 hours. After the second shot, within hours I had chills, a fever and aches. That night I was having hot spells and cold sweats and couldn't sleep well. Within the first month following my 2nd shot my husband and I began noticing that I was having problems with my short term memory, even within minutes of an event, action or conversation I would not remember what happened. I am still having short term memory loss issues 6 months later. *please note that about 5.5-6 months before receiving the vaccine I suffered a concussion/traumatic brain injury. Which left me with headaches, but no issues with my memory. Also in the first months following and continuing to present time, my menstrual cycle has become shorter, from 28 days pre vaccine to 24-22 days in the months following.

Other Meds: Levothyroxine, adderall

Current Illness: None

ID: 1692869
Sex: M
Age: 59
State: IN

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: n/a

Allergies: N/A

Symptom List: Injection site swelling, Limb discomfort

Symptoms: The patient arrived to the pharmacy to receive his first dose of Shingrix (shingles) and was mistakenly administered a dose of the Pfizer COVID19 vaccine. The patient confirmed to us that he already completed doses 1 and 2 of the Moderna COVID19 vaccine series in March and April 2021, respectively. No adverse events have been reported by the patient at this time (<24 hours later).

Other Meds: Tamsulosin Allopurinol Meloxicam

Current Illness: n/a

ID: 1692870
Sex: M
Age: 69
State: NY

Vax Date: 07/02/2021
Onset Date: 09/04/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Xray taken at Urgent Care, on July 31st 2021

Allergies: none

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

Symptoms: 30 Hrs after receiving injection, started having sore arm at site of injection. soreness persisted for 3 weeks. During the 4th week, unable to move right arm. No lifting strength. Went to Urgent Care Facility on July 31th, received x-ray and 5 day prescription for steroid pills. Pills helped very little. On Aug 3 went to a clinic. Received Cortisone injection in right arm. After One month had about 50% movement. I Schedule another appointment for Sept 14th 2021.

Other Meds: none

Current Illness: none

ID: 1692871
Sex: F
Age: 61
State: NC

Vax Date: 09/01/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies: Contrast I've dye , sulfa antibiotics, keflex

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

Symptoms: Developed an ugly reaction on left arm below vaccine site that doesn't go away or keeps returning, and itches morE that scabies!!! Hot , red and inflamed

Other Meds: Too many to list

Current Illness: Cad , COPD ,

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am