VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1580929
Sex: M
Age: 77
State: CT

Vax Date: 01/26/2021
Onset Date: 02/05/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: tested positive for COVID; A SPONTANEOUS report was received concerning a 78Years old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) on 26JAN2021 in left upper arm (non-dominant) The patient's medical history included is unknown. Event or Problem :Patient got first dose of Moderna vaccine on 26 Jan 2021 in left upper arm (non-dominant). The lot is #029L20A. No reactions when received his shot. On 5 Feb 2021 patient tested positive for COVID and has quarantined for 17 days. Both he and his wife got COVID around the same time(wife has had no injections). All of the COVID symptoms are gone except for a little taste and smell not return. Patient stated ok for safety to contact . Patient is due for second shot on 10 March which would be 42.5 days Treatment information was unknown. Action taken with mRNA-1273 in response to the events was not provided. On feb 5 2021 he tested for positive for COVID outcome is unknown a little taste and smell not return its outcome is also unknown The outcome of the events were unknown ITS A NON-SERIOUS CASE

Other Meds:

Current Illness:

ID: 1580930
Sex: F
Age: 68
State: PA

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided). Concomitant products included METFORMIN, OMEPRAZOLE and ALPRAZOLAM for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported taking ibuprofen approximately 6 hours after receiving the vaccine.

Other Meds: METFORMIN; OMEPRAZOLE; ALPRAZOLAM

Current Illness:

ID: 1580931
Sex: M
Age:
State: CA

Vax Date: 02/21/2021
Onset Date: 02/21/2021
Rec V Date: 08/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Injection site redness; having a little trouble on the same arm of the injection; neck pain; arm pain; stiff still; some redness about 2 inches length wise and 1.5 inches in width; pink color; A SPONTANOUS REPORT was received concerning a 68Years old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) he and his brother received the first dose of the Moderna Covid-19 vaccine yesterday morning at medical in Caller is not having an adverse event but his brother who received the vaccine in his left arm is having a little trouble on the same arm of the injection and his neck kind of bothers him. His brother's arm bothers him, stiff still, pain, some redness about 2 inches length wise and 1.5 inches in width. Pink color. He has not taken anything for his arm. Lot number reported is 029L20A for both of the patients. Caller is a 71 year old male and he takes Lisinopril, Methadone, Over the Counter Allergy relief His brother is a 68 year old male who takes Diphenhydramine, Hydroxyzine, Ibuprofen, Nortriptyline, Topiramate (stopped on Friday 19FEB2021), Lisinopril, Methadone, Sertraline, Lactulose, Docusate Treatment information was unknown. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events were UNKNOWN

Other Meds: DIPHENHYDRAMINE; HYDROXIZINE; IBUPROFEN; NORTRIPTYLINE; TOPIRAMATE; LISINOPRIL; METHADONE; SERTRALINE; LACTULOSE; DOCUSATE

Current Illness:

ID: 1580932
Sex: F
Age: 35
State: MA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Very weak; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very weak) and PYREXIA (Fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ASTHENIA (Very weak) and PYREXIA (Fever). At the time of the report, ASTHENIA (Very weak) and PYREXIA (Fever) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient experienced side effect few hour after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient took Ibuprofen 400mg and Tylenol 800 mg as the treatment medications. The patients symptoms persisted and the patient was planning to call emergency number and visit emergency room since she was scared.

Other Meds:

Current Illness:

ID: 1580933
Sex: F
Age: 81
State: DC

Vax Date: 01/22/2021
Onset Date: 02/20/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rash and sore; rash and sore; A Spontaneous Report was received concerning a 82 Years old, Female patient who received Moderna's COVID-19 vaccine (mRNA-1273) 2 doses and experienced rash, sore,red rash, itchiness, The patient's medical history is unknown On 22/jan/2021 patient received first dose of mRNA-1273 of batch number-013L20A, and on 19/feb/2021 she received second dose of vaccination Event or Problem With the first dose she got a rash and sore. The rash had the size of a quarter. Appeared a week after the first dose and lasted a couple of days. With the second dose had a red rash, sore, itching and it's bigger/ larger (3x3) than with the first shot. Noticed it on Saturday. rash is still there, the soreness is little less follow Up directly: Yes Treatment information was given as With a hot compress it seems to be relieved Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events were unknown

Other Meds:

Current Illness:

ID: 1580934
Sex: U
Age:
State: NC

Vax Date: 02/20/2021
Onset Date:
Rec V Date: 08/18/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Rash on face, arm, chest, and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on face, arm, chest, and back) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on face, arm, chest, and back). At the time of the report, RASH (Rash on face, arm, chest, and back) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1580935
Sex: M
Age: 73
State: CA

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: so weak and so tired; cannot go poop for 2 days; not very clear, cloudy mind; he has to use the walker; he did not drink and was dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (so weak and so tired), CONSTIPATION (cannot go poop for 2 days), VISION BLURRED (not very clear, cloudy mind), GAIT INABILITY (he has to use the walker) and DEHYDRATION (he did not drink and was dehydrated) in a 73-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 povided). On 20-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 FATIGUE (so weak and so tired), CONSTIPATION (cannot go poop for 2 days), VISION BLURRED (not very clear, cloudy mind), GAIT INABILITY (he has to use the walker) and DEHYDRATION (he did not drink and was dehydrated). At the time of the report, FATIGUE (so weak and so tired), CONSTIPATION (cannot go poop for 2 days), VISION BLURRED (not very clear, cloudy mind), GAIT INABILITY (he has to use the walker) and DEHYDRATION (he did not drink and was dehydrated) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Blood test: measured blood test and it's due to his he cannot go poop for 2 days. On 27-Jan-2021, Computerised tomogram: normal ct scan looked normol. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1580936
Sex: F
Age: 59
State: CA

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: typical vaccine side effects; itchiness, muscle pains, flu-like symptoms; itchiness, muscle pains, flu-like symptoms; itchiness, muscle pains, flu-like symptoms; progressed into neck pain, joint pain, fever; progressed into neck pain, joint pain, fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (typical vaccine side effects), VACCINATION SITE PRURITUS (itchiness, muscle pains, flu-like symptoms), MYALGIA (itchiness, muscle pains, flu-like symptoms), INFLUENZA LIKE ILLNESS (itchiness, muscle pains, flu-like symptoms) and ARTHRALGIA (progressed into neck pain, joint pain, fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE REACTION (typical vaccine side effects), VACCINATION SITE PRURITUS (itchiness, muscle pains, flu-like symptoms), MYALGIA (itchiness, muscle pains, flu-like symptoms), INFLUENZA LIKE ILLNESS (itchiness, muscle pains, flu-like symptoms), ARTHRALGIA (progressed into neck pain, joint pain, fever) and PYREXIA (progressed into neck pain, joint pain, fever). At the time of the report, VACCINATION SITE REACTION (typical vaccine side effects), VACCINATION SITE PRURITUS (itchiness, muscle pains, flu-like symptoms), MYALGIA (itchiness, muscle pains, flu-like symptoms), INFLUENZA LIKE ILLNESS (itchiness, muscle pains, flu-like symptoms), ARTHRALGIA (progressed into neck pain, joint pain, fever) and PYREXIA (progressed into neck pain, joint pain, fever) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1580937
Sex: F
Age: 83
State: CA

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Allergic reaction; Left arm started to itch (incredibly itchy); Left arm became swollen; Left arm became red at injection site and 5" below; Her back on the left side became incredibly itchy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), PRURITUS (Her back on the left side became incredibly itchy), VACCINATION SITE PRURITUS (Left arm started to itch (incredibly itchy)), VACCINATION SITE SWELLING (Left arm became swollen) and VACCINATION SITE ERYTHEMA (Left arm became red at injection site and 5" below) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (Amoxicillin) and Leg pain. Concomitant products included GABAPENTIN for Leg pain. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (Her back on the left side became incredibly itchy). On 25-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE PRURITUS (Left arm started to itch (incredibly itchy)), VACCINATION SITE SWELLING (Left arm became swollen) and VACCINATION SITE ERYTHEMA (Left arm became red at injection site and 5" below). On 19-Jan-2021, PRURITUS (Her back on the left side became incredibly itchy) had resolved. At the time of the report, HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE PRURITUS (Left arm started to itch (incredibly itchy)), VACCINATION SITE SWELLING (Left arm became swollen) and VACCINATION SITE ERYTHEMA (Left arm became red at injection site and 5" below) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds: GABAPENTIN

Current Illness: Allergy to antibiotic (Amoxicillin); Leg pain

ID: 1580938
Sex: F
Age: 78
State: FL

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: she had trouble raising my arm, had to make a big effort to raise my arm; She had also trouble swallowing her vitamins; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had trouble raising my arm, had to make a big effort to raise my arm) and DYSPHAGIA (She had also trouble swallowing her vitamins) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (she had trouble raising my arm, had to make a big effort to raise my arm). On 29-Jan-2021, the patient experienced DYSPHAGIA (She had also trouble swallowing her vitamins). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (she had trouble raising my arm, had to make a big effort to raise my arm) was resolving and DYSPHAGIA (She had also trouble swallowing her vitamins) outcome was unknown. Not Provided Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medications included vitamins A, B, C, D. Patient put ice on arm. Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up information received on 05-JUL-2021 and contains non significant information. Race information added.

Other Meds:

Current Illness:

ID: 1580939
Sex: F
Age: 41
State: AZ

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Swollen Armpit; Sore Arm; Bump under armpit was getting bigger and hurting her; A spontaneous report was received from a consumer concerning his wife a 41-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen armpit/ swelling, sore arm/ pain in extremity and bump under her armpit was getting bigger and hurting her/ lymphadenopathy. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 15 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch: 0322L20A) via unknown route for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient developed swollen armpit, sore arm and bump under her armpit was getting bigger and hurting her. Treatment for the event included tylenol. Action taken with mRNA-1273 in response to the events was not provided. The outcome of events, swollen armpit, sore arm and bump under her armpit was getting bigger and hurting her were resolving.

Other Meds:

Current Illness:

ID: 1580940
Sex: F
Age: 64
State: OK

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: arm was red, a little warm, and itchy like crazy. redness is the size of a tennis ball. the redness is down below the injection site; arm was red, a little warm, and itchy like crazy; arm was red, a little warm, and itchy like crazy.; only had a little redness around it the size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was red, a little warm, and itchy like crazy. redness is the size of a tennis ball. the redness is down below the injection site), SKIN WARM (arm was red, a little warm, and itchy like crazy), PRURITUS (arm was red, a little warm, and itchy like crazy.) and VACCINATION SITE ERYTHEMA (only had a little redness around it the size of a quarter) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. Previously administered products included for an unreported indication: SMALLPOX VACCINE. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (only had a little redness around it the size of a quarter). On 28-Jan-2021, the patient experienced ERYTHEMA (arm was red, a little warm, and itchy like crazy. redness is the size of a tennis ball. the redness is down below the injection site), SKIN WARM (arm was red, a little warm, and itchy like crazy) and PRURITUS (arm was red, a little warm, and itchy like crazy.). The patient was treated with CEFALEXIN (CEPHALEXINE) at a dose of 750 milligram twice a day. At the time of the report, ERYTHEMA (arm was red, a little warm, and itchy like crazy. redness is the size of a tennis ball. the redness is down below the injection site), SKIN WARM (arm was red, a little warm, and itchy like crazy), PRURITUS (arm was red, a little warm, and itchy like crazy.) and VACCINATION SITE ERYTHEMA (only had a little redness around it the size of a quarter) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product was reported. Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-Apr-2021, no new information was recorded

Other Meds:

Current Illness:

ID: 1580941
Sex: F
Age:
State: NV

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Ice cold legs; Circular itchy rash on top of chest; Throat felt swollen; burning sensation on both legs and underside of the arms; tingling sensation on both legs and underside of the arms; stinging sensation on both legs and underside of the arms; Injection site red and hot; Felt fatigued; body aches and pains; Extreme headache; Ached all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ached all over), PERIPHERAL COLDNESS (Ice cold legs), RASH PRURITIC (Circular itchy rash on top of chest), PHARYNGEAL SWELLING (Throat felt swollen) and BURNING SENSATION (burning sensation on both legs and underside of the arms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN (Ached all over), MYALGIA (body aches and pains) and HEADACHE (Extreme headache). On an unknown date, the patient experienced PERIPHERAL COLDNESS (Ice cold legs), RASH PRURITIC (Circular itchy rash on top of chest), PHARYNGEAL SWELLING (Throat felt swollen), BURNING SENSATION (burning sensation on both legs and underside of the arms), PARAESTHESIA (tingling sensation on both legs and underside of the arms), PAIN (stinging sensation on both legs and underside of the arms), INJECTION SITE ERYTHEMA (Injection site red and hot) and FATIGUE (Felt fatigued). The patient was treated with PREDNISONE at a dose of 120 mg. On 26-Jan-2021, PAIN (Ached all over) and HEADACHE (Extreme headache) had resolved, MYALGIA (body aches and pains) outcome was unknown. At the time of the report, PERIPHERAL COLDNESS (Ice cold legs), RASH PRURITIC (Circular itchy rash on top of chest), PHARYNGEAL SWELLING (Throat felt swollen), BURNING SENSATION (burning sensation on both legs and underside of the arms), PARAESTHESIA (tingling sensation on both legs and underside of the arms), PAIN (stinging sensation on both legs and underside of the arms), INJECTION SITE ERYTHEMA (Injection site red and hot) and FATIGUE (Felt fatigued) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications details were not reported by the reporter.

Other Meds:

Current Illness:

ID: 1580942
Sex: F
Age: 74
State: CA

Vax Date: 02/05/2021
Onset Date: 02/17/2021
Rec V Date: 08/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Redness (Injection Site); Itchiness (Injection site); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness (Injection Site)) and INJECTION SITE PRURITUS (Itchiness (Injection site)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness (Injection Site)) and INJECTION SITE PRURITUS (Itchiness (Injection site)). At the time of the report, INJECTION SITE ERYTHEMA (Redness (Injection Site)) and INJECTION SITE PRURITUS (Itchiness (Injection site)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1580943
Sex: F
Age: 79
State: OH

Vax Date: 01/26/2021
Onset Date: 02/03/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm a little sensitive; warm red good sized spot appeared around the injection site which has gotten larger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm a little sensitive) and VACCINATION SITE ERYTHEMA (warm red good sized spot appeared around the injection site which has gotten larger) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included Blood pressure medication for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm a little sensitive) and VACCINATION SITE ERYTHEMA (warm red good sized spot appeared around the injection site which has gotten larger). At the time of the report, VACCINATION SITE PAIN (Arm a little sensitive) and VACCINATION SITE ERYTHEMA (warm red good sized spot appeared around the injection site which has gotten larger) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds: Blood pressure medication

Current Illness:

ID: 1580944
Sex: F
Age: 78
State: IN

Vax Date: 01/27/2021
Onset Date: 02/27/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Shaking more than usual; A spontaneous report was received from a consumer concerning a 78-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Tremor. The patient's medical history included Parkinson's disease.. Products known to have been used by the patient, within two weeks prior to the event, not reported. On 27 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot 007ML0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient developed Tremor. Treatment for the event, was not reported. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, tremor was considered unknown.

Other Meds:

Current Illness:

ID: 1580945
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/18/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: sore arm for the 1st vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for the 1st vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for the 1st vaccine). At the time of the report, PAIN IN EXTREMITY (sore arm for the 1st vaccine) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment and concomitant medications were provided by reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1580946
Sex: M
Age:
State: NY

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 08/18/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: felt sleepy; soreness; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (felt sleepy), PAIN (soreness) and VACCINATION SITE PAIN (pain at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 19-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 SOMNOLENCE (felt sleepy), PAIN (soreness) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, SOMNOLENCE (felt sleepy), PAIN (soreness) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications included Tylenol. No concomitant medications were provided by reporter.

Other Meds:

Current Illness:

ID: 1580947
Sex: F
Age: 81
State:

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Injection site pain; Injection site swelling; A spontaneous report was received from a consumer concerning about a 81 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site pain and injection site swelling. The patient's medical history was not reported. Concomitant medications were reported as acetylsalicylic acid, metoprolol, isosorbide, losartan and fenofibrate. On 16 Feb 2021, prior to the onset of the events the patient received their second planned doses of mRNA-1273 (Batch number: unknown) via intramuscular in right upper arm for the prophylaxis of COVID-19 infection. Later the patient experienced events injection site pain and injection site swelling. Laboratory details was not mentioned. Treatment information was not provided. Action taken with mRNA-1273 in response to the event are unknown. The outcomes of the events injection site pain and injection site swelling remain unknown.

Other Meds: BABY ASPIRIN; METOPROLOL; ISOSORBIDE; LOSARTAN; FENOFIBRATE

Current Illness:

ID: 1580948
Sex: M
Age: 81
State: FL

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Shoulder is still sore; A spontaneous report was received from a consumer concerning a 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient's shoulder was sore/ arthralgia. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 12 Feb 2021, the patient's shoulder was sore. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of event, shoulder was sore was unknown.

Other Meds:

Current Illness:

ID: 1580949
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Fever; Chills; Body aches; Headache; Fatigue; A spontaneous report was received from a reporter(consumer) concerning unknown age, male patient , who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever,chills, body aches, headache, fatigue and temperature was about 103 degree fahrenheit. The patient medical history was not provided. The relevant concomitant medications were also not provided. On unknown date , prior to the consent of the events, the patients received their second of two planned doses of mRNA-1273(batch number: not provided) through the unknown route of administration for prophylaxis of COVID-19 injection. On unknown date the patient experienced pyrexia, chills, myalgia, headache, fatigue and temperature was about 103 degree Fahrenheit. Patient was feeling better Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown.

Other Meds:

Current Illness:

ID: 1580950
Sex: F
Age: 36
State: MA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: left arm pain; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm pain) and HEADACHE (slight headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. o28l20a) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm pain) and HEADACHE (slight headache). At the time of the report, PAIN IN EXTREMITY (left arm pain) and HEADACHE (slight headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications and treatment medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1580951
Sex: F
Age: 70
State:

Vax Date: 02/11/2021
Onset Date: 02/18/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Itching on arm; Transient pain on arm; A spontaneous report was received from a Consumer concerning a 70 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Itching on arm (Pruritus), Transient pain on arm (Pain in extremity). The patient's medical history was not provided. Relevant concomitant medication was reported ELIQUIS. On 11 FEB 2021, prior to the onset of the events the patient received their planned dose of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 18 FEB 2021, the patient experienced Itching on arm (Pruritus), Transient pain on arm (Pain in extremity). Laboratory details were not provided. Treatment information was provided as antibiotic. Action taken with mRNA-1273 in response to the events was not reported. At the of this report, the outcome of the event's Itching on arm (Pruritus), Transient pain on arm (Pain in extremity) was considered as unknown.

Other Meds: ELIQUIS

Current Illness:

ID: 1580952
Sex: F
Age: 77
State: GA

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Eyes Swollen almost shut; weak; dead arm; Itchy rash all over the body; chills; soreness in arm; tingling in arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash all over the body), EYE SWELLING (Eyes Swollen almost shut), AMBLYOPIA (weak), CHILLS (chills) and LIMB DISCOMFORT (soreness in arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (chills), LIMB DISCOMFORT (soreness in arm) and PARAESTHESIA (tingling in arm). On 19-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash all over the body). On an unknown date, the patient experienced EYE SWELLING (Eyes Swollen almost shut), AMBLYOPIA (weak) and HYPOAESTHESIA (dead arm). At the time of the report, RASH PRURITIC (Itchy rash all over the body), AMBLYOPIA (weak), CHILLS (chills), LIMB DISCOMFORT (soreness in arm) and HYPOAESTHESIA (dead arm) outcome was unknown. Treatment and concomitant medications were not provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Adverse events were updated.

Other Meds:

Current Illness:

ID: 1580953
Sex: F
Age: 68
State: FL

Vax Date: 02/03/2021
Onset Date: 02/15/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: A spontaneous report was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, ringing in ears/tinnitus, dull discomfort upon movement/discomfort, lethargy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) headache, ringing in ears, dull discomfort upon movement, lethargy. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), headache, ringing in ears, dull discomfort upon movement, lethargy was unknown.

Other Meds: OMEGA 3 FISH OILS

Current Illness:

ID: 1580954
Sex: F
Age:
State: FL

Vax Date: 12/23/2020
Onset Date:
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pain in the arm; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) and BACK PAIN (Back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A. and 025K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm) and BACK PAIN (Back pain). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in the arm) and BACK PAIN (Back pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medications were provided by reporter.

Other Meds:

Current Illness:

ID: 1580955
Sex: M
Age: 61
State: KS

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Very sick; high blood sugar; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (Very sick) and BLOOD GLUCOSE INCREASED (high blood sugar) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 virus test positive. Concurrent medical conditions included Diabetes mellitus (type 1 diabetes). Concomitant products included MONOCLONAL ANTIBODY 17-1A for COVID-19, INSULIN for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very sick) and BLOOD GLUCOSE INCREASED (high blood sugar). At the time of the report, ILLNESS (Very sick) and BLOOD GLUCOSE INCREASED (high blood sugar) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The treatment medication was not provided.

Other Meds: MONOCLONAL ANTIBODY 17-1A; INSULIN

Current Illness:

ID: 1580956
Sex: F
Age: 40
State: MN

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (regular arm pain/arm felt super achy/felt like she was punched in the arm), RASH MACULAR (Rash on both arms/8 spots on left arm/16 spots on right arm), RASH PRURITIC (noticed red bumps that were itchy on right forearm), SKIN LESION INFLAMMATION (Rash inflamed) and SKIN BURNING SENSATION (skin felt like it was on fire/"it felt hot") in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dust allergy and House dust mite allergy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication. On 10-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (regular arm pain/arm felt super achy/felt like she was punched in the arm). On 12-Feb-2021, the patient experienced AXILLARY PAIN (pain on left armpit), NAUSEA (nausea) and PYREXIA (fever of 101.6F). On 18-Feb-2021, the patient experienced RASH PRURITIC (noticed red bumps that were itchy on right forearm) and SKIN LESION INFLAMMATION (Rash inflamed). On 19-Feb-2021, the patient experienced RASH MACULAR (Rash on both arms/8 spots on left arm/16 spots on right arm). On 21-Feb-2021, the patient experienced SKIN BURNING SENSATION (skin felt like it was on fire/"it felt hot") and SKIN REACTION (skin around the bumps looked angry). The patient was treated with Bed rest for Pyrexia. On 17-Feb-2021, AXILLARY PAIN (pain on left armpit) had resolved. At the time of the report, PAIN IN EXTREMITY (regular arm pain/arm felt super achy/felt like she was punched in the arm), RASH MACULAR (Rash on both arms/8 spots on left arm/16 spots on right arm), RASH PRURITIC (noticed red bumps that were itchy on right forearm), SKIN LESION INFLAMMATION (Rash inflamed), SKIN BURNING SENSATION (skin felt like it was on fire/"it felt hot"), SKIN REACTION (skin around the bumps looked angry), NAUSEA (nausea) and PYREXIA (fever of 101.6F) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional concomitant medication use included birth control (type not specified) Treatment medications included ibuprofen, Benadryl and hydrocortisone cream. The consumer gave consent for Safety follow up. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Contact Info updated

Other Meds: PROZAC

Current Illness: Dust allergy; House dust mite allergy

ID: 1580957
Sex: F
Age: 60
State: CA

Vax Date: 01/22/2021
Onset Date: 01/29/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rash on her whole upper arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of RASH (rash on her whole upper arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for an unknown indication. The patient's past medical history included No adverse event. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced RASH (rash on her whole upper arm). At the time of the report, RASH (rash on her whole upper arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. no concomitant medications are provided by the reporter. treatment to the events are not provided.

Other Meds:

Current Illness:

ID: 1580958
Sex: F
Age: 65
State: NY

Vax Date: 02/19/2021
Onset Date:
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Fever; Tingling all along fingers and hands; Body aches; Arm sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), PARAESTHESIA (Tingling all along fingers and hands), MYALGIA (Body aches) and PAIN IN EXTREMITY (Arm sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), PARAESTHESIA (Tingling all along fingers and hands), MYALGIA (Body aches) and PAIN IN EXTREMITY (Arm sore). At the time of the report, PYREXIA (Fever), PARAESTHESIA (Tingling all along fingers and hands), MYALGIA (Body aches) and PAIN IN EXTREMITY (Arm sore) 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 and concomitant medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1580959
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Side effects after vaccination; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION COMPLICATION (Side effects after vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after vaccination). At the time of the report, VACCINATION COMPLICATION (Side effects after vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications and treatment details were provided.

Other Meds:

Current Illness:

ID: 1580960
Sex: F
Age: 75
State: CA

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Area where she had the injection was red; Tender rash; A lump; It was Itchy; It was hard; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt), VACCINATION SITE ERYTHEMA (Area where she had the injection was red), INJECTION SITE RASH (Tender rash), VACCINATION SITE SWELLING (A lump) and VACCINATION SITE PRURITUS (It was Itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt). On 20-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Area where she had the injection was red), INJECTION SITE RASH (Tender rash), VACCINATION SITE SWELLING (A lump), VACCINATION SITE PRURITUS (It was Itchy) and VACCINATION SITE INDURATION (It was hard). On 10-Feb-2021, VACCINATION SITE PAIN (Arm hurt) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Area where she had the injection was red), VACCINATION SITE SWELLING (A lump), VACCINATION SITE PRURITUS (It was Itchy) and VACCINATION SITE INDURATION (It was hard) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment and concomitant medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1580961
Sex: F
Age: 77
State: FL

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Blister; Rash; This spontaneous case was reported by a health care professional and describes the occurrence of BLISTER (Blister) and RASH (Rash) in a 77-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 historical condition reported.). On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced BLISTER (Blister) and RASH (Rash). At the time of the report, BLISTER (Blister) and RASH (Rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication were reported. Treatment medication included antibiotic ointment. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1580962
Sex: M
Age: 76
State: FL

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Tenderness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness in the injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Tenderness in the injection site). At the time of the report, VACCINATION SITE PAIN (Tenderness in the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment and concomitant medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1580963
Sex: F
Age:
State: TX

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Pregnant patient received the moderna vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the moderna vaccine) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-May-2020 and the estimated date of delivery was 23-Feb-2021. On 02-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the thirty-seventh week of the pregnancy. The vaginal delivery occurred on 03-Mar-2021, which was reported as Full-term. For neonate 1, the birth weight was 4170 grams (9lbs 3oz) with an APGAR score of 8 and 10 at (1, 5 minutes). The outcome was reported as Term Birth NOS. Baby's head was stuck and doctor had to use vacuum to help deliver him. Perinatal complications include JAUNDICE.. Male baby(Infant) length is 54.6cm, Head circumference is 45.7cm. On 02-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the moderna vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2020, Pregnancy test: positive (Positive) positive. On 20-Jul-2020, Blood test: normal (normal) normal. On 20-Jul-2020, Ultrasound scan: pregnant (Inconclusive) Pregnant. On 03-Dec-2020, Glucose tolerance test: 164 (High) 164. On 09-Dec-2020, Glucose tolerance test: 159,141, 165, 83 (Inconclusive) 159,141,165,83.. On 02-Mar-2021, Ultrasound scan: meconium in amniotic sac (Inconclusive) Meconium in amniotic sac.. 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 information was not provided. Medical history of the patient included-Maternal Grandma (Arthritis), Paternal Grandma (Arthritis, Glaucoma), Paternal Grandpa (Stroke). This case was linked to MOD-2021-080805 (Parent-Child Link). See case MOD-2021-080805 for details regarding the child case.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1580964
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of somnolence (sleepy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history provided. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced somnolence (sleepy). At the time of the report, somnolence (sleepy): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. This case linked to MOD-2021-020448; MOD-2021-020371 (E2B linked report). Sender's comments: MOD-2021-020448: Same reporter, reporter herself. MOD-2021-020371: Same reporter, reporter's sister.

Other Meds:

Current Illness:

ID: 1580965
Sex: F
Age: 80
State: IN

Vax Date: 01/20/2021
Onset Date: 01/22/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: high blood pressure; headache; red rash on arm above elbow; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), RASH ERYTHEMATOUS (red rash on arm above elbow) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included COLECALCIFEROL (VITAMIN D 3) and POTASSIUM for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced RASH ERYTHEMATOUS (red rash on arm above elbow). On an unknown date, the patient experienced HYPERTENSION (high blood pressure) and HEADACHE (headache). At the time of the report, HYPERTENSION (high blood pressure), RASH ERYTHEMATOUS (red rash on arm above elbow) and HEADACHE (headache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. This case was linked to MOD-2021-020519 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: No specific follow-up information recorded.

Other Meds: VITAMIN D 3; POTASSIUM

Current Illness: Hypertension

ID: 1580966
Sex: F
Age:
State: NJ

Vax Date: 01/27/2021
Onset Date: 02/17/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced NASOPHARYNGITIS (cold). At the time of the report, NASOPHARYNGITIS (cold) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1580967
Sex: M
Age: 75
State: WI

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: sleepiness; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of SOMNOLENCE (sleepiness) and FATIGUE (fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVETIRACETAM (KEPPRA), ATORVASTATIN, METOPROLOL, DOFETILIDE (TIKOSYN), RIVAROXABAN (XARELTO) and OMEPRAZOLE for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced SOMNOLENCE (sleepiness) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Jan-2021, SOMNOLENCE (sleepiness) and FATIGUE (fatigue) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked (E2B Linked Report).; Sender's Comments: Same patient, 2nd dose

Other Meds: KEPPRA; ATORVASTATIN; METOPROLOL; TIKOSYN; XARELTO; OMEPRAZOLE.

Current Illness:

ID: 1580968
Sex: F
Age:
State: NJ

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 08/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: Arm is so sore; Arm is red/ Red skin; Arm with a little tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm is red/ Red skin), TENDERNESS (Arm with a little tenderness) and PAIN IN EXTREMITY (Arm is so sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced ERYTHEMA (Arm is red/ Red skin) and TENDERNESS (Arm with a little tenderness). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is so sore). At the time of the report, ERYTHEMA (Arm is red/ Red skin), TENDERNESS (Arm with a little tenderness) and PAIN IN EXTREMITY (Arm is so sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1580969
Sex: F
Age: 54
State: TN

Vax Date: 01/04/2021
Onset Date: 01/05/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: tenderness; pain at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE PAIN (pain at injection site) and TENDERNESS (tenderness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE PAIN (pain at injection site). On 18-Jan-2021, the patient experienced TENDERNESS (tenderness). On 12-Jan-2021, INJECTION SITE PAIN (pain at injection site) had resolved. At the time of the report, TENDERNESS (tenderness) 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.

Other Meds:

Current Illness:

ID: 1580970
Sex: F
Age: 55
State: TX

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Can barely move her arm; Diarrhea; Body aches; Very swollen at the injection site; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Can barely move her arm), DIARRHOEA (Diarrhea), PAIN (Body aches), INJECTION SITE SWELLING (Very swollen at the injection site) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Suspected COVID-19 in July 2020. Concurrent medical conditions included No adverse event (Denies allergies). On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced LIMB DISCOMFORT (Can barely move her arm), DIARRHOEA (Diarrhea), PAIN (Body aches), INJECTION SITE SWELLING (Very swollen at the injection site), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Can barely move her arm), DIARRHOEA (Diarrhea), PAIN (Body aches), INJECTION SITE SWELLING (Very swollen at the injection site), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1580971
Sex: F
Age:
State: TX

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she still has a dark bruise on her arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (she still has a dark bruise on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced INJECTION SITE BRUISING (she still has a dark bruise on her arm). At the time of the report, INJECTION SITE BRUISING (she still has a dark bruise on her arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1580972
Sex: F
Age: 82
State: NY

Vax Date: 01/23/2021
Onset Date: 01/25/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rash is a little bit itchy; Rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash is a little bit itchy) and RASH (Rash all over the body) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. Concurrent medical conditions included Sensitive skin (Medical history reported as Sensitive skin/Fair skin.). On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH PRURITIC (Rash is a little bit itchy) and RASH (Rash all over the body). At the time of the report, RASH PRURITIC (Rash is a little bit itchy) and RASH (Rash all over the body) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: ADR form contains NNI

Other Meds:

Current Illness: Sensitive skin (Medical history reported as Sensitive skin/Fair skin.)

ID: 1580973
Sex: M
Age:
State: TX

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 08/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Nightsweats; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Nightsweats) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (Chills). On 12-Feb-2021, the patient experienced NIGHT SWEATS (Nightsweats). On 11-Feb-2021, CHILLS (Chills) had resolved. On 14-Feb-2021, NIGHT SWEATS (Nightsweats) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to US-MODERNATX, INC.-MOD-2021-020483 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-020483:MOD21-035131: Same reporter, reporter herself

Other Meds:

Current Illness:

ID: 1580974
Sex: F
Age:
State: MD

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Loss of Appetite; Fatigue; Swelling near the injection site; Fever; Sore arm; Swollen Arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (Loss of Appetite), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Swelling near the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen Arm). On 19-Feb-2021, the patient experienced PYREXIA (Fever), DECREASED APPETITE (Loss of Appetite), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Swelling near the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Jan-2021, PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen Arm) had resolved. At the time of the report, PYREXIA (Fever), DECREASED APPETITE (Loss of Appetite), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Swelling near the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. This case was linked to MOD-2021-020503 (E2B Linked Report).; Sender's Comments: MOD-2021-020503:Same patient, 1st dose

Other Meds: INSULIN

Current Illness: Diabetes

ID: 1580975
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided y the reporter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) had not resolved.

Other Meds:

Current Illness:

ID: 1580976
Sex: F
Age: 45
State: CA

Vax Date: 08/14/2021
Onset Date: 08/16/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Hot red skin at injection site with painful nodule under skin

Other Meds:

Current Illness:

ID: 1580977
Sex: F
Age: 45
State: AZ

Vax Date: 08/16/2021
Onset Date: 08/16/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies: Contact allergy to metals

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Fever & chills began at 11:30pm the same day. Beginning 24 hours after the vaccine, I began getting burning in both knees and my left hip. That lasted for about 12 hours and seems to have subsided as of now.

Other Meds: Citalopram

Current Illness: None

ID: 1580978
Sex: M
Age: 75
State: TN

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: COVID-19; Up all night, couldn't sleep; Awful dry cough; Sore left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INSOMNIA (Up all night, couldn't sleep), COUGH (Awful dry cough) and ARTHRALGIA (Sore left shoulder) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced ARTHRALGIA (Sore left shoulder). On 22-Jan-2021, the patient experienced INSOMNIA (Up all night, couldn't sleep) and COUGH (Awful dry cough). On 25-Jan-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at a dose of 1 dosage form; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 1 dosage form. On 24-Jan-2021, COUGH (Awful dry cough) had resolved. At the time of the report, COVID-19 (COVID-19), INSOMNIA (Up all night, couldn't sleep) and ARTHRALGIA (Sore left shoulder) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm