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

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1366823
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 06/02/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: HIGH BLOOD PRESSURE; DISSOCIATION; FEEL LIKE ROOFIED; CAN'T FOCUS ON CONVERSATION; DIZZINESS; BURNING SENSATION IN BRAIN; CHILLS; FEVER; HEADACHE; BODY ACHES; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headache. On 28-APR-2021, the subject experienced burning sensation in brain. On an unspecified date, the subject experienced high blood pressure, dissociation, feel like roofied, can't focus on conversation, and dizziness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) increased to 190/100. The action taken with covid-19 vaccine was not applicable. The patient recovered from high blood pressure, and body aches, chills, fever, and headache on APR-2021, and the outcome of burning sensation in brain, dizziness, dissociation, feel like roofied and can't focus on conversation was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1366824
Sex: M
Age:
State: LA

Vax Date:
Onset Date: 05/31/2021
Rec V Date: 06/02/2021
Hospital:

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Symptom List:

Symptoms: VACCINE ADMINISTERED TO INAPPROPRIATE AGE GROUP; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: 23-JUN-2021) .5 ml, administered on 31-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced vaccine administered to inappropriate age group. On 31-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to inappropriate age group and off label use was not reported. This report was non-serious. This report was associated with product quality complaint: 90000181255.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1366825
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 05/24/2021
Rec V Date: 06/02/2021
Hospital:

Vax Type:
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Symptoms: BLOOD VESSEL BURST IN RIGHT EYE; PAIN IN ARM; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: unknown) frequency 1 total, dose was not reported, administered at left arm on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, Patient's arm was also sore after getting the vaccine and resolved within a few days. On 31-MAY-2021, the patient looked in the mirror and noticed one of the blood vessels in the right eye had burst. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm on MAY-2021, and the outcome of blood vessel burst in right eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210600178- covid-19 vaccine ad26.cov2.s- blood vessels burst in the right eye. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1366826
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/02/2021
Hospital:

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Symptoms: LITTLE DIZZY; SHORT OF BREATH; FEELING HUNGRY; WEAKNESS; TIREDNESS; This spontaneous report received from a patient concerned a 39 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced little dizzy, short of breath, feeling hungry, weakness, and tiredness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from tiredness, and feeling hungry, and the outcome of little dizzy, short of breath and weakness was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1366827
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/25/2021
Rec V Date: 06/02/2021
Hospital:

Vax Type:
Manufacturer:
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Symptoms: FATIGUE; LOOSER STOOL THAN NORMAL; SORE ARM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816027, and batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced looser stool than normal. On 25-MAY-2021, the subject experienced sore arm. On 27-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from fatigue on 28-MAY-2021, and had not recovered from looser stool than normal, and sore arm. This report was non-serious.

Other Meds:

Current Illness:

Date Died:

ID: 1366828
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/02/2021
Hospital:

Vax Type:
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Symptoms: DEATH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died due to unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210600235 -COVID-19 VACCINE AD26.COV2.S- Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1366829
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 05/25/2021
Rec V Date: 06/02/2021
Hospital:

Vax Type:
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Symptoms: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned an 87 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no illness at the time of vaccination. the patient had no past history of similar event. the patient had no adverse event after any previous vaccination. the patient had no history of allergy to vaccine, drug, or food. the patient had no pre-existing acute illness 30 days prior to vaccination. the patient had no history of hospitalization in last 30 days. the patient had no family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine (suspension for injection, intramuscular, and batch number: 1805029 expiry: 25-MAY-2021) .5 ml, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced expired vaccine used. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case is a duplicate of 20210559435. This case, from the same reporter is linked to 20210549259 and 20210557958.

Other Meds:

Current Illness:

ID: 1366830
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 05/09/2021
Rec V Date: 06/02/2021
Hospital:

Vax Type:
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Symptoms: ITCHING ON THE FEET, ANKLES, ON THE BACK, HAND AND ARMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAY-2021, the subject experienced itching on the feet, ankles, on the back, hand and arms. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itching on the feet, ankles, on the back, hand and arms. This report was non-serious.

Other Meds:

Current Illness:

ID: 1366832
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 05/19/2021
Rec V Date: 06/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

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Symptom List:

Symptoms: FLANK PAIN; INABILITY TO FALL ASLEEP; HEADACHE; NAUSEA; INABILITY TO URINATE; CONSTIPATION; This spontaneous report received from a patient concerned a 31-year-old male. The patient's height, and weight were not reported. The patient's past medical history included back pain due to car accident a year ago, and dislocated disc in lower back and neck. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, RA10630, expiry: unknown) dose was not reported, 1 total administered on 19-MAY-2021 for prophylactic vaccination to left deltoid. No concomitant medications were reported. On 19-MAY-2021, for the first week, patient could not sleep at all and had a headache and nausea for about 3-4 days. Then it got better. As per patient, it was easier to sleep at the time of reporting, but still a little harder to fall asleep. Patient reported that he was having constipation and urinations issues since getting the vaccine. It was not painful to go to the bathroom but it took a while. Consumer woke up on 31-MAY-2021, and had excruciating pain in the back, flank area. It was hurting when he tried to move anyway to the left and if he used to touch it. He felt like he wants to scream. Consumer did consult with his PHP regarding the inability to fall asleep and problems with constipation. He was given some sleep medications and advised to take cranberry juice. HCP (health care professional) was not aware of the flank pain that consumer had that day. He was advised to call PHP or go to urgent care to determine cause of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea on MAY-2021, was recovering from inability to fall asleep, and had not recovered from constipation, flank pain, and inability to urinate. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210557948-COVID-19 VACCINE AD26.COV2.S - inability to urinate. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY

Other Meds:

Current Illness:

ID: 1366833
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 05/15/2021
Rec V Date: 06/02/2021
Hospital:

Vax Type:
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Symptoms: DISCONNECTED RETNA; This spontaneous report received from a patient concerned a 64-year-old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: unknown) dose was not reported, 1 total administered on 14-MAY-2021 for prophylactic vaccination to left arm. No concomitant medications were reported. On 15-MAY-2021, the patient started to experience intermittent flashing lights on his right eye, followed by a black line that goes across his right eye when his eyes are closed. Patient also experienced a "black curtain" effect. After a week of symptoms, the patient visited his MD and was diagnosed with a 'Disconnected Retna'. The patient had surgery for his right eye as per diagnosis on Tuesday, 25-MAY-2021. Patient was doing well so far with slight discomfort but no pain. Patient was going to see his ophthalmologist on 01-JUN-2021 for his post-op follow-up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Disconnected Retna. This report was Serious (Other Medically Important Condition).; Sender's Comments: V0: 20210558759-covid-19 vaccine ad26.cov2.s-Disconnected Retna.. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1366834
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: DIZZINESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness. The action taken with covid-19 vaccine was not applicable. The outcome of dizziness was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1366835
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 06/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

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Symptom List:

Symptoms: LITTLE NUMBNESS IN LEFT THIGH/NUMBNESS IN UPPER PART OF BACK; ARMS WHERE VACCINE WAS APPLIED TINGLING/HAND OF THE SAME ARM TINGLING WHEN LYING DOWN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number and expiry unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced little numbness in left thigh/numbness in upper part of back. On MAY-2021, the subject experienced arms where vaccine was applied tingling/hand of the same arm tingling when lying down. The action taken with covid-19 vaccine was not applicable. The outcome of the little numbness in left thigh/numbness in upper part of back and arms where vaccine was applied tingling/hand of the same arm tingling when lying down was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1366836
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/02/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: HEARING LOSS; TINNITUS; This spontaneous report received from a patient.. concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced hearing loss, and tinnitus. Reporter stated that there were many people in his group affected by tinnitus or hearing loss after being vaccinated (more than 2000). The reporter wanted to know that if the side effect would go away. And he also prayed if the side effects were temporary. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The outcome of the tinnitus and hearing loss was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210559168.; Sender's Comments: V0: 20210600421-COVID-19 VACCINE AD26.COV2.S-Hearing loss. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1366837
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 05/31/2021
Rec V Date: 06/02/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: ITCHY RED RAISED, SPLOTCHY RASH ON LOWER POSTERIOR REGION BACK SIDE OF BOTH THIGHS, BUTTOCKS AND LOWER BACK; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumption, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine(suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced itchy red raised, splotchy rash on lower posterior region back side of both thighs, buttocks and lower back. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from itchy red raised, splotchy rash on lower posterior region back side of both thighs, buttocks and lower back. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (4-5 drinks a month); Non-smoker

ID: 1366838
Sex: M
Age:
State: MT

Vax Date:
Onset Date: 05/30/2021
Rec V Date: 06/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: RED ITCHY RASH ON KNEES, ELBOWS, BELLY, LEGS AND ARMS; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 200 pounds, and height was not reported. The patient's pre-existing medical conditions included patient had no known history of allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced red itchy rash on knees, elbows, belly, legs and arms. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine was not applicable. The patient was recovering from red itchy rash on knees, elbows, belly, legs and arms. This report was non-serious.

Other Meds:

Current Illness:

ID: 1366839
Sex: F
Age: 27
State: CA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 06/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: heart racing; hyperventilation; shaking of arms and legs; panic attack; Faint after covid vaccine on awakeing,Vasovagal, Passed out; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Faint after covid vaccine on awakeing,Vasovagal, Passed out) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to nuts (Allergy to peanuts and tree nuts). On 27-Jan-2021 at 10:29 AM, 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 27-Jan-2021, the patient experienced SYNCOPE (Faint after covid vaccine on awakeing,Vasovagal, Passed out) (seriousness criterion medically significant) and PANIC ATTACK (panic attack). On 27-Jan-2021 at 10:29 AM, the patient experienced HYPERVENTILATION (hyperventilation) and TREMOR (shaking of arms and legs). On 27-Jan-2021 at 10:40 AM, the patient experienced PALPITATIONS (heart racing). On 27-Jan-2021, SYNCOPE (Faint after covid vaccine on awakeing,Vasovagal, Passed out) and PANIC ATTACK (panic attack) had resolved. At the time of the report, PALPITATIONS (heart racing), HYPERVENTILATION (hyperventilation) and TREMOR (shaking of arms and legs) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Blood pressure measurement: 148/88 mmHg (High) 148/88. On 27-Jan-2021, Heart rate: 100 (normal) 100. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitantly the patient was taking medications for birth control (unspecified). The patient received treatment with oxygen via NRB @15L. It was reported that patient approximately had 3 episodes. She reported no loss of consciousness and no loss of bladder or bowel control. Patient used pulse oximeter Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant follow up serious event updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Allergy to nuts (Allergy to peanuts and tree nuts)

ID: 1366840
Sex: F
Age: 67
State: NJ

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 06/02/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Vax Site:

Lab Data:

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Symptoms: Cellulitis; Itchy; Hot to the touch around the injection site; Left arm swelling; A hard lump; 4"x3" big red area; Pain in center of injection site; Lower lip got numb; This spontaneous case was reported by a nurse and describes the occurrence of CELLULITIS (Cellulitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypertension since an unknown date, GERD and Bowel dysfunction. Concomitant products included FISH OIL for Cholesterol, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) from an unknown date to 20-May-2021 for GERD, LISINOPRIL for Hypertension, VITAMIN D3 for Vitamin D deficiency, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and VITAMIN E NOS for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Lower lip got numb). On 15-Jan-2021, the patient experienced PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to the touch around the injection site), PERIPHERAL SWELLING (Left arm swelling), VACCINATION SITE MASS (A hard lump), VACCINATION SITE ERYTHEMA (4"x3" big red area) and VACCINATION SITE PAIN (Pain in center of injection site). On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Feb-2021, CELLULITIS (Cellulitis), PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to the touch around the injection site), PERIPHERAL SWELLING (Left arm swelling), VACCINATION SITE MASS (A hard lump), VACCINATION SITE ERYTHEMA (4"x3" big red area) and VACCINATION SITE PAIN (Pain in center of injection site) had resolved. At the time of the report, HYPOAESTHESIA ORAL (Lower lip got numb) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment included 7- day course of antibiotics. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-079616 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Patient details, medical history, dosing details and 2 events added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-079616:Second dose

Other Meds: PRILOSEC [OMEPRAZOLE MAGNESIUM]; LISINOPRIL; VITAMIN E NOS; VITAMIN D3; PROTONIX [OMEPRAZOLE]; FISH OIL

Current Illness: Hypertension

ID: 1366841
Sex: M
Age: 74
State: CA

Vax Date: 01/29/2021
Onset Date: 02/26/2021
Rec V Date: 06/02/2021
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Symptoms: Loss of balance; Disorientation; Difficult breathing; Was extremely cold; Was trembling; no strength; passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 74-year-old male 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. Concurrent medical conditions included Penicillin allergy, Fruit allergy (The patient have allergy towards bananas.) and Pollen allergy. Concomitant products included FENOFIBRATE, SERTRALINE, ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) and VITAMIN D3 for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), FEELING COLD (Was extremely cold), TREMOR (Was trembling) and ASTHENIA (no strength). On 27-Feb-2021, the patient experienced BALANCE DISORDER (Loss of balance), DISORIENTATION (Disorientation) and DYSPNOEA (Difficult breathing). On 26-Feb-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved. On 27-Feb-2021, FEELING COLD (Was extremely cold), TREMOR (Was trembling) and ASTHENIA (no strength) had resolved. At the time of the report, BALANCE DISORDER (Loss of balance), DISORIENTATION (Disorientation) and DYSPNOEA (Difficult breathing) outcome was unknown. Patient wok up 10 to 12 hours after receiving second shot and was extremely cold, trembling or shaking uncontrollably. All limbs and jaw could not stop trembling. Got out of bed to find another blanket and raise thermostat. Could not find thermostat (disoriented) struggled to find blanket. By the time patient found blanket he began to have great difficulty breathing. By the time patient stumbled into bed, he was gasping as if there was no air in the room. Stayed in bed gasping, trembling and freezing till he fell asleep or passed out. Patient had no strength to call for help, thought he was dying. Patient woke up about 8:00 AM with no illness, aches, pains or any physical issues. Patient had no further issues till date of report. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: No specific follow-up information recorded. On 24-May-2021: Follow up received on 25 May 2021 and it contain significant information. Additional new event added and one event upgrade the case to serious. Patient demographics updated. History, concomitant and narrative information also get updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: FENOFIBRATE; SERTRALINE; LUTEIN +; VITAMIN D3

Current Illness: Fruit allergy (The patient have allergy towards bananas.); Penicillin allergy; Pollen allergy

ID: 1366842
Sex: M
Age: 70
State: NM

Vax Date: 02/19/2021
Onset Date: 02/01/2021
Rec V Date: 06/02/2021
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Symptoms: 1st dose of the Moderna Covid-19 vaccine on 3 months ago; Itchy Sensation/ itchiness near injection site; Soreness near injection site; Redness near injection site; Rash near injection site; Swelling near the injection site; Neck Spasms - Left Side/muscle that runs along the area (trapezius) went into complete spasm/Extremely painful; Stiff neck/stiff neck on the side where the vaccine was given; Mild Itchy/Tingling Sensation in Extremities; Anaphylactic reaction/ unusual severe reaction; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021. The most recent information was received on 18-May-2021 and was forwarded to Moderna on 18-May-2021. This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction/ unusual severe reaction) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction/ unusual severe reaction) (seriousness criterion medically significant). On 27-Feb-2021, the patient experienced MUSCLE SPASMS (Neck Spasms - Left Side/muscle that runs along the area (trapezius) went into complete spasm/Extremely painful) and VACCINATION SITE ERYTHEMA (Redness near injection site). 27-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck/stiff neck on the side where the vaccine was given), PARAESTHESIA (Mild Itchy/Tingling Sensation in Extremities), VACCINATION SITE PRURITUS (Itchy Sensation/ itchiness near injection site), VACCINATION SITE PAIN (Soreness near injection site), VACCINATION SITE RASH (Rash near injection site) and VACCINATION SITE SWELLING (Swelling near the injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose of the Moderna Covid-19 vaccine on 3 months ago). On 28-Feb-2021, MUSCLE SPASMS (Neck Spasms - Left Side/muscle that runs along the area (trapezius) went into complete spasm/Extremely painful) had resolved. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction/ unusual severe reaction), MUSCULOSKELETAL STIFFNESS (Stiff neck/stiff neck on the side where the vaccine was given), PARAESTHESIA (Mild Itchy/Tingling Sensation in Extremities), PRODUCT DOSE OMISSION ISSUE (1st dose of the Moderna Covid-19 vaccine on 3 months ago), VACCINATION SITE PRURITUS (Itchy Sensation/ itchiness near injection site), VACCINATION SITE PAIN (Soreness near injection site), VACCINATION SITE ERYTHEMA (Redness near injection site), VACCINATION SITE RASH (Rash near injection site) and VACCINATION SITE SWELLING (Swelling near the injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Event of anaphylactic reaction added. Outcome updated to recovered. Treatment information was added.

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ID: 1366843
Sex: M
Age: 66
State: NV

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 06/02/2021
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Symptoms: sick as a dog; Kidney's almost shut down both times; had 2-3 attacks; Unexplainable pain in lower stomach area; Health declined quickly; Heart issue after first shot of vaccine; Lungs have gotten worse since the first shot; grabbing and pulling at his chest; Unable to sleep; Foul smelling diarrhea; Terrible chest pain; Could not breath/Very difficult to breathe; Could not eat anything; didn't take the second dose of the Moderna COVID-19 vaccine; Sick as a dog; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL IMPAIRMENT (Kidney's almost shut down both times), MYOCARDIAL INFARCTION (had 2-3 attacks) and ILLNESS (sick as a dog) in a 66-year-old male 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. Concurrent medical conditions included Peanut allergy, Fruit allergy (citrus allergy was reported.), Milk allergy (Dairy allergy was reported.), Drug allergy (demerol), Kidney disorder (Kidney disease was reported.) since 2008, Chronic pancreatitis since 2012, COPD since 2001, Heart disease, unspecified since 2000, Drug allergy (tramadol), Drug allergy (lorazepam), Food allergy and Food allergy. Concomitant products included ONDANSETRON, PANTOPRAZOLE, BUPRENORPHINE and SALBUTAMOL SULFATE (PROAIR HFA) for Chronic pancreatitis, LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]) for Hypertension, FLUOXETINE HYDROCHLORIDE (PROZAC) for Mood depression, AMMONIUM BROMIDE, POTASSIUM BROMIDE, SODIUM BROMIDE (BROMIDES), TIOTROPIUM BROMIDE (SPIRIVA) and DIAZEPAM (VALIUM) for an unknown indication. On 03-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RENAL IMPAIRMENT (Kidney's almost shut down both times) (seriousness criteria hospitalization, medically significant and intervention required), MYOCARDIAL INFARCTION (had 2-3 attacks) (seriousness criteria hospitalization, medically significant and intervention required), PRODUCT DOSE OMISSION ISSUE (didn't take the second dose of the Moderna COVID-19 vaccine) and ILLNESS (Sick as a dog). On 06-Mar-2021, the patient experienced ILLNESS (sick as a dog) (seriousness criteria hospitalization, medically significant and intervention required), DYSPNOEA (Could not breath/Very difficult to breathe) and FEEDING DISORDER (Could not eat anything). 06-Mar-2021, the patient experienced CHEST PAIN (Terrible chest pain). On 19-Mar-2021, the patient experienced DIARRHOEA (Foul smelling diarrhea). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Unexplainable pain in lower stomach area), GENERAL PHYSICAL HEALTH DETERIORATION (Health declined quickly), CARDIAC DISORDER (Heart issue after first shot of vaccine), LUNG DISORDER (Lungs have gotten worse since the first shot), CHEST DISCOMFORT (grabbing and pulling at his chest) and INSOMNIA (Unable to sleep). The patient was treated with TIOTROPIUM BROMIDE (oral) on 05-Mar-2021 at an unspecified dose and frequency; SIMETHICONE ongoing since an unknown date at an unspecified dose and frequency; PREDNISONE at a dose of 10 mg and OXYGEN at an unspecified dose and frequency. At the time of the report, RENAL IMPAIRMENT (Kidney's almost shut down both times) had not resolved and MYOCARDIAL INFARCTION (had 2-3 attacks), ILLNESS (sick as a dog), DYSPNOEA (Could not breath/Very difficult to breathe), FEEDING DISORDER (Could not eat anything), DIARRHOEA (Foul smelling diarrhea), ABDOMINAL PAIN UPPER (Unexplainable pain in lower stomach area), GENERAL PHYSICAL HEALTH DETERIORATION (Health declined quickly), CARDIAC DISORDER (Heart issue after first shot of vaccine), LUNG DISORDER (Lungs have gotten worse since the first shot), CHEST PAIN (Terrible chest pain), CHEST DISCOMFORT (grabbing and pulling at his chest), PRODUCT DOSE OMISSION ISSUE (didn't take the second dose of the Moderna COVID-19 vaccine), ILLNESS (Sick as a dog) and INSOMNIA (Unable to sleep) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal other. On an unknown date, SARS-CoV-2 test negative: negative negative. On an unknown date, Troponin: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient is on nebulizer treatment of tiotropium bromide and a lot of simethicone. Patient do not know if using either medication helped or not but that was my immidiate reaction. Now patient is on prednisone and feels like he's taking it just to breathe. Patient has had to go on 24 hr. oxygen since the first shot. Patient was negative for Covid-19 over the past 3 months at three different times. He continued to have terrible chest pain where he was grabbing and pulling at his chest, pain creeping up to his chest, could not breath or eat anything for 1 week after his first shot. Patient was in the ER on 10Mar2021. Caller stated he has chronic pancreatitis and breathing issues for which he was prescribed steroids, his doctor told him to decrease the prednisone to 10mg for 2 days prior and day of vaccination. Caller thinks he had a week long stroke since he had high Troponin level which resulted in visit to the hospital where the doctors thought he had septicemia. Caller stated he has not been able to sleep because he keeps having attacks of chest pains that last approximately 15 minutes in the middle of the sleep which occurs 4+ times per night. Kidney's have gotten worse since 1st shot vaccine. Doctors said "the kidney's took a shot" after the first shot of vaccine. Patient was admitted to the Hosp twice after the first shot because his kidneys almost shut down both times. Unexplainable, excruciating pain in chest and very difficult to breathe for approx. 10-15 minutes each attack. New, unexplainable pain in lower stomach area since 1st shot of vaccine. Doctors cannot explain. Patient is seeking legal action against Moderna. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18 May 2021,included patient demography (Ethnicity, race, height, weight), allergy to peanuts, citrus, dairy, Demerol, tramadol, lorazepam. Current medical condition kidney disease was updated. concomitant medications were buprenorphine, pantoprazole, ondansetron, losartan, Prozac with product indications were updated. Laboratory information EKG was updated. Events Kidney's have gotten worse, unexplainable pain in lower stomach area, my health has declined, lungs have gotten worse was updated. On 23-May-2021: follow-up appended, conmeds added, NF added to events, new events added, new allergies coded, generated narrative.; Sender's Comments: This case concerns a male patient of unknown age who missed second dose due other adverse events experienced post first dose of mRNA-1273. The other events show temporal association with the use of mRNA-1273 and a causal relationship cannot be excluded. However, the patient has concurrent history that confounds the reported events to include chronic pancreatitis, COPD, kidney and heart disorder. Missed dose is assessed as not applicable

Other Meds: ONDANSETRON; PANTOPRAZOLE; BROMIDES; SPIRIVA; BUPRENORPHINE; PROAIR HFA; VALIUM; LOSARTAN [LOSARTAN POTASSIUM]; PROZAC

Current Illness: Chronic pancreatitis; COPD; Drug allergy (tramadol); Drug allergy (lorazepam); Drug allergy (demerol); Food allergy; Fruit allergy (citrus allergy was reported.); Heart disease, unspecified; Kidney disorder (Kidney disease was reported.); Milk allergy (Dairy allergy was reported.); Peanut allergy

ID: 1366844
Sex: F
Age: 87
State: FL

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 06/02/2021
Hospital: Y

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Symptoms: felt great weight and pressure on my chest; did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021; did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot; couldn't swallow; antibodies absent; Fatigue/tiredness; Severe sore throat/not just a severe throat; Neck swelling; Facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (felt great weight and pressure on my chest) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Type 2 diabetes mellitus since an unknown date. Concurrent medical conditions included Drug allergy (allergic to medications), Allergy to animals and Perfume sensitivity. Concomitant products included LOSARTAN and METOPROLOL for Blood pressure high, ESZOPICLONE (LUNESTA) for Sleep disorder NOS, GLIMEPIRIDE for Type 2 diabetes mellitus. On 10-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 OROPHARYNGEAL PAIN (Severe sore throat/not just a severe throat), SWELLING (Neck swelling), SWELLING FACE (Facial swelling) and FATIGUE (Fatigue/tiredness). On 15-Apr-2021, the patient experienced DRUG SPECIFIC ANTIBODY (antibodies absent). On an unknown date, the patient experienced CHEST PAIN (felt great weight and pressure on my chest) (seriousness criterion hospitalization), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot) and DYSPHAGIA (couldn't swallow). The patient was hospitalized from 25-Mar-2021 to 26-Mar-2021 due to CHEST PAIN. The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, CHEST PAIN (felt great weight and pressure on my chest) and OROPHARYNGEAL PAIN (Severe sore throat/not just a severe throat) had resolved and SWELLING (Neck swelling), SWELLING FACE (Facial swelling), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of Moderna COVID-19 vaccine scheduled on 7APR2021/not going to get the second shot), DYSPHAGIA (couldn't swallow), DRUG SPECIFIC ANTIBODY (antibodies absent) and FATIGUE (Fatigue/tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Antibody test: negative (Negative) states that patient does not have any antibodies. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient's HCP advised to wait for two more weeks to receive the second dose of vaccine. Med Info Agent: *Crosslink with MOD21-058959, MOD21-062129, MOD21-076250, MOD21-085519* Call received from consumer who stated she had reported a previous event, but is frustrated because on the form it says if you have a problem, call us, but there is no number to call. Caller provided her address and confirmed contact information, contact information updated. The consumer stated she does not leave her house, and she does not have a fax machine, so it makes it difficult for her to send it back. The caller would like the company to know about this, but did not have any further requests. Consumer stated she will eventually have someone send it out for her. Caller stated it wasn't just a severe throat as the form mentions, she couldn't swallow, but did not elaborate. Consumer stated she is not going to get the second shot per providers direction, and stated she had no antibodies from the first dose. No further information provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Inappropriate schedule of vaccine administered and Product dose omission issue for mRNA-1273, lot # 044A21A with associated AEs. This case was linked to MOD-2021-058039 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2021: significant: event added On 03-May-2021: Missed dose On 20-May-2021: Significant follow-up received On 21-May-2021: VAER from uploaded; 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. This report refers to a case of Inappropriate schedule of vaccine administered and Product dose omission issue for mRNA-1273, lot # 044A21A with associated AEs.

Other Meds: GLIMEPIRIDE; LOSARTAN; METOPROLOL; LUNESTA

Current Illness: Allergy to animals; Drug allergy (allergic to medications); Perfume sensitivity; Type 2 diabetes mellitus

ID: 1366845
Sex: F
Age:
State: TX

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 06/02/2021
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Symptoms: Lymph node in both armpits neck on both sides of groin area were swollen for weeks; Heart felt like skipping a beat for no reason; Itchy neck area; Rash /hives neck area; Achy joints; Low grade fever; Chills; Achy neck/throat area; Chest pain with burning sensation; Loose stools; Sore gums; GI issues; Bloody diarrhea; Ringing/ hum noise in ear/ felt like indides were tremoring; Nausea; Joint and muscle aches over entire body; Didn't feel good/ felt awful; Not getting 2nd dose; Heacy feeling in chest; Bad headache; Fatigue; Mildly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 927A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis (Arthritis in numerous joints) since 2005, Sulfonamide allergy, Bee sting hypersensitivity, Latex allergy, Hashimoto's disease since 1992, Hypothyroidism since 1992, Vitiligo since 1968, Ulcer since 1985 and Migraine since 1999. Concomitant products included IBUPROFEN for Arthritis, LIOTHYRONINE SODIUM (CYTOMEL) for Hypothyroidism, ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine. On 20-Mar-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced CHEST DISCOMFORT (Heacy feeling in chest), FEELING ABNORMAL (Didn't feel good/ felt awful), PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) and FATIGUE (Fatigue). 20-Mar-2021, the patient experienced HEADACHE (Bad headache). On 21-Mar-2021, the patient experienced MYALGIA (Joint and muscle aches over entire body). On 23-Mar-2021, the patient experienced TINNITUS (Ringing/ hum noise in ear/ felt like indides were tremoring) and NAUSEA (Nausea). On 24-Mar-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) (seriousness criterion medically significant) and GASTROINTESTINAL DISORDER (GI issues). On an unknown date, the patient experienced NECK PAIN (Achy neck/throat area), CHEST PAIN (Chest pain with burning sensation), DIARRHOEA (Loose stools), GINGIVAL PAIN (Sore gums), PAIN IN EXTREMITY (Mildly sore arm), PRURITUS (Itchy neck area), SWELLING (Lymph node in both armpits neck on both sides of groin area were swollen for weeks), EXTRASYSTOLES (Heart felt like skipping a beat for no reason), RASH (Rash /hives neck area), ARTHRALGIA (Achy joints), PYREXIA (Low grade fever) and CHILLS (Chills). On 20-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (Bloody diarrhea), TINNITUS (Ringing/ hum noise in ear/ felt like indides were tremoring), NECK PAIN (Achy neck/throat area), CHEST PAIN (Chest pain with burning sensation), CHEST DISCOMFORT (Heacy feeling in chest), GINGIVAL PAIN (Sore gums), FEELING ABNORMAL (Didn't feel good/ felt awful), PRURITUS (Itchy neck area), SWELLING (Lymph node in both armpits neck on both sides of groin area were swollen for weeks), EXTRASYSTOLES (Heart felt like skipping a beat for no reason), RASH (Rash /hives neck area), ARTHRALGIA (Achy joints), PYREXIA (Low grade fever), CHILLS (Chills), MYALGIA (Joint and muscle aches over entire body) and FATIGUE (Fatigue) outcome was unknown, DIARRHOEA (Loose stools), GASTROINTESTINAL DISORDER (GI issues), NAUSEA (Nausea) and HEADACHE (Bad headache) had not resolved and PAIN IN EXTREMITY (Mildly sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient didn't went to the physician. Patient experienced sore gums with two sores that were bleeding which lasted for 48 hours. Patient had been to the dentist and had a routine cleaning in Jan 2021. No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Product dose omission issue for mRNA-1273, lot # 927A21A with associated AEs. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21 May 2021 included patient demographics, historical conditions, concomitant medications, additional events, outcome of the events was updated and the case was updated to serious case dur to the event diarrhoea haemorrhagic.; 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. This report refers to a case of Product dose omission issue for mRNA-1273, lot # 927A21A with associated AEs.

Other Meds: CYTOMEL; EXCEDRIN MIGRAINE; IBUPROFEN

Current Illness: Arthritis (Arthritis in numerous joints); Bee sting hypersensitivity; Hashimoto's disease; Hypothyroidism; Latex allergy; Migraine; Sulfonamide allergy; Ulcer; Vitiligo

ID: 1366846
Sex: F
Age: 39
State: VA

Vax Date: 03/10/2021
Onset Date: 03/11/2021
Rec V Date: 06/02/2021
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Symptoms: Lost weight; Nerve pain; increasing pain and vibrations all over body, burning, aching, pinching, stinging, throbbing,; Blood blisters (tiny all over body); Tip of tongue numb; Hand cramp - pinky finger on right hand turns inward painfully; Bladder and vaginal area goes completely numb. Can't feel anything. numbness, tingling; Paralysis of arms and legs; Paralysis of arms and legs; Feeling abnormal; Neck Pain; Costochondritis; Loss of bladder control; Burning sensations, burning under skin; Muscle spasm; Twitching; Tremor; Stomach cramps; Weakness; Loss of appetite; Nausea; Joint pain; Headache; She had fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MONOPLEGIA (Paralysis of arms and legs) and DIPLEGIA (Paralysis of arms and legs) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Tachycardia supraventricular since 2008, Allergic reaction to antibiotics (sulfur antibiotics) and Penicillin allergy. Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) from 11-Jan-2020 to 15-May-2021 for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (She had fatigue). On 12-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps), ASTHENIA (Weakness), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and HEADACHE (Headache). 12-Mar-2021, the patient experienced DECREASED APPETITE (Loss of appetite). On 16-Mar-2021, the patient experienced MUSCLE TWITCHING (Twitching) and TREMOR (Tremor). 16-Mar-2021, the patient experienced MUSCLE SPASMS (Muscle spasm). 16-Mar-2021, the patient experienced SKIN BURNING SENSATION (Burning sensations, burning under skin). On 18-Mar-2021, the patient experienced INCONTINENCE (Loss of bladder control). On 29-Mar-2021, the patient experienced COSTOCHONDRITIS (Costochondritis). On 01-Apr-2021, the patient experienced MONOPLEGIA (Paralysis of arms and legs) (seriousness criterion medically significant) and DIPLEGIA (Paralysis of arms and legs) (seriousness criterion medically significant). 01-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling abnormal) and NECK PAIN (Neck Pain). On 02-Apr-2021, the patient experienced HYPOAESTHESIA (Bladder and vaginal area goes completely numb. Can't feel anything. numbness, tingling). On 20-Apr-2021, the patient experienced MUSCLE SPASMS (Hand cramp - pinky finger on right hand turns inward painfully). On 21-Apr-2021, the patient experienced HYPOAESTHESIA ORAL (Tip of tongue numb). On 24-Apr-2021, the patient experienced BLOOD BLISTER (Blood blisters (tiny all over body)). On 01-May-2021, the patient experienced NEURALGIA (Nerve pain) and PAIN (increasing pain and vibrations all over body, burning, aching, pinching, stinging, throbbing,). On an unknown date, the patient experienced WEIGHT DECREASED (Lost weight). On 13-Mar-2021, HEADACHE (Headache) had resolved. On 01-Apr-2021, MONOPLEGIA (Paralysis of arms and legs), DIPLEGIA (Paralysis of arms and legs), FEELING ABNORMAL (Feeling abnormal) and NECK PAIN (Neck Pain) had resolved. On 22-Apr-2021, MUSCLE SPASMS (Hand cramp - pinky finger on right hand turns inward painfully) had not resolved, HYPOAESTHESIA ORAL (Tip of tongue numb) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps), MUSCLE TWITCHING (Twitching), TREMOR (Tremor), COSTOCHONDRITIS (Costochondritis), MUSCLE SPASMS (Muscle spasm), ASTHENIA (Weakness), DECREASED APPETITE (Loss of appetite), SKIN BURNING SENSATION (Burning sensations, burning under skin), INCONTINENCE (Loss of bladder control), HYPOAESTHESIA (Bladder and vaginal area goes completely numb. Can't feel anything. numbness, tingling), BLOOD BLISTER (Blood blisters (tiny all over body)), NEURALGIA (Nerve pain), NAUSEA (Nausea), FATIGUE (She had fatigue) and ARTHRALGIA (Joint pain) had not resolved and WEIGHT DECREASED (Lost weight) and PAIN (increasing pain and vibrations all over body, burning, aching, pinching, stinging, throbbing,) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient experienced tremors and occasionally , experienced muscle spasms few times a day with different locations, weakness presented as an constant symptom, muscle twitchings occurs daily but moving around, burning sensations appears during the tremors or after the tremors, joint pain worsening after tremors, the bladder and vaginal areas goes completely numb for an hour like an pinched nerves and happening after sitting on hard surface for 5 minutes , the patient could not able to walk or move for approx. 30 minutes when numbness presented. the patient experienced nerve pain which feels like hairs being plucked out and pain getting worse when bending the arm , neck part also feeling tingling and prickling type of pain. currently the patient experiencing the increased pain and vibrations all over the body ,burning, aching, pinching, stinging, throbbing, numbness, tingling, and many more. Treatment information was not reported/unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Patient details received, stating that the reporter herself is the patient. On 21-May-2021: Follow-up received 21May2021. Additional adverse events were added from ADR form and attached patient symptom log and two events were upgraded to serious per IME list.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: VIT D [COLECALCIFEROL]

Current Illness: Allergic reaction to antibiotics (sulfur antibiotics); Penicillin allergy; Tachycardia supraventricular

ID: 1366847
Sex: M
Age:
State: FL

Vax Date: 01/12/2021
Onset Date: 01/23/2021
Rec V Date: 06/02/2021
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Symptoms: arm pain; shoulder pain, knee, hip pain; Polymyalgia rheumatica; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021. The most recent information was received on 19-May-2021 and was forwarded to Moderna on 19-May-2021. This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Osteoarthritis since 2012, Eczema (Exacerbated since Mar 2021) and Polymyalgia rheumatica since 2020. Concomitant products included DUPILUMAB (DUPIXENT) for Eczema, IRBESARTAN for Hypertension, CELECOXIB (CELEBREX) for Osteoarthritis. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant). On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and ARTHRALGIA (shoulder pain, knee, hip pain). The patient was treated with METHYLPREDNISOLONE (oral) on 25-Feb-2021 for Polymyalgia rheumatica, at a dose of 4 milligram twice a day. At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica), PAIN IN EXTREMITY (arm pain) and ARTHRALGIA (shoulder pain, knee, hip pain) had not resolved. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Updated Event onset date of event - polymyalgia rheumatica. Updated concomitant medication - Celebrex and onset date of treatment medication. Updated patient demographics.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: IRBESARTAN; DUPIXENT; CELEBREX

Current Illness: Eczema (Exacerbated since Mar 2021); Hypertension; Osteoarthritis; Polymyalgia rheumatica

ID: 1366848
Sex: F
Age: 65
State: NV

Vax Date: 02/19/2021
Onset Date: 02/23/2021
Rec V Date: 06/02/2021
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Symptoms: Couldn't lift arm or get of bed; Baker's cyst; Left knee has been swollen/leg feels heavy and difficult to lift; Reactive arthritis flare; didn't receive the second dose,was advised not to; Stabbing pain in upper left arm, in the crease of arm/Stabbing pain in left elbow, right elbow, forearm, upper arm, left and right groin radiating down leg, sore arm; Excruciating joint pain; Fatigue; Severe body pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRITIS REACTIVE (Reactive arthritis flare) in a 65-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. The patient's past medical history included Streptococcal sore throat from 12-Feb-2021 to 17-Feb-2021, Shortness of breath (The patient reported no significant change in the disease condition.) in 2006, Sciatica (The patient reported a significant change in the disease condition.) in 1995 and Elbow tendinitis (The patient reported a significant change in the disease condition.) in 2017. Concurrent medical conditions included Drug allergy (Biaxin, citalopram, venlafaxine, trimethoprim, sulfamethoxazole.), Hypothyroidism (The dose is lowered from 125 mg to 112) since 1988, Asthma (The patient reported no significant change in the disease condition.) since 01-Dec-2020 and Chronic obstructive pulmonary disease (The patient reported no significant change in the disease condition.) since 01-Dec-2020. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy, MONTELUKAST from 01-Nov-2020 to an unknown date for Asthma, FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) from 15-Jan-2021 to an unknown date for COPD and Asthma, PANTOPRAZOLE from 08-Jan-2021 to an unknown date and CIMETIDINE from 04-Jan-2021 to an unknown date for Hyperacidity, EZETIMIBE from 23-Jun-2020 to an unknown date for Hyperlipidemia, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, PENICILLIN NOS from 12-Feb-2021 to 22-Feb-2021 for Streptococcal sore throat, BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), CALCIUM, VITAMIN D3, VITAMIN E NOS, MAGNESIUM and VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]) from 04-Jan-2021 to an unknown date for an unknown indication. On 19-Feb-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Severe body pain), ARTHRALGIA (Excruciating joint pain) and FATIGUE (Fatigue). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Stabbing pain in upper left arm, in the crease of arm/Stabbing pain in left elbow, right elbow, forearm, upper arm, left and right groin radiating down leg, sore arm). On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose,was advised not to). On 14-Apr-2021, the patient experienced ARTHRITIS REACTIVE (Reactive arthritis flare) (seriousness criterion medically significant) and JOINT SWELLING (Left knee has been swollen/leg feels heavy and difficult to lift). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't lift arm or get of bed) and SYNOVIAL CYST (Baker's cyst). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form; GABAPENTIN ongoing since an unknown date at a dose of 200 mg; CELECOXIB (CELEBREX) at a dose of 200 mg; METHYLPREDNISOLONE ongoing since an unknown date at a dose of 4 mg; METHOCARBAMOL ongoing since an unknown date at a dose of 750 mg as required; FERUMOXYTOL (FERAHEME) ongoing from 06-May-2021 at a dose of 1 dosage form, first infusion; FERUMOXYTOL (FERAHEME) on 13-May-2021 at a dose of 1 dosage form, second infusion and CORTISONE ongoing since an unknown date at a dose of 1 dosage form. On 08-Apr-2021, PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose,was advised not to) had resolved. At the time of the report, ARTHRITIS REACTIVE (Reactive arthritis flare), PAIN (Severe body pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't lift arm or get of bed), SYNOVIAL CYST (Baker's cyst), JOINT SWELLING (Left knee has been swollen/leg feels heavy and difficult to lift), PAIN IN EXTREMITY (Stabbing pain in upper left arm, in the crease of arm/Stabbing pain in left elbow, right elbow, forearm, upper arm, left and right groin radiating down leg, sore arm), ARTHRALGIA (Excruciating joint pain) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Blood albumin (3.8-4.8): 3.7 (normal) 3.7g/dL. On 08-Mar-2021, Blood cholesterol: 172 (normal) 172 mg/dl. On 08-Mar-2021, Blood glucose (65-99): 88 (normal) 88mg/dl. On 08-Mar-2021, Blood iron (45-160): 39 (Low) Low. On 08-Mar-2021, Eosinophil count (15-500): 1003 (High) 1003 cells per microlitre. On 08-Mar-2021, Glycosylated haemoglobin increased: 6.0 (High) Unknown. On 08-Mar-2021, Haematocrit: 33.9 (Low) 33.9 %. On 08-Mar-2021, Haemoglobin (11.7-15.5): 10.6 (Low) unknown. On 08-Mar-2021, Mean cell haemoglobin (27.0-33.0): 25.2 (Low) unknown. On 08-Mar-2021, Mean cell haemoglobin concentration (32.0-36.0): 31.3 (Low) Unknown. On 08-Mar-2021, Platelet count (140-400): 396 (normal) Unknown. On 08-Mar-2021, Protein total (6.1-8.1): 5.7 normal. On 08-Mar-2021, Prothrombin time (9.1-1.2): 9.8 (normal) Unknown. On 08-Mar-2021, Red blood cell count (3.80-5.10): 4.21 (normal) unknown. On 08-Mar-2021, Red cell distribution width increased (11.0-15.0): 15.2 (High) Unknown. On 08-Mar-2021, Serum ferritin (16-288): 6 (Low) Unknown. On 08-Mar-2021, Thyroid function test: negative (Negative) thyroid was off.. On 08-Mar-2021, White blood cell count (3.8-10.8): 7.6 (normal) unknown. On 19-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 14-Apr-2021, Magnetic resonance imaging: unknown (Inconclusive) Bakers cyst and fluid on knee. On 26-Apr-2021, X-ray: unknown (Inconclusive) Left knee x-ray: Moderate joint effusion. On 10-May-2021, Magnetic resonance imaging: unknown (Inconclusive) Mild hand subcutaneous edema and unknown (Inconclusive) Mild diffuse flexor tenosynovitis from CMC joint level to metacarpal midshaft level. On 12-May-2021, Blood albumin (3.8-4.8): 3.6 (Low) 3.6g/dL. On 12-May-2021, C-reactive protein: 27.5 (High) Unknown. On 12-May-2021, Eosinophil count (15-500): 57 (normal) 57 cells per microlitre. On 12-May-2021, Haematocrit: 37.8 (normal) 37.8%. On 12-May-2021, Haemoglobin (11.7-15.5): 11.9 (normal) Unknown. On 12-May-2021, Mean cell haemoglobin (27.0-33.0): 25.4 (Low) Unknown. On 12-May-2021, Mean cell haemoglobin concentration (32.0-36.0): 31.5 (Low) Unknown. On 12-May-2021, Platelet count (140-400): 458 (High) Unknown. On 12-May-2021, Protein total (6.1-8.1): 6.6 (normal) Unknown. On 12-May-2021, Red blood cell count (3.80-5.10): 4.69 (normal) Unknown. On 12-May-2021, Red cell distribution width increased (11.0-15.0): 16.5 (High) Unknown. On 12-May-2021, White blood cell count (3.8-10.8): 8.1 (normal) Unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The patient reported that she declined the administration of second dose and it was suggested by her physician. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Product dose omission issue for mRNA-1273, lot # 007M20A with associated AEs. Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received on 17-May-2021 and does not contain any new information On 21-May-2021: The second follow up received on 21-MAY-2021 and contain contact details of the reporter . The suspect drug dosage regime, medical history and events of the patient is

Other Meds: SYNTHROID; PANTOPRAZOLE; EZETIMIBE; MONTELUKAST; CIMETIDINE; BREO ELLIPTA; CLARITIN ALLERGIC; PROBIOTIC [BIFIDOBACTERIUM LACTIS]; CALCIUM; VITAMIN D3; VITAMIN E NOS; MAGNESIUM; SUPER B COMPLEX [VITAMIN B COMPLEX]; PENICILLIN NOS

Current Illness: Asthma (The patient reported no significant change in the disease condition.); Chronic obstructive pulmonary disease (The patient reported no significant change in the disease condition.); Drug allergy (Biaxin, citalopram, venlafaxine, trimethoprim, sulfamethoxazole.); Hypothyroidism (The dose is lowered from 125 mg to 112)

ID: 1366849
Sex: F
Age: 66
State: CT

Vax Date: 02/26/2021
Onset Date: 03/28/2021
Rec V Date: 06/02/2021
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Symptoms: Hearing sounds amplified; Sweating; Does not feel well; Trouble sleeping; tinnitus; migraine headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of TINNITUS (tinnitus) and MIGRAINE (migraine headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced TINNITUS (tinnitus) (seriousness criterion disability) and MIGRAINE (migraine headache) (seriousness criterion disability). On an unknown date, the patient experienced HYPERACUSIS (Hearing sounds amplified), HYPERHIDROSIS (Sweating), MALAISE (Does not feel well) and INSOMNIA (Trouble sleeping). The patient was treated with SUMATRIPTAN SUCCINATE (IMITREX DF) ongoing since an unknown date at a dose of 1 dosage form and METHYLPREDNISOLONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, TINNITUS (tinnitus), MIGRAINE (migraine headache), HYPERACUSIS (Hearing sounds amplified), HYPERHIDROSIS (Sweating), MALAISE (Does not feel well) and INSOMNIA (Trouble sleeping) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Fibrin D dimer: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications taken by the patient were not provided. Action taken with mRNA in response to the event/s was not applicable Very limited information regarding the events has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up information include:In general tab reporter details updated ln patient tab lab data includedIn product tab vaccine information updated and treatment information added.In event tab 2 events are added; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.

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ID: 1366850
Sex: F
Age: 63
State: TX

Vax Date: 03/12/2021
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Rec V Date: 06/02/2021
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Symptoms: Brain swelling due to vaccine; headache which is making her teeth and bones hurt; headache which is making her teeth and bones hurt; arm has been hurting and difficult to move; Shaking; Eyes were not tracking or working together. The right eye would move to the center; Jumbled eyesight/ Vision blurred and perspective is wrong; Eyesight very sensitive to light and sound; Pressure; really really bad headache/Extreme head pain; sometime has chills; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN OEDEMA (Brain swelling due to vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and FLUOXETINE HYDROCHLORIDE (FLUXOTINE) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BRAIN OEDEMA (Brain swelling due to vaccine) (seriousness criterion medically significant), TOOTHACHE (headache which is making her teeth and bones hurt), BONE PAIN (headache which is making her teeth and bones hurt), HYPOKINESIA (arm has been hurting and difficult to move), TREMOR (Shaking), BINOCULAR EYE MOVEMENT DISORDER (Eyes were not tracking or working together. The right eye would move to the center), VISION BLURRED (Jumbled eyesight/ Vision blurred and perspective is wrong), PHOTOPHOBIA (Eyesight very sensitive to light and sound), HEAD DISCOMFORT (Pressure), HEADACHE (really really bad headache/Extreme head pain), CHILLS (sometime has chills) and FATIGUE (Fatigue). At the time of the report, BRAIN OEDEMA (Brain swelling due to vaccine), TOOTHACHE (headache which is making her teeth and bones hurt), BONE PAIN (headache which is making her teeth and bones hurt), HYPOKINESIA (arm has been hurting and difficult to move), TREMOR (Shaking), BINOCULAR EYE MOVEMENT DISORDER (Eyes were not tracking or working together. The right eye would move to the center), VISION BLURRED (Jumbled eyesight/ Vision blurred and perspective is wrong), PHOTOPHOBIA (Eyesight very sensitive to light and sound), HEAD DISCOMFORT (Pressure), HEADACHE (really really bad headache/Extreme head pain), CHILLS (sometime has chills) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. In 2021, Magnetic resonance imaging: inconclusive (Inconclusive) Inconclusive. Patient reported that even pain medicines that she took for treatment did not help her. Reporter did not allow further contact. 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. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: New event added from TCR form On 19-May-2021: Case upgraded to serious; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: SYNTHROID; FLUXOTINE

Current Illness: Hypothyroidism

ID: 1366851
Sex: M
Age: 60
State: MS

Vax Date: 04/15/2021
Onset Date: 04/20/2021
Rec V Date: 06/02/2021
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Symptoms: Stones in his Kidney; Badly dehydrated; Urine has been dark; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Stones in his Kidney) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DEHYDRATION (Badly dehydrated) and CHROMATURIA (Urine has been dark). On an unknown date, the patient experienced NEPHROLITHIASIS (Stones in his Kidney) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (Stones in his Kidney), DEHYDRATION (Badly dehydrated) and CHROMATURIA (Urine has been dark) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medication was reported. Patient states that these events were not related to vaccine and declined further follow up. This case concerns a 60-year-old male with a serious unexpected event of nephrolithiasis, and nonserious unexpected dehydration and chromaturia. Event latency 6 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Follow-up was received on 23-may-2021. New event "Kidney stone" was added.; Sender's Comments: This case concerns a 60-year-old male with a serious unexpected event of nephrolithiasis, and nonserious unexpected dehydration and chromaturia. Event latency 6 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

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Current Illness:

ID: 1366852
Sex: M
Age: 76
State: PA

Vax Date: 03/26/2021
Onset Date: 04/23/2021
Rec V Date: 06/02/2021
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Symptoms: In case it was pneumonia; Not feeling good since the vaccine; severe dizziness; vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (In case it was pneumonia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. no medical history was reported by reporter. Concomitant products included OMEPRAZOLE, METOPROLOL TARTRATE, LOVASTATIN, CLOPIDOGREL, FINASTERIDE, HYDROCHLOROTHIAZIDE (THIAZIDE), MONTELUKAST, FUROSEMIDE, FELODIPINE, BUSPIRONE, SPIRONOLACTONE, DOXAZOSIN MESYLATE, LABETALOL, ASA and IRON for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIZZINESS (severe dizziness) and VERTIGO (vertigo). On an unknown date, the patient experienced PNEUMONIA (In case it was pneumonia) (seriousness criterion medically significant) and FEELING ABNORMAL (Not feeling good since the vaccine). At the time of the report, PNEUMONIA (In case it was pneumonia), DIZZINESS (severe dizziness), VERTIGO (vertigo) and FEELING ABNORMAL (Not feeling good since the vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, X-ray: inconclusive not able to determine if he had pneumonia. On an unknown date, SARS-CoV-2 test: negative tested twice for Covid-19 with Negative results both times. On 23-APR-2021 with in one hour of vaccination the patient began to experience severe dizziness and vertigo. The patient did not receive any treatment medications for the reported events. The patient reported that he had not been feeling very good since the vaccine, stating "I don't think this is a coincidence me getting sick after I got the vaccine". He was evaluated at the Emergency Room this past Sunday on 5/23/2021, because he still wasn't feeling very good. He states he had an X-ray done and was they were not able to determine if he had pneumonia, however they treated him with IV antibiotics in case it was pneumonia. He reports feeling "a little better" since the IV antibiotics. Action taken with mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR: AE details. Case upgraded to serious. additional adverse events were updated and narrative information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: OMEPRAZOLE; METOPROLOL TARTRATE; LOVASTATIN; CLOPIDOGREL; FINASTERIDE; THIAZIDE; MONTELUKAST; FUROSEMIDE; FELODIPINE; BUSPIRONE; SPIRONOLACTONE; DOXAZOSIN MESYLATE; LABETALOL; ASA; IRON

Current Illness:

ID: 1366853
Sex: F
Age: 65
State: IL

Vax Date: 01/02/2021
Onset Date: 01/30/2021
Rec V Date: 06/02/2021
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Symptoms: Rheumatoid arthritis flared up; Lack of drug effect; Early morning stiffness; Nodule on extremity; Headache; Very tired; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up), DRUG INEFFECTIVE (Lack of drug effect), MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. Concurrent medical conditions included Nodule since 2019, Teetotaller (Abstains from alcohol.), Drug allergy (Associated manifestation for the sulfa drugs allergy was rash and for the ACE inhibitors allergy was chest tightness), Peanut allergy (Associated manifestation for the peanut allergy was rash) and Non-smoker. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up), MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MUSCULOSKELETAL STIFFNESS (Early morning stiffness) and NODULE (Nodule on extremity) to be not related. No further causality assessments were provided for RHEUMATOID ARTHRITIS (Rheumatoid arthritis flared up) and DRUG INEFFECTIVE (Lack of drug effect). Treatment information were included prednisone and acetaminophen. Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Nodule and Musculoskeletal stiffness as these events are stated as unrelated by the HCP reporter. This case was linked to MOD-2021-096000 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Nodule and Musculoskeletal stiffness as these events are stated as unrelated by the HCP reporter.

Other Meds: HUMIRA; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Drug allergy (Associated manifestation for the sulfa drugs allergy was rash and for the ACE inhibitors allergy was chest tightness); Nodule; Non-smoker; Peanut allergy (Associated manifestation for the peanut allergy was rash); Teetotaller (Abstains from alcohol.)

ID: 1366854
Sex: M
Age: 17
State: CA

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 06/02/2021
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Symptoms: Patient felt lightheaded, dizzy, popping and ringing in ears, blurred vision, and fainted for a few seconds. This occurred about 5-10 min following vaccination. Most likely a vasovagal syncope reaction. No history of allergic reactions nor syncope. After laying patient down and elevating his legs, he felt much better. Patient remained in this position for about 15 minutes. He then sat up, ate a snack, and drank water and was observed for an additional 15 minutes. Vitals were within normal range. Patient stated feeling"normal" and "fine" after this and he was able to go home without additional issues.

Other Meds:

Current Illness:

ID: 1366856
Sex: F
Age: 38
State:

Vax Date: 06/02/2021
Onset Date: 06/02/2021
Rec V Date: 06/02/2021
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Symptoms: PT reported to the Clinic around 1500. PT stated she received the second dose of the Moderna Vaccine around 1330. PT stated she started to break out in pin point hives on both arms around 1450. PT stated she has had hives after a flu vaccine before. PT states it was over a decade ago. PT denies any difficulty breathing or any other symptoms. I called the on call provider and the PT was seen in clinic at 1536.

Other Meds:

Current Illness:

ID: 1366857
Sex: F
Age: 17
State: VA

Vax Date: 05/29/2021
Onset Date: 06/02/2021
Rec V Date: 06/02/2021
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Allergies: None

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Symptoms: Got period 2 weeks early days after vaccine that?s heavier than normal

Other Meds: Ibuprofen

Current Illness: None

ID: 1366858
Sex: F
Age: 30
State: GA

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 06/02/2021
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Allergies: PCN

Symptom List:

Symptoms: Developed rash - bilateral axilla the day after she received Pfizer vaccine came in to Urgent Care on 5/5/2021 because rash had not cleared up Administered depomedrol 40 mg IM x 1 Prescribed kenalog cream to apply to rash ***Tested positive for SARS-CoV-2 on 4/12/2021***

Other Meds:

Current Illness: n/a

ID: 1366859
Sex: F
Age: 40
State: FL

Vax Date: 03/31/2021
Onset Date: 03/19/2021
Rec V Date: 06/02/2021
Hospital: Y

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Symptoms: aneurysm; dizziness; started to shake; hives on face; pain in my arm; vomited fluids with foam; Feel like a numbness in the right side of tongue; Feel like a numbness in throat; face turned numb/ head was numbed; numbness on the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANEURYSM (aneurysm), DIZZINESS (dizziness), TREMOR (started to shake), URTICARIA (hives on face), HYPOAESTHESIA (numbness on the arm), HYPOAESTHESIA ORAL (Feel like a numbness in the right side of tongue), PHARYNGEAL HYPOAESTHESIA (Feel like a numbness in throat), HYPOAESTHESIA (face turned numb/ head was numbed), PAIN IN EXTREMITY (pain in my arm) and VOMITING (vomited fluids with foam) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 031A21B) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on the arm) (seriousness criterion hospitalization). On 27-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA ORAL (Feel like a numbness in the right side of tongue) (seriousness criterion hospitalization), PHARYNGEAL HYPOAESTHESIA (Feel like a numbness in throat) (seriousness criterion hospitalization), HYPOAESTHESIA (face turned numb/ head was numbed) (seriousness criterion hospitalization) and VOMITING (vomited fluids with foam) (seriousness criterion hospitalization). On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in my arm) (seriousness criterion hospitalization). On 19-May-2021, the patient experienced TREMOR (started to shake) (seriousness criterion hospitalization) and URTICARIA (hives on face) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANEURYSM (aneurysm) (seriousness criterion hospitalization) and DIZZINESS (dizziness) (seriousness criterion hospitalization). The patient was hospitalized until 21-May-2021 due to ANEURYSM, DIZZINESS, HYPOAESTHESIA, HYPOAESTHESIA, HYPOAESTHESIA ORAL, PAIN IN EXTREMITY, PHARYNGEAL HYPOAESTHESIA, TREMOR, URTICARIA and VOMITING. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination adverse reaction, at a dose of 25 milligram; LORATADINE for Vaccination adverse reaction, at an unspecified dose and frequency; FAMOTIDINE for Hyperacidity, at an unspecified dose and frequency and PREDNISONE for Vaccination adverse reaction, at an unspecified dose and frequency. At the time of the report, ANEURYSM (aneurysm), DIZZINESS (dizziness), TREMOR (started to shake), URTICARIA (hives on face), HYPOAESTHESIA (numbness on the arm), HYPOAESTHESIA ORAL (Feel like a numbness in the right side of tongue), PHARYNGEAL HYPOAESTHESIA (Feel like a numbness in throat), HYPOAESTHESIA (face turned numb/ head was numbed), PAIN IN EXTREMITY (pain in my arm) and VOMITING (vomited fluids with foam) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Angiogram: inconclusive (Inconclusive) An Aneurysm was found.. In May 2021, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. In May 2021, Magnetic resonance imaging: inconclusive (Inconclusive) No obstruction seen in arteries of brain. In May 2021, Scan with contrast: obstruction in artery (Inconclusive) Obstruction found in one of the arteries of brain. Concomitant product use was not provided by the reporter. Patient was also prescribed EpiPen for treatment of vaccination adverse reaction. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Updated events after the scheduled second dose of mRNA-1273 - Aneurysm, Tremor, Urticaria, Hypoesthesia upper extremities, dizziness, pain in extremity. Updated seriousness criteria of events to Hospitalization. Updated Medical Confirmation to Yes. Updated Diagnostic Data - CT scan, Angiogram, MRI scan and contrast media study. Updated treatment medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1366860
Sex: F
Age: 39
State: ME

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 06/02/2021
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Symptoms: Tingly from head to toe; Short of breath; Chest is like tight; Pains in intestine; Tired; Headache; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingly from head to toe), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest is like tight), GASTROINTESTINAL PAIN (Pains in intestine), FATIGUE (Tired) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PARAESTHESIA (Tingly from head to toe) (seriousness criterion medically significant), DYSPNOEA (Short of breath) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest is like tight) (seriousness criterion medically significant), GASTROINTESTINAL PAIN (Pains in intestine) (seriousness criterion medically significant), FATIGUE (Tired) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA (Tingly from head to toe), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest is like tight), GASTROINTESTINAL PAIN (Pains in intestine), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Side effects started after 20 minutes of receiving the shot. Patient went to the hospital. Patient stated that she was sleeping well and drinking lots of water. Concomitant product use was not provided by the reporter. Treatment for the event included ibuprofen. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1366861
Sex: F
Age: 64
State: FL

Vax Date: 04/19/2021
Onset Date: 04/17/2021
Rec V Date: 06/02/2021
Hospital: Y

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Symptoms: Face is red as a tomato; Face is swollen; Throat is closed and cannot breathe; Chest pain; Body aches; Her throat keeps closing up on her/ throat began to close up and off; Almost passing out; Almost passing out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (Her throat keeps closing up on her/ throat began to close up and off), NEAR DEATH EXPERIENCE (Almost passing out), ERYTHEMA (Face is red as a tomato), SWELLING FACE (Face is swollen), DYSPNOEA (Throat is closed and cannot breathe), CHEST PAIN (Chest pain), PRESYNCOPE (Almost passing out) and MYALGIA (Body aches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PRESYNCOPE (Almost passing out) (seriousness criterion hospitalization). On 17-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROAT TIGHTNESS (Her throat keeps closing up on her/ throat began to close up and off) (seriousness criteria hospitalization and life threatening) and NEAR DEATH EXPERIENCE (Almost passing out) (seriousness criteria hospitalization and medically significant). On 18-May-2021, the patient experienced ERYTHEMA (Face is red as a tomato) (seriousness criterion hospitalization), SWELLING FACE (Face is swollen) (seriousness criterion hospitalization), DYSPNOEA (Throat is closed and cannot breathe) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and MYALGIA (Body aches) (seriousness criterion hospitalization). The patient was hospitalized until 18-May-2021 due to CHEST PAIN, DYSPNOEA, ERYTHEMA, MYALGIA, NEAR DEATH EXPERIENCE, PRESYNCOPE, SWELLING FACE and THROAT TIGHTNESS. At the time of the report, THROAT TIGHTNESS (Her throat keeps closing up on her/ throat began to close up and off) had not resolved and NEAR DEATH EXPERIENCE (Almost passing out), ERYTHEMA (Face is red as a tomato), SWELLING FACE (Face is swollen), DYSPNOEA (Throat is closed and cannot breathe), CHEST PAIN (Chest pain), PRESYNCOPE (Almost passing out) and MYALGIA (Body aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Chest X-ray: (Inconclusive) Lungs look good. No concomitant medications were reported. Treatment included epinephrine (EpiPen), morphine, 2 breathing treatments (unknown) and diphenhydramine (Benadryl). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received on 18 May 2021. The product details updated. Event details updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1366862
Sex: M
Age:
State: MI

Vax Date: 04/14/2021
Onset Date: 05/13/2021
Rec V Date: 06/02/2021
Hospital: Y

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Symptoms: They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine; His lungs were filled with fluid; After 2nd dose, next day morning at 9AM, he didn't feel well while at work; He had upset stomach; He started feeling light headed while driving/very light headed; When he walked in the house, he was short of breath; Turned gray/about a minute and half later, he turned purple and blue; His oxygen was dropped to low 70s; His BP dropped to 80/50; His entire torso was covered in a rash; Very nauseous; On the way home, he started vomiting; He felt little achy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine) and PULMONARY OEDEMA (His lungs were filled with fluid) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine) (seriousness criteria hospitalization and medically significant), PULMONARY OEDEMA (His lungs were filled with fluid) (seriousness criteria hospitalization and medically significant), VACCINATION COMPLICATION (After 2nd dose, next day morning at 9AM, he didn't feel well while at work), ABDOMINAL DISCOMFORT (He had upset stomach), DIZZINESS (He started feeling light headed while driving/very light headed), DYSPNOEA (When he walked in the house, he was short of breath), SKIN DISCOLOURATION (Turned gray/about a minute and half later, he turned purple and blue), OXYGEN SATURATION DECREASED (His oxygen was dropped to low 70s), BLOOD PRESSURE DECREASED (His BP dropped to 80/50), RASH (His entire torso was covered in a rash), NAUSEA (Very nauseous), VOMITING (On the way home, he started vomiting) and MYALGIA (He felt little achy). The patient was hospitalized from 13-May-2021 to 14-May-2021 due to ANAPHYLACTIC REACTION and PULMONARY OEDEMA. At the time of the report, ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine), PULMONARY OEDEMA (His lungs were filled with fluid), VACCINATION COMPLICATION (After 2nd dose, next day morning at 9AM, he didn't feel well while at work), ABDOMINAL DISCOMFORT (He had upset stomach), DIZZINESS (He started feeling light headed while driving/very light headed), DYSPNOEA (When he walked in the house, he was short of breath), SKIN DISCOLOURATION (Turned gray/about a minute and half later, he turned purple and blue), OXYGEN SATURATION DECREASED (His oxygen was dropped to low 70s), BLOOD PRESSURE DECREASED (His BP dropped to 80/50), RASH (His entire torso was covered in a rash), NAUSEA (Very nauseous), VOMITING (On the way home, he started vomiting) and MYALGIA (He felt little achy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Blood pressure measurement: 80/50 (Low) 80/50. On 13-May-2021, Oxygen saturation: low 70s (Low) low 70s. Patient's concomitant medication included nasal spray. He was admitted to the hospital. They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine. The patient was discharged from the hospital on 14-May-2021 evening. The patient was treated with Epi-pen and steroids. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1366863
Sex: F
Age:
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Rec V Date: 06/02/2021
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Symptoms: Herpes; shingles; rash that spread; small heart shaped redness on left shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES VIRUS INFECTION (Herpes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (Herpes) (seriousness criterion medically significant), HERPES ZOSTER (shingles), RASH (rash that spread) and VACCINATION SITE ERYTHEMA (small heart shaped redness on left shoulder). At the time of the report, HERPES VIRUS INFECTION (Herpes), HERPES ZOSTER (shingles), RASH (rash that spread) and VACCINATION SITE ERYTHEMA (small heart shaped redness on left shoulder) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-142373 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1366864
Sex: F
Age: 57
State: TX

Vax Date: 03/12/2021
Onset Date: 04/09/2021
Rec V Date: 06/02/2021
Hospital: Y

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Symptoms: elevated blood pressure; elevated heart rate; severe chest pain; lots of fatigue; joint pain rotating around to different area; Cold hands and feet; Vomiting; Headache; Face was flushed; lips numb; body shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressure) and HEART RATE INCREASED (elevated heart rate) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant past medical history was provided. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressure) (seriousness criterion hospitalization prolonged), HEART RATE INCREASED (elevated heart rate) (seriousness criterion hospitalization prolonged), HYPOAESTHESIA ORAL (lips numb) and TREMOR (body shaking). On 11-Apr-2021, the patient experienced FLUSHING (Face was flushed), VOMITING (Vomiting) and HEADACHE (Headache). On 17-Apr-2021, the patient experienced ARTHRALGIA (joint pain rotating around to different area) and PERIPHERAL COLDNESS (Cold hands and feet). On 14-May-2021, the patient experienced CHEST PAIN (severe chest pain) and FATIGUE (lots of fatigue). The patient was hospitalized on 11-Apr-2021 due to BLOOD PRESSURE INCREASED and HEART RATE INCREASED. The patient was treated with AMLODIPINE ongoing since an unknown date at an unspecified dose and frequency; LORAZEPAM (ATIVAN) ongoing since an unknown date at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at an unspecified dose and frequency; HEPARIN ongoing since an unknown date at an unspecified dose and frequency; METOPROLOL SUCCINATE ongoing since an unknown date at a dose of 25 mg; AMLODIPINE ongoing since an unknown date at a dose of 5 mg and LORAZEPAM (ATIVAN) ongoing since an unknown date at a dose of .5 mg twice a day. At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressure), HEART RATE INCREASED (elevated heart rate), ARTHRALGIA (joint pain rotating around to different area) and FATIGUE (lots of fatigue) had not resolved and CHEST PAIN (severe chest pain), HYPOAESTHESIA ORAL (lips numb), TREMOR (body shaking), FLUSHING (Face was flushed), PERIPHERAL COLDNESS (Cold hands and feet), VOMITING (Vomiting) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood pressure measurement: 210/114 mmHg (High) elevated. On 09-Apr-2021, Heart rate: 115 (High) elevated. On 11-Apr-2021, Blood pressure measurement: 257/120 mmHg (High) elevated. On 11-Apr-2021, Heart rate: 118 (High) elevated. On 11-Apr-2021, Hepatic enzyme: elevated (High) highly elevated. On 17-Apr-2021, Blood pressure measurement: elevated mmHg (High) elevated. On 17-Apr-2021, Heart rate: elevated (High) elevated. On 17-Apr-2021, Hepatic enzyme: elevated (High) elevated. On 14-May-2021, Blood pressure measurement: 176/111 mmHg (High) elevated. On 14-May-2021, Electrocardiogram: lv damage (abnormal) changed from before ad LV damage. On 14-May-2021, Heart rate: 114 (High) elevated. On 14-May-2021, Troponin: elevated (High) elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 09/Apr/2021,the patient was taken to emergency room with blood pressure increased and heart rate increased and was released from ER without being checked. On 11/Apr/2021, she was admitted, was given a bunch of medications and was sent home by 13/Apr/2021. On 17/Apr/2021 she went to facility, with elevated BP and HR, liver enzymes were still elevated along with other events and received medications. On 18/Apr/2021 blood tests, computerized tomography (CT) scan, troponin levels, electrocardiogram (ECG) were performed (results not provided) . She was released on 19/Apr/2021. On 14/May/2021, she woke up with severe chest pain, elevated BP, and elevated HR and went to ER where they indicated her troponin level was elevated, did another CT scan and transported her back to facility. The same day they did blood tests, CT scan, troponin levels (results not provided), and an ECG that changed from before with possible LV damage. She was released the same day. On 17/May/2021, she went to cardiology. She was to wear a Holter monitor for 30 days. She also saw a rheumatologist that wants her to get X-rays and a nerve conduction study for the joint pain. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1366865
Sex: M
Age:
State: IL

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

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Symptoms: Broke out on the whole face, neck, arm and hand/looked like he had a mix of Measleas and Rubella/that is how bad his rash was; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MORBILLIFORM (Broke out on the whole face, neck, arm and hand/looked like he had a mix of Measleas and Rubella/that is how bad his rash was) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MORBILLIFORM (Broke out on the whole face, neck, arm and hand/looked like he had a mix of Measleas and Rubella/that is how bad his rash was) (seriousness criterion hospitalization). At the time of the report, RASH MORBILLIFORM (Broke out on the whole face, neck, arm and hand/looked like he had a mix of Measleas and Rubella/that is how bad his rash was) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1366866
Sex: M
Age: 67
State: IL

Vax Date: 09/23/2017
Onset Date: 04/01/2021
Rec V Date: 06/02/2021
Hospital: Y

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Symptoms: Hallucinations; STOPPED BREATHING; Drug interaction; Arm infection; Sleeplessness; Memory loss; Unable to walk; This spontaneous case was reported by a physician and describes the occurrence of RESPIRATORY ARREST (STOPPED BREATHING) and HALLUCINATION (Hallucinations) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products CARBIDOPA, LEVODOPA (DUOPA) suspension for Parkinson's disease and AMANTADINE HYDROCHLORIDE (GOCOVRI) capsule for an unknown indication. The patient's past medical history included Non-smoker since an unknown date and Abstains from alcohol since an unknown date. Concurrent medical conditions included Drug allergy (SULFA DRUGS MANIFESTED BY SWELLING). Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for Catheter removal, ZOLPIDEM TARTRATE for Sleepiness, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and VITAMIN D NOS for Supplementation therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroidectomy, CARBIDOPA;LEVODOPA, LEVOTHYROXINE, PARACETAMOL (TYLENOL) and CARMELLOSE SODIUM (THERA TEARS) for an unknown indication. On 23-Sep-2017, the patient started CARBIDOPA, LEVODOPA (DUOPA) (Percutaneous) 1 dosage form. In 2018, CARBIDOPA, LEVODOPA (DUOPA) (Percutaneous) dosage was changed to dosage form. In 2020, the patient started AMANTADINE HYDROCHLORIDE (GOCOVRI) (Oral) 274 mg once a day. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced RESPIRATORY ARREST (STOPPED BREATHING) (seriousness criteria hospitalization and medically significant) and GAIT INABILITY (Unable to walk). On 23-Apr-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criteria hospitalization and medically significant) and AMNESIA (Memory loss). On 28-Apr-2021, the patient experienced INSOMNIA (Sleeplessness). On 01-May-2021, the patient experienced LOCALISED INFECTION (Arm infection). On an unknown date, the patient experienced DRUG INTERACTION (Drug interaction). The patient was hospitalized on 28-Apr-2021 due to HALLUCINATION, and then for 12 days due to RESPIRATORY ARREST. In April 2021, RESPIRATORY ARREST (STOPPED BREATHING) had resolved. On 28-Apr-2021, GAIT INABILITY (Unable to walk) had resolved. On 03-May-2021, HALLUCINATION (Hallucinations) and INSOMNIA (Sleeplessness) had resolved. In May 2021, LOCALISED INFECTION (Arm infection) had resolved. At the time of the report, AMNESIA (Memory loss) had not resolved and DRUG INTERACTION (Drug interaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RESPIRATORY ARREST (STOPPED BREATHING), HALLUCINATION (Hallucinations), GAIT INABILITY (Unable to walk), INSOMNIA (Sleeplessness) and AMNESIA (Memory loss) to be probably related and LOCALISED INFECTION (Arm infection) to be not related. No further causality assessment was provided for DRUG INTERACTION (Drug interaction). Whilst hospitalized, unknown labs and diagnostic tests were performed with normal results. The patient was treated with unknown antibiotic intravenously during the hospitalization to treat infection in the left arm caused by the intravenous line. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Initial additional included patient demographics, medical history, new event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: CARBIDOPA;LEVODOPA; LEVOTHYROXINE; XANAX; ZOLPIDEM TARTRATE; TYLENOL; THERA TEARS; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D NOS; SYNTHROID; FLOMAX [MORNIFLUMATE]

Current Illness: Abstains from alcohol; Drug allergy (SULFA DRUGS MANIFESTED BY SWELLING); Non-smoker

ID: 1366867
Sex: M
Age: 70
State: CA

Vax Date: 01/26/2021
Onset Date: 03/26/2021
Rec V Date: 06/02/2021
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Symptoms: blood clot in the left lower leg; left ankle swelling; left foot pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot in the left lower leg) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included METOPROLOL for Hypertension. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced JOINT SWELLING (left ankle swelling) and PAIN IN EXTREMITY (left foot pain). On 12-May-2021, the patient experienced THROMBOSIS (blood clot in the left lower leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clot in the left lower leg), JOINT SWELLING (left ankle swelling) and PAIN IN EXTREMITY (left foot pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Ultrasound scan: abnormal (abnormal) Diagnosed with blood clot in the left lower leg. Other concomitant medication include statin for cholesterol. Treatment medication for events included Xarelto. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: METOPROLOL

Current Illness:

ID: 1366868
Sex: M
Age: 19
State: MD

Vax Date: 05/07/2021
Onset Date: 05/07/2021
Rec V Date: 06/02/2021
Hospital: Y

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Symptoms: Dizziness/ dizzy; Weakness/ very weak; Seizures; Fainted; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizures), SYNCOPE (Fainted), DIZZINESS (Dizziness/ dizzy) and ASTHENIA (Weakness/ very weak) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization and medically significant) and SYNCOPE (Fainted) (seriousness criteria hospitalization and medically significant). On 16-May-2021, the patient experienced DIZZINESS (Dizziness/ dizzy) (seriousness criterion hospitalization) and ASTHENIA (Weakness/ very weak) (seriousness criterion hospitalization). The patient was hospitalized on 07-May-2021 due to SEIZURE and SYNCOPE, then on 16-May-2021 due to ASTHENIA and DIZZINESS. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SEIZURE (Seizures) and SYNCOPE (Fainted) outcome was unknown and DIZZINESS (Dizziness/ dizzy) and ASTHENIA (Weakness/ very weak) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Description: During the day of the injection, at 5 to 10 minutes, the patient fainted and had seizures that required hospitalization. Also, on 16 May 2021 the patient required hospitalization again because of the dizziness and weakness. The patient was still dizzy and was very weak. The patient had a consult with a neurologist and who told that the symptoms were probably becasue of the vaccine. Other treatment information included unspecified pill for dizziness at the hospital. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1366869
Sex: F
Age: 39
State: IL

Vax Date: 12/23/2020
Onset Date:
Rec V Date: 06/02/2021
Hospital: Y

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Symptoms: Blurred vision; Fast heart rate; Tingling; numbness of skin especially limbs and face; Muscle weakness; 2nd dose not taken; Sore arm; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Fast heart rate), PARAESTHESIA (Tingling), HYPOAESTHESIA (numbness of skin especially limbs and face), MUSCULAR WEAKNESS (Muscle weakness) and VISION BLURRED (Blurred vision) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast heart rate) (seriousness criterion hospitalization), PARAESTHESIA (Tingling) (seriousness criterion hospitalization), HYPOAESTHESIA (numbness of skin especially limbs and face) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion hospitalization), VISION BLURRED (Blurred vision) (seriousness criterion hospitalization), INTENTIONAL PRODUCT USE ISSUE (2nd dose not taken) and MYALGIA (Sore arm). The patient was hospitalized from 08-Jan-2021 to 09-Jan-2021 due to HEART RATE INCREASED, HYPOAESTHESIA, MUSCULAR WEAKNESS and PARAESTHESIA. At the time of the report, HEART RATE INCREASED (Fast heart rate), PARAESTHESIA (Tingling), HYPOAESTHESIA (numbness of skin especially limbs and face), MUSCULAR WEAKNESS (Muscle weakness), VISION BLURRED (Blurred vision), INTENTIONAL PRODUCT USE ISSUE (2nd dose not taken) and MYALGIA (Sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information, if any, was not provided by the reporter. Treatment information for the events included metoprolol (unknown dose/directions) and acupuncture treatment to get the nerve sensation back. On 05 Jan 2021, the patient went to an emergency room due to the events. On 08 Jan 2021, the patient went back to the hospital and was admitted. Blood work and a stress test were performed. Results of these tests were not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1366870
Sex: M
Age: 22
State: OH

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 06/02/2021
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Symptoms: Hepatitis infectious mononucleosis; tired; Sore Left Injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of HEPATITIS INFECTIOUS MONONUCLEOSIS (Hepatitis infectious mononucleosis) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, IBUPROFEN for an unknown indication. On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE PAIN (Sore Left Injection site arm). On 06-May-2021, the patient experienced FATIGUE (tired). On 17-May-2021, the patient experienced HEPATITIS INFECTIOUS MONONUCLEOSIS (Hepatitis infectious mononucleosis) (seriousness criterion medically significant). The patient was treated with AZITHROMYCIN ongoing since an unknown date at an unspecified dose and frequency and AMOXICILLIN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEPATITIS INFECTIOUS MONONUCLEOSIS (Hepatitis infectious mononucleosis), VACCINATION SITE PAIN (Sore Left Injection site arm) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Alanine aminotransferase: 620 (Inconclusive) 620. On 12-May-2021, Aspartate aminotransferase: 540 (Inconclusive) 540. On 14-May-2021, Alanine aminotransferase: 650 (Inconclusive) 650. On 14-May-2021, Aspartate aminotransferase: 330 (Inconclusive) 330. Blood work was drawn on 19-May-2021; results unknown/ not reported. Treatment: Patient received Azithromycin on 12-May-2021 but was not able to tolerate because of vomiting so he was switched to Amoxicillin which was stopped on 19-May-2021. The patient had been taking levocetirizine for allergies since early spring 2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: IBUPROFEN; XYZAL

Current Illness:

ID: 1366871
Sex: F
Age: 57
State: KY

Vax Date: 01/19/2021
Onset Date: 02/25/2021
Rec V Date: 06/02/2021
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Symptoms: blood clots; leg pain due to clots; chills; diarrhea worse than when I had covid; chest pains; nerve sensations up and down back and arms; blood pressure went up; higher fever than when got covid; headaches; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (blood clots) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Patient had Covid-19 last year in April and experienced blood clot.) in April 2020 and Thrombosis (Patient had Covid-19 last year in April and experienced blood clot.) in April 2020. Concurrent medical conditions included Hypothyroidism, Blood pressure and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, HYDROCHLOROTHIAZIDE and METOPROLOL for Blood pressure, LEVOTHYROXINE for Hypothyroidism, POTASSIUM for Potassium, VITAMIN B NOS, VITAMIN D NOS and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for Vitamin supplementation, SAMBUCUS NIGRA (ELDERBERRY EXTRACT) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure went up), PYREXIA (higher fever than when got covid) and HEADACHE (headaches). On 15-May-2021, the patient experienced DIARRHOEA (diarrhea worse than when I had covid). In May 2021, the patient experienced CHEST PAIN (chest pains) and PARAESTHESIA (nerve sensations up and down back and arms). On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant), PAIN IN EXTREMITY (leg pain due to clots) and CHILLS (chills). On 16-May-2021, DIARRHOEA (diarrhea worse than when I had covid) had resolved. At the time of the report, THROMBOSIS (blood clots), CHEST PAIN (chest pains), PARAESTHESIA (nerve sensations up and down back and arms), BLOOD PRESSURE INCREASED (blood pressure went up), PAIN IN EXTREMITY (leg pain due to clots), PYREXIA (higher fever than when got covid), HEADACHE (headaches) and CHILLS (chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: LEVOTHYROXINE; VITAMIN B NOS; VITAMIN D NOS; CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS; POTASSIUM; HYDROCHLOROTHIAZIDE; METOPROLOL; CETRIZINE; ALLEGRA; ELDERBERRY EXTRACT

Current Illness: Allergy; Blood pressure; Hypothyroidism

ID: 1366872
Sex: F
Age:
State: CA

Vax Date: 05/13/2021
Onset Date: 05/14/2021
Rec V Date: 06/02/2021
Hospital:

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Symptoms: felt like they were asphyxiating; chest felt tired; tired; body aches; was wanting to vomit, nausea; pain in the pit of stomach; nose swollen, got big; dizziness; nose hurt; nose like a tomato; felt decayed, body feels watery like is loosening; This spontaneous case was reported by a consumer and describes the occurrence of ASPHYXIA (felt like they were asphyxiating) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Rheumatoid arthritis, Gastritis, Blood pressure high and Rhinitis. Concomitant products included THIAMINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), OMEPRAZOLE, LORATADINE and VITAMIN D3 for an unknown indication. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced ABDOMINAL PAIN UPPER (pain in the pit of stomach), NASAL OEDEMA (nose swollen, got big), DIZZINESS (dizziness), NASAL DISCOMFORT (nose hurt), ERYTHEMA (nose like a tomato), FEELING ABNORMAL (felt decayed, body feels watery like is loosening), MYALGIA (body aches) and NAUSEA (was wanting to vomit, nausea). On 19-May-2021, the patient experienced ASPHYXIA (felt like they were asphyxiating) (seriousness criterion medically significant), CHEST DISCOMFORT (chest felt tired) and FATIGUE (tired). At the time of the report, ASPHYXIA (felt like they were asphyxiating), CHEST DISCOMFORT (chest felt tired), ABDOMINAL PAIN UPPER (pain in the pit of stomach), NASAL OEDEMA (nose swollen, got big), DIZZINESS (dizziness), NASAL DISCOMFORT (nose hurt), ERYTHEMA (nose like a tomato), FEELING ABNORMAL (felt decayed, body feels watery like is loosening), FATIGUE (tired), MYALGIA (body aches) and NAUSEA (was wanting to vomit, nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional concomitant product: Unspecified cholesterol medication, high blood pressure medication and natural herbs. Treatment information not provided. Based on the current available information and temporal association between the use of the product and the start date of the events Abdominal pain upper, Nasal oedema, Dizziness, Nasal discomfort, Erythema, Feeling abnormal, Myalgia, and Nausea, a causal relationship cannot be excluded. Concerning the events Asphyxia, Chest discomfort, and Fatigue, very limited information regarding these events has been provided at this time. However, the patient's injection of thymine prior to experiencing Asphyxia, Chest discomfort, and Fatigue remains as a confounder. Further information can't be 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 Abdominal pain upper, Nasal oedema, Dizziness, Nasal discomfort, Erythema, Feeling abnormal, Myalgia, and Nausea, a causal relationship cannot be excluded. Concerning the events Asphyxia, Chest discomfort, and Fatigue, very limited information regarding these events has been provided at this time. However, the patient's injection of thymine prior to experiencing Asphyxia, Chest discomfort, and Fatigue remains as a confounder. Further information can't be requested.

Other Meds: THIAMINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; OMEPRAZOLE; LORATADINE; VITAMIN D3

Current Illness:

ID: 1366873
Sex: M
Age: 42
State: NJ

Vax Date: 01/28/2021
Onset Date: 05/03/2021
Rec V Date: 06/02/2021
Hospital:

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Symptoms: Possible Lymphoma Diagnosis; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHOMA (Possible Lymphoma Diagnosis) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (Patient's antibody response was noted as 'robust' and it did not require any hospitalization at the time.) in March 2021. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced LYMPHOMA (Possible Lymphoma Diagnosis) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (Possible Lymphoma Diagnosis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Basophil count (0.01-0.07): 0 (Inconclusive) basophils: 0. On 03-May-2021, Lymphocyte count (17.0-48): 55.0 (Inconclusive) lymphocytes: 55.0. On 03-May-2021, Monocyte count (6-13): 4.0 (Inconclusive) monocytes 4.0. On 03-May-2021, Neutrophil count (0.99-3.2): 7.44 (Inconclusive) Total Neutrophil Level: 7.44. On 03-May-2021, Neutrophil percentage (38-73): 36 (Inconclusive) Differential: Neutrophils 36.0. On 03-May-2021, White blood cell count (3.6-9.9): 12.6 (Inconclusive) WBC 12.6. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information not reported. No concomitant medications reported. Additional diagnostic results: On 03-May-2021, Markers: CD5 positive/dim, CD19 positive/mod, CD20 positive/dim, CD23 positive/dim, CD38 positive/dim, CD45 positive/bright, HLA-BR positive/mod, S-Lambda positive/dim. Evidence of Monoclonal B cell population CD5+CD23+B-CLL phenotype. As of 19-MAY-2021, the patient has not been officially diagnosed with Lymphoma, but it is suspected. Company comment: Very limited information regarding this event has been provided at this time. Further follow up is not possible.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further follow up is not possible.

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Current Illness:

ID: 1366874
Sex: M
Age: 45
State: CA

Vax Date: 03/29/2021
Onset Date:
Rec V Date: 06/02/2021
Hospital: Y

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Symptoms: Bell's Palsy; Missed second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-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 BELL'S PALSY (Bell's Palsy) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (Missed second dose of the vaccine). The patient was hospitalized from 20-Apr-2021 to 22-Apr-2021 due to BELL'S PALSY. The patient was treated with VALACICLOVIR at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's Palsy) and PRODUCT DOSE OMISSION ISSUE (Missed second dose of the vaccine) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment provided to the patient with unspecified steroids. Company comment: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. This report also refers to a case of Product dose omission issue for mRNA-1273, lot unknown with no associated AEs.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. This report also refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.

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Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 03 October 2021 5:28pm