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
74,695
AK1,647
AL5,421
AR3,446
AS44
AZ13,429
CA58,777
CO11,087
CT7,917
DC1,642
DE1,691
FL36,817
FM3
GA13,565
GU82
HI2,209
IA4,352
ID2,487
IL19,594
IN22,678
KS4,314
KY6,988
LA4,768
MA14,056
MD12,038
ME3,021
MH8
MI18,109
MN11,432
MO8,995
MP30
MS2,703
MT2,155
NC15,564
ND1,276
NE2,750
NH2,886
NJ17,503
NM3,737
NV4,135
NY33,140
OH18,260
OK5,982
OR8,045
PA22,735
PR2,125
QM2
RI1,923
SC6,133
SD1,140
TN8,776
TX34,601
UT4,069
VA14,064
VI50
VT1,679
WA13,945
WI10,473
WV2,235
WY810
XB5
XL1
XV2

ID: 1537246
Sex: F
Age:
State:

Vax Date: 12/27/2020
Onset Date: 01/04/2021
Rec V Date: 08/09/2021
Hospital:

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Symptom List:

Symptoms: large welt that is itchy, raised, hot; large welt that is itchy, raised, hot; large welt that is itchy, raised, hot; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (large welt that is itchy, raised, hot), VACCINATION SITE PRURITUS (large welt that is itchy, raised, hot) and VACCINATION SITE SWELLING (large welt that is itchy, raised, hot) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The patient's past medical history included Intra-uterine contraceptive device insertion since an unknown date. Concomitant products included LEVONORGESTREL for Prevention, ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE WARMTH (large welt that is itchy, raised, hot), VACCINATION SITE PRURITUS (large welt that is itchy, raised, hot) and VACCINATION SITE SWELLING (large welt that is itchy, raised, hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (large welt that is itchy, raised, hot), VACCINATION SITE PRURITUS (large welt that is itchy, raised, hot) and VACCINATION SITE SWELLING (large welt that is itchy, raised, hot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. 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: LEXAPRO; LEVONORGESTREL

Current Illness: Intra-uterine contraceptive device insertion

ID: 1537247
Sex: F
Age:
State:

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 08/09/2021
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Symptoms: Painful breast; Breastfeeding; Rash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Painful breast), MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) and VACCINATION SITE RASH (Rash in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Painful breast), MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) and VACCINATION SITE RASH (Rash in the injection site). At the time of the report, BREAST PAIN (Painful breast), MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding) and VACCINATION SITE RASH (Rash in the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This is a case of product exposure during breastfeeding, who experienced vaccination site rash and breast pain. 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. The causality for maternal exposure during breast feeding is assessed as not applicable. Patient will continue to be contacted for further monitoring of AEs.

Other Meds:

Current Illness:

ID: 1537248
Sex: F
Age: 25
State: FL

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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Symptoms: Arm is really warm; Arm soreness; Redness; Swelling; Headaches; Body aches; Runny nose; A spontaneous report was received from a consumer who was a 25-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced arm soreness, redness, swelling, headache, body aches, runny nose and her arm was really warm. The patient's medical history was not provided. Concomitant product use was not provided. On 30 Dec 2020, the patient received her first dose of mRNA-1273 (Lot number: 011J20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, after receiving the mRNA-1273 vaccine, she had a small amount of soreness, redness and swelling for two to three days and disappeared. However, she experienced them again on 06 Jan 2021. On 08 Jan 2021 her arm was more swollen and her arm was really warm on that day. On unreported date, she experienced headache, body aches and runny nose. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not provided. The outcome of the events, arm soreness, redness, swelling, headache, body aches, runny nose and feeling of warm were not reported.; Reporter's Comments: This case concerns a 25-year-old, female patient. The patient's medical history was not provided. The patient experienced BS expected event of injection site pain, erythema, swelling, headache, and unexpected event of Ache NOS, rhinorrhea and injection site warmth. The events of injection site pain, erythema and swelling after 1 day, injection site warmth after 8 days and headache, Ache NOS, rhinorrhea on unspecified date after the first dose of mRNA-1273 (Lot number: 011J20A) administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537249
Sex: M
Age:
State: FL

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/09/2021
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Symptoms: Felt very uncomfortable this morning; Sore arm and Back is really sore this morning; Achy all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy all over), DISCOMFORT (Felt very uncomfortable this morning) and PAIN (Sore arm and Back is really sore this morning) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Back discomfort (Back issues off and on) and Hypertension. Concomitant products included ATENOLOL for Hypertension. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (Achy all over). On 07-Jan-2021, the patient experienced DISCOMFORT (Felt very uncomfortable this morning) and PAIN (Sore arm and Back is really sore this morning). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Achy all over), DISCOMFORT (Felt very uncomfortable this morning) and PAIN (Sore arm and Back is really sore this morning) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: ATENOLOL

Current Illness: Back discomfort (Back issues off and on); Hypertension

ID: 1537250
Sex: M
Age:
State:

Vax Date:
Onset Date: 01/01/2021
Rec V Date: 08/09/2021
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Symptoms: Son having a fever; A spontaneous report was received from a consumer concerning of an unknown age male patient, who received Moderna's COVID-19 vaccine and developed a fever. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the event, the patient received their first of two doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 01 Jan 2021, after receiving his vaccination, the patient began to develop a fever. The exact temperature of the fever was not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the event, fever, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of fever, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537251
Sex: F
Age: 40
State: NV

Vax Date: 12/27/2020
Onset Date: 01/03/2021
Rec V Date: 08/09/2021
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Symptoms: A large rash on my left arm that was itchy; Arm tightness; Warm to the touch; Had pain on injection site; Big rash on the injection site; Swollen rash on injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (A large rash on my left arm that was itchy), LIMB DISCOMFORT (Arm tightness), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PAIN (Had pain on injection site) and VACCINATION SITE RASH (Big rash on the injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included VITAMIN D3 for an unknown indication. On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (A large rash on my left arm that was itchy), LIMB DISCOMFORT (Arm tightness), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PAIN (Had pain on injection site), VACCINATION SITE RASH (Big rash on the injection site) and VACCINATION SITE SWELLING (Swollen rash on injection site). On 08-Jan-2021, VACCINATION SITE PRURITUS (A large rash on my left arm that was itchy), LIMB DISCOMFORT (Arm tightness), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PAIN (Had pain on injection site), VACCINATION SITE RASH (Big rash on the injection site) and VACCINATION SITE SWELLING (Swollen rash on injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that the patient was prescribed a topical cream (unspecified). The patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on 24-Jan-2021 in right arm. This case was linked to MOD-2021-082291 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: FUP obtained included: new events after dose 1, second dose details and adverse events associated with it.; Reporter's Comments: This case concerns a female of unknown age who experienced NS events of unexpected limb discomfort and expected injection site pain, Injection site swelling, Injection site rash. Event onset occurred on Day 2 after the first dose of mRNA-1273, followed by other events on Day 8. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association.

Other Meds: VITAMIN D3

Current Illness:

ID: 1537252
Sex: F
Age: 59
State:

Vax Date: 12/23/2020
Onset Date: 01/02/2021
Rec V Date: 08/09/2021
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Symptoms: swelling in arm; Redness in the arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (swelling in arm) and VACCINATION SITE ERYTHEMA (Redness in the arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SJ20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided). Concomitant products included LISINOPRIL for an unknown indication. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling in arm) and VACCINATION SITE ERYTHEMA (Redness in the arm). At the time of the report, VACCINATION SITE SWELLING (swelling in arm) and VACCINATION SITE ERYTHEMA (Redness in the arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reportedly, Red swollen injection site a week after vaccination is an expected effect and resolved in all the participants after a week or so. Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Outcome updated,information added to the narrative; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LISINOPRIL

Current Illness:

ID: 1537253
Sex: F
Age: 28
State: OH

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 08/09/2021
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Symptoms: Pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination. The patient's past medical history included No adverse event (Medical history not provided). On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1537254
Sex: F
Age: 45
State: NJ

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

Symptoms: burning pain in back of legs; Painful lymph nodes under arms/swelling in armpit glands; Headache; Swollen and painful neck lymph node, supraclavicular; muscle pain; Pain in back and legs; pain in legs; Bad pain behind right knee/Joint pains; Fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in back and legs), PAIN IN EXTREMITY (pain in legs), BURNING SENSATION (burning pain in back of legs), AXILLARY PAIN (Painful lymph nodes under arms/swelling in armpit glands) and ARTHRALGIA (Bad pain behind right knee/Joint pains) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Endometriosis. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Dec-2020, the patient experienced VACCINATION SITE PAIN (sore arm). On 29-Dec-2020, the patient experienced BACK PAIN (Pain in back and legs), PAIN IN EXTREMITY (pain in legs), ARTHRALGIA (Bad pain behind right knee/Joint pains), FATIGUE (Fatigue) and MYALGIA (muscle pain). On 07-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen and painful neck lymph node, supraclavicular). On an unknown date, the patient experienced BURNING SENSATION (burning pain in back of legs), AXILLARY PAIN (Painful lymph nodes under arms/swelling in armpit glands) and HEADACHE (Headache). At the time of the report, BACK PAIN (Pain in back and legs), PAIN IN EXTREMITY (pain in legs), BURNING SENSATION (burning pain in back of legs), AXILLARY PAIN (Painful lymph nodes under arms/swelling in armpit glands), HEADACHE (Headache) and VACCINATION SITE PAIN (sore arm) outcome was unknown and ARTHRALGIA (Bad pain behind right knee/Joint pains), FATIGUE (Fatigue), MYALGIA (muscle pain) and LYMPHADENOPATHY (Swollen and painful neck lymph node, supraclavicular) had not resolved. concomitant medication was not provided. Treatment information was not provided. This case was linked to MOD-2021-108110 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient demographics, medical history updated, therapy details of Moderna vaccine, additional events reported (burning pain in back of legs, muscle pain, Swollen and painful neck lymph node, supraclavicular).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1537255
Sex: F
Age:
State: TN

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

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Symptoms: armpit pain; Redness; A report was received from a consumer concerning a female patient who experienced pain and redness in her armpit after receiving the Moderna COVID-19 vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (batch# was not provided) for prophylaxis of COVID-19 infection on 30 Dec 2020. She expressed that she experienced axillary pain and noticed also that her axillary area had a reddish discoloration. The patient informed that she felt pain in her arm when it rested on her side. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, axillary pain and redness, is unknown. The reporter did not provide an assessment for the events of axillary pain and redness.; Sender's Comments: This case concerns a female of unknown age who experienced NS events of unexpected Erythema and expected Axillary pain. Erythema occurred Day 1 after the first dose of mRNA-1273, followed by Axillary pain Day 8. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-002918:case invalid US-MODERNATX, INC.-MOD-2021-002925:

Other Meds:

Current Illness:

ID: 1537256
Sex: F
Age: 40
State: TX

Vax Date: 12/28/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
Hospital:

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Symptom List:

Symptoms: sore arm; swollen and retractable lymph node above the collar bone; pain at the injection site; fatigue; A spontaneous report was received from a consumer/pharmacist concerning a 40 year old patient who developed pain in the injection site, swollen and retractable lymph nodes, fatigue, and a sore arm. The patient's medical history and relevant concomitant medications were not reported. On 28 Dec 2020, the same day as onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient experienced pain at the injection site beginning on 28 Dec 2020. On 30 Dec 2020 the patient developed a swollen and retractable lymph node, fatigue and a sore arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events pain in the injection site, swollen and retractable lymph node, fatigue and sore arm were not reported. Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1537257
Sex: F
Age:
State: NM

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

Vax Type:
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Symptom List:

Symptoms: color was going down arms; hurts to the bone; hurts really deep; localized swelling; Redness; A spontaneous report was received from a consumer who was a 44-year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced localized swelling, redness, huge lump underneath, color is going down my arms, hurts really deep, hurts to the bone which was getting worse and not better. The patient's medical history was not provided. Concomitant medications reported included diphenhydramine citrate, ibuprofen and melatonin. On 29 Dec 2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 in the left upper arm for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient experienced localized swelling and redness. On 07 Jan 2021, she reported that the redness was much worse, she developed a huge lump underneath, the color was going down her arms and it hurt really deep and to the bone. The condition was worsening and not getting better. Treatment for the events included Advil and Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, localized swelling, redness, huge lump underneath, color is going down my arms, hurts really deep and hurts to the bone which was getting worse and not better were not reported.; Reporter's Comments: This case concerns a 44-year old, female patient. The patient's medical history was not provided. The patient experienced NS, expected event of injection site swelling, erythema, injection site pain and unexpected event of Pain NOS, skin coloration. The events of injection site swelling , erythema occurred on the same day, events of Injection site pain, Pain NOS, skin discoloration occurred 10 days after the first dose of mRNA-1273. Treatment for the events included Advil and Benadryl. 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: ADVIL PM [DIPHENHYDRAMINE CITRATE;IBUPROFEN]; MELATONIN

Current Illness:

ID: 1537258
Sex: M
Age: 68
State: MA

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 08/09/2021
Hospital:

Vax Type:
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Symptoms: heart rate going faster (ka-bunk, ka-bunk); muscles and bones aching; muscles and bones aching; very very very very tired; slight headache; A spontaneous report was received from a consumer who was a 68-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscles and bones aching, slight headache, heart rate going faster (ka-bunk, ka-bunk) and felt very tired. The patient's medical history was not provided. No concomitant medications were reported. On 06 Jan 2021, approximately one day prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly on the left arm for prophylaxis of COVID-19 infection. On the morning of 07 Jan 2021, the patient woke up feeling very tired with muscles and bones aching and a slight headache. He also noticed that his heart rate was going faster (ka-bunk, ka-bunk) one hour prior to reporting the events. Treatment for the events included ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, very tired, muscles and bones aching, slight headache and heart rate going faster was not reported.; Reporter's Comments: This case concerns a 68 year old male who experienced nonserious unexpected events of heart rate increase and bone pain, as wells as nonserious listed events of fatigue, myalgia, and headache. The events occurred approximately 1 day after first dose of mRNA-1273 administration. Treatment for the events included ibuprofen. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537259
Sex: F
Age: 64
State: TX

Vax Date: 12/23/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
Hospital:

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Symptom List:

Symptoms: Experienced swelling, burning, and slight itching at the injection spot; Experienced swelling, burning, and slight itching at the injection spot; Experienced swelling, burning, and slight itching at the injection spot; A spontaneous report was received from a consumer, concerning herself, a 64-year-old female patient, who received Moderna's COVID-19 vaccine and experienced swelling, burning, and itching at the injection spot. The patient's medical history was not provided. Concomitant product use was not provided. On 23-Dec-2020, approximately seven days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025J20-2A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection. On 30-Dec-2020, 7 days after the shot of vaccine, the patient experienced swelling, burning and slight itching at the injection spot (not too bad). Hence, she was treated with ibuprofen and the first dose of which helped patient 50% and the second dose provided full relief from the symptoms. These event had lasted for two days. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events, experienced swelling, burning and itching at the injection spot was resolved on 01-Jan-2021.; Reporter's Comments: This case concerns a 64 year old, female patient, who experienced a non-serious expected event of injection site pruritus, injection site pain, and injection site swelling. The events occurred 8 days after first dose of mRNA-1273, lot # 039K20A. Treatment included Advil. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537260
Sex: M
Age: 73
State:

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/09/2021
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Symptoms: Burning eyes; swelling in face; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EYE IRRITATION (Burning eyes) and SWELLING FACE (swelling in face) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No Medical History reported). Concomitant products included CARVEDILOL, HYDROCHLOROTHIAZIDE, BETAHISTINE, POTASSIUM CHLORIDE and TIMOLOL MALEATE (TIMOPTIC) for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced EYE IRRITATION (Burning eyes) and SWELLING FACE (swelling in face). The patient was treated with PREDNISONE at a dose of 20 mg. At the time of the report, EYE IRRITATION (Burning eyes) outcome was unknown and SWELLING FACE (swelling in face) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; 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: CARVEDILOL; HYDROCHLOROTHIAZIDE; BETAHISTINE; POTASSIUM CHLORIDE; TIMOPTIC

Current Illness:

ID: 1537261
Sex: F
Age: 31
State:

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
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Symptoms: bump is bigger this time and it doesn't look like it's gonna go away; hardness; redness; swelling; regular pain at the injection site; This spontaneous case was reported by a physician and describes the occurrence of CONDITION AGGRAVATED (bump is bigger this time and it doesn't look like it's gonna go away), VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (regular pain at the injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077K204) for COVID-19 vaccination. Concomitant products included PANTOPRAZOLE, METFORMIN, CALCIUM, SODIUM CITRATE (CITRATE), ZINC and VITAMINS NOS for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (regular pain at the injection site). On 31-Dec-2020, the patient experienced VACCINATION SITE INDURATION (hardness), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling). On 06-Jan-2021, the patient experienced CONDITION AGGRAVATED (bump is bigger this time and it doesn't look like it's gonna go away). At the time of the report, CONDITION AGGRAVATED (bump is bigger this time and it doesn't look like it's gonna go away), VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (regular pain at the injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were reported.; Sender's Comments: This case concerns a 41-year-old female who experienced NS events of unexpected condition aggravated and expected vaccination site pain, vaccination site erythema, vaccination site swelling, vaccination site induration. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: PANTOPRAZOLE; METFORMIN; CALCIUM; CITRATE; ZINC; VITAMINS NOS

Current Illness:

ID: 1537262
Sex: F
Age: 64
State: TX

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/09/2021
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Symptoms: Red, hot, inflamed, rash on her arm; Inflamed rash on her arm; Insanely itchy rash; insanley itch rash; Red, hot, inflamed, rash on her arm; Injection site pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Red, hot, inflamed, rash on her arm), VACCINATION SITE INFLAMMATION (Inflamed rash on her arm), VACCINATION SITE RASH (Insanely itchy rash), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE PRURITUS (insanley itch rash) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K204 and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypothyroidism since 20-Dec-1999. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 20-Dec-1999 to an unknown date for Thyroid activity decreased. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 04-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Red, hot, inflamed, rash on her arm), VACCINATION SITE INFLAMMATION (Inflamed rash on her arm), VACCINATION SITE RASH (Insanely itchy rash), VACCINATION SITE PRURITUS (insanley itch rash) and VACCINATION SITE ERYTHEMA (Red, hot, inflamed, rash on her arm). On 30-Dec-2020, VACCINATION SITE PAIN (Injection site pain) had resolved. On 08-Jan-2021, VACCINATION SITE WARMTH (Red, hot, inflamed, rash on her arm), VACCINATION SITE INFLAMMATION (Inflamed rash on her arm) and VACCINATION SITE RASH (Insanely itchy rash) had resolved. At the time of the report, VACCINATION SITE PRURITUS (insanley itch rash) and VACCINATION SITE ERYTHEMA (Red, hot, inflamed, rash on her arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the events included over the counter steroid cream and Allegra. Follow-up received on 26-Mar-2021 included patient demographics, dose and event details. Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Height is being addedOn 21 JAN 2021 patient took second vaccineBatch no of first dose addedCurrent condition of hypothyroidism and concomitant medication Levothyroxine 25mcg being addedPatient ethnicity addedEvent outcome added.Treatment information added; Reporter's Comments: This case is cross-linked with case MOD21-01915. This case concerns a 64-year-old female who experienced NS events of unexpected peripheral swelling, rash erythematous, rash pruritic, and expected injection site pain. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved or resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: LEVOTHYROXIN

Current Illness: Hypothyroidism

ID: 1537263
Sex: F
Age: 61
State: CA

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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Symptoms: injection site soreness; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (injection site soreness) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The patient's past medical history included Abscess drainage on 05-Jan-2021. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (injection site soreness) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Vaccination site pain, at an unspecified dose and frequency. On 30-Dec-2020, VACCINATION SITE PAIN (injection site soreness) and FATIGUE (fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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: 1537264
Sex: F
Age:
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Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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Symptoms: Dizziness; Nauseous; head hurts really bad; Chills; The spontaneous report was received from a health technician (reporting on self), concerning a 57-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, head hurts really bad (headache), dizziness and chills. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020 morning the patient received their first of two planned doses of mRNA-1273 (batch number: 039K20A) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection. On the night of 30 Dec 2020 or 31 Dec 2020 in the morning, she felt nauseas, her head hurt really bad, feels dizzy and she had chills, but she did not have fever. The patient was treated with ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, nausea, head hurts really bad, dizziness and chills was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537265
Sex: F
Age: 69
State: FL

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 08/09/2021
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Symptoms: Itchiness in the arm; Arm was red; Arm was hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was hot), VACCINATION SITE PRURITUS (Itchiness in the arm) and VACCINATION SITE ERYTHEMA (Arm was red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE WARMTH (Arm was hot) and VACCINATION SITE ERYTHEMA (Arm was red). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness in the arm). At the time of the report, VACCINATION SITE WARMTH (Arm was hot), VACCINATION SITE PRURITUS (Itchiness in the arm) and VACCINATION SITE ERYTHEMA (Arm was red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537266
Sex: F
Age: 70
State: NJ

Vax Date: 12/30/2020
Onset Date: 01/01/2021
Rec V Date: 08/09/2021
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Symptoms: Diarrhea; Weakness in the legs; Back pain; Injection site soreness; Fatigue; A Spontaneous report was received from a healthcare professional concerning a 70 year old female patient who was participating in the mRNA-1273 Emergency Use Program and developed diarrhea, injection site soreness, back pain, weakness in her legs, and fatigue. The patient's medical history included elevated cholesterol, hypertension, and an unspecified thyroid disorder. Concomitant medications reported included atorvastatin, olmesartan, and levothyroxine. On 30 Dec 2020, approximately two days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 01 Jan 2021,the patient experienced diarrhea, injection site soreness, back pain, weakness in her legs, and fatigue. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events diarrhea, injection site soreness, back pain, weakness in her legs, and fatigue was not reported. Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Other Meds: ATORVASTATIN; OLMESARTAN; LEVOTHYROXINE

Current Illness: Cholesterol; Hypertension; Thyroid disorder NOS

ID: 1537267
Sex: F
Age: 27
State: VA

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 08/09/2021
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Symptoms: Injection site redness; Swelling of the lymph nodes in her armpit, half an inch in size; Extremely itchy; Rash around vaccination site; Painful lymph nodes in armpit; Hurts to lower arm, sore; Feel sore and tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Extremely itchy), FATIGUE (Feel sore and tired), VACCINATION SITE RASH (Rash around vaccination site), AXILLARY PAIN (Painful lymph nodes in armpit) and VACCINATION SITE PAIN (Hurts to lower arm, sore) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included IBUPROFEN. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced FATIGUE (Feel sore and tired) and VACCINATION SITE PAIN (Hurts to lower arm, sore). On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Extremely itchy), VACCINATION SITE RASH (Rash around vaccination site) and AXILLARY PAIN (Painful lymph nodes in armpit). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency. On 09-Jan-2021, AXILLARY PAIN (Painful lymph nodes in armpit) and VACCINATION SITE PAIN (Hurts to lower arm, sore) had resolved. On 10-Jan-2021, VACCINATION SITE PRURITUS (Extremely itchy) and VACCINATION SITE RASH (Rash around vaccination site) had resolved. At the time of the report, FATIGUE (Feel sore and tired) and VACCINATION SITE ERYTHEMA (Injection site redness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up information was added on 16 April 2021. Second dose information and a new events (injection site erythema, injection site rash and injection site pruritis), race, ethnicity, event treatment, event outcome was 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.

Other Meds: IBUPROFEN

Current Illness:

ID: 1537268
Sex: U
Age: 53
State: WA

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
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Symptoms: redness over the injection site; feeling tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (feeling tired) and INJECTION SITE ERYTHEMA (redness over the injection site) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Benadryl). On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced FATIGUE (feeling tired). On 07-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness over the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (topical) for Injection site redness, at an unspecified dose and frequency. At the time of the report, FATIGUE (feeling tired) had resolved and INJECTION SITE ERYTHEMA (redness over the injection site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient treatment includes topical cream/ gel Benadryl as a treatment. The treatment was topical as the patient is allergic to Benadryl. Concomitant medication was not provided. Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2021: No specific follow-up information recorded.; 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: Drug allergy (Benadryl)

ID: 1537269
Sex: F
Age: 45
State: NH

Vax Date: 12/29/2020
Onset Date: 01/05/2021
Rec V Date: 08/09/2021
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Symptoms: Burning feeling at injection site; Swelling; Burning Feeling at injection site; redness; warm to touch at injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE WARMTH (warm to touch at injection site), VACCINATION SITE PAIN (Burning feeling at injection site), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Burning Feeling at injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE WARMTH (warm to touch at injection site), VACCINATION SITE PAIN (Burning feeling at injection site), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Burning Feeling at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE WARMTH (warm to touch at injection site), VACCINATION SITE PAIN (Burning feeling at injection site), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Burning Feeling at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication included Antibiotic. No concomitant medications were reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537270
Sex: F
Age:
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Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 08/09/2021
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Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In December 2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). In December 2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not reported. Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this Female with an unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy for this female with unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

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Current Illness:

ID: 1537271
Sex: U
Age:
State: TX

Vax Date: 01/05/2021
Onset Date: 01/07/2021
Rec V Date: 08/09/2021
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Symptoms: Fever of 103F; A spontaneous report was received from a pharmacist, concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 103F. The patient's medical history was not provided. Concomitant medications were not reported. On 05 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (batch unknown) for prophylaxis of COVID-19 infection. On 05 JAN 2021, the patient received the vaccine and two days later, on 07 JAN 2021, she experienced fever of 103F. The reporter hung up and declined to provide any additional information upon outbound of the call. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, fever of 103F, was considered unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced a NS expected event of fever. Event onset occurred 3 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537272
Sex: M
Age:
State:

Vax Date: 12/29/2020
Onset Date: 01/02/2021
Rec V Date: 08/09/2021
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Symptoms: slight issue with some blood issues; Slight headache; A spontaneous report was received from a consumer concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight issue with some blood issues and slight headache. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29-DEC-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 02 Jan 2021, the patient felt slight issues with some blood issues which lasted part of one evening and subsided and that he had no further problems other than a slight headache. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. Outcome of the events, slight issue with some blood issues was recovered and slight headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested for details about the blood issue the patient experienced.

Other Meds:

Current Illness:

ID: 1537273
Sex: M
Age: 60
State: NY

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 08/09/2021
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Symptoms: Body aches; Loss of appetite; Headache; fever of 101.8F; Nausea; fatigue; Chills; A spontaneous report was received from a nurse concerning a 60-year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced headache, fever, nausea, body aches, fatigue, chills and loss of appetite. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Dec 2020, approximately 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the morning of 31 Dec 2020, the patient experienced headache, fever of 101.8F, nausea, body aches, fatigue, chills, and loss of appetite. Treatment for the event included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of headache, fever, nausea, body aches, fatigue, chills and loss of appetite, were recovered.; Reporter's Comments: This case concerns a 66-year-old female who experienced NS events of unexpected pain and decreased appetite and expected headache, fever, chills, fatigue, nausea. Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment with paracetamol. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537274
Sex: F
Age: 44
State: CA

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 08/09/2021
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Symptoms: pustules multiple it's painful; Pustules between her brows and multiples on face; A spontaneous report was received from a 44 year old female healthcare facility staff member who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed painful pustules in between brows, spreading down to the upper corner of the mouth and chin, and multiple on her face. The patient's medical history was not provided. Concomitant medications reported included vitamin E, vitamin C, vitamin D3, fish oil, biotin and collagen. On 31 Dec 2020, approximately two hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot# 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 31 Dec 2020, approximately two hours after the vaccine, patient developed pustules in between her brows. On 1 Jan 2021, she noticed multiples on her face, painful and spreading down the upper corner of the mouth going to the chin. Treatment for the event included hydroxyzine hydrochloride on 1 Jan 2021 and diphenhydramine on 2 Jan 2021. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, developed painful pustules in between brows, spreading down to the upper corner of the mouth and chin, and multiple on her face, was considered Not Resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: VITAMIN E [VITAMIN E NOS]; FISH OIL; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; BIOTIN; COLLAGEN

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

ID: 1537275
Sex: F
Age: 33
State: OR

Vax Date: 12/26/2020
Onset Date: 01/02/2021
Rec V Date: 08/09/2021
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Symptoms: injection site got swollen and growing; injection site red; injection site hot; injection site itchy; A spontaneous report was received from a 33 year old female healthcare facility staff member who was participating in the mRNA-1273 Emergency Use Program and developed red, hot, itchy, swollen injection site that is expanding. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Dec 2020, approximately 7 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot# 025J20-2A) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 2 Jan 2021, the patient noted that the injection site became swollen, red, hot and itchy and was expanding with time. Treatment for the event included diphenhydramine every six hours and ibuprofen. Action taken with mRNA-1273 in response to the event is not provided. The outcome of the events, developed red, hot, itchy, swollen injection site that is expanding, were considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

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

ID: 1537276
Sex: F
Age: 30
State: TX

Vax Date: 01/02/2021
Onset Date: 01/01/2021
Rec V Date: 08/09/2021
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Symptoms: chills; fever; joint pain; soreness to the injection site; A spontaneous report was received from a health care professional concerning a 30-years-old, female patient, who received Moderna's COVID-19 Vaccine and who experienced soreness to the injection site, chills, fever 101 Fahrenheit (F) and joint pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On 01 JAN 2021 at 11:40 AM, the patient received the first of two planned doses of mRNA-1273 (batch number: 025L20A) intramuscularly left deltoid for prophylaxis of COVID-19 infection. On 01 JAN 2021, the patient experienced soreness to the injection site. On the same day at 11PM the patient reported chills, fever of 101 F and joint pain. On 03 JAN 2021, she still had low grade fever of 100.4 F, joint pain and woke up with chills. The patient stated that fever, chills, joint pain were resolved after taking acetaminophen, but the injection site was still painful. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, chills, fever 101 F and joint pain was resolved on the 03 JAN 2021. The event soreness to the injection site was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of chills, pyrexia, arthralgia and vaccination site pain, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537277
Sex: F
Age:
State: NC

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 08/09/2021
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Symptoms: Rash; Node in the injection site; Arm is swollen; Arm is swollen and sore; A spontaneous report was received from a nurse concerning a 46-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed injection site nodule, peripheral swelling, pain in extremity and a rash. The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (Lot number: 037KQ00) on 31 Dec 2020 in the left arm for prophylaxis of COVID-19 infection. A nurse who is the patient called to report she received the Moderna COVID-19 vaccine on 31 Dec 2020. The next day, she noted a "node" at the injection site. The left arm was swollen and sore with rash. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. Outcome of the events, injection site nodule, peripheral swelling, pain in extremity and a rash, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537278
Sex: F
Age: 65
State: NY

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 08/09/2021
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Symptoms: cold hand; pins and needles; blisters; weak; dizzy; headache; Injection arm numb; A spontaneous report was received from a nurse concerning a 65-year-old, female patient who experienced right arm numbness, dizziness, headaches, weakness, paresthesia as well as a cold and blistered right hand. The patient's medical history was not provided. No relevant concomitant medications were provided. On 31 DEC 2020, the patient received her first of two planned doses of mRNA-1273 vaccine (batch# 025J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 01 JAN 2021, the patient woke up in the middle of the night with a numb right hand. On 02 JAN 2021 she developed dizziness headache and weakness which kept her bedridden through 03 JAN 2021. ON 04 JAN 2021, the patient started experiencing pins and needles on the right hand as she noticed that her right hand felt very cold and some round blisters were visible on the hand. There was no report of any interventions or treatment received by the patient regarding the events. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, numbness right arm was recovered on 01-JAN-2021. The outcome of other events, dizziness, headaches, weakness, paresthesia as well as a cold and blistered right hand were considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537279
Sex: M
Age:
State:

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
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Symptoms: slight headache; A spontaneous report was received from a non-health professional concerning a male consumer who received Moderna's COVID-19 vaccine and developed a slight headache. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. The patient received the vaccine and developed a slight headache for the remainder of the day. He reported no further adverse reactions and felt fine overall. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, a slight headache, was not provided.; Reporter's Comments: This case concerns a male of unknown age who experienced NS expected event of headache. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcome known. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537280
Sex: F
Age: 74
State: FL

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
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Symptoms: lump on the injection site; injection site warmth; injection site itching; injection site redness; soreness on the injection site; A report was received from a consumer who was a 74 year old, patient who was participating in the mRNA-1273 Emergency Use Program and experienced soreness on the injection site, a lump on the injection site, and itchiness and warmth at the injection site. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 039R2019- patient unsure of number as the vaccination card was illegible) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. The patient reported that she received the Moderna Covid-19 vaccine on 29 Dec 2020 and 12-24 hours later had experienced soreness on the injection site, which spontaneously resolved. On 05 Jan 2021, 7 days after the vaccination, she felt a lump on the injection site which was less than 2 inches in size, itchy, and warm to the touch. The patient took her own temperature, 98.9F. On 07 Jan 2021, she stated that there is no more lump felt, but now the site is blotchy, pink in color and irregularly shaped. Treatment for the events included paracetamol and diphenhydramine hydrochloride. Action taken with mRNA-1273 in response to the events was not reported. The event, soreness on injection site was considered resolved on 05 Jan 2021. The events lump on the injection site, and itchiness and warmth at the injection site were considered resolved on 08 Jan 2021.; Reporter's Comments: This case concerns a 74-year-old female who had NS events of unexpected injection site warmth, injection site mass and expected injection site pain, injection site erythema, injection site pruritus. Event onset Day 1 after first dose mRNA-1273, with later events on Day 8. Treatment paracetamol and diphenhydramine. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537281
Sex: F
Age: 34
State: CA

Vax Date: 12/29/2020
Onset Date: 01/02/2021
Rec V Date: 08/09/2021
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Symptoms: The injection site became very sensitive; lymph node swelling/lymph node inflammation; Injection site red; Injection site scratchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE HYPERSENSITIVITY (The injection site became very sensitive), LYMPHADENOPATHY (lymph node swelling/lymph node inflammation), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE PRURITUS (Injection site scratchy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No adverse event history). On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced INJECTION SITE HYPERSENSITIVITY (The injection site became very sensitive), LYMPHADENOPATHY (lymph node swelling/lymph node inflammation), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE PRURITUS (Injection site scratchy). At the time of the report, INJECTION SITE HYPERSENSITIVITY (The injection site became very sensitive), LYMPHADENOPATHY (lymph node swelling/lymph node inflammation), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE PRURITUS (Injection site scratchy) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient has a medical history was not provided. No relevant concomitant medication was reported. 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; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537282
Sex: F
Age:
State:

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/09/2021
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Symptoms: Have not felt good since having this vaccine; having a reaction to it; A spontaneous report was received from a female consumer who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced not feeling good since receiving vaccine and having a reaction to it. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 1 Jan 2020, patient reports not feeling good since receiving vaccine and having a reaction to it. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, not feeling good since receiving vaccine and having a reaction to it was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced NS unexpected events of malaise and an unspecified adverse event (having a reaction to it). Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537283
Sex: F
Age: 58
State: PR

Vax Date: 12/26/2020
Onset Date: 01/02/2021
Rec V Date: 08/09/2021
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Symptoms: Has temperature; Itch a lot; Red spot appear on the injection site; A spontaneous report was received from a caregiver concerning a 58-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a red spot at the vaccine injection site, has a temperature, and itches a lot. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26-Dec-2020, approximately 8 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J208) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 02-Jan-2021, the caregiver called to report that the patient developed a red spot on the vaccine injection site of her left arm. The red spot was a half dollar in diameter, no bump, almost flat, and very red like a rose. The vaccine site also has temperature and itched a lot. Consent was given for HCP follow up. Treatment for the events included hydrocortisone ointment, applied daily that was started on 02-Jan-2021. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537284
Sex: M
Age: 93
State: TX

Vax Date: 01/01/2021
Onset Date: 01/03/2021
Rec V Date: 08/09/2021
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Symptoms: Wheezy; A spontaneous report was received from a consumer who was a 93-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed wheezing. The patient's medical history was not provided. No relevant concomitant medications were reported. On 01 Jan 2021, approximately two days prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of COVID-19 infection. On 03 Jan 2021, the patient felt that her breathing was wheezy which worsened at night. On 04 Jan 2021, the patient's condition improved. No treatment was received by the patient for wheezing. Action taken with mRNA-1273 in response to the events was not reported. The event, wheezing was considered recovering.; Reporter's Comments: This case concerns a 93-year-old male patient, who experienced a non-serious unexpected event of Wheezing. The event occurred approximately 2 days after first dose of mRNA-1273, lot # unknown. No treatment was received by the patient for wheezing. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537285
Sex: F
Age:
State:

Vax Date:
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Rec V Date: 08/09/2021
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Symptoms: Soreness in arm; A spontaneous report was received from healthcare facility staff member, concerning a female patient who was participating in the mRNA-1273 Emergency Program and who experienced soreness in the arm. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 on an undisclosed date intramuscularly for prophylaxis of COVID-19 infection. Patient received the Moderna vaccine on an undisclosed date as did her husband. Her husband reported that they both experienced arm soreness following vaccine administration. Treatment information was not provided. Action taken with mRNA-1273 in response to the event, soreness in arm, was not provided. The outcome of the events, soreness in arm, was not reported. The reporter did not provide a causality assessment for the events, soreness in the arm.; Reporter's Comments: This case concerns a female of unknown age who had a nonserious expected event of pain in extremity. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537286
Sex: F
Age: 61
State: VA

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 08/09/2021
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Symptoms: Sensitivity to light; Tenderness in lymph nodes in neck and groin; Dizziness; Soreness in arm; Fatigue; Mild headache; A spontaneous report, was received from a nurse practitioner (patient), concerning herself, a 61-years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, sensitivity to light (photophobia), soreness in arm (pain in extremity), fatigue, mild headache (headache), and tenderness in lymph nodes in neck and groin (lymph node pain). The patient's medical history was not provided. Concomitant medication reported included venlafaxine hydrochloride and sertraline for depression. On 30 Dec 2020, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot number: 039K20A), intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 31 Dec 2020, the patient experienced soreness in her arm, dizziness, fatigue and a mild headache. These symptoms improved over the next two days. Then on day four after the vaccine, on 03 Jan 2021, the patient experienced a bad headache, sensitivity to light and tenderness in lymph nodes in neck and groin. Treatment for the events included acetaminophen, plenty of water and rest. As of 04 Jan 2021, the patient reported that she was feeling better and has less headache, lingering fatigue and no longer in need of pain-relieving medicine. Action taken with second dose of mRNA-1273 in response to the events was not provided/unknown. The outcome of the events, dizziness, sensitivity to light, soreness in arm, fatigue, mild headache, and tenderness in lymph nodes in neck and groin were resolving at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds: EFFEXOR; SERTRALINE

Current Illness:

ID: 1537287
Sex: F
Age: 53
State: FL

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 08/09/2021
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Symptoms: fever; headache; Chills; feeling foggy; Tired; A report was received from nurse concerning a 53-year-old, a female patient who developed a foggy feeling, fatigue, headache, fever and chills after receiving the Moderna COVID-19 vaccine. The patient's medical history was not provided. Concomitant medication reported include vedolizumab and rosuvastatin. The dosing descriptions were not provided. The patient received her first of two planned doses of mRNA-1273 vaccine 30 DEC 2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 31 DEC 2020 and 01 JAN 2021, the patient reported to have experienced fogginess and a feeling of tiredness. On the night of 02 JAN 2021, she suddenly developed a fever, headache and chills. The intensity and duration of the headache, fever, and chills were not provided. There was no complaint of any localized discomfort or weakness in the patient's left arm. On that same night, the patient reported that she took acetaminophen. However, the outcome of the events was not reported. Any action taken regarding the completion of the second dosing of the vaccine was not communicated.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: ENTYVIO; CRESTOR

Current Illness:

ID: 1537288
Sex: F
Age:
State:

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 08/09/2021
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Symptoms: fast heartbeat; kind of dizzy; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fast heartbeat and was kind of dizzy earlier. The patient's medical history was not provided. Concomitant medications reported included tamoxifen. On 04 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: not reported) for prophylaxis of COVID-19 infection. On the same day, the patient experienced a fast heartbeat and was kind of dizzy earlier. The patient mentioned that she has been taking tamoxifen for 4.5 years and enquired if this concomitant medication was causing the side effects. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, fast heartbeat and kind of dizzy was not reported.; Reporter's Comments: This case concerns a female patient of unknown age, who experienced non-serious unexpected events of Heart rate increased and Dizziness. The events occurred on the same date after first dose of mRNA-1273, lot # unknown. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

Other Meds: TAMOXIFEN

Current Illness:

ID: 1537289
Sex: F
Age: 63
State: TX

Vax Date: 12/26/2020
Onset Date: 01/02/2020
Rec V Date: 08/09/2021
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Symptoms: Tender at injection site; Redness at injection site; Swollen arm; Sore arm; Flu-like symptoms; A spontaneous report was received from a dentist concerning a 63 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm, flu-like symptoms, tender at injection site, redness at injection site and a swollen arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Dec 2020, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch no: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 27 Dec 2020, the patient developed a sore arm. On 02 Jan 2021, she experienced flu-like symptoms. Additionally patient also developed tenderness, redness and swollen arm, which was getting bigger, 4 inch long by 3 inches wide at the injection site. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, sore arm and flu-like symptoms was unknown. The outcome of the events, tender at injection site, redness at injection site and a swollen arm was considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1537290
Sex: F
Age: 54
State: AL

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 08/09/2021
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Symptoms: heart racing; light headed; dry mouth; fingers and feet tingling with sharp pain; A spontaneous report (United States) was received from a consumer concerning a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart racing/palpitations, lightheaded/dizziness, mouth dry/dry mouth, and fingers and feet tingling with sharp pain/paraesthesia. The patient's medical history included cancer. Concomitant medication included tamoxifen. On 04 JAN 2021, the patient received the first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly on her right arm for prophylaxis of COVID-19 infection. On 04 JAN 2021, the patient experienced heart racing, lightheaded, mouth dry, fingers and feet tingling with sharp pain. Treatment for the events included acetaminophen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, heart racing, lightheaded, mouth dry, fingers and feet tingling with sharp pain was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested

Other Meds: TAMOXIFEN

Current Illness:

ID: 1537291
Sex: F
Age: 40
State: OR

Vax Date: 01/02/2021
Onset Date: 01/04/2021
Rec V Date: 08/09/2021
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Symptoms: cough; headache; fever 98.7F; chills; right lung started to hurt when she exhaled; salivating; runny nose; itchy throat; A spontaneous report was received from a consumer concerning a 40 -years -old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced her right lung started to hurt when she exhaled and had a fever 98.7F and was salivating and had chills, runny nose and itchy throat, next morning the fever was 102.5 F, had cough and headache. The patient's medical history as reported by the reporter as she had allergies to almonds, beets, peaches, figs and seasonal allergies. Concomitant medication was not reported. On 02 Jan 2021 7 pm, two days prior to the onset of the events, patient received their first two doses of mRNA-1273 (Lot number: 025J20-2A) through an unknown route at right shoulder for prophylaxis of COVID-19 infection. On 04 Jan 2021 morning, her right lung started to hurt when she exhaled and had a fever 98.7F. She could not sleep at night because of the lung pain and was salivating and had chills,runny nose and itchy throat. On 05 J an 2021 morning the fever was 102.5 F. She also had cough and headache. She had not taken any treatment medications. Treatment activities for event was reported as none. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events,experienced her right lung started to hurt when she exhaled and had a fever 98.7F, she could not sleep at night because of the lung pain and was salivating and had chills, runny nose and itchy throat, next morning the fever was 102.5 F, had cough and headache was unknown. Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Allergy (Patient reported allergies to almonds, beets, peaches, figs and seasonal allergies.)

ID: 1537292
Sex: F
Age: 45
State: NJ

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 08/09/2021
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Symptoms: swollen glands were on the same side where you had the injection; muscle aches; joint pain; swollen lynph node under her arm which eventually went away; soreness in left arm at injection site; was very tired; supra clavicular node which has not gone away; discoloration on 2 of her of bottom teeth on the left side; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (supra clavicular node which has not gone away), TOOTH DISCOLOURATION (discoloration on 2 of her of bottom teeth on the left side), LYMPHADENOPATHY (swollen glands were on the same side where you had the injection), MYALGIA (muscle aches) and ARTHRALGIA (joint pain) in a 45-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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced TOOTH DISCOLOURATION (discoloration on 2 of her of bottom teeth on the left side). On an unknown date, the patient experienced LYMPHADENOPATHY (supra clavicular node which has not gone away), LYMPHADENOPATHY (swollen glands were on the same side where you had the injection), MYALGIA (muscle aches), ARTHRALGIA (joint pain), LYMPHADENOPATHY (swollen lynph node under her arm which eventually went away), INJECTION SITE PAIN (soreness in left arm at injection site) and FATIGUE (was very tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, prn and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK, prn. At the time of the report, LYMPHADENOPATHY (supra clavicular node which has not gone away) had not resolved, TOOTH DISCOLOURATION (discoloration on 2 of her of bottom teeth on the left side), MYALGIA (muscle aches), ARTHRALGIA (joint pain), INJECTION SITE PAIN (soreness in left arm at injection site) and FATIGUE (was very tired) outcome was unknown and LYMPHADENOPATHY (swollen glands were on the same side where you had the injection) and LYMPHADENOPATHY (swollen lynph node under her arm which eventually went away) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2021: No specific follow-up information recorded.; 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.

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Current Illness:

ID: 1537293
Sex: F
Age: 66
State: NY

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 08/09/2021
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Symptoms: Woke up with a horrible vertigo; Woke up with a horrible headache; Slept most of the day; Had sore arm; A spontaneous report was received from a healthcare professional concerning a 66-year old, female patient who received Moderna's COVID-19 vaccine and experienced sore arm, horrible headache, horrible vertigo and slept most of the day. The patient's medical history included Lyme disease. Concomitant medications included Carvedilol, Escitalopram and Hydrochlorothiazide. On 31 Dec 20, Thursday, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (011J20A) intramuscularly for prophylaxis of COVID-19 infection. On 01 Jan 21, Friday, the patient experienced had a sore arm which had resolved by the time of report. On 02 Jan 21, Saturday, the patient reported woke up with a horrible headache and slept most of the day. On 03 Jan 21, she woke up with horrible vertigo. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event sore arm was considered resolved. The outcome of event vertigo was considered not resolved. The outcome of the events, headache and slept most of the day was not reported.; Reporter's Comments: This case concerns a 66-year-old female with medical history of Lyme disease who had NS unexpected events of somnolence, vertigo, pain in extremity and NS expected event of headache. Event onset occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Vertigo ongoing, sore arm resolved, but other outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: CARVEDILOL; ESCITALOPRAM; HYDROCHLOROTHIAZIDE

Current Illness: Lyme disease

ID: 1537294
Sex: F
Age: 63
State: NJ

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/09/2021
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Symptoms: Soreness of the arm; Slight Headache; Chills; Nauseous; Freezing; Sweating; Gassy; I had a feeling that i had to run to the bathroom but nothing ever came out; ASpontaneous report was received from a Healthcare Professional concerning a 63-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced freezing, chills, sweating, nauseous, gassy, had a feeling that I had to run to the bathroom but nothing came out, slight headache and soreness of the arm. The patient's medical history was not provided. Concomitant medications reported included paracetamol. On 29 Dec 2020, approximately 1 day prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29 Dec 2020, the patient woke up that evening freezing, had chills, was sweating, nauseous, gassy, and had a feeling she had to run to the bathroom but nothing came out. These symptoms only lasted the night. On 30 Dec 2020, she had a slight headache and soreness of the arm. Treatment for the event included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The event(s) freezing, chills, sweating, nauseous, gassy, and had a feeling that I had to run to the bathroom but nothing came out, were considered resolved on 29 Dec 2020. The outcome of the event(s) slight headache and soreness of the arm were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

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ID: 1537295
Sex: M
Age:
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Vax Date: 01/04/2021
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Rec V Date: 08/09/2021
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Symptoms: Sore arm at the injection site; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided). On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment for the event is unknown. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; 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.

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Total 2021 VAERS Injuries: 608,285

Page last modified: 03 October 2021 5:28pm