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: 1288520
Sex: F
Age: 64
State: TX

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 05/05/2021
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: The needle came out on her arm / received half of the dose; The needle came out on her arm, thus wasting part of the dose; The needle came out on her arm, thus wasting part of the dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 28th April 2021, the patient received the 2nd dose of Shingrix. On 28th April 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown. Additional information was provided as follows: This case was reported by pharmacist for herself. The pharmacist reported that she received the 2nd dose of Shingrix and the needle came out on her arm, thus wasting part of the dose, which led to accidental underdose, exposure via skin contact and Inadvertent exposure to vaccine. The patient received half of the dose. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1288521
Sex: F
Age:
State:

Vax Date: 04/28/2021
Onset Date: 05/02/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Arm swollen at injection site; Arm / red at injection site; Warm at injection site; Extreme headache; Fever; "Not feeling well"; Stomach pain; Lightheadedness; Vomiting; Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced headache, feeling unwell, injection site swelling, injection site erythema, injection site warmth, stomach pain, light headedness, vomiting, diarrhea and fever. On an unknown date, the outcome of the headache, feeling unwell, injection site swelling, injection site erythema, injection site warmth, stomach pain, light headedness, vomiting, diarrhea and fever were not recovered/not resolved. It was unknown if the reporter considered the headache, feeling unwell, injection site swelling, injection site erythema, injection site warmth, stomach pain, light headedness, vomiting, diarrhea and fever to be related to Shingrix. Additional details were reported as follows: This case was reported by patient for herself. Age at vaccination was not applicable. Patient reported that she had a shingrix shot and after 4 days experienced extreme headache not feeling well at swollen red and warm at injection site stomach pain lightheadedness vomiting and diarrhea and a fever. Caller stated she had to disconnect due to a telehealth appointment with her HCP. Unable to obtain address date of birth dose of shingrix route and dosage of vaccine lot and expiration date. Symptoms started 4 days after injection and not resolved. Unable to obtain HCP information. Did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1288522
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/05/2021
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 Name: Body temperature; Result Unstructured Data: below 100

Allergies:

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

Symptoms: PASSED OUT 11 HOURS FROM THE TIME OF VACCINATION; This spontaneous report received from a patient concerned a 27 year old male with unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date patient passed out 11 hours from the time of vaccination. Patient had slept two hours with his head elevated. Near the end of his pee he passed out in the bathroom. He had another person with him, helping him stay hydrated. Temperature was staying below 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of passed out 11 hours from the time of vaccination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210502538-covid-19 vaccine ad26.cov2.s-Passed out 11 hours from the time of vaccination . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1288523
Sex: M
Age:
State: OR

Vax Date:
Onset Date:
Rec V Date: 05/05/2021
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: GROIN PAIN; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203a21a, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced groin pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.t The patient had not recovered from groin pain. This report was non-serious.

Other Meds:

Current Illness:

ID: 1288524
Sex: F
Age:
State: MT

Vax Date:
Onset Date: 04/28/2021
Rec V Date: 05/05/2021
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: COUGHING; THROBBING/PULSATING SENSATION AT INJECTION SITE; DIFFICULT TO SLEEP; INDENTATION FROM SHOULDER TO TRICEP AREA; FEELING OF PASSING OUT; VOMITING; ACHINESS/BODY ACHES; TIREDNESS; NAUSEA; INJECTION SITE SWELLING; DIFFICULTY IN BREATHING; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included swelling due to penicillins, throat closes due to marijuana, throat swelling due to marijuana, and hives in mouth due to marijuana, and concurrent conditions included type 2 diabetes, migraine, insomnia, penicillin allergy, alcohol user, smoker, and marijuana abuse, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced break out in rash and feeling sick when treated with gabapentin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included zolpidem for insomnia, cyclobenzaprine for migraine, fluoxetine for migraine, ketorolac for migraine, and promethazine for migraine. On 28-APR-2021, the subject experienced difficulty in breathing. On 28-APR-2021 14:00, the subject experienced indentation from shoulder to tricep area. On 28-APR-2021 14:00, the subject experienced feeling of passing out. On 28-APR-2021 14:00, the subject experienced vomiting. On 28-APR-2021 14:00, the subject experienced achiness/body aches. On 28-APR-2021 14:00, the subject experienced tiredness. On 28-APR-2021 14:00, the subject experienced nausea. On 28-APR-2021 14:00, the subject experienced injection site swelling. On 28-APR-2021 17:00, the subject experienced difficult to sleep. On 29-APR-2021, the subject experienced coughing. On 29-APR-2021, the subject experienced throbbing/pulsating sensation at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site swelling, indentation from shoulder to tricep area, tiredness, achiness/body aches, feeling of passing out, nausea, vomiting, difficulty in breathing, coughing, difficult to sleep, and throbbing/pulsating sensation at injection site. This report was non-serious.

Other Meds: PROMETHAZINE; KETOROLAC; CYCLOBENZAPRINE; FLUOXETINE; ZOLPIDEM

Current Illness: Alcohol use (once or twice a month); Insomnia; Marijuana abuse; Migraine; Penicillin allergy; Smoker (Half a pack per day); Type II diabetes mellitus

ID: 1288525
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/05/2021
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: UNABLE TO STAND UP; HEAVINESS IN BOTH LEGS; PAIN IN LEFT UPPER THIGH; HEADACHE; BACK ACHE; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included back pain, and concurrent conditions included irritable bowel syndrome (ibsd) with major constipation, abstains alcohol, and cigarette smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of report. The patient experienced cannot breath when treated with tetanus vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced back ache, pain in left upper thigh, headache. On 01-MAY-2021 and heaviness in both legs. On 02-MAY-2021, the subject experienced unable to stand up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heaviness in both legs, headache, pain in left upper thigh, back ache, and unable to stand up. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Cigarette smoker (1 pack a day); Irritable bowel syndrome

ID: 1288526
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 05/02/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: RASH ON BOTH ARMS (GOTTEN A LITTLE BIGGER); ARM ITCHING; RASH ON BOTH ARMS (ARM CREASES IN THE FRONT AND IT IS OVAL SIZE AND ABOUT 3 INCHES LONG); This spontaneous report received from a patient concerned a 45 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the subject experienced arm itching. On 02-MAY-2021, the subject experienced rash on both arms (arm creases in the front and it is oval size and about 3 inches long). Treatment medications included: cortisone. On 03-MAY-2021, the subject experienced rash on both arms (gotten a little bigger). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on both arms (arm creases in the front and it is oval size and about 3 inches long), arm itching, and rash on both arms (gotten a little bigger). This report was non-serious.

Other Meds:

Current Illness:

ID: 1288527
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/05/2021
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: MUSCLE CRAMPS; ARM SORENESS; CHILLS; SPLITTING HEADACHE; This spontaneous report received from a patient via an unspecified company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced muscle cramps, arm soreness, chills, and splitting headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps, chills, and splitting headache, and the outcome of arm soreness was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1288528
Sex: F
Age:
State: NJ

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

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

Lab Data: Test Date: 2021; Test Name: Doppler studies; Result Unstructured Data: blood clots in both legs

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: DEEP VEIN THROMBOSIS IN LEGS; This spontaneous report received from a patient concerned a female patient of unspecified age. The patient's height, and weight were not reported. The patient's concomitant medical conditions included non smoker. The patient is a Zumba teacher. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041821A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, reported as several days after vaccination, the patient felt some discomfort in the leg. The patient took Tylenol and rested for two weeks, however it did not improve. The patient went to the doctor for a follow up and physical and the doctor ordered a doppler, which showed blood clots in both legs. The doctor immediately placed the patient on Eliquis 5mg. Patient reported that she needs to see a cardiologist and hematologist because she now has a DVT (deep vein thrombosis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the DVT was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210505469-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness: Non-smoker

ID: 1288529
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/05/2021
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: CHILLS; FELT WEAK; FEVERISH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, feeling weak, and feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, feeling weak, and feverish. This report was non-serious.

Other Meds:

Current Illness:

ID: 1288530
Sex: F
Age:
State:

Vax Date: 03/10/2021
Onset Date: 03/23/2021
Rec V Date: 05/05/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: COVID-19; The doctor had advised her that she needs to wait 90 days before receiving the second shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer and Mastectomy (left breast cancer surgery). On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (The doctor had advised her that she needs to wait 90 days before receiving the second shot). On 23-Mar-2021, PRODUCT DOSE OMISSION ISSUE (The doctor had advised her that she needs to wait 90 days before receiving the second shot) had resolved. At the time of the report, COVID-19 (COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. The patients treatment medication information included Bamlanivimab and another drug of which she does not recall. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1288531
Sex: M
Age: 74
State: KY

Vax Date: 03/30/2021
Onset Date: 04/04/2021
Rec V Date: 05/05/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: stage 4 brain aneurysm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTRACRANIAL ANEURYSM (stage 4 brain aneurysm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced INTRACRANIAL ANEURYSM (stage 4 brain aneurysm) (seriousness criteria hospitalization, disability and medically significant). The patient was hospitalized from 04-Apr-2021 to 23-Apr-2021 due to INTRACRANIAL ANEURYSM. At the time of the report, INTRACRANIAL ANEURYSM (stage 4 brain aneurysm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment and investigations done while patient was hospitalized were not reported. Concomitant medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1288532
Sex: M
Age: 80
State: MO

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 05/05/2021
Hospital: Y

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: breaking hip; Consumer put pressure on the leg and it collapsed; right leg feel asleep; Patient missed his second dose because he had to get a surgery; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HIP FRACTURE (breaking hip) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic and Overweight. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HIP FRACTURE (breaking hip) (seriousness criteria hospitalization and medically significant), FALL (Consumer put pressure on the leg and it collapsed), HYPOAESTHESIA (right leg feel asleep) and PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose because he had to get a surgery). The patient was treated with Surgery for Hip fracture. At the time of the report, HIP FRACTURE (breaking hip) had not resolved, FALL (Consumer put pressure on the leg and it collapsed) and PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose because he had to get a surgery) had resolved and HYPOAESTHESIA (right leg feel asleep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The treatment reported was surgery for breaking his hip. No concomitant medication information was provided. Caregiver states the fall was not related to vaccine. Caregiver did not provided information whether consumer was hospitalized and what kind of care he got afterwards. He did not have much information since he was calling with a medical inquiry. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Diabetic; Overweight

ID: 1288533
Sex: F
Age: 80
State: IL

Vax Date: 04/21/2021
Onset Date: 04/27/2021
Rec V Date: 05/05/2021
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: couldn't think of words; Severe headache - mostly on left side; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (couldn't think of words) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001CR1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included METOPROLOL TARTRATE (LOPRESSOR) and LATANOPROST for an unknown indication. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced MENTAL IMPAIRMENT (couldn't think of words) (seriousness criterion medically significant), HEADACHE (Severe headache - mostly on left side) and CHILLS (severe chills). On 28-Apr-2021, MENTAL IMPAIRMENT (couldn't think of words), HEADACHE (Severe headache - mostly on left side) and CHILLS (severe chills) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No laboratory details was given. No treatment information was given. Patient stated two occurrences of this type of episode on 27 Apr 2021 and 28 Apr 2021. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested

Other Meds: LOPRESSOR; LATANOPROST

Current Illness:

ID: 1288534
Sex: F
Age: 57
State: CA

Vax Date: 04/28/2021
Onset Date: 04/29/2021
Rec V Date: 05/05/2021
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: Cant think; Pain in arm; Fuzzy head; Arm pain,achy and everything,bodyache; slight headache; chills; feeling nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Cant think) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014-C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in January 2021. Concomitant products included CALCIUM and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MENTAL IMPAIRMENT (Cant think) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm), FEELING ABNORMAL (Fuzzy head), MYALGIA (Arm pain,achy and everything,bodyache), HEADACHE (slight headache), CHILLS (chills) and NAUSEA (feeling nauseous). At the time of the report, MENTAL IMPAIRMENT (Cant think), PAIN IN EXTREMITY (Pain in arm), FEELING ABNORMAL (Fuzzy head), MYALGIA (Arm pain,achy and everything,bodyache), HEADACHE (slight headache), CHILLS (chills) and NAUSEA (feeling nauseous) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication includes Liver supplement (herb). Treatment information was not reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: CALCIUM; FOSAMAX

Current Illness:

ID: 1288535
Sex: M
Age: 79
State: SC

Vax Date: 03/06/2021
Onset Date: 04/02/2021
Rec V Date: 05/05/2021
Hospital: Y

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: Urinary tract infection; More than 36 days have passed since first dose given (6Mar2021), still hasn't had 2nd dose; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (More than 36 days have passed since first dose given (6Mar2021), still hasn't had 2nd dose). The patient was hospitalized on 02-Apr-2021 due to URINARY TRACT INFECTION. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) and INCOMPLETE COURSE OF VACCINATION (More than 36 days have passed since first dose given (6Mar2021), still hasn't had 2nd dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication use was not reported. Treatment information was not reported. It was noted by the reporter that the event "urinary tract infection" was not due to the vaccine but due to something that the patient ate. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1288536
Sex: M
Age: 75
State: OR

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rash from elbow to armpit all the way to the back; Vertigo; Nausea/vomiting; Tired/ could not make 2 steps; Nausea, vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash from elbow to armpit all the way to the back) and VERTIGO (Vertigo) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 016821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported by the reporter. Concomitant products included ATORVASTATIN, DABIGATRAN ETEXILATE MESILATE (PRADAXA) and METFORMIN for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash from elbow to armpit all the way to the back) (seriousness criterion medically significant), VERTIGO (Vertigo) (seriousness criterion medically significant), VOMITING (Nausea/vomiting), FATIGUE (Tired/ could not make 2 steps) and NAUSEA (Nausea, vomiting). At the time of the report, RASH (Rash from elbow to armpit all the way to the back), VERTIGO (Vertigo), VOMITING (Nausea/vomiting), FATIGUE (Tired/ could not make 2 steps) and NAUSEA (Nausea, vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patent stated that 6 to 10 days after the administration of the second vaccine the patient started to develop a rash from his elbow to his armpit, then the next day the rash was all the way to his back. Patient also experienced nausea, vomiting and vertigo. The patient went to the emergency room on 21-APR-2021 and was prescribed prednisone, ibuprofen, loratadine. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: ATORVASTATIN; PRADAXA; METFORMIN

Current Illness:

ID: 1288537
Sex: F
Age: 68
State: AR

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 05/05/2021
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: Was delirious for 2 days; Wasn't feeling good; Had high blood pressure; Had chills; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Was delirious for 2 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Vertigo and Dizziness. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DELIRIUM (Was delirious for 2 days) (seriousness criterion medically significant), FEELING ABNORMAL (Wasn't feeling good), HYPERTENSION (Had high blood pressure), CHILLS (Had chills) and PYREXIA (Had fever). On 04-Apr-2021, DELIRIUM (Was delirious for 2 days), FEELING ABNORMAL (Wasn't feeling good), HYPERTENSION (Had high blood pressure), CHILLS (Had chills) and PYREXIA (Had fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information not provided. Patient reported that all the possible adverse events subsided by 04-Apr-2021. Patient stated that she took combination medication of nexium, antihistamine, and unspecified third product which alleviated the adverse events. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1288538
Sex: F
Age:
State: NY

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 05/05/2021
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: Peripheral neuropathy got worsened; Dizziness; Weakness in her legs; Could not walk; Could not feel her legs; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy got worsened) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included BP and Peripheral neuropathy. On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy got worsened) (seriousness criterion medically significant), DIZZINESS (Dizziness), MUSCULAR WEAKNESS (Weakness in her legs), GAIT DISTURBANCE (Could not walk), LIMB DISCOMFORT (Could not feel her legs) and NAUSEA (Nausea). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy got worsened), DIZZINESS (Dizziness), MUSCULAR WEAKNESS (Weakness in her legs), GAIT DISTURBANCE (Could not walk), LIMB DISCOMFORT (Could not feel her legs) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 in response to the event was not applicable. The patient using BP and peripheral neuropathy medication currently. The patient called physician and got medicines for nausea. Company Comment: Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.

Other Meds:

Current Illness: BP; Peripheral neuropathy

ID: 1288539
Sex: M
Age: 75
State: CA

Vax Date: 03/28/2021
Onset Date: 04/20/2021
Rec V Date: 05/05/2021
Hospital: Y

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

Lab Data: Test Date: 20210421; Test Name: cat scan; Result Unstructured Data: CT scan showed multiple Pulmonary emboli like a spray of blood clots

Allergies:

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

Symptoms: Multiple Pulmonary Emboli on both sides of the lungs\ multiple Pulmonary emboli like a spray of blood clots in the lungs; had trouble breathing; sharp pain on the right side of the chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Multiple Pulmonary Emboli on both sides of the lungs\ multiple Pulmonary emboli like a spray of blood clots in the lungs), DYSPNOEA (had trouble breathing) and CHEST PAIN (sharp pain on the right side of the chest) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 007C21A) for COVID-19 vaccination. The patient's medical history was not provided. Concomitant products included SIMVASTATIN for an unknown indication. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PULMONARY EMBOLISM (Multiple Pulmonary Emboli on both sides of the lungs\ multiple Pulmonary emboli like a spray of blood clots in the lungs) (seriousness criteria hospitalization and medically significant), DYSPNOEA (had trouble breathing) (seriousness criterion hospitalization) and CHEST PAIN (sharp pain on the right side of the chest) (seriousness criterion hospitalization). The patient was hospitalized from 20-Apr-2021 to 21-Apr-2021 due to CHEST PAIN, DYSPNOEA and PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Multiple Pulmonary Emboli on both sides of the lungs\ multiple Pulmonary emboli like a spray of blood clots in the lungs), DYSPNOEA (had trouble breathing) and CHEST PAIN (sharp pain on the right side of the chest) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Computerised tomogram: multiple pulmonary emboli CT scan showed multiple Pulmonary emboli like a spray of blood clots. Patient was taken to emergency room (ER) on 20-APR-2021. Patient was discharged next day given prescription of blood thinners and pain medications. Action taken with mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: SIMVASTATIN

Current Illness:

ID: 1288540
Sex: M
Age: 40
State: CA

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 05/05/2021
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: Helicobacter pylori; arm pain; a little bit cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HELICOBACTER INFECTION (Helicobacter pylori) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included AMLODIPINE for Hypertension. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and FEELING COLD (a little bit cold). On an unknown date, the patient experienced HELICOBACTER INFECTION (Helicobacter pylori) (seriousness criterion medically significant). At the time of the report, HELICOBACTER INFECTION (Helicobacter pylori), PAIN IN EXTREMITY (arm pain) and FEELING COLD (a little bit cold) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273, the report did not provide any causality assessment. The patient was prescribed to take lansoprazole 30 milligrams, amoxicillin 500 milligrams, and clarithromycin 500 milligrams for 14 days to treat Helicobacter pylori. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: AMLODIPINE

Current Illness: Blood pressure abnormal

ID: 1288541
Sex: F
Age:
State: WA

Vax Date: 03/09/2021
Onset Date: 04/09/2021
Rec V Date: 05/05/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Double pneumonia; Heart attack; was hospitalized was not able to get second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Double pneumonia) and MYOCARDIAL INFARCTION (Heart attack) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced OFF LABEL USE (was hospitalized was not able to get second dose). On an unknown date, the patient experienced PNEUMONIA (Double pneumonia) (seriousness criterion hospitalization) and MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). The patient was hospitalized on 31-Mar-2021 due to PNEUMONIA. On 09-Apr-2021, OFF LABEL USE (was hospitalized was not able to get second dose) had resolved. At the time of the report, PNEUMONIA (Double pneumonia) and MYOCARDIAL INFARCTION (Heart attack) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient wanted to know if she should repeat first dose. It was reported that patient was on "a lot" of concomitant medications but did not specify. The patient was in the intensive care unit. No treatment medication was reported. Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1288542
Sex: F
Age: 41
State: TX

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: NONE

Allergies: IODINE CONTRAST MEDIA, TRIPLE ANTIBIOTIC, FIRE ANT

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

Symptoms: I was alright during my 30 min wait after the shot but when I arrived home I noticed my right back hand seemed a little red. After taking a nap for 2 hours I went to the bathroom and noticed a raised rash on my left cheek and a raised rash on the same back hand as well as a rashed red rash on my right and left arm ( forearm and upper arm) a raised rash on my upper torso and neck. very small bumps and thick like eczema. a day later the skin began to peel a little. I immediately called the pharmacy and was told to take Benadryl. they also asked if I had shortness of breath which I didnt. The rash doesnt itch its just swollen and to report it to VAERS as well as my MD. I texted the Medical center right afterwards but they were closed and I was told they would pass the information on to my Dr. But I never got around to messaging VAERS till now. I asked the pharmacy to renew my epipen and I told them I had Benadryl and famotidine at home and I would take it if necessary. I only took 1 benadryl 25mg cap. the rash died down after 5 days. it burned to put lotion on my skin and the dead skin flaked off . It's still a little thick like eczema

Other Meds: ZINC 50MG, VITAMIN C 1000MG, SUPER B COMPLEX, STORE BRAND GENERIC FOR CENTRUM MULTIVITAMIN, CRESTOR 10MG, PROPRANOLOL 40MG, ASPIRIN 325MG, PEPCID 20MG, DOCUSATE S,

Current Illness: LEG PAIN ALONG MY RIGHT SHIN X 9 MONTHS. JOINT PAIN X 4 MONTHS. PETECHIAE ON ARMS AND TORSO AND SKIN RASH 2 WEEKS PRIOR

ID: 1288543
Sex: F
Age: 38
State: GA

Vax Date: 04/12/2021
Onset Date: 04/12/2021
Rec V Date: 05/05/2021
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: No

Symptom List: Injection site pain, Pain

Symptoms: Brain fog Swollen lymph nodes under arm

Other Meds: None

Current Illness: None

ID: 1288545
Sex: F
Age: 65
State: FL

Vax Date: 04/05/2021
Onset Date: 04/22/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: Sonogram at hospital ER 4/27/21. ****important. In mt description I put wrong date on beginning of adverse reaction after shingles shot had flipped my calendar and can?t go back on this report. Mouth burning Sat April 24 2021. At primary Dr nd ER both on Tuesday 4/27/21

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Second vaccine not in list, COVID Pfizer done on 2/3/21 and 2/24/21 all info in my descriptions. Shingles shot at pharmacy given above and in my description. 4/5/21

Other Meds: Dexilant, ambien, singular

Current Illness: I am 65 years old. I just went on vars reporting system and it says if shots were over six weeks ago I could not participate, but I just read that adverse reactions can happen after that date. I also have a possible second theory on my adverse reaction that happened to me last week, went to my primary, mentioned it to pharmacy where I got second dose of shingles and needed up at hospital Er, and mentioned reporting...but no one seemed to decide to report from their end and if they did, I was not told. I had my first Pfizer shot at shopping center 2/3/21. Only mild symptoms mainly at shot arm. Second COVID same place 2/24/21. I did have fatigue that started that evening from a morning shot and had a headache that lasted the second day after shot. I had my first Shingrix shingles shot in Oct 2020. Normally one gets second shingles in six months. With COVID hitting I concentrated on that...the COVID shots listed above. After second COVID I asked pharmacist about when to get second shingles. They suggested I wait at least two weeks. I was told second shingles shot is tougher by them, and many retired friend I know. I am an active adult, finally getting back to the gym after COVID shots and playing some tennis. I decided to wait a little longer and had my second Shingrix shot 4/5/2021. This hit me hard. I was in bed for four days. Fever, chills, adverse stomach pain, headache...flu symptoms. I do go to a Dr. I have Barrett?s esophagus and take famotidine twice a day. The stomach pain got severe. I went to health clinic and the nurse practit

ID: 1288546
Sex: M
Age: 25
State: MA

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: None yet

Allergies: Minor allergy to some pitted fruit/stone fruit (peaches, plums, apricots)

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

Symptoms: I received the J&J vaccine after 1 PM, on Tuesday, May 4th. Around 9PM that night (last night) I started experiencing chills and a dull, aching pain focused in my testicles, groin and lower abdomen.

Other Meds: 80mg prozac/fluoxetine daily, zyrtec (one 10mg gel daily), multivitamin

Current Illness: None

ID: 1288547
Sex: F
Age: 30
State: IN

Vax Date: 05/03/2021
Onset Date: 05/03/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: none

Allergies: None

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: fever almost 12 hours after injections. Highest was 99.8. Body aches & chills. Headache. Side Effects lasted until 4pm the following day.

Other Meds: prenatal vitamins

Current Illness: none

ID: 1288548
Sex: M
Age: 59
State: MN

Vax Date: 05/04/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: None

Allergies: None

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Headache, body ache, fatigue - started morning after injection - treating with Ibuprofen and rest

Other Meds: Daily multi-vitamin, Omega-3 Fish Oils Supplement

Current Illness: Diabetes Type 2

ID: 1288549
Sex: F
Age: 44
State: CA

Vax Date: 03/12/2021
Onset Date: 04/19/2021
Rec V Date: 05/05/2021
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: Examination by dermatologist followed by diagnosis of Alopecia Aratea and scalp injections.

Allergies: No

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Hair loss

Other Meds: Synthroid, Cymbalta, Vitamin D, Multivitamin, xulane patch, Propanalol

Current Illness: Multiple Sclerosis

ID: 1288550
Sex: F
Age: 47
State: PA

Vax Date: 04/21/2021
Onset Date: 04/25/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: NONE YET

Allergies: NONE

Symptom List: Nausea

Symptoms: PAIN/SORENESS IN LEFT ARM FOR 2-3 DAYS, PAIN STARTED IN PELVIC REGION 4 DAYS AFTER INJECTION AND THEN MOVED TO LOWER RIGHT SIDE OF ABDOMEN, GROIN AREA AND INTENSIFIED ON DAY 7-8. PAIN WORSE WHEN I LIFT MY RIGHT LEG. PAIN LEVEL HAS DECREASED BUT ON DAY 14, THE AREA IS STILL PAINFUL AND I'M CONSIDERING GOING TO SEEK TREATMENT FROM MY DOCTOR AT THIS POINT.

Other Meds: NONE

Current Illness: NONE

ID: 1288551
Sex: F
Age: 49
State: FL

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: BP 101/60, HR 66, O2Sat 98.

Allergies:

Symptom List: Injection site pain

Symptoms: Patient requested help after complaining of vertigo after receiving her vaccine. Patient was assessed by EMS and nursing and she stated she felt better and was okay to go home and rest.

Other Meds:

Current Illness:

ID: 1288552
Sex: F
Age: 42
State: MA

Vax Date: 04/27/2021
Onset Date: 04/29/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: none yet

Allergies: Sulfa drugs, Penicillin, Erythromicin, general sensitivity to antibiotics.

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

Symptoms: Arm pain right after first dose, could not do much the first two days, Tylenol did not help at all. First dose triggered severe menstrual cramps two days later. Pain was an 8/9 on a scale of 1-10. Like labor pains. Trouble standing, walking, sitting comfortably. Full dose of Tylenol did not help. Heavy bleeding. Tongue and throat mild numbness at the height of pain. Extremely painful to pass stool and urinate. Worst pain lasted two days. 8 days later mild cramps persist, passing stool still uncomfortable. Day 7 cramps got worse for half a day. bleeding/spotting lasted 7 days (usually 3). Night 7 arm started to hurt again and itch, hives formed injection spot. Next morning (now) arm feels hot, itchy, sore and irritated. Still cramping in lower abdomen today.

Other Meds: none

Current Illness: none

ID: 1288553
Sex: M
Age: 17
State: VA

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

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

Lab Data:

Allergies:

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

Symptoms: Error: Patient Too Young for Vaccine Administered

Other Meds:

Current Illness:

ID: 1288554
Sex: F
Age: 41
State: PA

Vax Date: 05/04/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
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: no

Symptom List: Tremor

Symptoms: covid arm, headache, nausea, pain neck, very sore arm at injection site, difficulty to lift arm, fever

Other Meds: synthroid, birth control, magnesium, b complex, zyrtec, singulair, probiotic

Current Illness: no

ID: 1288555
Sex: F
Age: 72
State: CA

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 05/05/2021
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: Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient reported experiencing rash and hives after recieving her first dose of the vaccine. After her second dose, she noticed her skin started to become bumpy and red around the injection site. Patient also reported bleeding under the skin. Patient was referred to primary care physician and dermatologist.

Other Meds:

Current Illness:

ID: 1288556
Sex: F
Age: 40
State: TX

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

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

Symptoms: Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in right arm from shoulder to finger

Other Meds:

Current Illness:

ID: 1288557
Sex: M
Age: 34
State: FL

Vax Date: 05/04/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
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: No

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

Symptoms: Fever and headache

Other Meds: No

Current Illness: No

ID: 1288558
Sex: F
Age: 62
State: IL

Vax Date: 05/01/2021
Onset Date: 05/02/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Systemic: Dizziness / Lightheadness-Severe

Other Meds:

Current Illness:

ID: 1288559
Sex: M
Age: 32
State: IN

Vax Date: 05/03/2021
Onset Date: 05/05/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies: N/a

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

Symptoms: Tired, achy, headache, fever, chills, nausea, muscle aches, dizziness, couldn't lift arm past 90 degrees. All symptoms showed up about 4 hours after shot (12 pm) and did not subside until about 1 pm Tuesday May 4th.

Other Meds: Lexapro, nexium, claratin

Current Illness: N/a

ID: 1288560
Sex: F
Age: 17
State: TX

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 05/05/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Error: Patient Too Young for Vaccine Administered

Other Meds:

Current Illness:

ID: 1288561
Sex: M
Age: 53
State: MI

Vax Date: 04/05/2021
Onset Date: 04/07/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data: None to date

Allergies: None

Symptom List: Pain in extremity

Symptoms: Ringing in ears, persistent...

Other Meds: Alopurinol for Gout

Current Illness: None

ID: 1288592
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Very strong reaction; This spontaneous report was received a currently 42-year-old female patient. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (dose, route, lot number and expiration date were not reported). On an unknown date, the patient experienced a very strong reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown). The outcome of the event was not provided. The reporter considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown).

Other Meds:

Current Illness:

ID: 1288593
Sex: U
Age:
State: VA

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-APR-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot # T039454, and expiration date since it makes match with the auto-populated expiration date 14-DEC-2021) (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine was stored in the temperature of 9 degrees Celsius for 10 hours and 56 minutes. There were no previous temperature excursions reported. The improper storage was recorded by digital data logger. There was no additional adverse event reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2104USA003768.

Other Meds:

Current Illness:

ID: 1288594
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 15 to 20 minutes after administration of the vaccine, consumer's mouth and tongue began to swell; 15 to 20 minutes after administration of the vaccine, consumer's mouth and tongue began to swell; consumer broke out in hives; This spontaneous report was received from a patient's grandmother and refers to a male patient of unknown age. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On an unknown date (also reported as years ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On the same date, 15 to 20 minutes after administration of the vaccine, the patient's mouth and tongue began to swell and he broke out in hives. On an unknown date, he sought medical attention. The unspecified injection and unspecified medication were given to treat the reaction. The outcome of the events was not reported. The causality assessment between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.

Other Meds:

Current Illness:

ID: 1288595
Sex: U
Age:
State: MO

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 05/05/2021
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: no adverse event; temperature excursion with PROQUAD and VARIVAX; a patient was inadvertently administered both PROQUAD and VARIVAX on the same day; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-APR-2021, the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml injection, lot # T010288, expiration date: 20-SEP-2021 (route of administration and anatomical location were not reported) for prophylaxis and with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml injection, lot # T015999, expiration date: 08-MAY-2022 (route of administration and anatomical location were not reported) for prophylaxis (Incorrect product storage and Accidental overdose). Administered doses of vaccines underwent the temperature excursion of 6 to 14 degrees Fahrenheit (F) (10 F) for 45 minutes. Digital data logger was not involved. The vaccines underwent previous temperature excursion of 6 to 14 F (13 F) for 15 minutes. No other adverse event was reported.

Other Meds:

Current Illness:

ID: 1288596
Sex: U
Age:
State: MI

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: No additional adverse experiences; administration of an expired dose of ROTATEQ; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 27-APR-2021, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2ml, single dose, orally, lot # 1676327 was confirmed to be valid, expiration date 19-APR-2021 for prophylaxis. No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1288597
Sex: U
Age:
State: IA

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional AE reported.; expired dose of ROTATEQ administered to a patient; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 28-APR-2021, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 1 dose (exact dose was not reported), orally, lot # 1660946 was confirmed to be valid, expiration date 10-APR-2021 for prophylaxis. No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1288598
Sex: F
Age: 60
State: TX

Vax Date: 12/05/2014
Onset Date: 01/07/2015
Rec V Date: 05/05/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: bell's palsy; herpes simplex; This spontaneous report was received from a consumer referring to herself, a 60-year-old female patient. The patient's medical history included peripheral swelling and swelling after received two unspecified tetanus vaccines. The patient's concurrent conditions and concomitant medications were not provided. On 05-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, route, vaccination schedule, anatomical site, lot# and expiration date were not provided). On 07-JAN-2015, the patient experienced bell's palsy and was hospitalized on an unknown date due to this event; during hospitalization the patient was diagnosed with herpes simplex. The patient went out from hospital after one and a half days. The outcome of bell's palsy and herpes simplex was not provided. The causality assessment between the occurrence of the events and the suspect vaccine administration was not provided. Upon internal review, the event of bell's palsy was considered to be medically significant.

Other Meds:

Current Illness:

ID: 1288599
Sex: U
Age: 22
State: AZ

Vax Date: 04/01/2019
Onset Date: 04/28/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No additional AE details are available; a patient who started the GARDASIL 9 series 2 years ago and came to their office yesterday (4/28/2021) to receive their second dose; This spontaneous report was received from a medical assistant referring to a 24 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. In April 2019 (also reported as 2 years ago), the patient started with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail, route, lot# and expiration date were unknown) for prophylaxis. On 28-APR-2021 (also reported as yesterday), the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail, route, lot# and expiration date were unknown) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1288600
Sex: U
Age:
State: MN

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 05/05/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Confirmed with the customer that no other AE occurred.; a dose of PROQU AD that was administered after experiencing a temperature excursion.; This spontaneous report was received from a other health professional and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-APR-2021,the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 1 dose, lot # t028139, expiration date 15-FEB-2022 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. Albumin status for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) has been verified as recombinant human albumin (rHA). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of (-10.7) Celsius for 1 hour and 6 minutes. Data logger was involved. There were no previous excursions reported.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am