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: 1568207
Sex: F
Age: 79
State: TN

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: the lower half of her right eye is bloodshot; It is just sort of red; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (the lower half of her right eye is bloodshot) and OCULAR HYPERAEMIA (It is just sort of red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 immunisation. Concomitant products included ALLOPURINOL (ELAVIL [ALLOPURINOL]), LISINOPRIL, AMITRIPTYLINE, LORAZEPAM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced OCULAR HYPERAEMIA (the lower half of her right eye is bloodshot) and OCULAR HYPERAEMIA (It is just sort of red). At the time of the report, OCULAR HYPERAEMIA (the lower half of her right eye is bloodshot) and OCULAR HYPERAEMIA (It is just sort of red) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product includes blood pressure medication. No treatment was provided.

Other Meds: ELAVIL [ALLOPURINOL]; LISINOPRIL; AMITRIPTYLINE; LORAZEPAM; BABY ASPIRIN

Current Illness:

ID: 1568208
Sex: F
Age: 67
State: AZ

Vax Date: 03/09/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
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: Heart was beating fast; Stressed after seeing her arm; Big red spot on her right arm; Is still sore; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart was beating fast), STRESS (Stressed after seeing her arm), VACCINATION SITE ERYTHEMA (Big red spot on her right arm) and VACCINATION SITE PAIN (Is still sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included AMLODIPINE for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TACHYCARDIA (Heart was beating fast), STRESS (Stressed after seeing her arm), VACCINATION SITE ERYTHEMA (Big red spot on her right arm) and VACCINATION SITE PAIN (Is still sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Heart was beating fast), STRESS (Stressed after seeing her arm), VACCINATION SITE ERYTHEMA (Big red spot on her right arm) and VACCINATION SITE PAIN (Is still sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was not planning to get the second shot.

Other Meds: AMLODIPINE

Current Illness:

ID: 1568209
Sex: F
Age: 70
State: PR

Vax Date: 02/14/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
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: Lightheadedness / dizziness; High fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness / dizziness), PYREXIA (High fever), CHILLS (Chills) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 001B21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PYREXIA (High fever), CHILLS (Chills) and NAUSEA (Nausea). On 17-Mar-2021, the patient experienced DIZZINESS (Lightheadedness / dizziness). The patient was treated with ACETAMINOPHEN for Fever, at an unspecified dose and frequency and ZINGIBER OFFICINALE (GINGER [ZINGIBER OFFICINALE]) for Nausea, at a dose of Tea. On 17-Mar-2021, PYREXIA (High fever), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, DIZZINESS (Lightheadedness / dizziness) had not resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 101 (High) 101 F and 102 (High) 102 F. Concomitant product use was not provided. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1568210
Sex: F
Age: 52
State: NY

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
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: Reddish Rash on the Vaccine Site 3" Round; Reddish Rash on the Vaccine Site 3" Round/ 9 days after first dose I woke up with a baseball size rash around the injection site which lasted about 4-5 days; Diarrhea; Fatigue; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Fatigue), VACCINATION SITE PAIN (Sore Injection Site), VACCINATION SITE ERYTHEMA (Reddish Rash on the Vaccine Site 3" Round) and VACCINATION SITE RASH (Reddish Rash on the Vaccine Site 3" Round/ 9 days after first dose I woke up with a baseball size rash around the injection site which lasted about 4-5 days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder. Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) and VITAMINS NOS for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore Injection Site). On 18-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Reddish Rash on the Vaccine Site 3" Round) and VACCINATION SITE RASH (Reddish Rash on the Vaccine Site 3" Round/ 9 days after first dose I woke up with a baseball size rash around the injection site which lasted about 4-5 days). The patient was treated with ALLERGY MEDICATION (oral) for Vaccination site rash, at a dose of 2 allergy pills for 2 days. On 10-Mar-2021, DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Sore Injection Site) had resolved. On 23-Mar-2021, VACCINATION SITE RASH (Reddish Rash on the Vaccine Site 3" Round/ 9 days after first dose I woke up with a baseball size rash around the injection site which lasted about 4-5 days) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Reddish Rash on the Vaccine Site 3" Round) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. This case was linked to MOD-2021-066596 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Added patient demographics (Date of Birth, Medical history), second dose of the drug, concomitant medications. Updated the outcome of the event (Vaccination site rash) from unknown to recovered. On 07-May-2021: Follow up received on 07-MAY-2021 and does not contain any new information for first dose.

Other Meds: LEVOXYL; VITAMINS NOS

Current Illness: Autoimmune disorder

ID: 1568211
Sex: F
Age: 64
State: NE

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 08/15/2021
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: Soreness; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Soreness) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 immunisation. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 milliliter. On 18-Feb-2021, the patient experienced PAIN (Soreness) and FATIGUE (Fatigue). At the time of the report, PAIN (Soreness) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information provided. This case was linked to US-MODERNATX, INC.-MOD-2021-049706 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-049706:Crosslinked with dose 2

Other Meds:

Current Illness:

ID: 1568212
Sex: F
Age: 73
State: VA

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
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: Fast heart rate; Raised blood pressure; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Fast heart rate), HYPERTENSION (Raised blood pressure) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 10:00 PM, the patient experienced PALPITATIONS (Fast heart rate), HYPERTENSION (Raised blood pressure) and PYREXIA (Fever). At the time of the report, PALPITATIONS (Fast heart rate), HYPERTENSION (Raised blood pressure) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Blood pressure increased: 213/97 mmHg (High) Raised blood pressure (BP 213/97 mmhg). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1568213
Sex: F
Age: 82
State: IL

Vax Date: 03/12/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: rash is still very sore; Rash on chest/Rash under breast(s)/Very sore rash; Shingles blisters from center of chest under her right breast and around the back; hurting on right side of her breast front to back; right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm was sore), BREAST PAIN (hurting on right side of her breast front to back), HERPES ZOSTER (Shingles blisters from center of chest under her right breast and around the back), RASH PAPULAR (rash is still very sore) and RASH (Rash on chest/Rash under breast(s)/Very sore rash) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (right arm was sore). On 14-Mar-2021, the patient experienced BREAST PAIN (hurting on right side of her breast front to back). On 16-Mar-2021, the patient experienced HERPES ZOSTER (Shingles blisters from center of chest under her right breast and around the back). On an unknown date, the patient experienced RASH PAPULAR (rash is still very sore) and RASH (Rash on chest/Rash under breast(s)/Very sore rash). The patient was treated with GABAPENTIN at a dose of 1 dosage form; VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at a dose of 1 dosage form and PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 2 dosage form as necessary. On 13-Mar-2021, PAIN IN EXTREMITY (right arm was sore) had resolved. At the time of the report, BREAST PAIN (hurting on right side of her breast front to back), HERPES ZOSTER (Shingles blisters from center of chest under her right breast and around the back), RASH PAPULAR (rash is still very sore) and RASH (Rash on chest/Rash under breast(s)/Very sore rash) had not resolved. Not Provided No concomitant product was reported. Symptoms: Patient reported that she has shingles and shingles are dried but not resolved yet, she still has rash which is very sore. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received: Added event outcome, treatment medication.

Other Meds:

Current Illness:

ID: 1568214
Sex: F
Age: 84
State: MA

Vax Date: 02/27/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
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: delay in side effects; injection arm irritated; injection arm itchy; injection arm red; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (delay in side effects), LIMB DISCOMFORT (injection arm irritated), INJECTION SITE PRURITUS (injection arm itchy) and VACCINATION SITE ERYTHEMA (injection arm red) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for an unknown indication. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced SKIN REACTION (delay in side effects), LIMB DISCOMFORT (injection arm irritated), INJECTION SITE PRURITUS (injection arm itchy) and VACCINATION SITE ERYTHEMA (injection arm red). At the time of the report, SKIN REACTION (delay in side effects), LIMB DISCOMFORT (injection arm irritated), INJECTION SITE PRURITUS (injection arm itchy) and VACCINATION SITE ERYTHEMA (injection arm red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were given by the reporter. Treatment included Benadryl was noted.

Other Meds:

Current Illness:

ID: 1568215
Sex: U
Age: 77
State:

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
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: Received Covid-19 vaccine on March 18 following a temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Covid-19 vaccine on March 18 following a temperature excursion) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Covid-19 vaccine on March 18 following a temperature excursion). On 18-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received Covid-19 vaccine on March 18 following a temperature excursion) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact No concomitant medications were reported. No treatment related information has been reported.

Other Meds:

Current Illness:

ID: 1568216
Sex: F
Age: 64
State: NE

Vax Date: 02/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
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: patient was administered a 1 mL instead of the 0.5 mL of the second dose; A spontaneous report was received from a physician concerning 64 years old female patient, who received moderna's COVID-19 vaccine (mRNA-1273) and patient was administered a 1 mL instead of the 0.5 mL of the second dose (Incorrect dose administered). The patient's medical history, as provided by the reporter was unknown. Concomitant medications as provided by the reporter was unknown On 18 Feb 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:031L20A) in left arm for prophylaxis of COVID-19 infection. The patient experienced mild soreness and fatigue after the first dose. On 18 Mar 2021, the patient was administered 1 ml instead of 0.5 ml of the second dose of Moderna vaccine (lot number: 032M20A) intramuscularly in his right arm.. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of event the patient was administered a 1 mL instead of the 0.5 mL of the second dose was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 032M20A with no associated AEs.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-049697:Crosslinked with dose 1

Other Meds:

Current Illness:

ID: 1568217
Sex: F
Age: 71
State: AL

Vax Date: 02/18/2021
Onset Date: 02/20/2021
Rec V Date: 08/15/2021
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: experiencing "allergies"; nose is stuffy; scratchy throat; sinus drainage; sinus infection; bad headaches; felt tired / stayed in bed off and on for two weeks / feels tired; felt like she had the flu; the injection made her sick; had weakness; had dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), VACCINATION COMPLICATION (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness) and SINUSITIS (sinus infection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seasonal allergy, Hypertension, Heart disease, unspecified (with heart palpitations) and Migraine headache. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), VACCINATION COMPLICATION (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness), HEADACHE (bad headaches) and FATIGUE (felt tired / stayed in bed off and on for two weeks / feels tired). On 11-Mar-2021, the patient experienced SINUSITIS (sinus infection). On 18-Mar-2021, the patient experienced HYPERSENSITIVITY (experiencing "allergies"), NASAL CONGESTION (nose is stuffy), THROAT IRRITATION (scratchy throat) and SINUSITIS (sinus drainage). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu), VACCINATION COMPLICATION (the injection made her sick), ASTHENIA (had weakness), DIZZINESS (had dizziness), SINUSITIS (sinus infection), THROAT IRRITATION (scratchy throat), SINUSITIS (sinus drainage) and HEADACHE (bad headaches) outcome was unknown and HYPERSENSITIVITY (experiencing "allergies"), NASAL CONGESTION (nose is stuffy) and FATIGUE (felt tired / stayed in bed off and on for two weeks / feels tired) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported concomitant medications for her current medical conditions, not otherwise specified. On 24-Feb-2021, the patient presented to her healthcare provider and allergy shots were administered. No additional treatment was reported for the events.

Other Meds:

Current Illness: Heart disease, unspecified (with heart palpitations); Hypertension; Migraine headache; Seasonal allergy

ID: 1568218
Sex: F
Age: 71
State: VA

Vax Date: 01/30/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
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: cramp in her left thigh; pain in her chest; Chills; headache; Fever; muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramp in her left thigh), CHEST PAIN (pain in her chest), CHILLS (Chills), HEADACHE (headache) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (headache), PYREXIA (Fever), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain). On 10-Mar-2021, the patient experienced CHEST PAIN (pain in her chest). On 11-Mar-2021, the patient experienced MUSCLE SPASMS (cramp in her left thigh). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (cramp in her left thigh), CHEST PAIN (pain in her chest), CHILLS (Chills), HEADACHE (headache), PYREXIA (Fever), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown. Concomitant medications were not reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-JUN-2021 and contains non-significant information. Updated email and address of the reporter

Other Meds:

Current Illness:

ID: 1568219
Sex: M
Age: 68
State: MI

Vax Date: 03/13/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
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: body aches; Sore arm; Mild Symptoms; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PAIN IN EXTREMITY (Sore arm), GENERAL SYMPTOM (Mild Symptoms) and FATIGUE (fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. Concomitant products included ATORVASTATIN, ENALAPRIL and TRAVOPROST for an unknown indication. On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (body aches), PAIN IN EXTREMITY (Sore arm), GENERAL SYMPTOM (Mild Symptoms) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Mar-2021, PAIN (body aches) and FATIGUE (fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and GENERAL SYMPTOM (Mild Symptoms) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. Action taken with mRNA-1273 in response to the events were Not Applicable

Other Meds: ATORVASTATIN; ENALAPRIL; TRAVOPROST

Current Illness:

ID: 1568220
Sex: F
Age: 64
State: NM

Vax Date: 02/05/2021
Onset Date: 02/08/2021
Rec V Date: 08/15/2021
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: COVID-19; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a 64-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 medical history was provided.). On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, 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) (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 reported.

Other Meds:

Current Illness:

ID: 1568221
Sex: U
Age: 36
State:

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 08/15/2021
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: received Covid-19 vaccine on March 18 following temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No Medical History information was reported. On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1568222
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: Side effects; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effects). At the time of the report, ADVERSE EVENT (Side effects) 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. No treatment information was provided. This case was linked to MOD-2021-049532 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up was received on 07-may-2021 and contains no significant information

Other Meds:

Current Illness:

ID: 1568223
Sex: F
Age: 81
State: MO

Vax Date: 03/02/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
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: Vaccination site pain; Arm was itchy; Erythema; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm was itchy), ERYTHEMA (Erythema) and VACCINATION SITE PAIN (Vaccination site pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PRURITUS (Arm was itchy) and ERYTHEMA (Erythema). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PRURITUS (Arm was itchy), ERYTHEMA (Erythema) and VACCINATION SITE PAIN (Vaccination site pain) 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. The concomitant medications on use were not provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1568224
Sex: U
Age: 46
State:

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 08/15/2021
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: received Covid-19 vaccine on March 18 following temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received Covid-19 vaccine on March 18 following temperature excursion) 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. No treatment related information has been reported.

Other Meds:

Current Illness:

ID: 1568225
Sex: F
Age: 81
State: FL

Vax Date: 03/05/2021
Onset Date: 03/14/2021
Rec V Date: 08/15/2021
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: Hot to Touch Sensation - Near Injection Site; Swelling - Near Injection Site; Hardness - Near Injection Site; Itchy - Near Injection Site; Rash - Near Injection Site; Arm Pain - Near Injection Site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE INDURATION (Hardness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19. Concomitant products included CITALOPRAM for Antidepressant therapy, MELATONIN for Sleep disorder. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE INDURATION (Hardness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site). At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE INDURATION (Hardness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. concomitant product included supplements for general health. Treatment included cold compress as advised by HCP to alleviate the symptoms.

Other Meds: MELATONIN; CITALOPRAM

Current Illness:

ID: 1568226
Sex: F
Age: 51
State: GA

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
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: itchy rash around neck/itchy rash around chin/itchy rash around face/itchy rash around back; itchy all the way down inner legs; right arm hot/right hand hot; body sore; fever; right arm swollen/right arm swollen; right arm red/right hand red; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash around neck/itchy rash around chin/itchy rash around face/itchy rash around back), PRURITUS (itchy all the way down inner legs), VACCINATION SITE WARMTH (right arm hot/right hand hot), MYALGIA (body sore) and PYREXIA (fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Allergy to animals (Allergies to cats,shelfish), Latex allergy, Allergy to molds, Grass allergy, Allergy to nuts, Drug allergy (Allergic to lisinopril, speralactose, tramadol, cipro, sulfur.), Multiple allergies (Allergic to rye, barley, cherries, chocolate, dust mites, roach feces.) and Penicillin allergy. Concomitant products included EPINEPHRINE (EPIPEN), BUMETANIDE, BUPROPION, CYCLOBENZAPRINE, PANTOPRAZOLE, PRAZOSIN, CARVEDILOL, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), FLUTICASONE, RISPERIDONE, DICLOFENAC SODIUM, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), METFORMIN HYDROCHLORIDE (METFORMIN ER), MULTIVITAMINS [VITAMINS NOS], GABAPENTIN, LUBIPROSTONE (AMITIZA), CITALOPRAM, DICYCLOMINE [DICYCLOVERINE] and LEVOFLOXACIN HEMIHYDRATE (LEVOZINE [LEVOFLOXACIN HEMIHYDRATE]) for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced RASH PRURITIC (itchy rash around neck/itchy rash around chin/itchy rash around face/itchy rash around back), PRURITUS (itchy all the way down inner legs), VACCINATION SITE WARMTH (right arm hot/right hand hot), MYALGIA (body sore), PYREXIA (fever), VACCINATION SITE SWELLING (right arm swollen/right arm swollen) and VACCINATION SITE ERYTHEMA (right arm red/right hand red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL ALLERGY/COLD) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itchy rash around neck/itchy rash around chin/itchy rash around face/itchy rash around back), PRURITUS (itchy all the way down inner legs), VACCINATION SITE WARMTH (right arm hot/right hand hot), VACCINATION SITE SWELLING (right arm swollen/right arm swollen) and VACCINATION SITE ERYTHEMA (right arm red/right hand red) had not resolved and MYALGIA (body sore) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: EPIPEN; BUMETANIDE; BUPROPION; CYCLOBENZAPRINE; PANTOPRAZOLE; PRAZOSIN; CARVEDILOL; ENTRESTO; FLUTICASONE; RISPERIDONE; DICLOFENAC SODIUM; B12 [CYANOCOBALAMIN]; METFORMIN ER; MULTIVITAMINS [VITAMINS NOS]; GABAPENTIN; AMITIZA; CITALOPRAM; DI

Current Illness: Allergy to animals (Allergies to cats,shelfish); Allergy to molds; Allergy to nuts; Drug allergy (Allergic to lisinopril, speralactose, tramadol, cipro, sulfur.); Grass allergy; Latex allergy; Multiple allergies (Allergic to rye, barley, cherries, chocolate, dust mites, roach feces.); Penicillin allergy

ID: 1568227
Sex: F
Age: 86
State: MN

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 08/15/2021
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: felt sick; really bad arm; achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), LIMB DISCOMFORT (really bad arm), MYALGIA (achy) and FATIGUE (tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ILLNESS (felt sick), LIMB DISCOMFORT (really bad arm), MYALGIA (achy) and FATIGUE (tired). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 15-Feb-2021, ILLNESS (felt sick), LIMB DISCOMFORT (really bad arm), MYALGIA (achy) and FATIGUE (tired) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-049727 (Patient Link).

Other Meds:

Current Illness:

ID: 1568228
Sex: M
Age: 41
State: NJ

Vax Date: 03/09/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
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: Felt Very sick; cough; tested positive for Covid-19 after 1st vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt Very sick), COUGH (cough) and COVID-19 (tested positive for Covid-19 after 1st vaccination) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ILLNESS (Felt Very sick), COUGH (cough) and COVID-19 (tested positive for Covid-19 after 1st vaccination). At the time of the report, ILLNESS (Felt Very sick), COUGH (cough) and COVID-19 (tested positive for Covid-19 after 1st vaccination) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product information was not provided. Treatment Medicines include Cough Medications (no specific details) to help up with cough. This case was linked to MOD21-056951 (E2B Linked Report).; Sender's Comments: MOD21-056951:Crosslinked Patient with Wife case

Other Meds:

Current Illness:

ID: 1568229
Sex: F
Age: 42
State: NJ

Vax Date: 02/28/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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: fever; COVID-19; cough that did not go away for over a week; feeling tired; arm swelled a little bit; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), COUGH (cough that did not go away for over a week), FATIGUE (feeling tired), VACCINATION SITE SWELLING (arm swelled a little bit) and PYREXIA (fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. No medical history was reported. On 28-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced COUGH (cough that did not go away for over a week), FATIGUE (feeling tired) and VACCINATION SITE SWELLING (arm swelled a little bit). On 10-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), COUGH (cough that did not go away for over a week), FATIGUE (feeling tired), VACCINATION SITE SWELLING (arm swelled a little bit) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. 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 medication was not reported. Treatment medication included unspecified Cough medicine for Cough

Other Meds:

Current Illness:

ID: 1568230
Sex: F
Age: 58
State: VA

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
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: Can't smell; Dry Mouth; Lost Taste; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Can't smell), DRY MOUTH (Dry Mouth) and AGEUSIA (Lost Taste) in a 58-year-old female patient who received mRNA-1273 (batch no. 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ANOSMIA (Can't smell), DRY MOUTH (Dry Mouth) and AGEUSIA (Lost Taste). At the time of the report, ANOSMIA (Can't smell), DRY MOUTH (Dry Mouth) and AGEUSIA (Lost Taste) outcome was unknown. Not Provided The action taken with mRNA-1273 (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested

Other Meds:

Current Illness:

ID: 1568231
Sex: F
Age: 74
State: NY

Vax Date: 02/15/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
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: little bit downer; Little bit downer; felt worse; woke up not feeling well; nauseous; temperature of 100.3; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (little bit downer), FEELING ABNORMAL (felt worse), MALAISE (woke up not feeling well), NAUSEA (nauseous) and PYREXIA (temperature of 100.3) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Blood pressure. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PYREXIA (temperature of 100.3) and VACCINATION SITE PAIN (sore arm). On 16-Mar-2021, the patient experienced FEELING ABNORMAL (felt worse), MALAISE (woke up not feeling well) and NAUSEA (nauseous). On 17-Mar-2021, the patient experienced DEPRESSED MOOD (little bit downer). 17-Mar-2021, the patient experienced FATIGUE (Little bit downer). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and CALCIUM CARBONATE, MAGNESIUM CARBONATE (TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE]) at an unspecified dose and frequency. On 15-Mar-2021, PYREXIA (temperature of 100.3) and VACCINATION SITE PAIN (sore arm) had resolved. On 16-Mar-2021, FEELING ABNORMAL (felt worse), MALAISE (woke up not feeling well) and NAUSEA (nauseous) had resolved. At the time of the report, DEPRESSED MOOD (little bit downer) and FATIGUE (Little bit downer) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Body temperature: 100.3 (High) 100.3. Patient received Candy cane(Peppermint), Chamomile tea as treatment. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds: LISINOPRIL

Current Illness: Hypertension

ID: 1568232
Sex: F
Age: 57
State: NY

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
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: felt like someone was stepping on my throat and back/ I thought I was possibly having a heart attack, a collapsed lung, extreme acid reflux or something stuck in my throat; Primary care office who said not to get 2nd vaccine; Indigestion; Pressure on her back; Felt like she wasnt getting oxygen to her legs; Unable to get out of bed; sayed out of work; weird bout of diarrhea/ two bouts of diarrhea; throat on fire; Difficulty in breathing/ breathless for about 9 days/ trouble breathing; Coughing/gas in chest; Gas in chest; Chest pain; felt vey ill; fatigue/exhaustion/ exhausted/ recurring fatigue; chills; extremely tired/ extreme fatigue/ fatigue the night of vaccine; Throat tightness; joints felt tighter than usual; slight tightness in throat became flame thrower; pain in the arm/ arm pain; feeling kind of stiff/ difficulty bending over and lying down/felt like oxygen not getting to muscles/ couldnt bend over; Slept a lot; Aching bones; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (joints felt tighter than usual), MUSCULOSKELETAL STIFFNESS (feeling kind of stiff/ difficulty bending over and lying down/felt like oxygen not getting to muscles/ couldnt bend over), PAIN IN EXTREMITY (pain in the arm/ arm pain), CHEST DISCOMFORT (felt like someone was stepping on my throat and back/ I thought I was possibly having a heart attack, a collapsed lung, extreme acid reflux or something stuck in my throat) and THROAT IRRITATION (throat on fire) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to vaccine (flu vaccine) since 2011, Allergy to antibiotic (cipro), Allergy to antibiotic (Flagyl), Allergy to antibiotic (amox-clav), Irritable bowel syndrome since 01-Jan-1998, Diverticulitis since 01-Jan-1998, Acid reflux (esophageal) since 01-Jan-1998, Osteoporosis since 03-Jan-2019, Osteopenia since 03-Jan-2019 and Heart fluttering (saw a heart doctor at one point). Concomitant products included PROBIOTICS NOS from 08-Mar-2011 to an unknown date and MAGNESIUM from 01-Jan-2021 to an unknown date for Irritable bowel syndrome, VITAMIN C [ASCORBIC ACID] from 08-Mar-1973 to an unknown date for Prophylactic, VITAMINS NOS (MULTIVIT [VITAMINS NOS]) from 08-Mar-1973 to an unknown date for Supplementation therapy. On 02-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced JOINT STIFFNESS (joints felt tighter than usual), MUSCULOSKELETAL STIFFNESS (feeling kind of stiff/ difficulty bending over and lying down/felt like oxygen not getting to muscles/ couldnt bend over), PAIN IN EXTREMITY (pain in the arm/ arm pain) and THROAT IRRITATION (slight tightness in throat became flame thrower). On 02-Mar-2021 at 2:45 PM, the patient experienced THROAT TIGHTNESS (Throat tightness). On 03-Mar-2021, the patient experienced FATIGUE (extremely tired/ extreme fatigue/ fatigue the night of vaccine). On 04-Mar-2021, the patient experienced CHILLS (chills). On 06-Mar-2021, the patient experienced THROAT IRRITATION (throat on fire), DYSPNOEA (Difficulty in breathing/ breathless for about 9 days/ trouble breathing), COUGH (Coughing/gas in chest), FLATULENCE (Gas in chest), CHEST PAIN (Chest pain) and FATIGUE (fatigue/exhaustion/ exhausted/ recurring fatigue). 06-Mar-2021, the patient experienced MALAISE (felt vey ill). On 10-Apr-2021, the patient experienced DIARRHOEA (weird bout of diarrhea/ two bouts of diarrhea). On an unknown date, the patient experienced CHEST DISCOMFORT (felt like someone was stepping on my throat and back/ I thought I was possibly having a heart attack, a collapsed lung, extreme acid reflux or something stuck in my throat), BONE PAIN (Aching bones), IMPAIRED WORK ABILITY (sayed out of work), PRODUCT DOSE OMISSION ISSUE (Primary care office who said not to get 2nd vaccine), DYSPEPSIA (Indigestion), MUSCULOSKELETAL DISCOMFORT (Pressure on her back), LIMB DISCOMFORT (Felt like she wasnt getting oxygen to her legs), BEDRIDDEN (Unable to get out of bed) and SOMNOLENCE (Slept a lot). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 04-Mar-2021, FATIGUE (extremely tired/ extreme fatigue/ fatigue the night of vaccine) had resolved. On 11-Mar-2021, THROAT IRRITATION (throat on fire) had resolved. On 15-Mar-2021, MUSCULOSKELETAL STIFFNESS (feeling kind of stiff/ difficulty bending over and lying down/felt like oxygen not getting to muscles/ couldnt bend over), PAIN IN EXTREMITY (pain in the arm/ arm pain), DYSPNOEA (Difficulty in breathing/ breathless for about 9 days/ trouble breathing) and CHEST PAIN (Chest pain) had resolved with sequelae, IMPAIRED WORK ABILITY (sayed out of work) and THROAT IRRITATION (slight tightness in throat became flame thrower) had resolved. At the time of the report, JOINT STIFFNESS (joints felt tighter than usual), CHEST DISCOMFORT (felt like someone was stepping on my throat and back/ I thought I was possibly having a heart attack, a collapsed lung, extreme acid reflux or something stuck in my throat), FLATULENCE (Gas in chest), BONE PAIN (Aching bones), THROAT TIGHTNESS (Throat tightness), PRODUCT DOSE OMISSION ISSUE (Primary care office who said not to get 2nd vaccine), SOMNOLENCE (Slept a lot) and CHILLS (chills) had resolved, COUGH (Coughing/gas in chest), MALAISE (felt vey ill), DIARRHOEA (weird bout of diarrhea/ two bouts of diarrhea), DYSPEPSIA (Indigestion), MUSCULOSKELETAL DISCOMFORT (Pressure on her back), LIMB DISCOMFORT (Felt like she wasnt getting oxygen to her legs) and BEDRIDDEN (Unable to get out of bed) outcome was unknown and FATIGUE (fatigue/exhaustion/ exhausted/ recurring fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 100f (High) 100F. On 08-Mar-2021, SARS-CoV-2 test: negative (Negative) negative and negative (Negative) Negative. On 01-Jun-2021, Allergy test: not allergic to shellfish (Negative) not allergic to shellfish. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. On 02-Mar-2021, the patient experienced slight tightness in throat after she left the vaccine clinic and she had arm pain and fatigue the night of the vaccine. On 06-Mar-2021 the patient felt very ill when she woke having difficulty breathing, bending over, coughing, gas in chest, feeling like a flame thrower in her trachea and like someone was stepping on her back; occasional elevated temperature, extreme fatigue, aching bones, sleeping a lot, unable to lie on back and these strong symptoms lasted three days. The patient stayed out of work until 15-Mar-2021. She felt like oxygen was not getting to her muscles until about 10-Apr-2021, when she had a weird bout of diarrhea after which her muscles felt better but at time of report was still having issues with exhaustion. She thought she was possibly having a heart attack, a collapsed lung, extreme acid reflux or something stuck in her throat. After she read about Covid and myocarditis, she said she was pretty sure this is what she started to have on 04-Mar-2021 as she said her symptoms seemed to fit. Other test included: On unreported dates: body temperature reported as occasional elevated temperature and Covid antibody test result of 32 (units not specified). The patient was advised by two physicians not to get the second dose of the vaccine. Patient states that most of the symptoms has subsided now, aside from the recurring fatigue. This case was linked to MOD-2021-049648 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up report was received, and include information for lab, treatment medication and new events.

Other Meds: VITAMIN C [ASCORBIC ACID]; MULTIVIT [VITAMINS NOS]; PROBIOTICS NOS; MAGNESIUM

Current Illness: Acid reflux (esophageal); Allergy to antibiotic (Flagyl); Allergy to antibiotic (cipro); Allergy to antibiotic (amox-clav); Allergy to vaccine (flu vaccine); Diverticulitis; Heart fluttering (saw a heart doctor at one point); Irritable bowel syndrome; Osteopenia; Osteoporosis

ID: 1568233
Sex: F
Age: 69
State: SC

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
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: flu like symptoms; feels terrible; whole body aches; Fever of 101 degree F; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feels terrible), PAIN (whole body aches) and PYREXIA (Fever of 101 degree F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feels terrible), PAIN (whole body aches) and PYREXIA (Fever of 101 degree F). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feels terrible), PAIN (whole body aches) and PYREXIA (Fever of 101 degree F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Pyrexia: 101 (High) Fever of 101 degree F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1568234
Sex: F
Age: 71
State: AL

Vax Date: 02/14/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
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: Severe Diarrhea; soreness of left arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe Diarrhea) and PAIN IN EXTREMITY (soreness of left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DIARRHOEA (Severe Diarrhea) and PAIN IN EXTREMITY (soreness of left arm). On 16-Mar-2021, DIARRHOEA (Severe Diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness of left arm) outcome was unknown. Not Provided No Concomitant medications were reported. No Treatments were reported.

Other Meds:

Current Illness:

ID: 1568235
Sex: F
Age:
State: IL

Vax Date: 03/14/2021
Onset Date: 03/14/2021
Rec V Date: 08/15/2021
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: bad body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (bad body aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced MYALGIA (bad body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (bad body aches) outcome was unknown. treatment details included Tylenol. This case was linked to MOD21-051352, MOD21-052525, MOD-2021-041187, MOD-2021-041187 (Patient Link).

Other Meds:

Current Illness:

ID: 1568236
Sex: F
Age: 29
State: VA

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Vaccination while pregnant; sore arm; slight headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccination while pregnant), MYALGIA (sore arm) and HEADACHE (slight headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 23-Sep-2020 and the estimated date of delivery was 30-Jun-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccination while pregnant), MYALGIA (sore arm) and HEADACHE (slight headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-third week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccination while pregnant) and MYALGIA (sore arm) had resolved and HEADACHE (slight headache) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: positive (Positive) positive. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds:

Current Illness:

ID: 1568237
Sex: M
Age: 67
State: WI

Vax Date: 02/25/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: rash on his palm of hands, fingers, sole of his feet, between his toes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his palm of hands, fingers, sole of his feet, between his toes) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. Concomitant products included SIMVASTATIN for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced RASH (rash on his palm of hands, fingers, sole of his feet, between his toes). At the time of the report, RASH (rash on his palm of hands, fingers, sole of his feet, between his toes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Health care provider prescribed Prednisone for treatment.

Other Meds: SIMVASTATIN.

Current Illness:

ID: 1568238
Sex: M
Age:
State: KY

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 08/15/2021
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: Nauseous before getting the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NAUSEA (Nauseous before getting the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Nauseous. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nauseous before getting the vaccine). At the time of the report, NAUSEA (Nauseous before getting the vaccine) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant and treatment information were not provided.

Other Meds:

Current Illness: Nauseous

ID: 1568239
Sex: F
Age: 72
State: PA

Vax Date: 03/14/2021
Onset Date: 03/14/2021
Rec V Date: 08/15/2021
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: sweat; kept waking up; Fever; little rash underneath; swollen in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (little rash underneath), VACCINATION SITE SWELLING (swollen in the injection site), HYPERHIDROSIS (sweat), PYREXIA (Fever) and INSOMNIA (kept waking up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On 14-Mar-2021, the patient experienced RASH (little rash underneath), VACCINATION SITE SWELLING (swollen in the injection site) and PYREXIA (Fever). On 15-Mar-2021, the patient experienced HYPERHIDROSIS (sweat) and INSOMNIA (kept waking up). At the time of the report, RASH (little rash underneath) and VACCINATION SITE SWELLING (swollen in the injection site) had not resolved, HYPERHIDROSIS (sweat) and INSOMNIA (kept waking up) outcome was unknown and PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No Treatments were reported.

Other Meds:

Current Illness:

ID: 1568240
Sex: F
Age: 53
State: NJ

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/15/2021
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: arm swollen; Little soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Little soreness) and PERIPHERAL SWELLING (arm swollen) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. Concomitant products included METHOTREXATE, FLUCLOXACILLIN SODIUM (FLUCACID), ALPRAZOLAM and SERTRALINE for an unknown indication. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (Little soreness). On 17-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swollen). At the time of the report, PAIN (Little soreness) and PERIPHERAL SWELLING (arm swollen) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatments were reported.

Other Meds: METHOTREXATE; FLUCACID; ALPRAZOLAM; SERTRALINE

Current Illness: Immunocompromised

ID: 1568241
Sex: M
Age: 71
State: OH

Vax Date: 02/01/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
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: Bronchitis; Sickness; Cold; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), NASOPHARYNGITIS (Cold) and BRONCHITIS (Bronchitis) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced ILLNESS (Sickness) and NASOPHARYNGITIS (Cold). On 16-Mar-2021, the patient experienced BRONCHITIS (Bronchitis). At the time of the report, ILLNESS (Sickness), NASOPHARYNGITIS (Cold) and BRONCHITIS (Bronchitis) outcome was unknown. Not Provided No concomitant and treatment medication were provided Action taken with mRNA-1273 Moderna vaccine was Not applicable

Other Meds:

Current Illness:

ID: 1568242
Sex: M
Age: 67
State: CT

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 08/15/2021
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: Asthma cleared up/eyes cleared up/right hand started to gain more strength after vaccine.; Asthma has gotten worse and he has been getting more asthma attacks lately; His eyes also are a little more blurry and foggy; Laryngitis; Cramps in his legs and hands; Doesn't have fluid in his lungs but does have shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Asthma cleared up/eyes cleared up/right hand started to gain more strength after vaccine.), ASTHMA (Asthma has gotten worse and he has been getting more asthma attacks lately), VISION BLURRED (His eyes also are a little more blurry and foggy), LARYNGITIS (Laryngitis) and MUSCLE SPASMS (Cramps in his legs and hands) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. Concomitant products included VITAMINS NOS for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Asthma cleared up/eyes cleared up/right hand started to gain more strength after vaccine.), ASTHMA (Asthma has gotten worse and he has been getting more asthma attacks lately), VISION BLURRED (His eyes also are a little more blurry and foggy), LARYNGITIS (Laryngitis), MUSCLE SPASMS (Cramps in his legs and hands) and DYSPNOEA (Doesn't have fluid in his lungs but does have shortness of breath). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Asthma cleared up/eyes cleared up/right hand started to gain more strength after vaccine.) had resolved, ASTHMA (Asthma has gotten worse and he has been getting more asthma attacks lately), LARYNGITIS (Laryngitis) and DYSPNOEA (Doesn't have fluid in his lungs but does have shortness of breath) outcome was unknown and VISION BLURRED (His eyes also are a little more blurry and foggy) and MUSCLE SPASMS (Cramps in his legs and hands) was resolving. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds: VITAMINS NOS

Current Illness: Asthma

ID: 1568243
Sex: F
Age: 60
State: TX

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 08/15/2021
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: arm sore; felt a little tired; will not receive second dose on time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), FATIGUE (felt a little tired) and PRODUCT DOSE OMISSION ISSUE (will not receive second dose on time) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included CARVEDILOL and PANTOPRAZOLE for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore), FATIGUE (felt a little tired) and PRODUCT DOSE OMISSION ISSUE (will not receive second dose on time). At the time of the report, PAIN IN EXTREMITY (arm sore), FATIGUE (felt a little tired) and PRODUCT DOSE OMISSION ISSUE (will not receive second dose on time) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided

Other Meds: CARVEDILOL; PANTOPRAZOLE

Current Illness:

ID: 1568244
Sex: U
Age: 22
State:

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
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: Received Covid-19 vaccine on March 18 following temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Covid-19 vaccine on March 18 following temperature excursion) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Covid-19 vaccine on March 18 following temperature excursion). On 18-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received Covid-19 vaccine on March 18 following temperature excursion) had resolved. 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 related information has been reported.

Other Meds:

Current Illness:

ID: 1568245
Sex: M
Age: 63
State: FL

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
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: feel achy; arm started to hurt and was bothering him; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm started to hurt and was bothering him) and PAIN (feel achy) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm started to hurt and was bothering him). On 18-Mar-2021, the patient experienced PAIN (feel achy). At the time of the report, PAIN IN EXTREMITY (arm started to hurt and was bothering him) and PAIN (feel achy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1568246
Sex: F
Age:
State:

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
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: wheezing; elevated temp; throat felt like fire; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (wheezing), BODY TEMPERATURE INCREASED (elevated temp) and THROAT IRRITATION (throat felt like fire) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 26-Feb-2021, the patient experienced WHEEZING (wheezing), BODY TEMPERATURE INCREASED (elevated temp) and THROAT IRRITATION (throat felt like fire). At the time of the report, WHEEZING (wheezing), BODY TEMPERATURE INCREASED (elevated temp) and THROAT IRRITATION (throat felt like fire) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No Treatments were reported. Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional information included onset date and outcome of the events.

Other Meds:

Current Illness:

ID: 1568247
Sex: F
Age: 58
State: NJ

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 08/15/2021
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: Lump at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE MASS (Lump at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump at injection site). At the time of the report, VACCINATION SITE MASS (Lump at injection site) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication list was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1568248
Sex: F
Age: 31
State: NC

Vax Date: 03/09/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
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: rash at injection site the size of a fist; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site the size of a fist) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at injection site the size of a fist). At the time of the report, VACCINATION SITE RASH (rash at injection site the size of a fist) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No Treatments were reported.

Other Meds:

Current Illness:

ID: 1568249
Sex: F
Age: 65
State: VA

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
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: COVID ARM; big red whelp; immediate itching; States the injection was not administered in muscle, states "it was low on my arm"; felt flu like; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (States the injection was not administered in muscle, states "it was low on my arm"), INFLUENZA LIKE ILLNESS (felt flu like), INJECTION SITE REACTION (COVID ARM), PRURITUS (immediate itching) and URTICARIA (big red whelp) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included HYDROCODONE for an unknown indication. On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (States the injection was not administered in muscle, states "it was low on my arm"), INFLUENZA LIKE ILLNESS (felt flu like) and PRURITUS (immediate itching). On 17-Mar-2021, the patient experienced INJECTION SITE REACTION (COVID ARM) and URTICARIA (big red whelp). The patient was treated with HYDROCORTISONE ongoing since an unknown date at a dose of 1 dosage form. On 15-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (States the injection was not administered in muscle, states "it was low on my arm") had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (felt flu like), INJECTION SITE REACTION (COVID ARM), PRURITUS (immediate itching) and URTICARIA (big red whelp) outcome was unknown.

Other Meds: HYDROCODONE

Current Illness:

ID: 1568250
Sex: F
Age: 34
State: AR

Vax Date: 03/13/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
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: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Mar-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 31-Aug-2020 and the estimated date of delivery was 13-Jun-2021. On 13-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-seventh week of the pregnancy. On 13-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1568251
Sex: M
Age:
State: KY

Vax Date: 03/16/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
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: Weird chest pains; Not hard to breath but sometimes it is; Has been down; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Weird chest pains), DYSPNOEA (Not hard to breath but sometimes it is), DEPRESSED MOOD (Has been down) and PYREXIA (Fever) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced CHEST PAIN (Weird chest pains), DYSPNOEA (Not hard to breath but sometimes it is), DEPRESSED MOOD (Has been down) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 18-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, CHEST PAIN (Weird chest pains), DYSPNOEA (Not hard to breath but sometimes it is) and DEPRESSED MOOD (Has been down) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1568252
Sex: M
Age: 69
State: FL

Vax Date: 03/10/2021
Onset Date: 03/11/2021
Rec V Date: 08/15/2021
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: sore throat; goes to the bathroom more often for bowel movements; felt tired; felt lightheaded; broke out in sweats; rash that was light pink; swollen; urinates less at night; sleeps longer with more "deep sleep" and more "REM"; had "side effects"; "couldn't walk in straight line"; lightheaded, dizzy; Fever 99F; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (had "side effects"), GAIT DISTURBANCE ("couldn't walk in straight line"), DIZZINESS (lightheaded, dizzy), PERIPHERAL SWELLING (swollen) and DIZZINESS (felt lightheaded) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy and Drug allergy (oxycontin). On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ADVERSE REACTION (had "side effects"), GAIT DISTURBANCE ("couldn't walk in straight line"), DIZZINESS (lightheaded, dizzy) and PYREXIA (Fever 99F). On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen), OLIGURIA (urinates less at night) and SOMNOLENCE (sleeps longer with more "deep sleep" and more "REM"). On 13-Mar-2021, the patient experienced RASH (rash that was light pink). On 14-Mar-2021, the patient experienced DIZZINESS (felt lightheaded) and HYPERHIDROSIS (broke out in sweats). On 17-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), BOWEL MOVEMENT IRREGULARITY (goes to the bathroom more often for bowel movements) and FATIGUE (felt tired). At the time of the report, ADVERSE REACTION (had "side effects"), GAIT DISTURBANCE ("couldn't walk in straight line"), DIZZINESS (lightheaded, dizzy), PERIPHERAL SWELLING (swollen), DIZZINESS (felt lightheaded), HYPERHIDROSIS (broke out in sweats), OROPHARYNGEAL PAIN (sore throat), BOWEL MOVEMENT IRREGULARITY (goes to the bathroom more often for bowel movements), OLIGURIA (urinates less at night), SOMNOLENCE (sleeps longer with more "deep sleep" and more "REM"), FATIGUE (felt tired), RASH (rash that was light pink) and PYREXIA (Fever 99F) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 99F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness: Drug allergy (oxycontin); Penicillin allergy

ID: 1568253
Sex: F
Age: 67
State: MN

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
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: shakes; cough; sore throat; arm was sore; diarrhea; fatigue; body aches from head to toe; fever of 101.1 degrees F; severe headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (arm was sore) and DIARRHOEA (diarrhea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced TREMOR (shakes), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (arm was sore), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (body aches from head to toe), PYREXIA (fever of 101.1 degrees F), HEADACHE (severe headache) and CHILLS (chills). On 28-Feb-2021, TREMOR (shakes), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (body aches from head to toe), PYREXIA (fever of 101.1 degrees F), HEADACHE (severe headache) and CHILLS (chills) had resolved. On 06-Mar-2021, PAIN IN EXTREMITY (arm was sore) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Pyrexia: 101.1 (High) fever of 101.1 degrees F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment for the events included Tylenol every 4 hours. Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: initial additional

Other Meds:

Current Illness:

ID: 1568254
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: Delayed the 2nd dose of the vaccine for 44 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Delayed the 2nd dose of the vaccine for 44 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Delayed the 2nd dose of the vaccine for 44 days). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Delayed the 2nd dose of the vaccine for 44 days) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1568255
Sex: F
Age: 81
State: CA

Vax Date: 02/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
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: severe pain in her spine; her skin is burning to the touch its on and off; arm is swollen; head really hurts; More fatigue than normal/tired; Nausea; Body aches; Can't eat chicken anymore; Stomach cramps; Seem to not feel well; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (severe pain in her spine), BURNING SENSATION (her skin is burning to the touch its on and off), PERIPHERAL SWELLING (arm is swollen), FOOD INTOLERANCE (Can't eat chicken anymore) and ABDOMINAL PAIN UPPER (Stomach cramps) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046a21a and 027h20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Yellow fever: Yellow fever vaccine (When patient was 21 years old). Past adverse reactions to the above products included No adverse event with Yellow fever vaccine. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced SPINAL PAIN (severe pain in her spine), BURNING SENSATION (her skin is burning to the touch its on and off) and PERIPHERAL SWELLING (arm is swollen). 17-Mar-2021, the patient experienced HEADACHE (head really hurts). On an unknown date, the patient experienced FOOD INTOLERANCE (Can't eat chicken anymore), ABDOMINAL PAIN UPPER (Stomach cramps), MALAISE (Seem to not feel well), FATIGUE (More fatigue than normal/tired), NAUSEA (Nausea) and MYALGIA (Body aches). At the time of the report, SPINAL PAIN (severe pain in her spine), BURNING SENSATION (her skin is burning to the touch its on and off), PERIPHERAL SWELLING (arm is swollen) and HEADACHE (head really hurts) outcome was unknown and FOOD INTOLERANCE (Can't eat chicken anymore), ABDOMINAL PAIN UPPER (Stomach cramps), MALAISE (Seem to not feel well), FATIGUE (More fatigue than normal/tired), NAUSEA (Nausea) and MYALGIA (Body aches) had resolved. No concomitant medication was reported. Patient had put ice on her neck, spine and arm as treatment. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-112132 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-May-2021 contains significant information including updated historic vaccine and added new events myalgia, nausea, fatigue, malaise, abdominal pain upper, foof intolerance.

Other Meds:

Current Illness:

ID: 1568256
Sex: F
Age: 53
State: TX

Vax Date: 03/11/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
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: Tingling in left arm; Numbness in left arm; Enough to wake her up from sleep; Hurting left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in left arm), HYPOAESTHESIA (Numbness in left arm), SLEEP DISORDER (Enough to wake her up from sleep) and PAIN IN EXTREMITY (Hurting left arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 040A21A) for COVID-19 vaccination. The patient's past medical history included Postmenopausal symptoms. Concurrent medical conditions included Hypertension (Under control), Latex allergy, Allergy to chemicals and Soap allergy. Concomitant products included OLMESARTAN, ESTRADIOL, MULTIPLUS, EPINEPHRINE (EPIPEN) and VITAMINS NOS (VIT B COMPLEXE [VITAMINS NOS]) for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Mar-2021, the patient experienced PARAESTHESIA (Tingling in left arm), HYPOAESTHESIA (Numbness in left arm), SLEEP DISORDER (Enough to wake her up from sleep) and PAIN IN EXTREMITY (Hurting left arm). At the time of the report, PARAESTHESIA (Tingling in left arm), HYPOAESTHESIA (Numbness in left arm), SLEEP DISORDER (Enough to wake her up from sleep) and PAIN IN EXTREMITY (Hurting left arm) outcome was unknown. No treatment related information has been reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: OLMESARTAN; ESTRADIOL; MULTIPLUS; EPIPEN; VIT B COMPLEXE [VITAMINS NOS]

Current Illness: Allergy to chemicals; Hypertension (Under control); Latex allergy; Soap allergy

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm