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: 1539642
Sex: F
Age:
State:

Vax Date: 01/07/2021
Onset Date: 01/15/2021
Rec V Date: 08/10/2021
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: Redness; Swollen injection site; Tenderness; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed redness, swollen injection site and tenderness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 07 Jan 2021, approximately eight days prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient experienced side effects which included redness, swollen injection site and tenderness. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, redness, swollen injection site and tenderness was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1539643
Sex: F
Age: 41
State: TX

Vax Date: 01/03/2021
Onset Date: 01/07/2021
Rec V Date: 08/10/2021
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: This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history.). On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. 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. This case concerns a female of unknown age with a nonserious expected event of lymphadenopathy. Treatment not reported. Event outcome unknown. Based on the current available information and temporal association between the use of the product and the start date of the lymphadenopathy, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a female of unknown age with a nonserious expected event of lymphadenopathy. Treatment not reported. Event outcome unknown. Based on the current available information and temporal association between the use of the product and the start date of the lymphadenopathy, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1539644
Sex: F
Age: 42
State: LA

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/10/2021
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: 35 weeks pregnant received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (35 weeks pregnant received vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The patient's past medical history included Fibromyalgia (stable.) on 01-Jan-2021. Concurrent medical conditions included Drug allergy (Allergies to Percodan,Percocet.), Morning sickness, Gestational diabetes, Hyperthyroidism and Shaking. Concomitant products included METFORMIN for Gestational diabetes, LEVOTHYROXINE for Hyperthyroidism, AMITRIPTYLINE HYDROCHLORIDE (AMITRIP) for Shaking. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 01-May-2020 and the estimated date of delivery was 18-Feb-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (35 weeks pregnant received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the thirty-seventh week of the pregnancy. On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (35 weeks pregnant received vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Glucose tolerance test: abnormal gestational diabetes. In 2020, Ultrasound foetal: pregnant pregnancy confirmation. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. There was no treatment medication reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Upon internal review on 21-Jul-2021, patient, events, analysis and regulatory reports tabs were updated.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 42-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds: METFORMIN; LEVOTHYROXINE; AMITRIP

Current Illness: Drug allergy (Allergies to Percodan,Percocet.); Gestational diabetes; Hyperthyroidism; Morning sickness; Shaking

ID: 1539645
Sex: F
Age: 34
State: OK

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 08/10/2021
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: developed itchiness and a big welp around the injection site; a "big knot" and it is hot and itchy; big welp around the injection site, describes it as "big knot"; Itching in different places of her body; a little bruise on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in different places of her body), CONTUSION (a little bruise on the injection site), VACCINATION SITE PRURITUS (developed itchiness and a big welp around the injection site), VACCINATION SITE WARMTH (a "big knot" and it is hot and itchy) and VACCINATION SITE MASS (big welp around the injection site, describes it as "big knot") in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PRURITUS (Itching in different places of her body) and CONTUSION (a little bruise on the injection site). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (developed itchiness and a big welp around the injection site), VACCINATION SITE WARMTH (a "big knot" and it is hot and itchy) and VACCINATION SITE MASS (big welp around the injection site, describes it as "big knot"). At the time of the report, PRURITUS (Itching in different places of her body) and CONTUSION (a little bruise on the injection site) had resolved and VACCINATION SITE PRURITUS (developed itchiness and a big welp around the injection site), VACCINATION SITE WARMTH (a "big knot" and it is hot and itchy) and VACCINATION SITE MASS (big welp around the injection site, describes it as "big knot") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1539646
Sex: F
Age:
State:

Vax Date: 01/02/2021
Onset Date: 01/02/2021
Rec V Date: 08/10/2021
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: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient 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 02-Jan-2021, 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 02-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 02-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34ear-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1539647
Sex: F
Age: 50
State: WA

Vax Date: 12/30/2020
Onset Date: 01/06/2021
Rec V Date: 08/10/2021
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: on the left side swollen supraclavicular lymph nodes; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (on the left side swollen supraclavicular lymph nodes) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (on the left side swollen supraclavicular lymph nodes). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (on the left side swollen supraclavicular lymph nodes) 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. No concomitant medications were reported. Patient has not taken any treatment.; 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: 1539648
Sex: F
Age: 41
State: CA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/10/2021
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: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 41-year-old female patient (gravida 5, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol since 2000, Infertility and Allergy (allergy to poultry). Concomitant products included PROGESTERONE for Infertility, METFORMIN for Polycystic ovarian syndrome, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and FAMOTIDINE (PEPCID AC) for Pregnancy, CALCIUM LEVOMEFOLATE (METHYL FOLATE) for Prenatal care, MARIJUANA for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 16-Jul-2020 and the estimated date of delivery was 18-Apr-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-sixth week of the pregnancy. On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2020, Pregnancy test: (Positive) Positive. On an unknown date, Glucose tolerance test normal: normal (normal) normal. On an unknown date, Prenatal screening test: normal (normal) normal. On an unknown date, Ultrasound abdomen: (Inconclusive) no result. 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 treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 41-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Patient was contacted for AE follow-up, which is still pending.

Other Meds: MARIJUANA; PROGESTERONE; METFORMIN; METHYL FOLATE; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; PEPCID AC

Current Illness: Allergy (allergy to poultry); High cholesterol; Infertility

ID: 1539649
Sex: F
Age: 32
State: NY

Vax Date: 12/28/2020
Onset Date: 01/01/2021
Rec V Date: 08/10/2021
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: Breastfeeding; Big welt, rash; Big welt, rash; This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding), URTICARIA (Big welt, rash) and VACCINATION SITE RASH (Big welt, rash) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J02A) for COVID-19 vaccination. The patient's past medical history included Pregnancy. On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding), URTICARIA (Big welt, rash) and VACCINATION SITE RASH (Big welt, rash). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding), URTICARIA (Big welt, rash) and VACCINATION SITE RASH (Big welt, rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-043890 (Parent-Child Link). See case MOD-2021-043890 for details regarding the child case.; Sender's Comments: This is a case of product exposure during breastfeeding with associated AEs of urticaria and rash. Patient will continue to be contacted for further monitoring of AEs.

Other Meds:

Current Illness:

ID: 1539650
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/10/2021
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: Rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a patient of an unknown age and gender 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 RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 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.; 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: 1539651
Sex: F
Age: 46
State: RI

Vax Date: 12/31/2020
Onset Date: 01/08/2021
Rec V Date: 08/10/2021
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: Dizzy; Vertigo; Feeling sick; Nausea; her arms were super itchy; A spontaneous report was received from a 46-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced feeling sick, nausea, vertigo, itchy arms, and dizziness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 31-Dec-2020, approximately 8 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 026L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection. The patient took the first dose of Moderna COVID-19 vaccine on 31-Dec -020 and on 8-Jan-2021 she started feeling sick. She became nauseous and had vertigo. She reported that her arms were super itchy, and she felt dizzy. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, experienced feeling sick, nausea, vertigo, itchy arms, and dizziness were considered unknown.; Sender's Comments: This case concerns a 46-year-old female who experienced non-serious events of unexpected malaise, dizziness, vertigo and expected nausea, pruritus. Event onset occurred 8 days 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: 1539652
Sex: M
Age:
State: NJ

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/10/2021
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: elevated blood pressure; headache; felt queasy; chills; intermittent chills for few hours; palpitations within 3 minutes; felt flushed; heart rate increased; Diaphoretic; This spontaneous case was reported by a physician and describes the occurrence of HYPERTENSION (elevated blood pressure), PALPITATIONS (palpitations within 3 minutes), FLUSHING (felt flushed), HEART RATE INCREASED (heart rate increased) and HYPERHIDROSIS (Diaphoretic) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Shellfish allergy, Contrast media allergy and Premature ventricular contractions since 01-May-2004. Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) from 01-May-2004 to an unknown date for Premature ventricular contractions, VIT D [VITAMIN D NOS], FISH OIL and PSYLLIUM HYDROPHILIC MUCILLOID (METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]) for an unknown indication. On 08-Jan-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PALPITATIONS (palpitations within 3 minutes). 08-Jan-2021, the patient experienced FLUSHING (felt flushed). 08-Jan-2021, the patient experienced HEART RATE INCREASED (heart rate increased). 08-Jan-2021, the patient experienced HYPERHIDROSIS (Diaphoretic) and CHILLS (chills). 08-Jan-2021, the patient experienced CHILLS (intermittent chills for few hours). On 09-Jan-2021, the patient experienced HYPERTENSION (elevated blood pressure), HEADACHE (headache) and NAUSEA (felt queasy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 08-Jan-2021 at a dose of 50 milligram. On 08-Jan-2021, HYPERHIDROSIS (Diaphoretic), CHILLS (chills) and CHILLS (intermittent chills for few hours) had resolved. At the time of the report, HYPERTENSION (elevated blood pressure), HEADACHE (headache) and NAUSEA (felt queasy) was resolving and PALPITATIONS (palpitations within 3 minutes), FLUSHING (felt flushed) and HEART RATE INCREASED (heart rate increased) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 140/90 (Inconclusive) Inconclusive and 140-160/93-100 (High) Elevated. On an unknown date, Heart rate: 110 (High) increased and 75 (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-212255 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow-up information received on 31-MAR-2021, added contact information. On 07-Jun-2021: Follow-up information received on 7-JUN-2021, updated address, patient details(age, height, weight, race, ethnicity, relevant history, lab data), added vaccine details, concomitant medications, updated action taken and re-challenge field. Added additional events.

Other Meds: TOPROL XL; VIT D [VITAMIN D NOS]; FISH OIL; METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]

Current Illness: Contrast media allergy; Premature ventricular contractions; Shellfish allergy

ID: 1539653
Sex: F
Age: 71
State: FL

Vax Date: 01/02/2021
Onset Date: 01/04/2021
Rec V Date: 08/10/2021
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: Shoulder suddenly swollen, hot and red; Shoulder suddenly swollen, hot and red; Shoulder suddenly swollen, hot and red; Increasingly worse seasonal allergies; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (Increasingly worse seasonal allergies), SWELLING (Shoulder suddenly swollen, hot and red), ERYTHEMA (Shoulder suddenly swollen, hot and red) and SKIN WARM (Shoulder suddenly swollen, hot and red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced SEASONAL ALLERGY (Increasingly worse seasonal allergies). On 10-Jan-2021, the patient experienced SWELLING (Shoulder suddenly swollen, hot and red), ERYTHEMA (Shoulder suddenly swollen, hot and red) and SKIN WARM (Shoulder suddenly swollen, hot and red). At the time of the report, SEASONAL ALLERGY (Increasingly worse seasonal allergies), SWELLING (Shoulder suddenly swollen, hot and red), ERYTHEMA (Shoulder suddenly swollen, hot and red) and SKIN WARM (Shoulder suddenly swollen, hot and red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and treatment information 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:

Current Illness:

ID: 1539654
Sex: F
Age: 71
State: TX

Vax Date: 01/02/2021
Onset Date: 01/05/2021
Rec V Date: 08/10/2021
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: Warmth at injection site; Swelling at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The patient's past medical history included No adverse effect (No Medical History Provided). On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmth at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE WARMTH (Warmth at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Concomitant medication was not provided.; 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 events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1539655
Sex: F
Age:
State: MD

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 08/10/2021
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: Pregnant; Pain in the injection site; sore arm; This spontaneous pregnancy case was reported by an other health care professional and describes the occurrence of PREGNANCY (Pregnant), INJECTION SITE PAIN (Pain in the injection site) and PAIN IN EXTREMITY (sore arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 13-Jan-2021, 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 01-Jul-2021. On 14-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain in the injection site) and PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced PREGNANCY (Pregnant). At the time of the report, PREGNANCY (Pregnant) had resolved and INJECTION SITE PAIN (Pain in the injection site) and PAIN IN EXTREMITY (sore 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 medications were not provided. Treatment details were not provided; Sender's Comments: This is a case of product exposure during pregnancy in this 34-year-old female patient who also experienced Injection site pain and Pain in extremity. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1539656
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/10/2021
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: Pain in the arm; Rash in the arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) and RASH (Rash in the arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm) and RASH (Rash in the arm). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and RASH (Rash in the arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Concomitant and treatment information 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:

Current Illness:

ID: 1539657
Sex: F
Age: 90
State: MN

Vax Date: 12/30/2020
Onset Date: 01/08/2021
Rec V Date: 08/10/2021
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: This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in a 90-year-old female patient 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). Concomitant products included MORPHINE for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Company Comment: This case concerns a 74-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event 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.; Reporter's Comments: Sender's Comments: This case concerns a 74-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event 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: MORPHINE

Current Illness:

ID: 1539658
Sex: M
Age:
State:

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/10/2021
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: 101 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (101 fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (101 fever). At the time of the report, PYREXIA (101 fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 101 (High) fever. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1539659
Sex: F
Age: 39
State: CA

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 08/10/2021
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: Injection site became hot; Injection site became red; Injection site became red, hot and painful; Lymph nodes were swollen; Injection site got sore; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Injection site became hot), LYMPHADENOPATHY (Lymph nodes were swollen), VACCINATION SITE PAIN (Injection site got sore), VACCINATION SITE ERYTHEMA (Injection site became red) and VACCINATION SITE PAIN (Injection site became red, hot and painful) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11J20A) 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. On 01-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site got sore). On 06-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes were swollen). On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site became hot), VACCINATION SITE ERYTHEMA (Injection site became red) and VACCINATION SITE PAIN (Injection site became red, hot and painful). On 02-Jan-2021, VACCINATION SITE PAIN (Injection site got sore) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site became hot), LYMPHADENOPATHY (Lymph nodes were swollen) and VACCINATION SITE ERYTHEMA (Injection site became red) outcome was unknown and VACCINATION SITE PAIN (Injection site became red, hot and painful) had not 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1539660
Sex: F
Age:
State: TX

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 08/10/2021
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: Vaccine exposure during pregnancy; Soreness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN (Soreness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination. No Medical History was provided by the reporter. On 11-Jan-2021 at 2:50 PM, 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 17-Mar-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN (Soreness). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 11-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN (Soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were reported. No treatment information was provided. Company comment:This is a case of product exposure during pregnancy with the associated event of Pain for this female patient. Based on the current available information and temporal association between the use of the product and the start date of the event (Pain), a causal relationship cannot be excluded. The 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 the associated event of Pain for this female patient. Based on the current available information and temporal association between the use of the product and the start date of the event (Pain), a causal relationship cannot be excluded. The patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1539661
Sex: F
Age: 23
State:

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 08/10/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling goes up to bra strap and down to wrist), INJECTION SITE INDURATION (hard and tight around vaccine area), INJECTION SITE ERYTHEMA (arm is red around vaccine area) and INJECTION SITE RASH (blotch around vaccine area) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025-J20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling goes up to bra strap and down to wrist), INJECTION SITE INDURATION (hard and tight around vaccine area), INJECTION SITE ERYTHEMA (arm is red around vaccine area) and INJECTION SITE RASH (blotch around vaccine area). At the time of the report, PERIPHERAL SWELLING (swelling goes up to bra strap and down to wrist), INJECTION SITE INDURATION (hard and tight around vaccine area), INJECTION SITE ERYTHEMA (arm is red around vaccine area) and INJECTION SITE RASH (blotch around vaccine area) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Injection site erythema, Injection site rash, and injection site induration are consistent with the known safety profile of the vaccine; Reporter's Comments: Based on the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Injection site erythema, Injection site rash, and injection site induration are consistent with the known safety profile of the vaccine

Other Meds:

Current Illness:

ID: 1539662
Sex: M
Age:
State:

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 08/10/2021
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: Rash all over the entire arm,red; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH ERYTHEMATOUS (Rash all over the entire arm,red) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Rash all over the entire arm,red). At the time of the report, RASH ERYTHEMATOUS (Rash all over the entire arm,red) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case concerns a male of unknown age who experienced a nonserious expected event of rash erythematous. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment included diphenhydramine. Event ongoing. 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.; Reporter's Comments: This case concerns a male of unknown age who experienced a nonserious expected event of rash erythematous. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment included diphenhydramine. Event ongoing. 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: 1539663
Sex: F
Age: 58
State: CA

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/10/2021
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: cannot move her arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (cannot move her arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced MOBILITY DECREASED (cannot move her arm). At the time of the report, MOBILITY DECREASED (cannot move her 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 did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: TCR; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1539664
Sex: F
Age: 61
State: NJ

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/10/2021
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: Injection site hardness; injection site appears like a cellulitis; Injection site feels warm to touch; injection site redness; injection site sore, achy/painful; injection site swollen/severe swelling; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE CELLULITIS (injection site appears like a cellulitis), INJECTION SITE WARMTH (Injection site feels warm to touch), INJECTION SITE INDURATION (Injection site hardness), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE PAIN (injection site sore, achy/painful) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy. Concomitant products included VITAMIN B COMPLEX, VITAMIN D3 and BIOTIN for Supplementation therapy. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site feels warm to touch), INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE PAIN (injection site sore, achy/painful) and INJECTION SITE SWELLING (injection site swollen/severe swelling). On 17-Jan-2021, the patient experienced INJECTION SITE CELLULITIS (injection site appears like a cellulitis). On an unknown date, the patient experienced INJECTION SITE INDURATION (Injection site hardness). At the time of the report, INJECTION SITE CELLULITIS (injection site appears like a cellulitis), INJECTION SITE WARMTH (Injection site feels warm to touch), INJECTION SITE INDURATION (Injection site hardness), INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE PAIN (injection site sore, achy/painful) and INJECTION SITE SWELLING (injection site swollen/severe swelling) 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. The patient went to urgent care on 17-Jan-2021 and saw a nurse practioner who diagnosed the patient's symptoms as cellulitis of right arm at injection site. The patient was prescribed with Cephalexin 500 mg 4 times a day for 10 days and the symptoms resolved. 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 05-Apr-2021: The significant follow up case was received on 07-APR-2021. Concomitant medications are added. Events are added.

Other Meds: VITAMIN B COMPLEX; VITAMIN D3; BIOTIN

Current Illness: Drug allergy

ID: 1539665
Sex: F
Age: 29
State: PA

Vax Date: 12/29/2020
Onset Date: 01/06/2021
Rec V Date: 08/10/2021
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: Redness at injecton at the site of injection; Tender at the site of injection; Swollen at the site of injection; Itchy at the injection; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at injecton at the site of injection), INJECTION SITE PAIN (Tender at the site of injection), INJECTION SITE SWELLING (Swollen at the site of injection) and INJECTION SITE PRURITUS (Itchy at the injection) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no reported medical history). On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at injecton at the site of injection), INJECTION SITE PAIN (Tender at the site of injection), INJECTION SITE SWELLING (Swollen at the site of injection) and INJECTION SITE PRURITUS (Itchy at the injection). At the time of the report, INJECTION SITE ERYTHEMA (Redness at injecton at the site of injection), INJECTION SITE PAIN (Tender at the site of injection), INJECTION SITE SWELLING (Swollen at the site of injection) and INJECTION SITE PRURITUS (Itchy at the injection) was resolving. 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 relevant concomitant medications were reported. Treatment information provided included the use of OTC antihistamines for this reaction. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1539666
Sex: F
Age:
State: IL

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/10/2021
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: Nausea; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) 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 reported medical history). On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On 05-Jan-2021, NAUSEA (Nausea) and HEADACHE (Headache) 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. 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 Reporter did not allow further contact; 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: 1539667
Sex: F
Age:
State: NY

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/10/2021
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: Sweats; Had about a week of Sleeping; Muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Sweats), SOMNOLENCE (Had about a week of Sleeping) and MYALGIA (Muscle aches) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced HYPERHIDROSIS (Sweats), SOMNOLENCE (Had about a week of Sleeping) and MYALGIA (Muscle aches). At the time of the report, HYPERHIDROSIS (Sweats), SOMNOLENCE (Had about a week of Sleeping) and MYALGIA (Muscle aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment related information has been 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 events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1539668
Sex: F
Age: 51
State: RI

Vax Date: 01/02/2021
Onset Date: 01/02/2021
Rec V Date: 08/10/2021
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: more than moderate pain in my arm, it is not the injection site itself, but in the upper arm, it does not radiate and is concentrated in upper arm; I couldn't use or lift my arm hurting; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (more than moderate pain in my arm, it is not the injection site itself, but in the upper arm, it does not radiate and is concentrated in upper arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use or lift my arm hurting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced PAIN IN EXTREMITY (more than moderate pain in my arm, it is not the injection site itself, but in the upper arm, it does not radiate and is concentrated in upper arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use or lift my arm hurting). The patient was treated with IBUPROFEN for Pain, at a dose of 800 milligram every four hours. At the time of the report, PAIN IN EXTREMITY (more than moderate pain in my arm, it is not the injection site itself, but in the upper arm, it does not radiate and is concentrated in upper arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use or lift my arm hurting) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported.; 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:

ID: 1539669
Sex: F
Age:
State: TX

Vax Date: 12/31/2020
Onset Date: 01/02/2021
Rec V Date: 08/10/2021
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: Pain in injection site; rash; Redness in injection site; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH (rash), INJECTION SITE ERYTHEMA (Redness in injection site) and INJECTION SITE PAIN (Pain in injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and INJECTION SITE ERYTHEMA (Redness in injection site). On 07-Jan-2021, the patient experienced RASH (rash). On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain in injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH (rash), INJECTION SITE ERYTHEMA (Redness in injection site) and INJECTION SITE PAIN (Pain in injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. This case concerns a 30-year-old female who experienced nonserious events of unexpected pain in extremity and expected injection site pain, injection site erythema and rash. Event onset occurred 3 days 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.; Reporter's Comments: This case concerns a 30-year-old female who experienced nonserious events of unexpected pain in extremity and expected injection site pain, injection site erythema and rash. Event onset occurred 3 days 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: 1539670
Sex: F
Age: 54
State: WI

Vax Date: 01/08/2021
Onset Date: 01/11/2021
Rec V Date: 08/10/2021
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: Numbness in both arms; Weakness in both arms; Tingling same arm of injection; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in both arms), MUSCULAR WEAKNESS (Weakness in both arms), PARAESTHESIA (Tingling same arm of injection) and VACCINATION SITE PAIN (Soreness at the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for an unknown indication. The patient's past medical history included No adverse event (No reported medical history). On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness in both arms), MUSCULAR WEAKNESS (Weakness in both arms), PARAESTHESIA (Tingling same arm of injection) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, HYPOAESTHESIA (Numbness in both arms), MUSCULAR WEAKNESS (Weakness in both arms), PARAESTHESIA (Tingling same arm of injection) and VACCINATION SITE PAIN (Soreness at the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1539671
Sex: M
Age: 15
State: RI

Vax Date: 08/07/2021
Onset Date: 08/09/2021
Rec V Date: 08/10/2021
Hospital: Y

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

Lab Data:

Allergies: PEANUT, SESAME, SHELLFISH, SOYBEAN, WALNUT, CORN, FISH

Symptom List: Nausea

Symptoms: CHEST PAIN, ELEVATED TROPONIN WITH EKG CHANGES, SUSPECTED MYOCARDITIS

Other Meds: NONE

Current Illness: none

ID: 1539672
Sex: M
Age: 66
State: FL

Vax Date: 03/21/2021
Onset Date: 07/02/2021
Rec V Date: 08/10/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Injection site pain

Symptoms: Lost power in legs feet couldn?t t walk lost control of blaster urine released no control broke out in psoriasis very severe ALL over body some bleeding major severe pain all over body Was like body exploading inside out felt like seriously gonna die for first 20 days went to 2 different hospitals 2 days in first one 4 days in second one ,,,, neither hospital knew what was wrong. With me after ct scans and blood urine tests d,,,, NO Answers. Been here 5 weeks getting better no treatment s

Other Meds: Metformin attenonal. Lisinopril alippuronal.

Current Illness: None

ID: 1539674
Sex: F
Age:
State: NH

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/10/2021
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: Arm red; Extremely sore; Itching; This spontaneous case was reported by a consumer and describes the occurrence of 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 reported medical history.). On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided This case concerns a female of unknown age who experienced nonserious unexpected events of erythema, pruritus, and pain in extremity. 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. Reporter did not allow further contact; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected events of erythema, pruritus, and pain in extremity. 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: 1539675
Sex: F
Age: 99
State: TN

Vax Date: 01/02/2021
Onset Date: 01/09/2021
Rec V Date: 08/10/2021
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: Itching really bad; Swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching really bad) and SWELLING (Swelled up) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PRURITUS (Itching really bad) and SWELLING (Swelled up). At the time of the report, PRURITUS (Itching really bad) and SWELLING (Swelled up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant product use was not provided by the reporter. Treatment medication included Paracetamol and ice. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1539676
Sex: F
Age: 42
State: CT

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 08/10/2021
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: Injection site pain; Muscle pain; Joint pain; Chills; Fatigue; I think I had a fever; This spontaneous case was reported by an occupational therapist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 31-Dec-2020 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021 at 3:00 AM, the patient experienced VACCINATION SITE PAIN (Injection site pain) and ARTHRALGIA (Joint pain). 01-Jan-2021 at 3:00 AM, the patient experienced MYALGIA (Muscle pain), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (I think I had a fever). On 02-Jan-2021, VACCINATION SITE PAIN (Injection site pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (I think I had a fever) 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 and treatment information 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:

Current Illness:

ID: 1539677
Sex: F
Age: 24
State: NJ

Vax Date: 01/10/2021
Onset Date: 01/10/2021
Rec V Date: 08/10/2021
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: Diarrhea; eyelid itch; mild arm sore; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), EYELIDS PRURITUS (eyelid itch) and PAIN IN EXTREMITY (mild arm sore) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), EYELIDS PRURITUS (eyelid itch) and PAIN IN EXTREMITY (mild arm sore). On 10-Jan-2021, EYELIDS PRURITUS (eyelid itch) had resolved. At the time of the report, DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (mild arm sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1539678
Sex: F
Age:
State: NY

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 08/10/2021
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: Fever 100 F; Muscle Aches; A spontaneous report was received from a consumer concerning a 48-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever 100 F (Fahrenheit) and muscle aches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 09 Jan 2021, the patient developed a fever 100 F and muscle aches and the symptoms were still going on. Treatment for the events included paracetamol. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, fever and muscle aches, was considered not recovered/not resolved.; 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:

ID: 1539679
Sex: F
Age: 43
State: TX

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 08/10/2021
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: Injection site is warm; Injection site is welted; Injection site is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE URTICARIA (Injection site is welted) and VACCINATION SITE ERYTHEMA (Injection site is red) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No recorded medical history). On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE URTICARIA (Injection site is welted) and VACCINATION SITE ERYTHEMA (Injection site is red). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE URTICARIA (Injection site is welted) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown. 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. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1539680
Sex: M
Age: 52
State: CA

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 08/10/2021
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: Arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. On 08-Jan-2021, The patient experience arm pain. Outcome of the event was unknown The consumer's health care professional recommended Tylenol and Ice. This case concerns a 52-year-old male who experienced a nonserious unexpected event of Pain in extremity. Event onset occurred 2 days after the first dose of mRNA-1273. Treatment unknown. Event outcome not reported. 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.; Reporter's Comments: This case concerns a 52-year-old male who experienced a nonserious unexpected event of Pain in extremity. Event onset occurred 2 days after the first dose of mRNA-1273. Treatment unknown. Event outcome not reported. 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: 1539681
Sex: F
Age: 66
State: TX

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 08/10/2021
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: Headache in the forefront; Muscle pain; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache in the forefront) and MYALGIA (Muscle pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included AMLODIPINE and METFORMIN for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (Headache in the forefront) and MYALGIA (Muscle pain). On 08-Jan-2021, HEADACHE (Headache in the forefront) had resolved. At the time of the report, MYALGIA (Muscle pain) 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. Treatment for the event included paracetamol. This case concerns a 66-year-old female who experienced nonserious expected events of headache and myalgia. Event onset occurred 2 days after the first dose of mRNA-1273. Treatment with paracetamol. 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.; Reporter's Comments: This case concerns a 66-year-old female who experienced nonserious expected events of headache and myalgia. Event onset occurred 2 days after the first dose of mRNA-1273. Treatment with paracetamol. 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: AMLODIPINE; METFORMIN

Current Illness:

ID: 1539682
Sex: F
Age: 59
State: PA

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 08/10/2021
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: injection site knot; exhausted; chills; Joint aches and pain; body aches and pain; Headache; Nausea; injection site swelling; injection site redness; fever not over 100? F; unable to eat for days; injection site black and blue and hard; injection site was black and blue and hard; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (unable to eat for days), INJECTION SITE MASS (injection site knot), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DECREASED APPETITE (unable to eat for days), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (injection site redness) and PYREXIA (fever not over 100? F). On 07-Jan-2021 at 3:00 AM, the patient experienced CHILLS (chills), ARTHRALGIA (Joint aches and pain), MYALGIA (body aches and pain), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced INJECTION SITE MASS (injection site knot) and FATIGUE (exhausted). At the time of the report, DECREASED APPETITE (unable to eat for days), INJECTION SITE MASS (injection site knot), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard), CHILLS (chills), ARTHRALGIA (Joint aches and pain), MYALGIA (body aches and pain), HEADACHE (Headache), NAUSEA (Nausea), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (injection site redness), PYREXIA (fever not over 100? F) and FATIGUE (exhausted) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: (Negative) Negative results 09 Jan 2021. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was 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:

ID: 1539683
Sex: F
Age:
State: NV

Vax Date: 01/05/2021
Onset Date: 01/10/2021
Rec V Date: 08/10/2021
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: Headaches 5 days after getting the Moderna COVID-19 Vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (Headaches 5 days after getting the Moderna COVID-19 Vaccine) 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 reported medical history). On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced HEADACHE (Headaches 5 days after getting the Moderna COVID-19 Vaccine). At the time of the report, HEADACHE (Headaches 5 days after getting the Moderna COVID-19 Vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case concerns a female of unknown age a nonserious expected event of headache. Event onset 6 days after first dose mRNA-1273. 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. Reporter did not allow further contact; Sender's Comments: This case concerns a female of unknown age a nonserious expected event of headache. Event onset 6 days after first dose mRNA-1273. 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: 1539684
Sex: F
Age:
State: NY

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/10/2021
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: The patient's past medical history included No adverse effect (no adverse event reported). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 05-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations). At the time of the report, PALPITATIONS (Heart palpitations) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, SARS-CoV-2 antibody test positive: positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: Healthcare professional (HCP) called in to report multiple adverse events and asked if she should receive the second dose. Adverse events included headache, fever, chills, chest pain, heart palpitations.

Other Meds: SYNTHROID

Current Illness:

ID: 1539685
Sex: F
Age:
State: AR

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/10/2021
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: Left facial numbness; arm soreness; A spontaneous report was received from a health care professional concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness/pain in extremity and left facial numbness/ hypoaesthesia. The patient's medical history was not provided. Concomitant medications was not reported. On 08-JAN-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly at unknown location for prophylaxis of COVID-19 infection. On 08 Jan 2021, after receiving the mRNA-1273, the patient felt arm soreness. on 10 Jan 2021, patient felt left facial numbness. Treatment for the events were unknown. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events pain in extremity and hypoaesthesia was 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:

ID: 1539686
Sex: F
Age: 31
State: NY

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 08/10/2021
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 who experienced sore arm, low-grade fever, headache, nausea and felt ill. The patient's medical history included anxiety. Products known to have been used by the patient, within two weeks prior to the event, included vitamin D, ethinylestradiol norethisterone acetate and sertraline. On 31-Dec-2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient received her vaccine on 31-Dec-2020. She reported a sore arm that resolved on 02-Jan-2021 (onset date/time not disclosed). On 09-Jan-2021, approximately ten days after receiving the vaccine, she experienced low-grade fever, headache, nausea and felt ill. AS of 10-Jan-2021, patient stated that she felt better. Treatment for the event included ibuprofen. Action taken with mRNA-1273 in response to the events, sore arm, low-grade fever, headache, nausea and felt ill, was not provided. The event, sore arm, was considered recovered/resolved on 02-Jan-2021. The events, low-grade fever, headache, nausea and felt ill, were considered recovered/resolved on 10-Jan-2021.; Reporter's Comments: This case concerns a 31-year-old female who experienced NS events of unexpected malaise and expected pain in extremity, headache, pyrexia, nausea. Event onset occurred the same day as the first dose of mRNA-1273. Treatment with ibuprofen. Events resolved. 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: VITAMIN D [VITAMIN D NOS]; JUNEL; SERTRALINE

Current Illness: Anxiety

ID: 1539687
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/10/2021
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: COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications and treatment information were not provided. Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Follow-up received on 24 Mar 2021 included no new information.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is Unlikely. Based on the known causative agent of COVID-19 infection, the event is assessed as unlikely related to mRNA-1273. It is likely that the patient was already infected with the virus but asymptomatic before being administered with the mRNA-1273 vaccine.

Other Meds:

Current Illness:

ID: 1539688
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/10/2021
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: Breastfeeding; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and is breastfeeding. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19. On an unknown date, the patient stated that she is breastfeeding and inquired about study enrollment. No treatment information provided. Treatment was not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the event, breastfeeding, was unknown.; 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: 1539689
Sex: F
Age: 62
State: TX

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 08/10/2021
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: Sitting down after 5 minutes she started not feeling well; feeling different; felt little nervous; Headache; Heartrate rapid; Blood pressure 169/90; Shortness of breath; Felt hot blood through her body like hot oil through her body, for 1 minute; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt hot blood through her body like hot oil through her body, for 1 minute), MALAISE (Sitting down after 5 minutes she started not feeling well), FEELING ABNORMAL (feeling different) and NERVOUSNESS (felt little nervous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The patient's past medical history included Rhythm nodal and Arthritis rheumatoid. Concurrent medical conditions included Arrhythmia and Hypertension. Concomitant products included CARVEDILOL, VALSARTAN, FLECAINIDE, METHOTREXATE, ADALIMUMAB (HUMIRA), ESCITALOPRAM OXALATE (LEXAPRO), BUSPIRONE and AMLODIPINE for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FEELING HOT (Felt hot blood through her body like hot oil through her body, for 1 minute), FEELING ABNORMAL (feeling different) and NERVOUSNESS (felt little nervous). On an unknown date, the patient experienced MALAISE (Sitting down after 5 minutes she started not feeling well). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 07-Jan-2021, FEELING HOT (Felt hot blood through her body like hot oil through her body, for 1 minute) had resolved. At the time of the report, MALAISE (Sitting down after 5 minutes she started not feeling well), FEELING ABNORMAL (feeling different) and NERVOUSNESS (felt little nervous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Blood pressure measurement: 169/90 (High) 169/90. On 07-Jan-2021, Heart rate: rapid (abnormal) abnormal. 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. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, however medical arrhythmia and hypertension was assessed as potential trigger for blood pressure increased as well as for heart rate increased. Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant Follow-up Contains Patient demographic details,new concomitant medications added & new events also added; 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, however medical arrhythmia and hypertension was assessed as potential trigger for blood pressure increased as well as for heart rate increased.

Other Meds: CARVEDILOL; VALSARTAN; FLECAINIDE; METHOTREXATE; HUMIRA; LEXAPRO; BUSPIRONE; AMLODIPINE

Current Illness:

ID: 1539690
Sex: F
Age: 54
State: KY

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/10/2021
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: Broken pinky finger; Car accident; experiencing brain fogginess; Slight headache; Arm soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ROAD TRAFFIC ACCIDENT (Car accident), FEELING ABNORMAL (experiencing brain fogginess) and VACCINATION SITE PAIN (Arm soreness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M2OA and 01162OA) for COVID-19 vaccination. The patient's past medical history included COVID-19 in November 2020. Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure, ATORVASTATIN for Cholesterol, LINACLOTIDE (LINZESS) for Irritable bowel syndrome, ERGOCALCIFEROL for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). On 07-Jan-2021, the patient experienced ROAD TRAFFIC ACCIDENT (Car accident) and FEELING ABNORMAL (experiencing brain fogginess). On 09-Jan-2021, VACCINATION SITE PAIN (Arm soreness) had resolved. At the time of the report, ROAD TRAFFIC ACCIDENT (Car accident) and FEELING ABNORMAL (experiencing brain fogginess) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Significant follow up received on 16-Apr-2021: Added concomitant drug amlodipine, atorvastine, ergocalcif, linzess, moderna vaccine second dose, outcome and onset date of event brain fog.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded

Other Meds: NORVASC; ATORVASTATIN; LINZESS; ERGOCALCIFEROL

Current Illness:

ID: 1539691
Sex: F
Age: 37
State: TX

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 08/10/2021
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: got vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (got vaccine while pregnant) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. Concurrent medical conditions included Depression, Type 1 diabetes mellitus (no dates provided), Drug allergy (Azithromycin) and Infertility NOS (Could not get pregnant right away.). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Depression, IRON DEXTRAN (IRON [IRON DEXTRAN]) for Vitamin supplementation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 12-May-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (got vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-fourth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (got vaccine while pregnant) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2020, Pregnancy test: positive (Positive) Positive. On 23-Sep-2020, Ultrasound scan: normal (normal) normal. On 23-Oct-2020, Ultrasound scan: normal (normal) normal. On 30-Oct-2020, Ultrasound scan: normal (normal) normal. On 23-Dec-2020, Ultrasound scan: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient previous pregnancy details -delivered live full term baby . Treatment details was not reported by the reporter. This is a case of product exposure during pregnancy with no associated AEs for this 37-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 37-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds: LEXAPRO; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; IRON [IRON DEXTRAN]

Current Illness: Depression; Drug allergy (Azithromycin); Infertility NOS (Could not get pregnant right away.); Type 1 diabetes mellitus (no dates provided)

ID: 1539692
Sex: F
Age: 82
State: FL

Vax Date: 01/07/2021
Onset Date: 01/10/2021
Rec V Date: 08/10/2021
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: developed a UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (developed a UTI) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included no adverse event. On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced URINARY TRACT INFECTION (developed a UTI). At the time of the report, URINARY TRACT INFECTION (developed a UTI) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Although a temporal association exist, there is still limited information regarding the reported event at this time. Patient's medical history, list of concomitant medications, clinical details any laboratory test for UTI are lacking. Urinary tract infection is of an infective etiology and the risk increases with advanced age above 65 years hence assessed as unlikely related to product use.; Reporter's Comments: Although a temporal association exist, there is still limited information regarding the reported event at this time. Patient's medical history, list of concomitant medications, clinical details any laboratory test for UTI are lacking. Urinary tract infection is of an infective etiology and the risk increases with advanced age above 65 years hence assessed as unlikely related to product use.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm