VAERS 2021 Database www.vaers.hhs.gov

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







Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1340253
Sex: U
Age:
State: ID

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/22/2021
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: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional 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, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1340254
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 05/22/2021
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: PRESENCE IN LEFT LEG; BACK TENSION; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. 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: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced fatigue. On 12-MAY-2021, the subject experienced back tension. On 18-MAY-2021, the subject experienced presence in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from back tension, and fatigue, and had not recovered from presence in left leg. This report was non-serious.

Other Meds:

Current Illness:

ID: 1340255
Sex: M
Age:
State:

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/22/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: RAPID HEARTBEAT SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included rapid heartbeat symptoms, and covid-19. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 20-MAY-2021 15:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On MAY-2021, the subject experienced rapid heartbeat symptoms. The action taken with covid-19 vaccine was not applicable. The outcome of rapid heartbeat symptoms was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1340256
Sex: M
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 05/22/2021
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: SEVERE HEADACHES; This spontaneous report received from a patient 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: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested .No concomitant medications were reported. On an unspecified date, the subject experienced severe headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe headaches was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1340257
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 05/12/2021
Rec V Date: 05/22/2021
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: VOMITING; HEADACHE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included smoker, and concurrent conditions included non-alcoholic, and penicillin allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced vomiting. On 12-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from vomiting on 13-MAY-2021, and headache on 20-MAY-2021. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Penicillin allergy

ID: 1340258
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 05/19/2021
Rec V Date: 05/22/2021
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: UNCOMFORTABLE; FATIGUE; TOTAL BODY ACHES; CAN'T SLEEP; DIZZY; UNWELL; CHILLS; LEFT ARM IS SORE AT INJECTION SITE; WEAK; FELT NAUSEOUS; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pineapple allergy. 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: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 19-MAY-2021, the subject experienced total body aches. On 19-MAY-2021, the subject experienced can't sleep. On 19-MAY-2021, the subject experienced dizzy. On 19-MAY-2021, the subject experienced unwell. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced left arm is sore at injection site. On 19-MAY-2021, the subject experienced weak. On 19-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced uncomfortable. On 20-MAY-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unwell, dizzy, nausea, can't sleep, chills, uncomfortable, left arm is sore at injection site, total body aches, weak, and fatigue. This report was non-serious.

Other Meds:

Current Illness: Fruit allergy

ID: 1340259
Sex: F
Age:
State: ME

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/22/2021
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; This spontaneous report received from a patient concerned a female 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: Unknown) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash. This report was non-serious.

Other Meds:

Current Illness:

ID: 1340260
Sex: U
Age:
State: VA

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/22/2021
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: POTENTIAL ADMINISTRATION ERROR; VACCINE VIALS WERE TRANSPORTED IN A STYROFOAM BOX WITH ICE WITH NO TEMPERATURE READINGS FOR 30MIN; This spontaneous report received from a health care professional concerned multiple patients. 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 was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced vaccine vials were transported in a styrofoam box with ice with no temperature readings for 30min. On 20-MAY-2021, the subject experienced potential administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential administration error and vaccine vials were transported in a styrofoam box with ice with no temperature readings for 30min was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1340261
Sex: F
Age:
State:

Vax Date:
Onset Date: 05/15/2021
Rec V Date: 05/22/2021
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: DIZZY/LIGHT HEADED; STRANGE FEELING; OUT OF SORTS/DID NOT FEEL CONNECTED TO THE OUTSIDE WORLD; INCREASED PAIN; EXTREME HEADACHE; NAUSEOUS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, fibromyalgia, superventricular tachycardia, low thyroid, and autoimmune disease. 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 15-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAY-2021, the subject experienced dizzy/light headed. On 15-MAY-2021, the subject experienced nauseous. On 15-MAY-2021, the subject experienced out of sorts/did not feel connected to the outside world. On 15-MAY-2021, the subject experienced increased pain. On 15-MAY-2021, the subject experienced extreme headache. On 15-MAY-2021, the subject experienced strange feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy/light headed, nauseous, out of sorts/did not feel connected to the outside world, increased pain, extreme headache and strange feeling was not reported. This report was non-serious.

Other Meds:

Current Illness: Autoimmune disorder; Fibromyalgia; Hypothyroidism; Rheumatoid arthritis; Supraventricular tachycardia

ID: 1340262
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 05/20/2021
Rec V Date: 05/22/2021
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: BACK PAIN; NUMBNESS IN BACK AND ARMS; CHILLS FEELING HOT AND THEN COLD; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included post traumatic stress disorder, chest pain (heart and lungs problems), and body pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced back pain. On 20-MAY-2021, the subject experienced numbness in back and arms. On 20-MAY-2021, the subject experienced chills feeling hot and then cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills feeling hot and then cold, back pain, and numbness in back and arms. This report was non-serious.

Other Meds:

Current Illness: Chest pain; General body pain; Post-traumatic stress disorder

ID: 1340263
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: LOSS OF TASTE; This spontaneous report received from a pharmacist concerned a 30 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced loss of taste. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from loss of taste. This report was non-serious.

Other Meds:

Current Illness:

ID: 1340264
Sex: F
Age:
State: WA

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 05/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Severe allergic reaction; her BP went up to 195; Burning pain,skin burning like a severe sun burn,Reaction of burning skin travelled across arm,across chest; Could not sleep at night; Lymph nodes swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (Severe allergic reaction) and HYPERTENSIVE EMERGENCY (her BP went up to 195) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ALLERGY TO VACCINE (Severe allergic reaction) (seriousness criterion medically significant), HYPERTENSIVE EMERGENCY (her BP went up to 195) (seriousness criterion medically significant), PAIN (Burning pain,skin burning like a severe sun burn,Reaction of burning skin travelled across arm,across chest), INSOMNIA (Could not sleep at night) and LYMPHADENOPATHY (Lymph nodes swollen). At the time of the report, ALLERGY TO VACCINE (Severe allergic reaction), HYPERTENSIVE EMERGENCY (her BP went up to 195), PAIN (Burning pain,skin burning like a severe sun burn,Reaction of burning skin travelled across arm,across chest), INSOMNIA (Could not sleep at night) and LYMPHADENOPATHY (Lymph nodes swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment medication included diphenhydramine. On 19 Feb 2021, diphenhydramine was stopped and the burning pain returned. The patient talked more than normally she would.; 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: 1340265
Sex: F
Age: 67
State: FL

Vax Date: 01/07/2021
Onset Date: 01/26/2021
Rec V Date: 05/22/2021
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: body temperature; Result Unstructured Data: 95

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (hypothermia) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Shingles (chicken pox and shingles in 2001). Concomitant products included ROSUVASTATIN for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced HYPOTHERMIA (hypothermia) (seriousness criteria medically significant) and RASH (Rash on the side of face and around eyes). The patient was treated with VALACYCLOVIR HYDROCHLORIDE (VALTREX) ongoing from January 2021 for Shingles, at an unspecified dose and frequency. At the time of the report, HYPOTHERMIA (hypothermia), HERPES ZOSTER (Shingles) and RASH (Rash on the side of face and around eyes) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 95 (Low) 95. 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. This case was linked to US-MODERNATX, INC.-MOD-2021-118918 (E2B Linked Report). This case was linked to MOD-2021-118638 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Updated address and adverse events; 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: ROSUVASTATIN

Current Illness:

ID: 1340266
Sex: F
Age: 72
State: NJ

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 05/22/2021
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: Vaginal bleeding (Medium blood flow, Not Spotting); panicking; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 3:47 PM, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) (seriousness criterion medically significant) and PANIC REACTION (panicking). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) and PANIC REACTION (panicking) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was not taking any blood thinners and had no Chronic Medical conditions. Concomitant medications and treatment information was not provided. The patient reported that it was not Hemorrhoids and was panicking because she heard someone died from bleeding after receiving the vaccine. This case concerns a 72-year-old female with a serious unexpected event of vaginal hemorrhage, and nonserious unexpected panic reaction. Latency 3 days after first mRNA-1273 dose. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 72-year-old female with a serious unexpected event of vaginal hemorrhage, and nonserious unexpected panic reaction. Latency 3 days after first mRNA-1273 dose. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1340267
Sex: F
Age:
State: NE

Vax Date: 01/07/2021
Onset Date: 01/09/2021
Rec V Date: 05/22/2021
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: 20210109; Test Name: SARS-CoV-2; Test Result: Positive; Result Unstructured Data: positive.

Allergies:

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

Symptoms: This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Diagnosed with COVID a few days later) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID a few days later) (seriousness criteria medically significant). At the time of the report, COVID-19 (Diagnosed with COVID a few days later) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test: positive (Positive) positive. 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 product use was not provided by the reporter. No treatment information was provided. Company Comment: Causality for event COVID-19 is not applicable; Sender's Comments: Causality for event COVID-19 is not applicable.

Other Meds:

Current Illness:

ID: 1340268
Sex: M
Age: 43
State: LA

Vax Date: 01/08/2021
Onset Date: 01/28/2021
Rec V Date: 05/22/2021
Hospital:

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

Lab Data: Test Date: 20210128; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19) (seriousness criterion medically significant). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: Causality for event COVID-19 is not applicable; Sender's Comments: Causality for event COVID-19 is not applicable

Other Meds:

Current Illness:

ID: 1340269
Sex: F
Age: 76
State: MD

Vax Date: 01/22/2021
Onset Date: 01/27/2021
Rec V Date: 05/22/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia Rheumatica) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dairy intolerance, Drug allergy (allergic to Compazine), Hay fever since 1976, Osteopenia since 2000, Tinnitus since 2016 and Osteoarthritis since 1990. Concomitant products included MACROGOL 400 (BLINK TEARS) for Dry eye, VITAMINS NOS (MULTIPLE VITAMIN) for Multi-vitamin maintenance, VITAMIN D3, PROBIOTICS NOS, FISH OIL and HOMOCYSTEINE THIOLACTONE HYDROCHLORIDE for Routine health maintenance, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 01-Jan-2020 to an unknown date and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Sinusitis, MAGNESIUM CITRATE for an unknown indication, GLUCOSAMINE & CHONDORITIN. On 22-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced ARTHRALGIA (severe leg pain (both)/Pain seemed to concentrate in back of legs/intense pain in joints and muscles of the legs). On 21-Apr-2021, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia Rheumatica) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST DISCOMFORT (tightness in the chest). At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia Rheumatica) and ARTHRALGIA (severe leg pain (both)/Pain seemed to concentrate in back of legs/intense pain in joints and muscles of the legs) had not resolved and CHEST DISCOMFORT (tightness in the chest) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Additional concomitant medication taken at the start of the events included OsteoThera 4 times per day. On 27-Jan-2021, the patient experienced intense pain in the joints and muscles of the legs. She applied ice as treatment. Over the next 2-3 weeks pain moved to other joints and muscles with varied intensity; fatigue and weakness noted. Overtime it became very difficult for the patient to stand up from a seated position, walk, turn over when lying down, or bend over to sit down. On 09-Feb-2021 additional daily supplements were started: Pea Protein, Calcium D-Glucarate, Digestive Enzymes (Digest Gold), GI Motility Complex, Glutagenics Powder, Sun Fiber. The patient sought medical attention from her Primary Care Provider (PCP). The patient's ESR and CRP were elevated, indicative of an inflammatory condition. The patient was referred to Rheumatology. While she waited 5 weeks for the appointment, she experienced tightness in the chest and continued loss of function. She eventually went to the Emergency Room (ER) and 1 lab result was slightly elevated, indicative of Lyme disease. The ER doctor administered ketorolac and iodixanol and the patient started treatment with doxycycline. On 21-Apr-2021, doxycycline was stopped as additional lab tests for Lyme disease were normal. The patient was diagnosed with Polymyalgia Rheumatica and started treatment with Prednisone 15 mg daily (gradual tapering off was planned), heat, light stretching, and exercise to regain leg movement. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Additional initial received on 12-May-2021. Concomitant medication added; event added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; BLINK TEARS; FLONASE [MOMETASONE FUROATE]; VITAMIN D3; PROBIOTICS NOS; FISH OIL; MAGNESIUM CITRATE; MULTIPLE VITAMIN; HOMOCYSTEINE THIOLACTONE HYDROCHLORIDE; GLUCOSAMINE & CHONDORITIN

Current Illness: Dairy intolerance; Drug allergy (allergic to Compazine); Hay fever; Osteoarthritis; Osteopenia; Tinnitus

ID: 1340270
Sex: F
Age:
State: OR

Vax Date: 02/23/2021
Onset Date: 02/28/2021
Rec V Date: 05/22/2021
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: Olfactory hallucinations; Blood pressure spikes; Did not receive second dose; Agitated; Rapid heart beat; Tingly lips; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, OLFACTORY (Olfactory hallucinations) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced AGITATION (Agitated), PALPITATIONS (Rapid heart beat) and PARAESTHESIA ORAL (Tingly lips). On an unknown date, the patient experienced HALLUCINATION, OLFACTORY (Olfactory hallucinations) (seriousness criterion medically significant), BLOOD PRESSURE FLUCTUATION (Blood pressure spikes) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose). On 02-Mar-2021, AGITATION (Agitated), PALPITATIONS (Rapid heart beat) and PARAESTHESIA ORAL (Tingly lips) had resolved. At the time of the report, HALLUCINATION, OLFACTORY (Olfactory hallucinations) and BLOOD PRESSURE FLUCTUATION (Blood pressure spikes) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product used was not provided by the reporter. The patient called in to report that she did not receive the 2nd dose. She reported that she was still experiencing side effects from the 1st dose of the vaccine. Treatment information was not provided. 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. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-May-2021 will be submitted with initial report. Follow-up information included new adverse events.; 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: 1340271
Sex: M
Age:
State: GA

Vax Date: 02/07/2021
Onset Date: 02/22/2021
Rec V Date: 05/22/2021
Hospital: Y

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: Covid-19; GI bleed; low blood pressure; Dehydration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (GI bleed) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced COVID-19 (Covid-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (GI bleed) (seriousness criterion medically significant), HYPOTENSION (low blood pressure) and DEHYDRATION (Dehydration). The patient was hospitalized from 22-Feb-2021 to 28-Feb-2021 due to COVID-19. At the time of the report, COVID-19 (Covid-19), GASTROINTESTINAL HAEMORRHAGE (GI bleed), HYPOTENSION (low blood pressure) and DEHYDRATION (Dehydration) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medication provided. Treatment medications included dexamethasone and remdesivir. Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Correction for initial version: As per the initial source document, patient was admitted in hospital for 4 days due to COVID-19 but the case was not coded as serious based on hospitalization seriousness criteria. The correction has been made on 18-May-2021 upon identification. On 12-May-2021: Follow up received included events low blood pressure, dehydration, GI bleed were added

Other Meds:

Current Illness:

ID: 1340272
Sex: F
Age: 61
State: NY

Vax Date: 03/23/2021
Onset Date: 03/26/2021
Rec V Date: 05/22/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Fell again, breaking left leg; Breaking ankle; Breaking foot; Passed out; Stroke; Fell again; Swollen arm; Did not get second Covid shot; Joint pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Mar-2021. The most recent information was received on 12-May-2021 and was forwarded to Moderna on 13-May-2021. This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), LOSS OF CONSCIOUSNESS (Passed out), LOWER LIMB FRACTURE (Fell again, breaking left leg), ANKLE FRACTURE (Breaking ankle) and FOOT FRACTURE (Breaking foot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced ARTHRALGIA (Joint pain). On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged and medically significant), LOWER LIMB FRACTURE (Fell again, breaking left leg) (seriousness criterion hospitalization), ANKLE FRACTURE (Breaking ankle) (seriousness criterion hospitalization), FOOT FRACTURE (Breaking foot) (seriousness criterion hospitalization), FALL (Fell again), PERIPHERAL SWELLING (Swollen arm) and INCOMPLETE COURSE OF VACCINATION (Did not get second Covid shot). The patient was hospitalized for 13 days until 12-Apr-2021 due to CEREBROVASCULAR ACCIDENT, then until 12-Apr-2021 due to ANKLE FRACTURE, FOOT FRACTURE, LOSS OF CONSCIOUSNESS and LOWER LIMB FRACTURE. The patient was treated with Physical therapy for Cerebrovascular accident; Physical therapy for Lower limb fracture; Physical therapy for Ankle fracture and Physical therapy for Foot fracture. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), PERIPHERAL SWELLING (Swollen arm) and ARTHRALGIA (Joint pain) outcome was unknown, LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell again) and INCOMPLETE COURSE OF VACCINATION (Did not get second Covid shot) had resolved and LOWER LIMB FRACTURE (Fell again, breaking left leg), ANKLE FRACTURE (Breaking ankle) and FOOT FRACTURE (Breaking foot) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant product use was reported. Treatment medication included Benadryl. Very limited information regarding these events has been provided at this time. This case also refers to an incomplete schedule of vaccination. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Case upgraded to serious (Hospitalization), Added Additional events experienced, Events description, and updated Treatment information.

Other Meds:

Current Illness:

ID: 1340273
Sex: M
Age: 62
State: NY

Vax Date: 03/18/2021
Onset Date: 03/20/2021
Rec V Date: 05/22/2021
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: Stroke; Vertigo; Dizziness; High Blood Pressure; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), VERTIGO (Vertigo), DIZZINESS (Dizziness), HYPERTENSION (High Blood Pressure) and HEADACHE (Headache). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), VERTIGO (Vertigo), DIZZINESS (Dizziness), HYPERTENSION (High Blood Pressure) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were reported. Treatment information provided included steroids. Patient stated he in now in a walker due to having a stroke. Very limited information regarding these events has been provided at this time. Further information has been requested. However, the patient may deny additional follow-up. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Event fell diagnosed as stroke (Seriousness criteria - medically significant).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. However, the patient may deny additional follow-up.

Other Meds:

Current Illness:

ID: 1340274
Sex: F
Age:
State: OH

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 05/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: pink disscolouration; swelling below cheek bones; missed second dose; Chills; felt tired; headache; gland swelling; pain in lower part of arm; Hard Knot; cellulitis; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis) in an 84-year-old female patient 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 Cardiac disorder (heart condition) since an unknown date, Asthma since an unknown date, Drooling (excessive saliva while sleeping) since an unknown date, allergy (allergies-scheduled to have scope to check vocal chords.) since an unknown date, Dysautonomia since an unknown date and Sleep apnea (uses a CPAP machine for sleep apnea,) since an unknown date. Concurrent medical conditions included Throat discomfort. Concomitant products included ERYTHROMYCIN STEARATE (ERITHRIN [ERYTHROMYCIN STEARATE]) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant). On 25-Mar-2021, the patient experienced VACCINATION SITE MASS (Hard Knot). On an unknown date, the patient experienced LYMPHADENOPATHY (gland swelling), PAIN IN EXTREMITY (pain in lower part of arm), ERYTHEMA (pink disscolouration), SWELLING (swelling below cheek bones), PRODUCT DOSE OMISSION ISSUE (missed second dose), CHILLS (Chills), FATIGUE (felt tired) and HEADACHE (headache). At the time of the report, CELLULITIS (cellulitis), LYMPHADENOPATHY (gland swelling) and PAIN IN EXTREMITY (pain in lower part of arm) had not resolved, VACCINATION SITE MASS (Hard Knot) outcome was unknown and ERYTHEMA (pink disscolouration), SWELLING (swelling below cheek bones), PRODUCT DOSE OMISSION ISSUE (missed second dose), CHILLS (Chills), FATIGUE (felt tired) and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patients treatment medication included high-power antibiotics, cephalexin (Keflex )for 6 days. Self treated swollen lymph nodes with heat. 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. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: added the event (missed dose) and treatment medication; 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: ERITHRIN [ERYTHROMYCIN STEARATE]

Current Illness: Asthma; Cardiac disorder (heart condition); Drooling (excessive saliva while sleeping); Dysautonomia; Sleep apnea (uses a CPAP machine for sleep apnea,)

ID: 1340275
Sex: M
Age: 61
State: NC

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 05/22/2021
Hospital: Y

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

Lab Data: Test Date: 20210322; Test Name: Antibody test; Test Result: Inconclusive ; Result Unstructured Data: No antibodies were developed 10 days after 1st dose of vaccination.; Test Date: 202103; Test Name: Creatine test; Result Unstructured Data: Elevated creatine numbers.

Allergies:

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

Symptoms: kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass; very tired/very fatigue; urination trouble after the shot, he couldn't urinate anything,could'nt get out anything out of his body; sore arm; slept a lot after the shot; did not have any antibodies after the first vaccine of Moderna; very bad lower back pain both sides within a few hours of the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY RETENTION (kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Herpes virus infection (Improved after Shingles Vaccine.) on 24-Jun-2008. Previously administered products included for an unreported indication: SHINGRIX (First dose- Oct-2019 and Second dose-Feb-2020) from October 2019 to February 2021. Concurrent medical conditions included HIV infection since 18-Feb-1998, Renal agenesis (born without left kidney), Drug allergy (Fluroquine allergy), Contrast media allergy, Asthma since 24-Jun-2008, Mitral valve disease since 12-Apr-2010 and Diarrhea (Improved with daily Morphine ER) since 10-Jan-1996. Concomitant products included AMLODIPINE for Blood pressure management, RITONAVIR, ABACAVIR, DOLUTEGRAVIR SODIUM (TIVICAY), DARUNAVIR ETHANOLATE (PREZISTA) and ABACAVIR SULFATE (ZIAGEN) for HIV infection, ACYCLOVIR [ACICLOVIR], MORPHINE, PRAVASTATIN and FINASTERIDE for an unknown indication. On 12-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BACK PAIN (very bad lower back pain both sides within a few hours of the injection). On 12-Mar-2021 at 1:30 PM, the patient experienced URINARY RETENTION (kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass) (seriousness criteria hospitalization and medically significant). On 22-Mar-2021, the patient experienced DRUG INEFFECTIVE (did not have any antibodies after the first vaccine of Moderna). On an unknown date, the patient experienced DYSURIA (urination trouble after the shot, he couldn't urinate anything,could'nt get out anything out of his body), PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot after the shot) and FATIGUE (very tired/very fatigue). The patient was hospitalized on 15-Mar-2021 due to URINARY RETENTION. On 13-Mar-2021, URINARY RETENTION (kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass) had resolved with sequelae. On 22-Mar-2021, DRUG INEFFECTIVE (did not have any antibodies after the first vaccine of Moderna) outcome was unknown. At the time of the report, DYSURIA (urination trouble after the shot, he couldn't urinate anything,could'nt get out anything out of his body), PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot after the shot) and FATIGUE (very tired/very fatigue) outcome was unknown and BACK PAIN (very bad lower back pain both sides within a few hours of the injection) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood creatine: (High) Elevated creatine numbers.. On 22-Mar-2021, Antibody test: (Inconclusive) No antibodies were developed 10 days after 1st dose of vaccination.. On 22-Mar-2021, Blood creatine:. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient reported that he was born with only one kidney(Right). The patient was enrolled in a COVID-19 study for the last several months. Sequelae for the event of urinary retention included elevated creatine. No treatment was reported for the events. 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. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Event urinary retention was upgraded to serious. Seriousness criteria hospitalization was included for urinary retention. Lab data for antibody test and creatine test were added. Allergy (Fluroquine,contrast dye), historical vaccine(Shingles Vaccine), historical condition(Herpes Virus Infection) were updated in other relevant history. Current condition asthma, mitral valve disease and diarrhea were also added. On 12-May-2021: Additional information provided on 12-May-2021 included an additional event.; 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: AMLODIPINE; ACYCLOVIR [ACICLOVIR]; MORPHINE; PRAVASTATIN; FINASTERIDE; RITONAVIR; ABACAVIR; TIVICAY; PREZISTA; ZIAGEN

Current Illness: Asthma; Contrast media allergy; Diarrhea (Improved with daily Morphine ER); Drug allergy (Fluroquine allergy); HIV infection; Mitral valve disease; Renal agenesis (born without left kidney)

ID: 1340276
Sex: M
Age: 67
State: NJ

Vax Date: 01/21/2021
Onset Date: 02/28/2021
Rec V Date: 05/22/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210228; Test Name: %CT scan; Result Unstructured Data: Blood clot in both lung.

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot in each lung) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CALCIUM FRUCTOBORATE, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE, HYALURONIC ACID (MOVE FREE JOINT HEALTH) for Joint disorder NOS, MINERALS NOS, VITAMINS NOS (ONE A DAY [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 21-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced THROMBOSIS (blood clot in each lung) (seriousness criteria medically significant and life threatening). On 28-Feb-2021 at 6:00 PM, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, THROMBOSIS (blood clot in each lung) outcome was unknown and DYSPNOEA (shortness of breath) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Computerised tomogram: blood clot (abnormal) Blood clot in both lung. On 21Jan2021, patient had received the first dose of Moderna Covid-19 vaccine and about 4-5 days later, he began to noticed that his breathing was labored. At the time of the report, the patient did not think much about the labored breathing since he was older in age and thought it was due to exercise. Patient received second dose of Moderna COVID-19 Vaccine on 18-Feb-2021 and he reported that his breathing became more laboring where he needed to stop walking to catch his breath. He had 2 scan which revealed that he have a blood clot at each lung and he was prescribed Xarelto 15 mg twice a day, then he will begin Xarelto 20mg once a day on 20-MAY-2021. Patient is on Kirkland C 500mg as a concomitant medication as well. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Significant FU- outcome of the event.

Other Meds: ONE A DAY [MINERALS NOS;VITAMINS NOS]; MOVE FREE JOINT HEALTH

Current Illness:

ID: 1340277
Sex: M
Age: 60
State: IA

Vax Date: 04/05/2021
Onset Date: 04/30/2021
Rec V Date: 05/22/2021
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: 20210501; Test Name: Blood Test; Result Unstructured Data: Normal; Test Date: 20210501; Test Name: CT Scan; Result Unstructured Data: Normal; Test Date: 20210501; Test Name: EKG; Result Unstructured Data: Normal

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Stroke; Patient received his first dose of Moderna COVID19 Vaccine on 05-APR-2021 and second dose on 30-APR-2021; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021 at 10:30 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID19 Vaccine on 05-APR-2021 and second dose on 30-APR-2021). On 06-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. On 30-Apr-2021 at 10:30 AM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID19 Vaccine on 05-APR-2021 and second dose on 30-APR-2021) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Blood test: normal (normal) Normal. On 01-May-2021, Computerised tomogram: normal (normal) Normal. On 01-May-2021, Electrocardiogram: normal (normal) Normal. Concomitant medications were not reported. On 30 Apr 2021, the patient's right arm was numb and he had no feeling in it. He went to the emergency room on 01 May 2021. They thought he had a blood clot. His EKG, blood tests and CAT scan were normal. The patient reported his arm was still numb on 04 May 2021. It's like it was limp; he couldn't coordinate his hand when he tried to mow the law. He stated that he had no feeling in his arm and can't control his right hand. The patient was reported to have been diagnosed with a stroke on 06 May 2021 2021 and was to start rehab on 07 May 2021. 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. 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. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Stroke added as an event.

Other Meds:

Current Illness:

ID: 1340278
Sex: M
Age: 55
State:

Vax Date: 04/09/2021
Onset Date: 04/22/2021
Rec V Date: 05/22/2021
Hospital: Y

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: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash all over the body) and ADVERSE REACTION (Bad reaction) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. The patient's past medical history included Anemia. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), AMLODIPINE for Blood pressure high, FOLIC ACID for Folic acid supplementation, FERROUS SULFATE for Iron supplementation, TRAMADOL for Pain, PREDNISONE and HYDROXYCHLOROQUINE for Rheumatoid arthritis, SUCRALFATE for Stomach discomfort, FOLINIC ACID for Vitamin supplementation. On 09-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced RASH (Rash all over the body) (seriousness criteria hospitalization). On an unknown date, the patient experienced ADVERSE REACTION (Bad reaction) (seriousness criteria hospitalization). The patient was hospitalized for 1 day due to ADVERSE REACTION and RASH. At the time of the report, RASH (Rash all over the body) was resolving and ADVERSE REACTION (Bad reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included acyclovir and dexamethasone. Company comment: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.

Other Meds: PREDNISONE; TRAMADOL; HYDROXYCHLOROQUINE; PANTOPRAZOLE; FOLIC ACID; FOLINIC ACID; AMLODIPINE; SUCRALFATE; FERROUS SULFATE

Current Illness:

ID: 1340279
Sex: F
Age: 52
State: PA

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 05/22/2021
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: Test Date: 20210401; Test Name: chloride; Result Unstructured Data: 109 mmol/L; Test Date: 20210401; Test Name: blood pressure; Result Unstructured Data: Her blood pressure was very high. She didn't remember exact numbers, but stated it was something like 224/107.; Test Date: 20210401; Test Name: blood pressure; Result Unstructured Data: @15:15; Test Date: 20210401; Test Name: blood pressure; Result Unstructured Data: @16:30; Test Date: 20210401; Test Name: CO2; Result Unstructured Data: 22 mmol/l; Test Date: 20210401; Test Name: Chest X-Ray; Result Unstructured Data: Clear lungs. Thoracic portion of a ventriculoperitoneal shunt catheter was seen to the right of midline and appeared intact.; Test Date: 20210401; Test Name: EKG; Result Unstructured Data: EMT did an EKG and stated it was normal; Test Date: 20210401; Test Name: CBC diff; Result Unstructured Data: normal; Test Date: 20210401; Test Name: CMP; Result Unstructured Data: normal

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Headache, like her head was being squeezed in a vice and a screwdriver was in the right side of her skull; Vomiting; Coughing; Anaphylactic Reaction; Blood pressure was very high; started rubbing chest, did not feel the same way as when they first arrived at the facility; Dizzy; Vertigo; Feeling unwell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic Reaction) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anaphylaxis, Hypersensitivity reaction, Asthma, Hives (Hives/urticaria), Drug allergy (Codeine-Severe Vomiting. Morphine-Fell asleep within minutes of receiving Medication.), Hives (Severe Hives (High Tryptase Level). Under Care of Allergist, taking Bee Sting Shots and Xolair Shots. No hives since November of 2020,) since 01-Aug-2019 and Hydrocephalus on 01-Aug-2004. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 01-May-2020 to an unknown date and FAMOTIDINE from 01-May-2020 to an unknown date for Hives. On 01-Apr-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VERTIGO (Vertigo), MALAISE (Feeling unwell) and DIZZINESS (Dizzy). On 01-Apr-2021 at 1:15 PM, the patient experienced CHEST DISCOMFORT (started rubbing chest, did not feel the same way as when they first arrived at the facility). On 01-Apr-2021 at 1:20 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic Reaction) (seriousness criterion medically significant) and BLOOD PRESSURE INCREASED (Blood pressure was very high). On 01-Apr-2021 at 1:30 PM, the patient experienced COUGH (Coughing). On 01-Apr-2021 at 1:35 PM, the patient experienced VOMITING (Vomiting). On 01-Apr-2021 at 5:30 PM, the patient experienced HEADACHE (Headache, like her head was being squeezed in a vice and a screwdriver was in the right side of her skull). On 02-Apr-2021 at 1:00 PM, ANAPHYLACTIC REACTION (Anaphylactic Reaction) had resolved. At the time of the report, VERTIGO (Vertigo), COUGH (Coughing), MALAISE (Feeling unwell), DIZZINESS (Dizzy), CHEST DISCOMFORT (started rubbing chest, did not feel the same way as when they first arrived at the facility), VOMITING (Vomiting) and HEADACHE (Headache, like her head was being squeezed in a vice and a screwdriver was in the right side of her skull) had resolved and BLOOD PRESSURE INCREASED (Blood pressure was very high) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood chloride (96-106): 109 mmol/l High. On 01-Apr-2021, Blood pressure measurement (unk-unk mmHg): 224/107 mmHg (High) The nurse called the EMT who took her blood pressure about 20 minutes after receiving the injection. Her blood pressure was very high. She didn't remember exact numbers, but stated it was something like 224/107. The EMT asked her if she had taken her blood pressure medications that morning and she told him she does not take blood pressure medications., 194/107 mmHg (High) @15:15 and 194/110 mmHg (High) @16:30. On 01-Apr-2021, Carbon dioxide (24-32): 22 mmol/l Low. On 01-Apr-2021, Chest X-ray: normal (normal) Clear lungs. Thoracic portion of a ventriculoperitoneal shunt catheter was seen to the right of midline and appeared intact. On 01-Apr-2021, Electrocardiogram: normal (normal) EMT did an EKG and stated it was normal. On 01-Apr-2021, Full blood count: normal (normal) normal. On 01-Apr-2021, Metabolic function test: normal (normal) normal. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Patient was given two baby aspirin by mouth on 01 Apr 2021 and was then sent to the emergency room (ER) due to her blood pressure. Patient was not given anything for vomiting, but had continued to fill multiple emesis bags. Additional tests included cardiac monitor and continuous pulse oximetry. On 01 Apr 2021 at 19:30, the nurse started an IV and administered Zofran plus another medication the patient could not recall. The patient began to feel better, finished the IV and was able to stand without dizziness. The patient saw another ER physician at 23:30 who did not think the event were related to the vaccine. This physician sent the patient home (discharged at approximately 1:00 on 02 Apr 2021). On 08 Apr 2021, the patient saw her allergist who confirmed it was an anaphylactic reaction to the vaccine. Patient indicated that nausea/vomiting, difficulty breathing, chest tightness, and cough were signs and symptoms experienced. The patient's allergist informed the patient they were not to get the second Moderna shot. 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. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No New Information (NNI). On 19-May-2021: ADR response received which provided additional event details, outcomes, treatments, ER lab/diagnostic results.

Other Meds: CETRIZINE; FAMOTIDINE

Current Illness: Anaphylaxis; Asthma; Drug allergy (Codeine-Severe Vomiting. Morphine-Fell asleep within minutes of receiving Medication.); Hives (Severe Hives (High Tryptase Level) Under Care of Allergist, taking Bee Sting Shots and Xolair Shots. No hives since November of 2020,); Hives (Hives/urticaria); Hypersensitivity reaction.

ID: 1340280
Sex: U
Age: 44
State: IL

Vax Date: 04/26/2021
Onset Date: 05/06/2021
Rec V Date: 05/22/2021
Hospital:

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

Lab Data: Test Date: 202104; Test Name: Body temperature; Result Unstructured Data: increased; Test Date: 20210502; Test Name: Fecal disimpaction; Result Unstructured Data: Fecal manual dis-impaction for 2 days.; Test Date: 202105; Test Name: urine output; Result Unstructured Data: decreased,

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: transient loss of vision L eye; Urinary retention; constipation; L arm swelling & pain; Episodic ptosis; L arm swelling & pain; fever; headaches; possible TIA; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (possible TIA), BLINDNESS TRANSIENT (transient loss of vision L eye) and URINARY RETENTION (Urinary retention) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (possible TIA) (seriousness criterion medically significant). On an unknown date, the patient experienced BLINDNESS TRANSIENT (transient loss of vision L eye) (seriousness criterion medically significant), URINARY RETENTION (Urinary retention) (seriousness criterion medically significant), CONSTIPATION (constipation), PERIPHERAL SWELLING (L arm swelling & pain), EYELID PTOSIS (Episodic ptosis), PAIN IN EXTREMITY (L arm swelling & pain), PYREXIA (fever) and HEADACHE (headaches). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (possible TIA), BLINDNESS TRANSIENT (transient loss of vision L eye), URINARY RETENTION (Urinary retention), CONSTIPATION (constipation), PERIPHERAL SWELLING (L arm swelling & pain), EYELID PTOSIS (Episodic ptosis), PAIN IN EXTREMITY (L arm swelling & pain), PYREXIA (fever) and HEADACHE (headaches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: increased (High) increased. On 02-May-2021, Faecal disimpaction: abnormal Fecal manual dis-impaction for 2 days.. In May 2021, Urine output: decreased (Low) decreased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. On 06-May-2021, the patient reported that she called 911 and went to the emergency room for possible TIA (transient ischemic attack). No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start 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 of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1340281
Sex: M
Age: 57
State:

Vax Date: 02/24/2021
Onset Date: 03/23/2021
Rec V Date: 05/22/2021
Hospital: Y

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

Lab Data: Test Date: 20210424; Test Name: Creatinine; Test Result: Inconclusive ; Result Unstructured Data: 1.68; Test Date: 20210425; Test Name: Creatinine; Test Result: Inconclusive ; Result Unstructured Data: 1.59; Test Date: 20210426; Test Name: Creatinine; Test Result: Inconclusive ; Result Unstructured Data: 1.54; Test Date: 20210424; Test Name: Glucose; Test Result: Inconclusive ; Result Unstructured Data: 90; Test Date: 20210425; Test Name: Glucose; Test Result: Inconclusive ; Result Unstructured Data: 117; Test Date: 20210426; Test Name: Glucose; Test Result: Inconclusive ; Result Unstructured Data: 90; Test Date: 20210424; Test Name: Potassium; Test Result: Inconclusive ; Result Unstructured Data: 4.1; Test Date: 20210425; Test Name: Potassium; Test Result: Inconclusive ; Result Unstructured Data: 4.4; Test Date: 20210426; Test Name: Potassium; Test Result: Inconclusive ; Result Unstructured Data: 4.4; Test Date: 20210424; Test Name: Sodium; Test Result: Inconclusive ; Result Unstructured Data: 141; Test Date: 20210425; Test Name: Sodium; Test Result: Inconclusive ; Result Unstructured Data: 141; Test Date: 20210426; Test Name: Sodium; Test Result: Inconclusive ; Result Unstructured Data: 141; Test Date: 20210424; Test Name: Blood urea nitrogen; Test Result: Inconclusive ; Result Unstructured Data: 39; Test Date: 20210425; Test Name: Blood urea nitrogen; Test Result: Inconclusive ; Result Unstructured Data: 39; Test Date: 20210426; Test Name: Blood urea nitrogen; Test Result: Inconclusive ; Result Unstructured Data: 37; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: 101.1 F; Test Date: 20210421; Test Name: Catheterisation cardiac; Result Unstructured Data: Revealed moderate pulmonary hypertension with right atrium (RA) 7, right ventricle (RV) 12, pressure wave (PW) 15, PA 62/ 25/40, PA saturation 63 %, CO 7, CI 3.52; Test Date: 20210424; Test Name: Hemoglobin; Test Result: Inconclusive ; Result Unstructured Data: 8.4; Test Date: 20210425; Test Name: Hemoglobin; Test Result: Inconclusive ; Result Unstructured Data: 8.2; Test Date: 20210426; Test Name: Hemoglobin; Test Result: Inconclusive ; Result Unstructured Data: 8.3; Test Date: 20210424; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 146; Test Date: 20210425; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 159; Test Date: 20210426; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: 159; Test Date: 20210424; Test Name: Red blood cell count; Test Result: Inconclusive ; Result Unstructured Data: 3.31; Test Date: 20210425; Test Name: Red blood cell count; Test Result: Inconclusive ; Result Unstructured Data: 3.24; Test Date: 20210426; Test Name: Red blood cell count; Test Result: Inconclusive ; Result Unstructured Data: 3.30; Test Date: 202104; Test Name: Weight; Test Result: Inconclusive ; Result Unstructured Data: up by 4 lbs since discharge from hospital; Test Date: 2021; Test Name: Weight; Test Result: Inconclusi

Allergies:

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

Symptoms: Condition aggravated; Mitral valve incompetence; Condition aggravated; Steroid diabetes; pyrexia; Lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at; Diarrhea; Weight fluctuation; Limb discomfort; Rash; Acute hypoxemic respiratory failure; pulmonary arterial hypertension; Influenza B; COVID-19; COVID-19 pneumonia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACUTE RESPIRATORY FAILURE (Acute hypoxemic respiratory failure), COVID-19 PNEUMONIA (COVID-19 pneumonia), COVID-19 (COVID-19), PULMONARY ARTERIAL HYPERTENSION (pulmonary arterial hypertension), INFLUENZA (Influenza B), the first episode of CONDITION AGGRAVATED (Condition aggravated), MITRAL VALVE INCOMPETENCE (Mitral valve incompetence), the second episode of CONDITION AGGRAVATED (Condition aggravated), STEROID DIABETES (Steroid diabetes), PYREXIA (pyrexia), OEDEMA PERIPHERAL (Lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at), DIARRHOEA (Diarrhea), WEIGHT FLUCTUATION (Weight fluctuation), LIMB DISCOMFORT (Limb discomfort) and RASH (Rash) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension, METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) tablet for Systemic lupus erythematosus and an unknown indication and NIFEDIPINE for Hypertension. The patient's past medical history included Calcium deficiency, Obstructive sleep apnea syndrome, Peripheral arterial disease, Shortness of breath and Continuous positive airway pressure. Family history included COVID-19 (Brother covid-19 positive). Concurrent medical conditions included Pulmonary arterial hypertension (PAH/ High BP disorder/ increased pressure of pulmonary circulation) since 01-Aug-2019, Systemic lupus erythematosus (on CPAP), Hypercalcemia, Hypertension, Systemic lupus erythematosis, Peripheral arterial occlusive disease and Dyspnoea. Concomitant products included AMBRISENTAN (LETAIRIS), SILDENAFIL CITRATE (REVATIO), CALCIUM CITRATE, ERGOCALCIFEROL (CITRACAL + D [CALCIUM CITRATE;ERGOCALCIFEROL]), DIGOXIN (LANOXIN DIGOXIN), EPINEPHRINE (EPIPEN), ESCITALOPRAM OXALATE (LEXAPRO), FOLIC ACID (FOLVITE [FOLIC ACID]), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), FAMOTIDINE (PEPCID [FAMOTIDINE]), FUROSEMIDE (LASIX [FUROSEMIDE]), SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) and APIXABAN (ELIQUIS) for an unknown indication. On 01-Aug-2019, the patient TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .25 milligram every eight hours. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 1 milligram every eight hours On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.5 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .125 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 3.875 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 3 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.875 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to at an unspecified dose and TREPROSTINIL DIOLAMIN (ORENITRAM) (unknown route) dosage was changed to at an unspecified dose., METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) (unknown route) 16 milligram once a day and NIFEDIPINE (unknown route) at an unspecified dose. On 23-Mar-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant). On 06-Apr-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced ACUTE RESPIRATORY FAILURE (Acute hypoxemic respiratory failure) (seriousness criteria hospitalization and medically significant), PULMONARY ARTERIAL HYPERTENSION (pulmonary arterial hypertension) (seriousness criteria hospitalization and medically significant) and INFLUENZA (Influenza B) (seriousness criterion hospitalization). On an unknown date, the patient experienced the first episode of CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion hospitalization), MITRAL VALVE INCOMPETENCE (Mitral valve incompetence) (seriousness criteria hospitalization and medically significant), the second episode of CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion hospitalization), STEROID DIABETES (Steroid diabetes) (seriousness criteria hospitalization and medically significant), PYREXIA (pyrexia) (seriousness criterion hospitalization), OEDEMA PERIPHERAL (Lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), WEIGHT FLUCTUATION (Weight fluctuation) (seriousness criterion hospitalization), LIMB DISCOMFORT (Limb discomfort) (seriousness criterion hospitalization) and RASH (Rash) (seriousness criterion hospitalization). The patient was hospitalized from 23-Mar-2021 to 29-Mar-2021 due to COVID-19 PNEUMONIA, then on 06-Apr-2021 due to CONDITION AGGRAVATED, COVID-19, DIARRHOEA, INFLUENZA, LIMB DISCOMFORT, OEDEMA PERIPHERAL, PULMONARY ARTERIAL HYPERTENSION, PYREXIA, RASH, STEROID DIABETES and WEIGHT FLUCTUATION, and then on 16-Apr-2021 due to ACUTE RESPIRATORY FAILURE. On 29-Mar-2021, COVID-19 PNEUMONIA (COVID-19 pneumonia) outcome was unknown. On 26-Apr-2021, INFLUENZA (Influenza B) outcome was unknown. At the time of the report, ACUTE RESPIRATORY FAILURE (Acute hypoxemic respiratory failure), COVID-19 (COVID-19), PULMONARY ARTERIAL HYPERTENSION (pulmonary arterial hypertension), MITRAL VALVE INCOMPETENCE (Mitral valve incompetence), the last episode of CONDITION AGGRAVATED (Condition aggravated), STEROID DIABETES (Steroid diabetes), PYREXIA (pyrexia), OEDEMA PERIPHERAL (Lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at), DIARRHOEA (Diarrhea), WEIGHT FLUCTUATION (Weight fluctuation), LIMB DISCOMFORT (Limb discomfort) and RASH (Rash) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Weight: up by 4 lbs since discharge from hospital (Inconclusive) up by 4 lbs since discharge from hospital. On 21-Apr-2021, Catheterisation cardiac: abnormal (abnormal) Revealed moderate pulmonary hypertension with right atrium (RA) 7, right ventricle (RV) 12, pressure wave (PW) 15, PA 62/ 25/40, PA saturation 63 %, CO 7, CI 3.52. On 24-Apr-2021, Blood creatinine: 1.68 (Inconclusive) 1.68. On 24-Apr-2021, Blood glucose: 90 (Inconclusive) 90. On 24-Apr-2021, Blood potassium: 4.1 (Inconclusive) 4.1. On 24-Apr-2021, Blood sodium: 141 (Inconclusive) 141. On 24-Apr-2021, Blood urea: 39 (Inconclusive) 39. On 24-Apr-2021, Haemoglobin: 8.4 (Inconclusive) 8.4. On 24-Apr-2021, Platelet count: 146 (Inconclusive) 146. On 24-Apr-2021, Red blood cell count: 3.31 (Inconclusive) 3.31. On 24-Apr-2021, White blood cell count: 4.79 (Inconclusive) 4.79. On 25-Apr-2021, Blood creatinine: 1.59 (Inconclusive) 1.59. On 25-Apr-2021, Blood glucose: 117 (Inconclusive) 117. On 25-Apr-2021, Blood potassium: 4.4 (Inconclusive) 4.4. On 25-Apr-2021, Blood sodium: 141 (Inconclusive) 141. On 25-Apr-2021, Blood urea: 39 (Inconclusive) 39. On 25-Apr-2021, Haemoglobin: 8.2 (Inconclusive) 8.2. On 25-Apr-2021, Platelet count: 159 (Inconclusive) 159. On 25-Apr-2021, Red blood cell count: 3.24 (Inconclusive) 3.24. On 25-Apr-2021, White blood cell count: 5.51 (Inconclusive) 5.51. On 26-Apr-2021, Blood creatinine: 1.54 (Inconclusive) 1.54. On 26-Apr-2021, Blood glucose: 90 (Inconclusive) 90. On 26-Apr-2021, Blood potassium: 4.4 (Inconclusive) 4.4. On 26-Apr-2021, Blood sodium: 141 (Inconclusive) 141. On 26-Apr-2021, Blood urea: 37 (Inconclusive) 37. On 26-Apr-2021, Haemoglobin: 8.3 (Inconclusive) 8

Other Meds: LETAIRIS; REVATIO; CITRACAL + D [CALCIUM CITRATE;ERGOCALCIFEROL]; LANOXIN DIGOXIN; EPIPEN; LEXAPRO; FOLVITE [FOLIC ACID]; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; PEPCID [FAMOTIDINE]; LASIX [FUROSEMIDE]; ALDACTONE [SPIRONOLACTONE]; ELIQUIS;

Current Illness: Dyspnoea; Hypercalcemia; Hypertension; Peripheral arterial occlusive disease; Pulmonary arterial hypertension (PAH/ High BP disorder/ increased pressure of pulmonary circulation); Systemic lupus erythematosis; Systemic lupus erythematosus (on CPAP)

ID: 1340282
Sex: F
Age: 61
State: TX

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 05/22/2021
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: heart palpitations; itching all over the body; cannot walk very long, and legs are shaky.; short of breath; Athma exacerbations; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (short of breath), PALPITATIONS (heart palpitations) and PRURITUS (itching all over the body) in a 61-year-old female patient 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 Gastric bypass. Concurrent medical conditions included Asthma. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (short of breath) (seriousness criterion medically significant) and ASTHMA (Athma exacerbations). On an unknown date, the patient experienced PALPITATIONS (heart palpitations) (seriousness criterion medically significant), PRURITUS (itching all over the body) (seriousness criterion medically significant) and GAIT DISTURBANCE (cannot walk very long, and legs are shaky.). At the time of the report, DYSPNOEA (short of breath) and ASTHMA (Athma exacerbations) had not resolved and PALPITATIONS (heart palpitations), PRURITUS (itching all over the body) and GAIT DISTURBANCE (cannot walk very long, and legs are shaky.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. The patients treatment medication information included oxygen treatment, Benadryl, and prednisone. Company comment: 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. Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Additional Information Was received. Updated the reporters information and added events(Palpitations , Pruritus, Gait Disturbance); 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: Asthma

ID: 1340283
Sex: M
Age: 63
State: NJ

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 05/22/2021
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: feel weak; this one really scared me; bone pain; Dizzy; arm is still painful; I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened; Joint pain; Achy, body pain; worst experience, I was in coma for 2 days; hallucinated; was sweating all over; Did not eat in two days; not woke up, just sleep; This spontaneous case was reported by a consumer and describes the occurrence of COMA (worst experience, I was in coma for 2 days) and HALLUCINATION (hallucinated) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE and Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine and PNEUMOCOCCAL VACCINE. On 05-May-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced COMA (worst experience, I was in coma for 2 days) (seriousness criterion medically significant), HALLUCINATION (hallucinated) (seriousness criterion medically significant), HYPERHIDROSIS (was sweating all over), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep), BONE PAIN (bone pain), DIZZINESS (Dizzy), PAIN IN EXTREMITY (arm is still painful), CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened), ARTHRALGIA (Joint pain) and MYALGIA (Achy, body pain). On 07-May-2021, the patient experienced FEAR (this one really scared me) and ASTHENIA (feel weak). On 07-May-2021, COMA (worst experience, I was in coma for 2 days), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep) and CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened) had resolved. At the time of the report, HALLUCINATION (hallucinated), HYPERHIDROSIS (was sweating all over), FEAR (this one really scared me), DIZZINESS (Dizzy) and MYALGIA (Achy, body pain) outcome was unknown and BONE PAIN (bone pain), ASTHENIA (feel weak), PAIN IN EXTREMITY (arm is still painful) and ARTHRALGIA (Joint pain) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The patient did not receive any treatment medication. No concomitant medication was reported. The patient spoke to his doctor about not getting the 2nd shot. 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: 1340284
Sex: M
Age: 64
State: NV

Vax Date: 03/13/2021
Onset Date: 04/12/2021
Rec V Date: 05/22/2021
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: 202104; Test Name: ekg; Result Unstructured Data: Showed mild Heart Attack

Allergies:

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

Symptoms: This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) and CHEST PAIN (Pain in the chest) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. Concomitant products included LISINOPRIL and ATORVASTATIN. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria medically significant and life threatening), CHEST PAIN (Pain in the chest) (seriousness criterion life threatening), LETHARGY (Lethargic), DYSPEPSIA (Heart ache) and FATIGUE (Tired). On an unknown date, the patient experienced HEADACHE (Headache). On 14-Apr-2021, MYOCARDIAL INFARCTION (Myocardial infarction) and CHEST PAIN (Pain in the chest) outcome was unknown. At the time of the report, LETHARGY (Lethargic) and FATIGUE (Tired) had not resolved, DYSPEPSIA (Heart ache) was resolving and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Electrocardiogram: abnormal Showed mild Heart Attack. His doctor gave him nitroglycerin which he could not take due to headache and full aspirin. His cardiologist appointment is coming up on 25MAY2021. 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. Further information has been requested. This case was linked to MOD-2021-114362 (Patient Link).; 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. Further information has been requested.

Other Meds: LISINOPRIL; ATORVASTATIN

Current Illness: Penicillin allergy

ID: 1340285
Sex: F
Age:
State: MO

Vax Date: 04/03/2021
Onset Date: 05/01/2021
Rec V Date: 05/22/2021
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: body temperature; Test Result: Inconclusive ; Result Unstructured Data: 99.9

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis) in a 47-year-old female patient 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 Leukocytoclastic vasculitis (had that earlier couple years ago after I came back from vacation but it was on both the legs). Concurrent medical conditions included Migraine. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced INSOMNIA (didn't sleep all night), NAUSEA (nauseous) and VACCINATION SITE PAIN (injection site pain). On 02-May-2021, the patient experienced MIGRAINE (migraine), MALAISE (Not feeling great), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). On 03-May-2021, the patient experienced CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis) (seriousness criterion medically significant), PRURITUS (leg were itching) and RASH (had little red dots everywhere on right legs). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage), VACCINATION SITE BRUISING (Vaccination site bruising) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, CUTANEOUS VASCULITIS (looked like Leukocytoclastic vasculitis), INSOMNIA (didn't sleep all night), MIGRAINE (migraine), PRURITUS (leg were itching), MALAISE (Not feeling great), VACCINATION SITE HAEMORRHAGE (Vaccination site hemorrhage), VACCINATION SITE BRUISING (Vaccination site bruising), RASH (had little red dots everywhere on right legs), FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills), NAUSEA (nauseous), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (Inconclusive) 99.9. No relevant concomitant medications were reported. Treatment for the events included acetaminophen, Excedrin and ice pack. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the 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. This case was linked to MOD-2021-114413 (Patient Link).; 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: Migraine

ID: 1340286
Sex: F
Age:
State: WA

Vax Date: 04/14/2021
Onset Date: 04/22/2021
Rec V Date: 05/22/2021
Hospital:

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

Lab Data: Test Date: 20210501; Test Name: Chest examination; Result Unstructured Data: normal; Test Date: 20210501; Test Name: EKG; Result Unstructured Data: normal

Allergies:

Symptom List: Tremor

Symptoms: hiccups back; she felt her head is hot to the top; Chest tightness; Headache got worse; left arm twinges; Chest started hurting bad; extreme itchy left inner ear/ itchy left side of the neck; swollen up the left jaw; swollen lymph node on left side of the face; Sensation of and in left arm that was buzzing with alcohol and occasional ache; Neck muscle Pain affects swallowing; continuing neck pain that some days is lighter,neck muscle pain going up to mouth, up to tongue, going down to clavicle/felt like whiplash on the neck/front of neck sore; Neck muscle soreness; neck muscle Pain; general pain and soreness coupled with twinges of more acute pain; general ache; heart squeezing and angina; Chest pain; Chest pain felt like heart burn; painful hiccups; felt chest tightness; This spontaneous case was reported by a medical assistant (subsequently medically confirmed) and describes the occurrence of ANGINA PECTORIS (heart squeezing and angina) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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 MESALAMINE for Ulcer gastrointestinal. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced ANGINA PECTORIS (heart squeezing and angina) (seriousness criterion medically significant), HICCUPS (painful hiccups), CHEST DISCOMFORT (felt chest tightness), CHEST PAIN (Chest pain), DYSPEPSIA (Chest pain felt like heart burn) and MYALGIA (general pain and soreness coupled with twinges of more acute pain; general ache). On 23-Apr-2021, the patient experienced DYSPHAGIA (Neck muscle Pain affects swallowing), NECK PAIN (continuing neck pain that some days is lighter,neck muscle pain going up to mouth, up to tongue, going down to clavicle/felt like whiplash on the neck/front of neck sore), PAIN IN EXTREMITY (Sensation of and in left arm that was buzzing with alcohol and occasional ache) and MYALGIA (Neck muscle soreness; neck muscle Pain). On 29-Apr-2021, the patient experienced PRURITUS (extreme itchy left inner ear/ itchy left side of the neck), SWELLING FACE (swollen up the left jaw), LYMPHADENOPATHY (swollen lymph node on left side of the face), CHEST PAIN (Chest started hurting bad) and PAIN IN EXTREMITY (left arm twinges). On 05-May-2021, the patient experienced HICCUPS (hiccups back), HOT FLUSH (she felt her head is hot to the top), CHEST DISCOMFORT (Chest tightness) and HEADACHE (Headache got worse). On 23-Apr-2021, ANGINA PECTORIS (heart squeezing and angina), CHEST DISCOMFORT (felt chest tightness), CHEST PAIN (Chest pain) and DYSPEPSIA (Chest pain felt like heart burn) had resolved. On 27-Apr-2021, HICCUPS (painful hiccups), PAIN IN EXTREMITY (Sensation of and in left arm that was buzzing with alcohol and occasional ache) and MYALGIA (general pain and soreness coupled with twinges of more acute pain; general ache) had resolved. On 01-May-2021, PRURITUS (extreme itchy left inner ear/ itchy left side of the neck) had resolved. At the time of the report, DYSPHAGIA (Neck muscle Pain affects swallowing), NECK PAIN (continuing neck pain that some days is lighter,neck muscle pain going up to mouth, up to tongue, going down to clavicle/felt like whiplash on the neck/front of neck sore), SWELLING FACE (swollen up the left jaw), LYMPHADENOPATHY (swollen lymph node on left side of the face), CHEST PAIN (Chest started hurting bad), HICCUPS (hiccups back), HOT FLUSH (she felt her head is hot to the top), PAIN IN EXTREMITY (left arm twinges), CHEST DISCOMFORT (Chest tightness), MYALGIA (Neck muscle soreness; neck muscle Pain) and HEADACHE (Headache got worse) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Chest scan: normal (normal) normal. On 01-May-2021, Electrocardiogram: normal (normal) normal. 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. 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. The SD narrative is complex and a number of the captured events may be duplicates of each other, created due to potential varying descriptions of what may be the same event.; 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. The SD narrative is complex and a number of the captured events may be duplicates of each other, created due to potential varying descriptions of what may be the same event.

Other Meds: MESALAMINE

Current Illness:

ID: 1340287
Sex: F
Age: 35
State: MD

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 05/22/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (felt out of it) and ANAPHYLACTIC REACTION (anaphylactic reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Smoker and Detergent sensitivity (Thirteen years ago, contact allergies with Woolite and Tide laundry detergent) since 2008. Concomitant products included AMFETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication. On 30-Apr-2021 at 11:12 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (felt out of it) (seriousness criteria medically significant), ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant), DIZZINESS (felt dizzy), FEEDING DISORDER (unable to eat until 4pm) and DYSPNOEA (hard time breathing). On 30-Apr-2021 at 1:00 PM, the patient experienced OROPHARYNGEAL DISCOMFORT (throat started to clamp up). On 01-May-2021, the patient experienced PHARYNGEAL SWELLING (throat started to get a little swollen), THROAT IRRITATION (throat started to get a little itchy) and OROPHARYNGEAL PAIN (Sore throat). On 30-Apr-2021 at 4:00 PM, FEEDING DISORDER (unable to eat until 4pm) had resolved. At the time of the report, ALTERED STATE OF CONSCIOUSNESS (felt out of it), ANAPHYLACTIC REACTION (anaphylactic reaction), DIZZINESS (felt dizzy) and OROPHARYNGEAL DISCOMFORT (throat started to clamp up) was resolving and DYSPNOEA (hard time breathing), PHARYNGEAL SWELLING (throat started to get a little swollen), THROAT IRRITATION (throat started to get a little itchy) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient has never had a reaction to vaccines or latex. After waiting in the vaccinating provider's observation area, she felt fine. On the drive home she felt dizzy and a little out of it. Her Epi-Pen had expired. She took Claritin and laid down to see if the reaction would get better or worse. The symptoms got better 2.5-3 hours (3:30-4pm) later. Things were better and she felt fine. She took Claritin for a total of 4 days following the injection. She did contact her healthcare professional, who referred her to an allergist and her appointment with the allergist is pending. Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Anaphylactic reaction is consistent with the product safety profile; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Anaphylactic reaction is consistent with the product safety profile.

Other Meds: ADDERALL

Current Illness: Detergent sensitivity (Thirteen years ago, contact allergies with Woolite and Tide laundry detergent); Smoker

ID: 1340288
Sex: M
Age: 64
State: CA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 05/22/2021
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: Test Name: blood pressure; Result Unstructured Data: 229/147

Allergies:

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

Symptoms: blood pressure that was at 229/147; a terrible headache that continued to the next day to a migraine; terrible headache that continued to the next day to a migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure that was at 229/147) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced MIGRAINE (a terrible headache that continued to the next day to a migraine) and HEADACHE (terrible headache that continued to the next day to a migraine). On 31-Jan-2021, the patient experienced HYPERTENSION (blood pressure that was at 229/147) (seriousness criterion intervention required). On 31-Jan-2021, HYPERTENSION (blood pressure that was at 229/147) had resolved. At the time of the report, MIGRAINE (a terrible headache that continued to the next day to a migraine) and HEADACHE (terrible headache that continued to the next day to a migraine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure abnormal: 229/147 (abnormal) 229/147. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. On 31-Jan-2021, the patient went to urgent care due headache changing into a migraine. The reporter stated, urgent care would not provide treatment due to how high the blood pressure was and advised the patient to go to the emergency department. The patient went to the emergency department around 6:00 pm and was treated for elevated blood pressure of 229/147. The patient was not admitted nut was advised to follow up with a primary care physician. Treatment details were not provided. 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. This case was linked to US-MODERNATX, INC.-MOD-2021-114821 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-114821:

Other Meds:

Current Illness:

ID: 1340289
Sex: M
Age: 84
State: OH

Vax Date: 03/19/2021
Onset Date: 04/27/2021
Rec V Date: 05/22/2021
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: he crippled; not able to move; he has extreme pain/stabbing pain; he has overactive immune system; he can hardly walk; he can not do anything by himself/can not go to bathroom; can not get out of bed; he can not come down to eat so I need to bring food; when he is trying to lie down I need to lift up his feet,; he can barely feels his feet, its numb; This spontaneous case was reported by a consumer and describes the occurrence of DISABILITY (he crippled) and IMMOBILE (not able to move) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Polymyalgia. Concomitant products included PREDNISONE for Polymyalgia. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced DISABILITY (he crippled) (seriousness criterion medically significant), IMMOBILE (not able to move) (seriousness criterion medically significant), PAIN (he has extreme pain/stabbing pain), IMMUNE SYSTEM DISORDER (he has overactive immune system), GAIT DISTURBANCE (he can hardly walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he can not do anything by himself/can not go to bathroom), BEDRIDDEN (can not get out of bed), MOBILITY DECREASED (he can not come down to eat so I need to bring food), HYPOKINESIA (when he is trying to lie down I need to lift up his feet,) and HYPOAESTHESIA (he can barely feels his feet, its numb). At the time of the report, DISABILITY (he crippled), IMMOBILE (not able to move), PAIN (he has extreme pain/stabbing pain), IMMUNE SYSTEM DISORDER (he has overactive immune system), GAIT DISTURBANCE (he can hardly walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he can not do anything by himself/can not go to bathroom), BEDRIDDEN (can not get out of bed), MOBILITY DECREASED (he can not come down to eat so I need to bring food), HYPOKINESIA (when he is trying to lie down I need to lift up his feet,) and HYPOAESTHESIA (he can barely feels his feet, its numb) had not resolved. Not Provided Additional concomitant medications included blood pressure medication (not otherwise specified). Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. Though the events reported are expected due to the patient's medical history of polymyalgia, 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. This case was linked to MOD-2021-114778 (Patient Link).; Sender's Comments: Though the events reported are expected due to the patient's medical history of polymyalgia, 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: PREDNISONE

Current Illness: Polymyalgia

ID: 1340290
Sex: F
Age: 69
State: MD

Vax Date: 03/06/2021
Onset Date:
Rec V Date: 05/22/2021
Hospital: Y

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: Pre-scheduled surgery; Missed second dose time window due to surgery; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SURGERY (Pre-scheduled surgery) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) 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 an unknown date, the patient experienced SURGERY (Pre-scheduled surgery) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose time window due to surgery). At the time of the report, SURGERY (Pre-scheduled surgery) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose time window due to surgery) had resolved. 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. No concomitant drugs were reported. No treatment information was provided. Patient received the first dose of the Moderna COVID-19 vaccine on 06Mar2021. The patient was then hospitalized for a surgery that was believe to be pre-scheduled. Due to this surgery, the patient did not receive their second dose of the vaccine and is now outside of the allowed time window. The patient is looking to receive this second dose of the vaccine on 11May2021. No other side effects were reported from the first dose of the vaccine. This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # 027A21A and an AE of Surgery. Based on the current available information and temporal association between the use of the product and the start date of the event of Surgery, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # 027A21A and an AE of Surgery. Based on the current available information and temporal association between the use of the product and the start date of the event of Surgery, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1340291
Sex: M
Age: 18
State: MD

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 05/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Not feeling well; Feels hot; Achiness all over; Chills; inadvertently given the Moderna vaccine (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling well), FEELING HOT (Feels hot), MYALGIA (Achiness all over) and CHILLS (Chills) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (inadvertently given the Moderna vaccine (2nd dose)). On 11-May-2021, the patient experienced VACCINATION COMPLICATION (Not feeling well) (seriousness criterion medically significant), FEELING HOT (Feels hot) (seriousness criterion medically significant), MYALGIA (Achiness all over) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 10-May-2021, WRONG PRODUCT ADMINISTERED (inadvertently given the Moderna vaccine (2nd dose)) had resolved. At the time of the report, VACCINATION COMPLICATION (Not feeling well), FEELING HOT (Feels hot), MYALGIA (Achiness all over) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications and lab values were reported. No treatment related information has been reported. This report refers to a case of wrong product administered for mRNA -1273, lot # 044B21A with AEs. 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: This report refers to a case of wrong product administered for mRNA -1273, lot # 044B21A with AEs. 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: 1340292
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 05/22/2021
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: fell and broke her ankle; fell; This spontaneous case was reported by a consumer and describes the occurrence of ANKLE FRACTURE (fell and broke her ankle) and FALL (fell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANKLE FRACTURE (fell and broke her ankle) (seriousness criterion medically significant) and FALL (fell) (seriousness criterion medically significant). The patient was treated with Surgery for Ankle fracture. At the time of the report, ANKLE FRACTURE (fell and broke her ankle) and FALL (fell) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Treatment for ankle fracture included surgery. Company Comment Based on reporter's causality and lack of information regarding the events, the events are assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: contact information provided; serious criteria updated for events; Sender's Comments: Based on reporter's causality and lack of information regarding the events, the events are assessed as unlikely related to mRNA-1273.

Other Meds:

Current Illness:

ID: 1340293
Sex: F
Age: 53
State: CA

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 05/22/2021
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: 20210510; Test Name: Blood glucose; Test Result: Inconclusive; Result Unstructured Data: Slightly high blood glucose; Test Date: 20210512; Test Name: Blood glucose; Test Result: 320 mg/dl; Result Unstructured Data: High blood glucose.

Allergies:

Symptom List: Pain in extremity

Symptoms: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (Out of Control Blood Sugar (320 mg/dL)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, LOSARTAN for Prevention, INSULIN LISPRO (HUMALOG) for Type 1 diabetes mellitus. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced INJECTION SITE PAIN (A little injection site pain). On 11-May-2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (Out of Control Blood Sugar (320 mg/dL)) (seriousness criteria medically significant). On 11-May-2021, INJECTION SITE PAIN (A little injection site pain) had resolved. At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (Out of Control Blood Sugar (320 mg/dL)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Blood glucose: slightly high blood glucose mg/dl (Inconclusive) Slightly high blood glucose. On 12-May-2021, Blood glucose: 320 mg/dl (High) High blood glucose. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The night of vaccination, she had slightly high blood glucose, but it got worse as the days went by. On 12-May-2021, her blood glucose reading was 320 mg/dl. It's high even when she is not eating. She increased her insulin dose triple fold to control her blood glucose. She called her Doctor and waited for him to call back. She stated that she had a very good control over her blood glucose. She knew that the uncontrolled blood glucose was caused by the vaccine. 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: LOSARTAN; CRESTOR; HUMALOG

Current Illness: Type 1 diabetes mellitus

ID: 1340294
Sex: M
Age:
State: MO

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 05/22/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Hospitalization involving some serious health conditions; blood clot removed from legs; second dose has passed over 28 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Hospitalization involving some serious health conditions) and THROMBOSIS (blood clot removed from legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cardiac transplant in 2004. Concomitant products included TACROLIMUS and MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) for Prophylaxis against heart transplant rejection, APIXABAN (ELIQUIS) for Thrombosis prophylaxis. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization involving some serious health conditions) (seriousness criterion hospitalization), THROMBOSIS (blood clot removed from legs) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (second dose has passed over 28 days). The patient was treated with Surgery (blood clot removed) for Thrombosis. At the time of the report, HOSPITALISATION (Hospitalization involving some serious health conditions) and THROMBOSIS (blood clot removed from legs) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose has passed over 28 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information not provided. It was reported that, the patient missed an appointment for his second dose due to hospitalization involving some serious health conditions. The patient was in the hospital for extended period and underwent surgery to get blood clot removed from legs during the hospitalization. Very limited information has been provided for the event at this time. However, details of hospitalization and compliance with anti-coagulant therapy is required for further evaluation. This report also This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.; Sender's Comments: Very limited information has been provided for the event at this time. However, details of hospitalization and compliance with anti-coagulant therapy is required for further evaluation. This report also This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.

Other Meds: TACROLIMUS; MYCOPHENOLATE; ELIQUIS

Current Illness:

ID: 1340295
Sex: M
Age: 68
State: IL

Vax Date: 02/28/2021
Onset Date: 03/02/2021
Rec V Date: 05/22/2021
Hospital: Y

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

Lab Data: Test Date: 20210310; Test Name: Chest X Ray; Result Unstructured Data: COVID pneumonia; Test Date: 202103; Test Name: Computerized axial tomography; Test Result: Inconclusive ; Result Unstructured Data: No significant finding; Test Date: 20210303; Test Name: Rapid nasal swab test; Test Result: Positive ; Result Unstructured Data: Positive for CoVid 19 vaccine

Allergies:

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

Symptoms: COVID-19 pneumonia; Lost 17 pounds in 6 six days; Shortness of breath; Pain localised; Fever; Cough; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A and 028A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis. The patient's past medical history included Alcohol use from 1964 to 26-Dec-1989, Cigarette smoker from 1964 to 09-Sep-2010 and Ulcerative colitis. Concurrent medical conditions included Emphysema (Severe emphysema from smoking, started in 2003 or 2004.) since 2003 and Diabetes since 2013. Concomitant products included INSULIN ASPART (NOVOLOG), DULAGLUTIDE (TRULICITY) and INSULIN DEGLUDEC (TRESIBA) for Diabetes, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Emphysema, FISH OIL, ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]) and FOLIC ACID for Supplementation therapy. In 2014, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg twice a day. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant), COUGH (Cough) and PYREXIA (Fever). On 10-Mar-2021, the patient experienced WEIGHT DECREASED (Lost 17 pounds in 6 six days), DYSPNOEA (Shortness of breath) and PAIN (Pain localised). The patient was hospitalized for 7 days due to COVID-19 PNEUMONIA. On 16-Mar-2021, WEIGHT DECREASED (Lost 17 pounds in 6 six days) and PAIN (Pain localised) had resolved. At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia) was resolving, DYSPNOEA (Shortness of breath) had resolved and COUGH (Cough) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive for CoVid 19 vaccine. On 10-Mar-2021, Chest X-ray: abnormal (abnormal) COVID pneumonia. In March 2021, Computerised tomogram: inconclusive (Inconclusive) No significant finding. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 PNEUMONIA (COVID-19 pneumonia), WEIGHT DECREASED (Lost 17 pounds in 6 six days) and PAIN (Pain localised) to be not related. No further causality assessments were provided for DYSPNOEA (Shortness of breath), COUGH (Cough) and PYREXIA (Fever). Concomitant medications also included and unspecified probiotic. Treatment for the events included remdesivir, prednisone, paracetamol, and rivaroxaban. This case concerns a 68-year-old male with a serious unexpected event of COVID-19 pneumonia, and nonserious unexpected cough, dyspnea, pain, weight decreased, and expected pyrexia. Latency 2 days after first mRNA-1273 dose. Based on 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. This case was linked to MOD-2021-108848 (Patient Link).; Sender's Comments: This case concerns a 68-year-old male with a serious unexpected event of COVID-19 pneumonia, and nonserious unexpected cough, dyspnea, pain, weight decreased, and expected pyrexia. Latency 2 days after first mRNA-1273 dose. Based on 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: NOVOLOG; TRULICITY; TRESIBA; TRELEGY; FISH OIL; VITAMIN C PLUS [ASCORBIC ACID]; FOLIC ACID

Current Illness: Diabetes; Emphysema (Severe emphysema from smoking, started in 2003 or 2004.)

ID: 1340296
Sex: F
Age:
State: VA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 05/22/2021
Hospital:

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

Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:185; Comments: Fast heart rate. 185 BPM when lying down

Allergies:

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

Symptoms: Fast heart rate; dizziness; Nausea; vomiting; This is a spontaneous report from a contactable other hcp (Patient herself). A 37-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: EL8982), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 16:30 (age at the time of vaccination was 37-year-old) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included cyclic vomiting syndrome, Peanut allergy, Allergy to nuts from an unknown date and unknown if ongoing. Other medications in two weeks Concomitant medication(s) included nystatin (NYSTATIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took compazine [prochlorperazine edisylate], reglan [metoclopramide] , betadine [povidone-iodine] and experienced drug hypersensitivity. The patient has no COVID prior to vaccination. The patient has no other vaccine in 4 weeks.The patient was not tested for COVID post vaccination. The patient underwent lab tests and procedures which included heart rate: 185 on Fast heart rate. 185 BPM when lying down. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of fast heart rate (heart rate increased), nausea (nausea), dizziness (dizziness), vomiting (vomiting). As a result patient was in [Emergency room/department or urgent care]. Treatment received yes with IV fluids and Phenergan 12.5 mg. On 14Jan2021 18:00 The patient experienced fast heart rate (medically significant), nausea (medically significant) , dizziness (medically significant), vomiting (medically significant). The outcome of event was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the temporal association, there is a reasonable possibility that the administration of vaccination with BNT162B2 played a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: NYSTATIN

Current Illness:

ID: 1340297
Sex: M
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 05/22/2021
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: Caller indicates he takes "epifen 10mg and no hematoma formation".; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old male patient received dose 1 of bnt162b2 (BNT162B2, Solution for injection, (Batch/Lot Number: EL3302), via an unspecified route of administration on an unspecified date as SINGLE DOSE for an unspecified indication. Medical history included disability from an unknown date and unknown if ongoing. Concomitant medications included epinephrine (EPIPEN) taken for an unspecified indication, naproxen sodium (ALEVE), Aleve (Lot no NAA92FK expiry:Jun2023) taken for disability. Patient was responded by caller when vaccinating Persons with Increased Bleeding Risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection. He just wanted to find out if the things he did affect the potency. He said he did take a blood thinner. Secondly, the local station said one should not take any over the counter medication or pain killer, pain relief pills like aspirin, Ibuprofen, and it did not mention Aleve. The patient had asked whether he could antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. He was responded, recently too the Pfizer vaccine tuesday saw the warnings on the news channel all the things he should have done or not done, daily habits included Aleve, Norco. He was responded the interim ACIP guidelines note that Antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms was not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses was not available at this time and If you were a patient, you should discuss this with your healthcare provider. The patient took Epifen 10mg and no hematoma formation. The outcome of the event was unknown. Follow-up attempts were completed. No further information was expected.

Other Meds: EPIPEN; ALEVE

Current Illness:

ID: 1340298
Sex: M
Age:
State: FL

Vax Date: 01/15/2021
Onset Date: 01/26/2021
Rec V Date: 05/22/2021
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: severe debilitating back spasms; he suffered from "debilitating back spasms" due to a "movement he made. He added he also "had these spasms in the past; massive lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via unspecified route of administration on 15Jan2021 as 1st dose, single for covid-19 immunisation. The patient medical history included spasms, in the past. The concomitant medication was not reported. The patient reported that, he got the first dose of the Pfizer BioNTech vaccine on 15Jan2021. On 26Jan2021, he had a massive lower back pain, he needs to take a metronidazole injection then went to a regular metronidazole. On 26Jan2021, he got severe debilitating back spasms due to a movement he made and went to ER/urgent care where they gave him a dexamethasone shot, methylprednisolone shot, and a 6-8 course of oral prednisone. Is not sure if he was going to finish it, he took the dose 6 and 5, but did not to the 4 yesterday. Wants to make sure it's not causing more problems to finish that. The dexamethasone he believes is long acting and the methylprednisolone may be similar to the regular prednisone. The patient was feeling better, and the muscle relaxers are helping, but he wants to be sure that these medications did not diminish the effectiveness of the vaccine. The hospital was wanting him back to work on the 05Feb2021 to get the second dose, but he wants to be sure these medicines has not affected or impacted the first dose. The outcome of the events was recovering. The patient specified that his symptoms were not related to the vaccine. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the reported "severe debilitating back spasms" and "condition aggravated" cannot be excluded

Other Meds:

Current Illness:

ID: 1340299
Sex: F
Age:
State: VA

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 05/22/2021
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: Test Name: cholesterol; Result Unstructured Data: Test Result:High; Test Name: blood pressure; Result Unstructured Data: Test Result:off the charts/sky rocketed

Allergies:

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

Symptoms: hives; swelling in her throat or tongue; swelling in her throat or tongue; numbness on her lips; straight up her nose, and straight up through her head; It feel like there is pressure in her head; head congestion; She is scared; tongue started being numb; She had a metallic taste in her throat; blood pressure sky rocketed; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in Arm Left on 24Jan2021 02:15 PM (at the age of 71-year-old) as single dose for covid-19 immunization. Medical history included ongoing trigeminal neuralgia, ongoing high cholesterol and is on a cholesterol medication for that, medicine allergies (multiple drug allergies, She has a lot of allergies. She has 10 medicine allergies). Concomitant medication patient received in two weeks included gabapentin 300 taken for trigeminal neuralgia and Ongoing; montelukast; rosuvastatin and Cholesterol medication. The patient experienced tongue started being numb, she had a metallic taste in her throat, blood pressure sky rocketed on 24Jan2021 14:30, hives, swelling in her throat or tongue, swelling in her throat or tongue, numbness on her lips, straight up her nose, and straight up through her head, it feel like there is pressure in her head, head congestion, she is scared on an unspecified date. It was reported that the patient received an injection of the Pfizer-BioNTech COVID-19 vaccine on 24Jan2021. After the injection, she started experiencing a numbness of the tongue and a metallic taste and her blood pressure was "off the charts". She reports the numbness has progressed from the tongue to the lips and the forehead. She reports her tongue is not swollen although it feels like it is swollen and she has not experienced hives or constriction of the throat. Treatment has included Benadryl and Pepcid. The consumer reports the Benadryl helps but makes her drowsy and when she does not take it, her symptoms worsen again. The consumer reports a history of multiple drug allergies and trigeminal neuralgia. Immediately to 10 minutes after, her tongue started being numb. She had a metallic taste in her throat. Her blood pressure sky rocketed. Her daughter is an ER doctor who knows the EMT that was helping her. She suggested they give her Benadryl, but they only had IV Benadryl. That got her a ride to the emergency room. Her reactions to medications include hives or swelling in her throat or tongue. She has an epi pen which she uses when necessary. She avoids those medications at all costs. Her tongue is not as numb right now. She also has numbness on her lips, straight up her nose, and straight up through her head. It feel like there is pressure in her head. It is different than her Trigeminal Neuroglia. Which is a shooting pain sideways from her left ear. She has head congestion, her lips and nose are numb if she doesn't take Benadryl. If she takes Benadryl, she walks around all drowsy, and she can't drive. She had to run errands today. So she did not take Benadryl, and her tongue is numb again. She is scared about taking the second dose. She can't get the numbness to disappear. When she stops taking Benadryl it feels like her tongue is doubling in size, but it is not. Events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The patient underwent lab tests and procedures which included blood cholesterol: high, blood pressure: off the charts/sky rocketed on an unspecified date. Therapeutic measures were taken as a result of hives and swelling in her throat or tongue with Benadryl and Pepcid. The outcome of the event tongue started being numb, She had a metallic taste in her throat, blood pressure sky rocketed was not recovered and was unknown for other events. Follow-up attempts are completed. No further information is expected.

Other Meds: GABAPENTIN; MONTELUKAST; ROSUVASTATIN

Current Illness: Drug allergy (multiple drug allergies, She has a lot of allergies. She has 10 medicine allergies.); High cholesterol (She also has high cholesterol, and is on a cholesterol medication for that); Trigeminal neuralgia

ID: 1340300
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 05/22/2021
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: Test Name: SARS-CoV-2 test; Test Result: Positive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: 10 days after the vaccine, I received a positive PCR Coronavirus test result; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old female patient first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had positive PCR Coronavirus test. It was reported that two days after first Pfizer Coronavirus vaccine patient was exposed to someone who had the virus and 10 days after the vaccine, the patient had positive PCR Coronavirus test result. The following day patient's physician set her up to receive the monoclonal antibody infusion and told that she cannot get the second dose of the Pfizer vaccine for 90 days from the date she received the infusion, but her physician says she may have to start the vaccine over again. The outcome of event was unknown.

Other Meds:

Current Illness:

ID: 1340301
Sex: F
Age:
State: NC

Vax Date: 02/04/2021
Onset Date: 02/06/2021
Rec V Date: 05/22/2021
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: her period came back in less than the usual 28 days and was very heavy. It started on 06Feb2021 and was still ongoing (03Mar2021); This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 04Feb2021 (Lot Number: EL3247) at the age of 32 years old as 2nd dose, single for COVID-19 immunisation. Medical history included anxiety. Concomitant medication included buspirone and etonogestrel (NEXPLANON). The patient previously received BNT162B2, via an unspecified route of administration on the right arm on 14Jan2021 09:30 (Lot Number: EL3247) at the age of 32 years old as 1st dose, single for COVID-19 immunisation. The patient had no other vaccines in 4 weeks and had no known allergies. The patient didn't have COVID prior to the vaccination. The patient was not COVID tested post vaccination. The patient stated that with etonogestrel (NEXPLANON), her period came back in less than the usual 28 days and was very heavy. It started on 06Feb2021 and was still ongoing (03Mar2021). No treatment was done for the adverse event. The outcome of the event was not recovered. information about lot/batch number has been requested.

Other Meds: BUSPIRONE; NEXPLANON

Current Illness:

ID: 1340302
Sex: F
Age:
State: PA

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 05/22/2021
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: This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 15Feb2021 at 11:30 (Batch/Lot Number: EL9266) (at the age of 50-years-old) as 2nd dose, single for COVID-19 immunization. The vaccination facility type was nursing home. The patient's medical history was reported as none and concomitant medications were not reported. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks and other medication in two weeks. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ENS358) on 25Jan2021 at 03:30 PM via an unspecified route of administration, administered in left arm for COVID-19 vaccination. The patient reported that she was 2 years post-menopausal. She had a full period for 6 days starting the night of 15Feb2021 at 07:00 PM on the same day she received her second dose of COVID vaccine. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment included pelvic and internal ultrasound and scheduled uterine (as reported). The outcome of the event was recovering. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am