VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1536993
Sex: F
Age:
State: NJ

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Chills; Headache; Body aches; A spontaneous report was received from a consumer for a 60-year-old female patient who experienced chills, headache, and body aches. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 30 Dec 2020, the patient received his first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient experienced chills, headache and body ache. She took Tylenol and the headache improved. Action taken with mRNA-1273 in response to the event, chills, headache, and body aches, was not provided. The outcome for the event, chills and body ache, was not recovered/resolved. The outcome for the event, headache, was recovering/resolving.; Reporter's Comments: This case concerns a 60-year-old female with nonserious events of expected chills, headache, myalgia. Event onset the same day as the first dose of mRNA-1273. Treatment with Tylenol. Headache resolved, but chills and myalgia ongoing. 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: 1536994
Sex: F
Age: 43
State: TX

Vax Date: 12/23/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Rash on injection site; A spontaneous report was received from a 43 year old female consumer who was participating in the mRNA-1273 Emergency Use Program and developed rash at injection site. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 027KWA) intramuscularly in the left for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient started having a rash at injection site. Patient treated the injection site rash with ibuprofen with no effect. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, rash at injection site, was not known. The reporter did not provide an assessment for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of rash, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1536995
Sex: F
Age: 30
State: OH

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Jun-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) 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 medications reported by investigator No treatment medications provided by the reporter. This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1536996
Sex: F
Age: 50
State: TN

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Fatigue; Redness around injection site; Tenderness at injection site; Swollen and tiny bit raised at injection site; Arm is rashy and velvety; Defined dark circle at injection site; A spontaneous report was received from a consumer concerning a female patient who experienced fatigue, injection site erythema, injection site pain, injection site swelling, rash and injection site discoloration. The patient's medical history and concomitant product use were not provided by the reporter. On 30 Dec 2020, several hours prior to onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020 the patient developed a fatigue; redness, tenderness, discoloration, and swelling around the injection site; and rash. She treated the events with Tylenol. At the time of the report the outcome for the events was unknown. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events were not reported. The reporter did not provide causality for the events.; Reporter'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: 1536997
Sex: M
Age:
State: CA

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 08/09/2021
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: A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events body aches, fever and conscious but very weak. The patient's medical history was not provided. No Concomitant medications were reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection On 31 Dec 2020, the patient experienced body aches, fever and conscious but very weak. No treatment information was reported. The Action taken with mRNA-1273 in response to the events was unknown. The outcome for the events, body aches, fever and conscious but very weak was not reported.; Reporter's Comments: This case concerns a male of unknown age who experienced NS events of unexpected asthenia and expected pyrexia, myalgia. Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. 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:

Current Illness:

ID: 1536998
Sex: F
Age: 50
State: MS

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 08/09/2021
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: Chills; Body aches; A spontaneous reportwas received from a Consumer for a 50-year-old, female patient who received Moderna's COVID-19 vaccine and developed chills and body aches. The patient's medical history, as provided by the reporter, included fibromyalgia. Concomitant medications was not provided. On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 31 Dec 2020, the patient awoke with chills and body aches. Treatment for the events included acetaminophen, quetiapine and gabapentin. Action taken with the second dose of mRNA-1273 in response to the events was not reported. The outcome of the event(s) chills and body aches were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. However, patient's significant medical history of fibromyalgia may have been contributory.

Other Meds:

Current Illness: Fibromyalgia (mentions she has fibromyalgia.)

ID: 1536999
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 08/09/2021
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: A lot of pain around right eye; Right inner ear pain; A spontaneous report was received from a consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a lot of pain around right eye and right inner ear. The patient's medical history was not provided. No concomitant medications were reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# unknown). On an unknown date, the patient experienced a lot of pain around right eye and right inner ear. No treatment information was reported. The Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, a lot of pain around right eye and right inner ear was considered as unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender. The patient's medical history was not provided. The patient experienced an unexpected event of right eye pain and ear pain. The event occurred on unspecified date after the first dose of mRNA-1273 administration. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537000
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) while pregnant. The patient's medical and pregnancy history was not provided. No concomitant medications were reported. On 30 Dec 2020 , the patient received the first dose of mRNA-1273 for prophylaxis of COVID-19 infection. The date of the patient's positive pregnancy test and first day of the last menstrual period were not reported. The estimated date of conception and due date were not reported. Action taken with mRNA-1273 was unknown. The event exposure during pregnancy was considered resolved on 30 Dec 2020.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness: No adverse event (no medical history reported)

ID: 1537001
Sex: F
Age: 34
State: CA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Pregnant at time of vaccination; A spontaneous report was received from a Healthcare professional concerning a 34-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and got pregnant. The patient's medical history was not provided. The pregnancy history of the patient included 4 prior pregnancies with latest pregnancy details were: live birth, full term birth. No concomitant medications were reported. On 30 Dec 2020, the patient received the first dose of mRNA-1273 (Lot#: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On Dec 21 2020, the patient had a positive pregnancy test. The first day of the patient's last menstrual period was 24 Nov 2020. The estimated date of conception was 08 Dec 2020 and the due date was estimated as 30 Aug 2021. Action taken with mRNA-1273 was not applicable. The event Pregnant at time of vaccination was considered resolved on 30 Dec 2020.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1537002
Sex: F
Age:
State: CA

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 08/09/2021
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: 2 raised red hives on my arm below the vaccine injection site; Whole deltoid area was firm; Whole deltoid area was warm; Whole deltoid area was red; Bad pain in her armpit; armpit burning; Soreness at the injection site; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of soreness at injection site, bad pain in her armpit, armpit felt full, armpit felt uncomfortable, armpit burning, armpit has achy feeling, whole deltoid area was red, whole deltoid area was warm, whole deltoid area was firm and 2 raised red hives on my arm below the vaccine injection site. The patient's medical history was not provided. No concomitant medications were reported. On 22 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 011J20A). On the same day, the patient experienced soreness at injection site. The treatment information included advil. On 25 Dec 2020, the patient experienced bad pain in her armpit, armpit felt full, armpit felt uncomfortable, armpit burning, and armpit has achy feeling. No treatment information was reported. On 29 Dec 2020, the patient experienced whole deltoid area was red, whole deltoid area was warm, and whole deltoid area was firm. No treatment information was reported. On 30 Dec 2020, the patient experienced 2 raised red hives on my arm below the vaccine injection site. No treatment information was reported. The Action taken with mRNA-1273 in response to the events was unknown. The outcome for the event, soreness at injection site was considered as resolved on 24 Dec 2020. The outcome for the events, bad pain in her armpit, armpit felt full, armpit felt uncomfortable and armpit has achy feeling was considered as resolved on 27 Dec 2020. The outcome for the events, whole deltoid area was red, whole deltoid area was warm, and whole deltoid area was firm was considered as resolved on 30 Dec 2020. The outcome for the events, armpit burning and 2 raised red hives on my arm below the vaccine injection site was considered as not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537003
Sex: F
Age:
State:

Vax Date: 12/26/2020
Onset Date: 12/26/2020
Rec V Date: 08/09/2021
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: Tested weakly positive for COVID-19; Pretty bad headache; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine and experienced a weakly positive COVID-19 test and headache. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch: unknown) for prophylaxis of COVID-19 infection. On 26 Dec 2020, the patient received her vaccine. On 29 Dec 2020, the Tuesday after she developed a pretty bad headache. The patient also was tested for COVID-19 on an unknown date. The results showed weakly positive for COVID-19 virus. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was unknown. The outcome for the events, a weakly positive COVID-19 test and headache was not provided.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of Covid-19 is assessed as unlikely related. The causality for the event of headache remains possible.

Other Meds:

Current Illness:

ID: 1537004
Sex: F
Age: 42
State: OK

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Heart rate spiked to 129), FLUSHING (Face got very hot), ERYTHEMA (Face got very red), BLOOD GLUCOSE DECREASED (Blood sugar was low) and HYPERHIDROSIS (Sweaty palms) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypothyroidism, Polycystic ovarian syndrome, Raynaud's phenomenon, Penicillin allergy and Drug allergy (Cephalosporins). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) and MONTELUKAST for Allergy, LEVOTHYROXINE for Hypothyroidism, METFORMIN HYDROCHLORIDE (METFORMIN ER) for Polycystic ovarian syndrome. On 30-Dec-2020 at 2:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced PALPITATIONS (feeling of palpitaions). On 30-Dec-2020 at 3:02 PM, the patient experienced HEART RATE INCREASED (Heart rate spiked to 129), FLUSHING (Face got very hot), ERYTHEMA (Face got very red), BLOOD GLUCOSE DECREASED (Blood sugar was low), HYPERHIDROSIS (Sweaty palms), COUGH (Coughing) and DIZZINESS (Felt dizzy). On 06-Jan-2021, the patient experienced DYSPNOEA (Trouble breathing), HYPERSENSITIVITY (Feeling of having allergic reactions to several things) and VACCINATION SITE REACTION (Covid arm). On 05-Feb-2021, the patient experienced REFLUX GASTRITIS (Reflux), ASTHMA (Asthma attacks brough on by smells) and PRESYNCOPE (going to pass out). The patient was treated with OMEPRAZOLE for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Heart rate spiked to 129), FLUSHING (Face got very hot), ERYTHEMA (Face got very red), BLOOD GLUCOSE DECREASED (Blood sugar was low), HYPERHIDROSIS (Sweaty palms), COUGH (Coughing), DIZZINESS (Felt dizzy) and REFLUX GASTRITIS (Reflux) had resolved with sequelae, DYSPNOEA (Trouble breathing), ASTHMA (Asthma attacks brough on by smells), HYPERSENSITIVITY (Feeling of having allergic reactions to several things) and PRESYNCOPE (going to pass out) had resolved and VACCINATION SITE REACTION (Covid arm) and PALPITATIONS (feeling of palpitaions) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Blood glucose: 43 (Low) Low. On 30-Dec-2020, Heart rate: 169 (High) High. On an unknown date, Antibody test: 8.5 (normal) 8.5 and 44.5 (abnormal) 44.5. On an unknown date, Tryptase: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HEART RATE INCREASED (Heart rate spiked to 129), FLUSHING (Face got very hot), ERYTHEMA (Face got very red), BLOOD GLUCOSE DECREASED (Blood sugar was low), HYPERHIDROSIS (Sweaty palms), COUGH (Coughing), DIZZINESS (Felt dizzy), DYSPNOEA (Trouble breathing), REFLUX GASTRITIS (Reflux), ASTHMA (Asthma attacks brough on by smells), HYPERSENSITIVITY (Feeling of having allergic reactions to several things), PRESYNCOPE (going to pass out), VACCINATION SITE REACTION (Covid arm) and PALPITATIONS (feeling of palpitaions) to be related. The antibody level was measured when the patient's symptoms were worst and the level was 44.5. The patient was put on asthma medications. The patient stated she had never been on asthma medication in her life. The patient had to take 3 weeks of steroids to breathe and she had to start omerprazole after steroids. The antibody level fell to 8.5 and the symptoms were less severe. The patient was able to come off asthma medications, except Montelukast. The patient got tested for Mast Cell Activation Syndrome (MCAS), but tryptase test was negative. Treatment included snack intake for blood sugar, diphenhydramine (Benadryl), steroids unspecified, omeprazole and Montelukast. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Patients demographics, Medical history, lab tests, Concomitant medications, new events, out come of the events, and narrative were updated; 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: CLARITIN [LORATADINE]; LEVOTHYROXINE; METFORMIN ER; MONTELUKAST

Current Illness: Drug allergy (Cephalosporins); Hypothyroidism; Penicillin allergy; Polycystic ovarian syndrome; Raynaud's phenomenon

ID: 1537005
Sex: F
Age: 48
State: CA

Vax Date: 12/22/2020
Onset Date: 12/24/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm feels tight on the side; It had gotten much worse; Arm was red; Arm was warm; A spontaneous report was received from a nurse, a 48-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a red arm, arm was warm, and arm feels tight on side. The patient's medical history was not provided. Concomitant medications reported included ascorbic acid and cholecalciferol. On 22 Dec 2020, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 ([LOT# 025520-2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 24 Dec 2020, the patient noticed her arm was red and warm. By 31 Dec 2020, it had gotten worse as her arm was redder and warmer, and it felt tight on the side. She was concerned about how long the reaction lasted and reports never having a reaction like this to previous vaccines. She has rotated warm and cold compresses on the arm but has not taken treatment yet, though her primary care provider advised her to take Claritin. Treatment for the event included warm and cold compresses. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, arm was red, arm was warm, and arm feels tight on side, were unknown.; Reporter'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: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1537006
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed arm pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection, and shortly after developed arm pain (Vaccination site pain). Treatment for the event included ibuprofen. Action taken with mRNA-1273 in response to the event arm pain was not reported. The outcome of the event arm pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537007
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Covid-19; A spontaneous report was received from a consumer concerning a female patient who experienced COVID-19/MedDRA PT: COVID-19. The patient's medical history and concomitant product use were not provided/unknown by the reporter. On an unknown date the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 30-Dec-2020 the patient tested positive for COVID-19. At the time of the report the outcome for the events was unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event were unknown/not reported. The reporter did not provide causality for the event.; Reporter's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of tested positive for COVID and the product use is assessed as unlikely,

Other Meds:

Current Illness:

ID: 1537008
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: arm is swollen really bad to the point she can almost not lift it; arm is swollen really bad to the point she can almost not lift it; A spontaneous report was received from a consumer who is an adult female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe arm is swelling and inability to lift/move the vaccinated arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date in 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date in 2020, after the vaccine administration, the patient experienced severe arm is swelling and inability to lift/move the vaccinated arm. There was no treatment information provided. There were no relevant laboratory tests provided. Action taken with mRNA-1273 in response to the event of arm is swollen really bad to the point she can almost not lift it was not reported. The outcome for the events, severe arm is swelling and inability to lift/move the vaccinated arm, was unknown at the time of this report. Causality was not provided for the events, severe arm is swelling and inability to lift/move the vaccinated arm.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537009
Sex: F
Age: 65
State: MS

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Joint ache; Arms aching at the site of injection; feeling tired; A spontaneous report was received from a healthcare professional concerning a 75-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced arms aching at site of injection, joint ache and feeling tired after the vaccine. The patient's medical history, as provided by the reporter, included a bladder instillation and cystoscopy. Concomitant medications reported included betamethasone acetate/betamethasone sodium phosphate. On 30 Dec 2020 at 0700AM, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient underwent a cystoscopy for a prior bladder instillation procedure. During, the cystoscopy the patient was administered betamethasone acetate/betamethasone sodium phosphate, intravenously for one hour. The next day 30 Dec 2020 at 0700AM, she received her mRNA-1273 vaccination. She began to experience her arms aching at site of injection, joint ache and feeling tired after the vaccine. Treatment for the events included tramadol and clovinol, on 31 Dec 2020 at 0630AM. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, arms aching at site of injection, joint ache and feeling tired after the vaccine, are considered resolving. The reporter's assessment of causality for the events was not provided.; Reporter'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: CELESTONE CHRONODOSE

Current Illness:

ID: 1537010
Sex: M
Age: 52
State: NJ

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 08/09/2021
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: Slight tightness in the chest; Fatigue; A spontaneous report was received from a consumer, concerning himself, a 52-year-old, male patient, who received Moderna's COVID-19 vaccine and experienced slight tightness in the chest and fatigue. The patient's medical history reported included COVID-19. No relevant concomitant medications were reported. On 31 Dec 2020 at 11:00 AM, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number not provided) via unknown route for prophylaxis of COVID-19 infection. On 31 Dec 2020 at 02:30 PM, after vaccination, the patient was notified to be positive for COVID-19, which was tested on 29 Dec 2020. The patient experienced fatigue and slight tightness in the chest. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome for the events, slight tightness in the chest and fatigue were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: COVID-19

ID: 1537011
Sex: M
Age: 52
State: VA

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Angular blepharitis; Itching; Fatigue intermittent; Light headedness and dizziness; Sleepiness; Swelling at the injection site; He got the shot on Tuesday (Dec 29) and it is still sore today; Headache; A spontaneous report was received from consumer concerning a 52 years old male patient, who received Moderna's COVID-19 vaccine and experienced lightheadedness, dizziness, sleepiness, headache, sore injection site area, swelling at injection site, Angular blepharitis, Itching and Fatigue intermittent. The patient's medical history, as provided by the reporter, included temporomandibular joint (TMJ) and allergies. No relevant concomitant medications were reported. On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient experienced headache, swelling and soreness in the site of vaccination, fatigue intermittent. He also experienced lightheadedness, dizziness and sleepiness the same day as vaccination. The patient developed itching from 1 Jan 2021. The patient experienced Angular blepharitis since 04 Jan 2021. The patient is unsure if his headache is due to the vaccine or his TMJ. Treatment information included Claiiten once a day and Pepcid both since 13 Jan 2021 till 15 Jan 2021 for an unknown indication. Lab details were not reported. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, swelling, lightheadedness, dizziness, sleepiness, sore injection site area and swelling at injection site, angular blepharitis, itching and fatigue intermittent were considered as unknown. The outcome of the event headache was resolved on 15 Jan 2021. The reporter's assessment of causality for the events was not provided. Follow up: Follow-up received on 15 Jan 2021 included Batch number of the vaccine, treatment details and event headache details including start date and stop date. Other events were also reported included, angular blepharitis, itching and fatigue intermittent.; Reporter'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 patient's medical history of allergies and TMJ syndrome is a risk factor for headache and pruritus.

Other Meds:

Current Illness: TMJ syndrome

ID: 1537012
Sex: F
Age:
State:

Vax Date:
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm which is sore; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's covid-19 vaccine(mRNA-1273) and experienced arm was sore. The patient's medical history included back issues. No relevant concomitant medications were reported. On an unspecified date, the patient received their first dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection. On an unspecified date, the patient received Moderna COVID-19 Vaccine and experienced arm was sore (Pain in arm). Treatment details included three Ibuprofen for an evet arm was sore. Action taken with mRNA-1273 in response to the event arm was sore was not reported. The outcome of the event arm was sore was not reported.; Reporter'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: Back disorder NOS

ID: 1537013
Sex: M
Age: 60
State: NC

Vax Date: 12/29/2020
Onset Date: 12/31/2020
Rec V Date: 08/09/2021
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: Dry cough; Feels like he was coming down with a cold; Could not go to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not go to sleep), COUGH (Dry cough) and NASOPHARYNGITIS (Feels like he was coming down with a cold) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included COPD. On 29-Dec-2020, 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) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced INSOMNIA (Could not go to sleep) and NASOPHARYNGITIS (Feels like he was coming down with a cold). On an unknown date, the patient experienced COUGH (Dry cough). At the time of the report, INSOMNIA (Could not go to sleep), COUGH (Dry cough) and NASOPHARYNGITIS (Feels like he was coming down with a cold) had resolved. 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. Treatment medications included unspecified cold medicine. Concomitant therapy included an oxygen tank. 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 09-Apr-2021: updated event outcome and action taken (received second dose); 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: COPD

ID: 1537014
Sex: F
Age: 72
State: VA

Vax Date: 12/24/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Nose bleeding; Chest hurting; Having a headache getting worse in head; Arm sore; A spontaneous report was received from a consumer concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experiencing a headache right now, arm sore for a couple of days, nose is bleeding when blowing nose, and chest hurting. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Lot # 0111-20A) on 24 Dec 2020 in the left arm intramuscularly for prophylaxis of COVID-19 infection. The consumer called stating she received the Moderna COVID-19 vaccine on 24 Dec 2020 at a nursing home. Patient stated people says getting headache. Patient is having headache right now, getting worse in head, arm sore for a couple of days, nose is bleeding when blowing nose, chest hurting, no other symptoms. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The event, a headache right now, arm sore for a couple of days, nose is bleeding when blowing nose, and chest hurting, was considered unknown. The reporter did not provide an assessment of the event, a headache right now, arm sore for a couple of days, nose is bleeding when blowing nose, and chest hurting.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537015
Sex: F
Age: 60
State: MA

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: slight sore throat; GI upset; occasionally run a mild temperature; few raised areas near the injection site; fatigue/exhaustion; congestion; severe itching at the injection site and over the next hour it had spread over my entire body; entire left arm became extremely painful; Loss of apetite; Had a total body histamine response; coughing; Shaky voice; Outer body type of feeling; Numbness; itchy on her left shoulder which is the site of injection; Nausea; Body aches; swollen lymph glands; Chills; Headache; redness on her left shoulder which is the site of injection; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (Loss of apetite), HISTAMINE INTOLERANCE (Had a total body histamine response), COUGH (coughing), DYSPHONIA (Shaky voice) and AUTOSCOPY (Outer body type of feeling) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic, Allergy to nuts, Allergy to nuts, Hyperparathyroidism in March 2019 and GERD in November 2020. Concomitant products included LORATADINE for Allergy, FAMOTIDINE for GERD, PARACETAMOL (TYLENOL) and IBUPROFEN for Headache, SALBUTAMOL (ALBUTEROL HFA) for Shortness of breath. On 23-Dec-2020, 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Dec-2020, the patient experienced DECREASED APPETITE (Loss of apetite), HISTAMINE INTOLERANCE (Had a total body histamine response), COUGH (coughing), DYSPHONIA (Shaky voice), AUTOSCOPY (Outer body type of feeling), HYPOAESTHESIA (Numbness), INJECTION SITE PRURITUS (itchy on her left shoulder which is the site of injection), NAUSEA (Nausea), MYALGIA (Body aches), LYMPHADENOPATHY (swollen lymph glands), CHILLS (Chills), HEADACHE (Headache) and INJECTION SITE ERYTHEMA (redness on her left shoulder which is the site of injection). On 27-Dec-2020, the patient experienced PAIN IN EXTREMITY (entire left arm became extremely painful). On 30-Dec-2020, the patient experienced PRURITUS (severe itching at the injection site and over the next hour it had spread over my entire body). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (slight sore throat), ABDOMINAL DISCOMFORT (GI upset), PYREXIA (occasionally run a mild temperature), INJECTION SITE SWELLING (few raised areas near the injection site), FATIGUE (fatigue/exhaustion) and UPPER RESPIRATORY TRACT CONGESTION (congestion). At the time of the report, DECREASED APPETITE (Loss of apetite) outcome was unknown, HISTAMINE INTOLERANCE (Had a total body histamine response), COUGH (coughing), DYSPHONIA (Shaky voice), AUTOSCOPY (Outer body type of feeling), HYPOAESTHESIA (Numbness), INJECTION SITE PRURITUS (itchy on her left shoulder which is the site of injection), NAUSEA (Nausea), MYALGIA (Body aches), LYMPHADENOPATHY (swollen lymph glands), CHILLS (Chills), HEADACHE (Headache), INJECTION SITE ERYTHEMA (redness on her left shoulder which is the site of injection), OROPHARYNGEAL PAIN (slight sore throat), ABDOMINAL DISCOMFORT (GI upset), PAIN IN EXTREMITY (entire left arm became extremely painful), PYREXIA (occasionally run a mild temperature), INJECTION SITE SWELLING (few raised areas near the injection site), FATIGUE (fatigue/exhaustion) and UPPER RESPIRATORY TRACT CONGESTION (congestion) was resolving and PRURITUS (severe itching at the injection site and over the next hour it had spread over my entire body) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, COVID-19: negative (Negative) Negative. On 28-Dec-2020, Influenza virus test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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. Treatment for the event included diphenhydramine (Benadryl) and acetaminophen (Tylenol). Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2021: The patient information including medical history, concomitant medications, vaccine information and events were updated.; 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: LORATADINE; FAMOTIDINE; ALBUTEROL HFA; TYLENOL; IBUPROFEN

Current Illness: Allergy to antibiotic; Allergy to nuts

ID: 1537016
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Pregnancy. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product information was not provided. Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for a pregnant female of unknown age. The consumer will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness: Pregnancy

ID: 1537017
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Soreness in arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Soreness in arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history 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 VACCINATION SITE PAIN (Soreness in arm). At the time of the report, VACCINATION SITE PAIN (Soreness in arm) outcome was unknown. 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 and treatment information not provided Company comment: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. This case was linked to MOD-2021-002685 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537018
Sex: M
Age: 62
State: CA

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: had a loss of appetite; Malaise; Soreness in my upper right arm in the deltoid muscle that prevents him from sleeping on his right side/covers went on and off throughout the night; Alternating chills and fever; Alternating chills and fever; Soreness in my upper right arm in the deltoid muscle that prevents him from sleeping on his right side; A spontaneous report was received from a 62 year-old, male nurse, who is also the patient, who received Moderna's COVID-19 vaccine and experienced loss of appetite, malaise, soreness in my upper right arm in the deltoid muscle that prevents him from sleeping on his right side, covers went on and off throughout the night, and alternating chills and fever. The patient's medical history included receiving Varicella Zoster Vaccine in 2018. The patient received the first dose on Friday, and he was down on Saturday. Concomitant product use was not provided by the reporter. On 29 Dec 2020 at 14:00, approximately three hours prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection. On 29 Dec 2020, around dinner time, the patient had a loss of appetite and malaise. He went to bed early, and felt alternating chills and fever throughout the night. The patient did not take his temperature, but believed he was probably in the subclinical range, 99 degree range. The patient was not diaphoretic or sweating. The patient's covers went on and off throughout the night which is unusual for him. The patient still had soreness in his upper right arm in the deltoid muscle that prevented him from sleeping on his right side at the time of reporting. Action taken with mRNA-1273 in response to the event was unknown. The patient has his next vaccination scheduled on 26 Jan 2021. The outcome of the events loss of appetite, malaise, covers went on and off throughout the night, and alternating chills and fever was unknown. The event soreness in my upper right arm in the deltoid muscle that prevents him from sleeping on his right side was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 62-year-old male who experienced NS events of unexpected malaise, decrease appetite, poor quality sleep and expected fever, chills, arthralgia. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Arthralgia ongoing, other event outcomes unknown. 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:

Current Illness:

ID: 1537019
Sex: F
Age:
State:

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 immunisation. No Medical History information was reported. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 28-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment information was not provided. This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1537020
Sex: F
Age: 37
State: OH

Vax Date: 12/28/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: breaks out in a sweat; Runny nose; headache; fatigue; shortness of breath; stomach issues; diarrhea; stomach feels like it's burning; my ears have been hurting; congestion; sore throat; A spontaneous report was received from a healthcare professional for a 37-year-old, female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and developed fatigue, shortness of breath (dyspnoea), stomach issues (abdominal discomfort), diarrhea (diarrhoea), burning feeling in the stomach (dyspepsia), ear pain, headache, congestion (nasal congestion), runny nose (rhinorrhoea), sore throat (oropharyngeal pain) and breaking out in a sweat while doing the dishes (hyperhidrosis). The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29 Dec 2020, one day after receiving the vaccine, the patient reported fatigue, shortness of breath, stomach issues, diarrhea, stomach feels like it's burning, ears have been hurting, headache, congestion, runny nose and sore throat. The patient reported exposure to COVID-19 as she was caring for someone who had tested positive. They were awaiting COVID test results. On 31 Dec 2020, the patient reported breaking out in a sweat and has shortness of breath even doing the dishes. They reported that sore throat was not as bad. Treatment for the events included ibuprofen, omeprazole and bismuth salicylate. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, fatigue, shortness of breath, stomach issues, diarrhea, burning feeling in the stomach, ear pain, headache, congestion, runny nose, and breaking out in a sweat while doing the dishes were considered not recovered/not resolved. The outcome for the event, sore throat, was considered recovering/resolving.; Reporter's Comments: This case concerns a 37-year-old female who had NS events of unexpected dyspnea, abdominal discomfort, dyspepsia, diarrhea, nasal congestion, rhinorrhea, oropharyngeal pain, ear pain, hyperhidrosis and expected headache and fatigue. Event onset occurred Day 1 after the first dose of mRNA-1273. Treated with ibuprofen, omeprazole. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537021
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 20 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (20 weeks pregnant) 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (20 weeks pregnant). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (20 weeks pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1537022
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 08/09/2021
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: Pregnant; A spontaneous report was received from consumer who is a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was pregnant when vaccinated. The patient's medical and pregnancy history was not provided. Concomitant medications not provided. On an unknown date, the patient received the first dose of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection. The date of the patient's positive pregnancy test and first day of the last menstrual period were not reported. The estimated date of conception and due date were not reported. The patient received Moderna vaccine and was pregnant, also stated that she received the Tdap vaccine 19 days ago as well. Action taken with mRNA-1273 was not reported. The outcome for the event exposure during pregnancy is resolved/recovered.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1537023
Sex: U
Age:
State:

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 08/09/2021
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: back pain; toes and hands are really cold; mild dizziness; some chills; joint aches; headache; A spontaneous report was received from a female consumer of unknown age, who received Moderna's COVID-19 vaccine and experienced back pain, toes and hands are really cold, mild dizziness, some chills, joint aches, and headache. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection. On an unknown date, the patient was experiencing back pain, toes and hands are really cold, mild dizziness, some chills, joint aches, and headache. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, back pain, toes and hands are really cold, mild dizziness, some chills, joint aches, and headache were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1537024
Sex: F
Age: 36
State: TX

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Permanent scar; Severe redness; Swelling; Severe muscle pain, pain in arm; Pain in arm I received the vaccine; Arm was bright red; Fluid-filled vesicles at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was bright red), VACCINATION SITE VESICLES (Fluid-filled vesicles at injection site), SCAR (Permanent scar), VACCINATION SITE PAIN (Pain in arm I received the vaccine) and VACCINATION SITE ERYTHEMA (Severe redness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Food allergy (Pineapple) and Penicillin allergy. Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (TAYTULLA) for Contraception. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced ERYTHEMA (Arm was bright red), VACCINATION SITE VESICLES (Fluid-filled vesicles at injection site), VACCINATION SITE PAIN (Pain in arm I received the vaccine) and MYALGIA (Severe muscle pain, pain in arm). On 30-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (Severe redness) and VACCINATION SITE SWELLING (Swelling). On 09-Jan-2021, the patient experienced SCAR (Permanent scar). At the time of the report, ERYTHEMA (Arm was bright red) and SCAR (Permanent scar) outcome was unknown, VACCINATION SITE VESICLES (Fluid-filled vesicles at injection site) had resolved with sequelae and VACCINATION SITE PAIN (Pain in arm I received the vaccine), VACCINATION SITE ERYTHEMA (Severe redness), VACCINATION SITE SWELLING (Swelling) and MYALGIA (Severe muscle pain, pain in arm) 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 considered VACCINATION SITE VESICLES (Fluid-filled vesicles at injection site), VACCINATION SITE ERYTHEMA (Severe redness), VACCINATION SITE SWELLING (Swelling) and MYALGIA (Severe muscle pain, pain in arm) to be related. No further causality assessments were provided for ERYTHEMA (Arm was bright red), SCAR (Permanent scar) and VACCINATION SITE PAIN (Pain in arm I received the vaccine). Treatment details were not reported. Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow-up received on 31-MAR-2021 included patient's demographic details, allergic conditions, concomitant medication and events due to first shot of COVID-19 vaccination. On 27-May-2021: New event added.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds: TAYTULLA

Current Illness: Food allergy (Pineapple); Penicillin allergy

ID: 1537025
Sex: U
Age:
State: TX

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Positive for Covid-19; A spontaneous report was received from a patient who is also nurse of unknown age and gender. The patient is participating in the mRNA-1273 Emergency Use Program and had a positive for Covid-19 after vaccination. There was no relevant medical history or concomitant medications provided. On 29 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient was tested positive for Covid-19. The patient reports she received the Covid-19 vaccine on 29 Dec 2020 and after 24 hours started to have a fever and aches. There was no treatment information provided. Relevant laboratory test on 30 Dec 2020 included a positive SARS-CoV-2 by RT-PCR nasopharyngeal swab. Action taken with mRNA-1273 in response to the event of Positive for Covid-19 not reported. The outcome for the event of Positive for Covid-19 was unknown at the time of this report. Causality was not provided for the event of Positive for Covid-19.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537026
Sex: F
Age: 70
State: CO

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: post nasal drip; start losing taste; Have no taste; Arm hurt worse than tetanus shot; vomiting; fever; really bad headache; A spontaneous report was received from a nurse concerning a 70 year- old, female patient who received Moderna's COVID-19 vaccine and experienced arm pain, postnasal drip, loss of taste, vomiting, fever and headache. The patient's medical history was not provided. Concomitant medications reported included levothyroxine sodium. On 23 Dec 2020, approximately three hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025-J202A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 23 Dec 2020, the patient states reported arm pain ("worse than tetanus shot") lasting 36 hours, postnasal drip, lost of taste, vomiting, fever and a bad headache. On 30 Dec 2020, the patient reports "starting to feel better". No treatment information was provided. Action taken with mRNA-1273 in response to the event(s) was not reported. The outcome of the events, arm pain, postnasal drip, loss of taste, vomiting, fever and headache were considered recovering/resolving.; Reporter's Comments: This case concerns a 70-year-old female who experienced nonserious events of unexpected upper-airway cough syndrome, hypogeusia, ageusia, and expected vaccination site pain, fever, headache, vomiting. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events resolving. 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: SYNTHROID

Current Illness:

ID: 1537027
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) 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 medication details was reported. No treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1537028
Sex: F
Age:
State:

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: breastfeeding and received vaccine; A spontaneous report was received from a consumer concerning a female patient who was breastfeeding: Maternal exposure during breast feeding The patient's medical history and concomitant product use were not provided/unknown by the reporter. In Dec-2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 30-Dec-2020 the patient reported having had a baby on 01-Sep-2020 and was breastfeeding as the time first dose was received. At the time of the report the outcome for the events was unknown. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events were not reported. The reporter did not provide causality for the events.; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.

Other Meds:

Current Illness:

ID: 1537029
Sex: F
Age:
State:

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 08/09/2021
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: Pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 31-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. Patient delivered baby and have no adverse event for both mother and baby. On 31-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient delivered baby and have no issues and have no adverse events for mother and baby. No relevant concomitant medications reported. No treatment information was provided. Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female with an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-Jun-2021: Added delivery notes and updated pregnancy outcome was updated to retrospective.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female with an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1537030
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: A spontaneous report was received from a health care professional concerning a 24 year old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced limb discomfort, tenderness, pain, and discomfort. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Lot # 026L20A) on 30 Dec 2020 for in the left arm for prophylaxis of COVID-19 infection. Health care professional called to report she received the Moderna Covid-19 vaccine today, 30 Dec 2020 at 6:30PM, and her upper left arm is hurting. She reported that there is soreness, tenderness and uncomfortable pain on her upper left arm that she feels will persist. Treatment information was not provided but stated she plans on taking ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, limb discomfort, tenderness, pain, and discomfort, were considered as unknown.; Reporter's Comments: This case concerns a 24-year-old female who experienced NS events of unexpected discomfort and limb discomfort and expected tenderness and pain. Event onset occurred the same day as the first dose of mRNA-1273. Treatment included ibuprofen. Outcomes unknown. 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:

Current Illness:

ID: 1537031
Sex: F
Age:
State: NJ

Vax Date: 12/24/2020
Onset Date: 12/25/2020
Rec V Date: 08/09/2021
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: itchy rash; A spontaneous case was received from a customer who is a female patient (unkown age) that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy rashes on her neck. The patients' medical history is reported as allergy to antibiotics and cold medications. No relevant concomitant medications were reported. On 24-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) unkown route and location for prophylaxis of COVID-19 infection. On 25-Dec-2020, the patient developed itchy rashes on her neck and called in to inquire if she should visit her physician immediately or wait until the next day to visit her doctor. The action taken with mRNA-1273 in response to the adverse event was not reported. No treatment information was provided. The outcome of this event is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537032
Sex: F
Age: 60
State: CA

Vax Date: 12/26/2020
Onset Date: 12/26/2020
Rec V Date: 08/09/2021
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: Rapid heart rate of 80BPM; Mettalic taste in mouth; Diaphoretic; Low back ache; Blood pressure shoot up to 163/93; numbness of tongue and lips; Tingling of the tongue; Rash; A spontaneous report was received from a nurse concerning a 60 year-old, female patient who received Moderna's COVID-19 vaccine and experienced rash, became diaphoretic, rapid heart rate, metallic taste, tongue and lip numbness, tongue tingling, low back ache and high blood pressure. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Dec 2020, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Dec 2020, the patient developed a rash and became diaphoretic shortly after receiving the vaccination, She developed a heart rate of 80 beats per min (BPM) from baseline 60 BPM. She reported metallic taste in her mouth, her tongue and lips were numb, and she had tongue tingling. She also noted that she developed low back pain and her blood pressure increase to 163/93. Treatment for the event included diphenhydramine hydrochloride. Action taken with mRNA-1273 in response to the events was not reported. The event, rash, was considered recovering/resolving. The outcome of the events, diaphoretic, rapid heart rate, metallic taste, tongue and lip numbness, tongue tingling, low back ache and high blood pressure was unknown/not reported.; Reporter's Comments: This case concerns a 60 Y/O F who had NS unexpected heart rate increased, blood pressure high, hypoaesthesia oral, paraesthesia oral, dysgeusia, diaphoresis, back pain and NS expected rash. Event onset occurred 10 minutes after the first dose of mRNA-1273. Treatment included diphenhydramine. Rash resolving, other outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537033
Sex: F
Age:
State: VA

Vax Date: 12/26/2020
Onset Date: 12/26/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Fever; headache; Body ache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, headache and body aches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Dec 2020, the patient began to have a fever, headache and body aches. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, fever, headache and body aches was unknown.; Reporter's Comments: This case concerns a female of unknown age who had NS expected fever, headaches, myalgia. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. 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:

Current Illness:

ID: 1537034
Sex: U
Age:
State: TX

Vax Date: 12/26/2020
Onset Date: 12/26/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Breast feeding; A spontaneous report was received from Other Health Professional concerning a unknown patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) while breastfeeding (Vaccine exposure via breast milk). The patients medical history was not provided. No relevant concomitant medications were reported. On 26 Dec 2020, the patient received dose of mRNA-1273 via transmammary route (lot number: 037K20A). The patients mother stated that she received the vaccine and wanted to sign up for the pregnancy registry. The patients mother was not pregnant but she was breastfeeding (Vaccine exposure via breast milk). Action taken with mRNA-1273 in response to the event was not applicable at the time of reporting. The outcome for the event was not recovered.; Reporter's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.

Other Meds:

Current Illness:

ID: 1537035
Sex: M
Age:
State: TN

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: my left hand, hip and toward my back, from a scale of 1-10 felt like an 8-9 for the last 24 hours; my left hand, hip and toward my back, from a scale of 1-10 felt like an 8-9 for the last 24 hours; injection site is tender and the tenderness seems to be lasting longer than other vaccines; my left hand, hip and toward my back, from a scale of 1-10 felt like an 8-9 for the last 24 hours; A spontaneous report was received from a consumer, who is a male patient of an unknown age that received Moderna's COVID-19 Vaccine and experienced pain in left hand, hip, toward his back, and vaccine injection site tenderness. The patient's medical history included an unspecified disorder related to back pain. Concomitant product use included unspecified pain medication. On 22-Dec-2020 at around 2 o'clock, the patient received his first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in his left upper arm for prophylaxis of COVID-19 infection. That day, at around 4 o'clock, the patient had experienced pain on his left hand, hip and toward his back, pain intensity 8-9/10 for the last 24 hours. The vaccine injection site was tender which had seemed to last longer than any other vaccines that he had received in the past. Treatment for the events was not provided. Action taken with mRNA-1273 in response to the events were unknown. The events, back pain aggravated, pain in hip, pain in hand and vaccination site tenderness, is unknown.; Reporter'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: Back disorder NOS; Back pain

ID: 1537036
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: A spontaneous report was received from a consumer concerning themselves, a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and developed body aches. The patient's medical history was not provided. Concomitant product use was not provided. The patient received one of two planned doses of mRNA-1273, injection site was not reported, for prophylaxis of COVID-19 infection. The patient called in to report that they had body aches after administration of this vaccine. Treatment for the event was not reported. Action taken with mRNA-1273 was also not provided. The outcome was unknown for event.; Reporter's Comments: This case concerns a male of unknown age who experienced NS unexpected event of pain. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Pain event outcome unknown. 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:

Current Illness:

ID: 1537037
Sex: F
Age:
State: AR

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 08/09/2021
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: A spontaneous report was received from a nurse concerning herself the patient, a 43 year old female who developed warmth and redness at the injection site which was very firm to the touch and pain radiating on the right side from the base of the skull through her neck through her shoulders to her elbows. The first two days post receiving the injection she reported experiencing a headache bordering on a migraine. She also reported joint pain and muscle pain for 3 days. She stated she was sick for 5 days and her immune system crashed. Seven days post injection she reports her voice is scratchy, cold symptoms described as cough, running nose and sore throat. On 29-dec-2020 she reported an inflammation in her "lymphs", subclavian and axillary. She noted it was the lymph nodes right above the collar bones and arm pits. The patient states they are swollen and painful. The patient's medical history included an unspecified inflammatory issue and chronic bronchitis at least three times a year. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 lot number 039K20A in her right arm for prophylaxis of Covid -19. The described events began right after receiving the vaccination and some reported events continued to develop for the next 5 days. On 29-dec-2020 the patent, a nurse left a voicemail with the following information. She requested a call back. She received the mRNA 1273 vaccination in her right arm on 23-dec-2020. Within 2 hours of the vaccination she reported warmth and redness at the injection site for 2 days afterwards. The site was very warm to the touch. Two hours post injection she reported pain radiating on the right side from the base of her skull through her neck, through her shoulders to her elbows. On days 1 and 2 post vaccination she reported a headache bordering on a migraine. The patient reported she was sick for 5 days and symptomatic for 5 days. She stated her immune system crashed. On 30-dec-2020 the patient reported her voice is scratchy, cold symptoms of cough, running nose and a sore throat. She stated that she thought she was doing better until reporting on 29-dec-2020 that she developed an inflammation in her "lymphs's": subclavian and axillary. On the night of 28-dec-2020 she woke up and reported pain in her neck and shoulder due to the lymph node inflammation. The patient reported she had not been able to sleep on her right side where she got the injection. The patient also noted that little scratches on her hand from cleaning on the morning of 24-dec-2020 immediately turned red at the edges and were inflamed. She stated it was "not a normal healing process for her." The patient stated she alternately took Tylenol; and Ibuprofen (dose and frequency unknown). The patient took Mucinex (dose and frequency unknown) and reported taking additional supplements such as Vitamin C and D#. The patient also reported taking Tumeric for inflammation., The patient stated she wanted to document her experience as she noticed there was not a lot of clinical information on immunocompromised patients. The patient who is also a nurse also asked questions regarding issues specific to vaccine administration guidelines to provide to other vaccine administrator. This question was escalated to medical affairs. Action taken with the second planned dose of mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the event(s) was not reported. A follow up was received on 06 Mar 2021, patient states that she decided not to receive her second dose. Medical history included 27 for antibodies at 6 weeks. Treatment for the events was unknown. On an unspecified date, patient experienced episcleritis in her right eye and water blisters on her back and arms. The outcome of the events were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1537038
Sex: F
Age: 52
State: NY

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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: Headache; Muscle pain; Right arm pain from the injection site; Difficulty to move and stretch the arm; Swelling from the injection site; A spontaneous report was received from a consumer concerning a 52-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, pain, swelling to the arm, muscle pain and difficulty to move and stretch the arm. The patient's medical history was not provided. Concomitant product use was not provided. On 30-dec-2020, The patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 30-dec-2020, the patient experienced headache, pain, and swelling to the arm. Action taken with the second dose of mRNA-1273 in response to the events is not applicable. The outcome of the events headache,injection site pain and swelling to the arm, pain from injection site to the elbow, muscle pain and difficulty to move and stretch the arm were considered resolving.; Reporter'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: 1537039
Sex: F
Age:
State: WI

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pregnant and received the COVID-19 Vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the COVID-19 Vaccine) in a 37-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (Has been under control and not treated for 10 years) and Nickel sensitivity. Concomitant products included ASA for Pre-eclampsia, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and DOCUSATE SODIUM (STOOL SOFTENER) for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in May 2020 and the estimated date of delivery was 29-Jan-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the COVID-19 Vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the COVID-19 Vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient had 2 previous pregnancies. The first pregnancy was full term birth in 2017 and second pregnancy was full term birth in 2019. Reporter did not allow further contact; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds: PRENATAL VITAMINS; STOOL SOFTENER; ASA

Current Illness: Hypertension (Has been under control and not treated for 10 years); Nickel sensitivity

ID: 1537040
Sex: F
Age:
State:

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: 29 1/2 weeks pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (29 1/2 weeks pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (29 1/2 weeks pregnant). On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (29 1/2 weeks pregnant) 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. Concomitant product use was not reported. Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1537041
Sex: F
Age: 37
State: FL

Vax Date: 12/24/2020
Onset Date:
Rec V Date: 08/09/2021
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: PREGNANT; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (PREGNANT) in a 37-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination. Patient had prior use of nicotine. No known allergies were reported. The patient's past medical history included Alcohol use (occasional) from 1998 to 2019, Marijuana use (Rarely), Spontaneous abortion (on 2017 and 2008 (very early ectopic no intervention needed)) and Live birth on 29-Apr-2020. On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 20-Oct-2020 and the estimated date of delivery was 27-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (PREGNANT). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the ninth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (PREGNANT) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Blood glucose: normal. On 14-Apr-2021, Ultrasound scan: normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. concomitant medication was not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Followup information was received on 23-Apr-2021: Pregnancy dates (Date of LMP, delivery expected date) added, para and gravida added with previous pregnancy details.; Reporter's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy

Other Meds:

Current Illness:

ID: 1537042
Sex: M
Age:
State:

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 08/09/2021
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: feeling a bit hostile; nausea; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine, and who experienced nausea and feeling a bit hostile. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 22 Dec 2020, approximately ten minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (batch unknown) intramuscularly for prophylaxis of COVID-19 infection. On 22 Dec 2020, the patient felt nauseous after receiving the vaccine. Treatment information was not provided. On 24 Dec 2020, the patient started feeling hostile. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events nausea and feeling a bit hostile was unknown.; Reporter's Comments: This case concerns a male of unknown age who experienced a NS unexpected event of anxiety and NS expected events of nausea. Event onset occurred 10 minutes after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. 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:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm