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: 1567507
Sex: F
Age: 71
State: WI

Vax Date: 02/10/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Dark blue purple spot on the right hand about the size; Pain in the left Shoulder blade; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), SKIN DISCOLOURATION (Dark blue purple spot on the right hand about the size) and ARTHRALGIA (Pain in the left Shoulder blade) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (Soreness) and ARTHRALGIA (Pain in the left Shoulder blade). On 16-Mar-2021, the patient experienced SKIN DISCOLOURATION (Dark blue purple spot on the right hand about the size). At the time of the report, PAIN (Soreness), SKIN DISCOLOURATION (Dark blue purple spot on the right hand about the size) and ARTHRALGIA (Pain in the left Shoulder blade) outcome was unknown. No treatment information was provided.

Other Meds: SYNTHROID

Current Illness:

ID: 1567508
Sex: F
Age: 82
State:

Vax Date: 03/14/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. Concomitant products included METFORMIN, VITAMIN D3, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), AMLODIPINE and OMEPRAZOLE for an unknown indication. On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at a dose of UNK dosage form. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.

Other Meds: METFORMIN; VITAMIN D3; VITAMIN B 12 [VITAMIN B12 NOS]; AMLODIPINE; OMEPRAZOLE

Current Illness:

ID: 1567509
Sex: F
Age: 51
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Slight allergic reaction; Tongue tingled; Pulse went up to 118 within seconds; Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Slight allergic reaction), PARAESTHESIA ORAL (Tongue tingled), HEART RATE INCREASED (Pulse went up to 118 within seconds) and VISION BLURRED (Blurred vision) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HYPERSENSITIVITY (Slight allergic reaction), PARAESTHESIA ORAL (Tongue tingled), HEART RATE INCREASED (Pulse went up to 118 within seconds) and VISION BLURRED (Blurred vision). On 13-Mar-2021, PARAESTHESIA ORAL (Tongue tingled) had resolved. At the time of the report, HYPERSENSITIVITY (Slight allergic reaction), HEART RATE INCREASED (Pulse went up to 118 within seconds) and VISION BLURRED (Blurred vision) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Heart rate: 118 (High) pulse went up to 118 within seconds. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were reported. No Treatments were reported.

Other Meds:

Current Illness:

ID: 1567510
Sex: M
Age: 69
State: TX

Vax Date: 01/14/2021
Onset Date: 01/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: 3-4 days later he had diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (3-4 days later he had diarrhea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetic. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (3-4 days later he had diarrhea). The patient was treated with ELECTROLYTES NOS for Diarrhoea, at a dose of UNK dosage form and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at a dose of UNK dosage form. At the time of the report, DIARRHOEA (3-4 days later he had diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported. Treatment medications also Included yogurt and lots of water.

Other Meds:

Current Illness: Diabetic

ID: 1567511
Sex: M
Age: 71
State: MO

Vax Date: 03/14/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 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: Legs Rubbery; Weak; Feels like Flu; Swollen Lymph Gland the size of a baseball; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Legs Rubbery), ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Feels like Flu), LYMPHADENOPATHY (Swollen Lymph Gland the size of a baseball) and HEADACHE (Headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Legs Rubbery), ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Feels like Flu), LYMPHADENOPATHY (Swollen Lymph Gland the size of a baseball) and HEADACHE (Headache). At the time of the report, MUSCULAR WEAKNESS (Legs Rubbery), ASTHENIA (Weak), INFLUENZA LIKE ILLNESS (Feels like Flu), LYMPHADENOPATHY (Swollen Lymph Gland the size of a baseball) and HEADACHE (Headache) outcome was unknown. Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds:

Current Illness:

ID: 1567512
Sex: F
Age: 78
State: IN

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The patient's past medical history included Heart disorder (shortness of breath reported was found to be due to something with the heart). On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown. No concomitant medication were provided Treatment information provided as "Doctors treated the problem" Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received

Other Meds:

Current Illness:

ID: 1567513
Sex: F
Age: 82
State: MD

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. Concomitant products included VALACYCLOVIR [VALACICLOVIR] and PREDNISONE for Eye disorder NOS, APIXABAN (ELIQUIS), METOPROLOL, LATANOPROST, CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]), MAGNESIUM and SHARK CARTILAGE for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) had resolved. Treatment information was not provided This case was linked to MOD-2021-047824 (Patient Link).

Other Meds: ELIQUIS; VALACYCLOVIR [VALACICLOVIR]; METOPROLOL; LATANOPROST; PREDNISONE; CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]; MAGNESIUM; SHARK CARTILAGE

Current Illness:

ID: 1567514
Sex: F
Age: 78
State: MD

Vax Date: 03/14/2021
Onset Date: 03/14/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (knee unstable), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and NAUSEA (nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B2117) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Ulcerative colitis. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced FATIGUE (fatigue). On 15-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (knee unstable), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, MUSCULOSKELETAL DISCOMFORT (knee unstable), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported No treatment information were reported It was reported that Patient consulted HCP on 18 march 2021 Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Event outcome was updated as recovered/resolved.

Other Meds:

Current Illness: Ulcerative colitis

ID: 1567515
Sex: M
Age: 36
State: NY

Vax Date: 03/08/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: two to three days of being sick in bed; sinus pressure in face because of swelling of lymph nodes; blowing his nose a lot; knocked out; fever; throat hurting only on injection side (left side); glands of the left side of neck, collar bone, and jaw were swollen; swelling in the TMJ area; pain in the TMJ area; felt really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt really tired), ARTHRALGIA (pain in the TMJ area), CONFUSIONAL STATE (knocked out), PYREXIA (fever) and OROPHARYNGEAL PAIN (throat hurting only on injection side (left side)) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (felt really tired). On 10-Mar-2021, the patient experienced ARTHRALGIA (pain in the TMJ area) and JOINT SWELLING (swelling in the TMJ area). On 12-Mar-2021, the patient experienced CONFUSIONAL STATE (knocked out), PYREXIA (fever), OROPHARYNGEAL PAIN (throat hurting only on injection side (left side)) and LYMPHADENOPATHY (glands of the left side of neck, collar bone, and jaw were swollen). On an unknown date, the patient experienced ILLNESS (two to three days of being sick in bed), PARANASAL SINUS DISCOMFORT (sinus pressure in face because of swelling of lymph nodes) and NASAL CONGESTION (blowing his nose a lot). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at a dose of UNK dosage form. At the time of the report, FATIGUE (felt really tired), ARTHRALGIA (pain in the TMJ area), CONFUSIONAL STATE (knocked out), PYREXIA (fever), OROPHARYNGEAL PAIN (throat hurting only on injection side (left side)), LYMPHADENOPATHY (glands of the left side of neck, collar bone, and jaw were swollen), PARANASAL SINUS DISCOMFORT (sinus pressure in face because of swelling of lymph nodes), NASAL CONGESTION (blowing his nose a lot) and JOINT SWELLING (swelling in the TMJ area) outcome was unknown and ILLNESS (two to three days of being sick in bed) was resolving. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1567516
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: swelling in the injection site; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling in the injection site) and VACCINATION SITE PAIN (pain in the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Bee sting hypersensitivity and Ant bite. 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 INJECTION SITE SWELLING (swelling in the injection site) and VACCINATION SITE PAIN (pain in the injection site). At the time of the report, INJECTION SITE SWELLING (swelling in the injection site) and VACCINATION SITE PAIN (pain in the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No Treatments were reported. Reporter did not allow further contact

Other Meds:

Current Illness: Ant bite; Bee sting hypersensitivity

ID: 1567517
Sex: F
Age:
State: NH

Vax Date: 03/04/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Wicked Headache) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (Wicked Headache). At the time of the report, HEADACHE (Wicked Headache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. Treatment information not provided.

Other Meds:

Current Illness:

ID: 1567518
Sex: F
Age: 50
State: NH

Vax Date: 02/13/2021
Onset Date: 03/14/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Feverish; Bone aches; Tired; Small movable lump under my armpit; This spontaneous case was reported by a nurse and describes the occurrence of AXILLARY MASS (Small movable lump under my armpit), PYREXIA (Feverish), BONE PAIN (Bone aches) and FATIGUE (Tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced AXILLARY MASS (Small movable lump under my armpit). On 15-Mar-2021, the patient experienced PYREXIA (Feverish), BONE PAIN (Bone aches) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, AXILLARY MASS (Small movable lump under my armpit), PYREXIA (Feverish), BONE PAIN (Bone aches) and FATIGUE (Tired) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1567519
Sex: M
Age: 69
State: PA

Vax Date: 01/31/2021
Onset Date: 02/28/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Missed the second dose; A spontaneous report was received from a consumer concerning for himself, a 70-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event missed the second dose/product dose omission issue, The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 31Jan2021, prior to the onset of the event the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A or 630L20A) via unknown route on Left Arm for prophylaxis of COVID-19 infection. On 28Feb2021, patient missed the second dose because his appointment was cancelled. He was now just getting back from out of town and wants to schedule his second dose. Action taken with mRNA-1273 in response to the event was Unknown. The outcome of event Missed the second dose was recovered on 28Feb2021, at the time of this report.

Other Meds:

Current Illness:

ID: 1567520
Sex: M
Age:
State: TX

Vax Date: 03/01/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were provided. No Treatments were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1567521
Sex: F
Age: 53
State:

Vax Date: 03/05/2021
Onset Date: 03/06/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Hives all over the body; Itches like crazy; Affecting the breathing; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (Hives all over the body), PRURITUS (Itches like crazy) and DYSPNOEA (Affecting the breathing) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The patient's past medical history included Diabetes (Reported diagnosed with Diabetes 2 years ago) in 2019. Concomitant products included MAGNESIUM, VITAMIN E NOS (VITAMIN E + MAGNESIUM), MULTI VIT and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Hives all over the body), PRURITUS (Itches like crazy) and DYSPNOEA (Affecting the breathing). The patient was treated with CORTISONE for Hives, at a dose of UNK dosage form. At the time of the report, URTICARIA (Hives all over the body), PRURITUS (Itches like crazy) and DYSPNOEA (Affecting the breathing) 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: VITAMIN E + MAGNESIUM; MULTI VIT; VIT D [COLECALCIFEROL]

Current Illness:

ID: 1567522
Sex: F
Age:
State: IL

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH (a five inch circle), FATIGUE (extreme fatigue/unusually tired), CHILLS (almost felt was going to get the chills) and FEELING ABNORMAL (something isn't quite right) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RASH (a five inch circle). On 05-Mar-2021, the patient experienced FATIGUE (extreme fatigue/unusually tired). On an unknown date, the patient experienced CHILLS (almost felt was going to get the chills), FEELING ABNORMAL (something isn't quite right), DYSPNOEA (felt was a little short of breath), PYREXIA (felt like I had a slight fever in my body) and COUGH (felt was about to get a cough). On 15-Mar-2021, PAIN IN EXTREMITY (sore arm), RASH (a five inch circle), FATIGUE (extreme fatigue/unusually tired), CHILLS (almost felt was going to get the chills), FEELING ABNORMAL (something isn't quite right), DYSPNOEA (felt was a little short of breath), PYREXIA (felt like I had a slight fever in my body) and COUGH (felt was about to get a cough) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatments were reported.

Other Meds: OMEPRAZOLE; VIT D [COLECALCIFEROL]

Current Illness:

ID: 1567523
Sex: F
Age: 41
State: NY

Vax Date: 03/04/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: itchy; red; hot; Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash), PRURITUS (itchy), ERYTHEMA (red) and FEELING HOT (hot) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. No medical information history was reported. Concomitant products included MERCAPTOPURINE for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced RASH (Rash). On 13-Mar-2021, the patient experienced PRURITUS (itchy), ERYTHEMA (red) and FEELING HOT (hot). The patient was treated with CLINDAMYCIN at an unspecified dose and frequency and CLOBETASOL PROPIONATE at an unspecified dose and frequency. At the time of the report, RASH (Rash) was resolving and PRURITUS (itchy), ERYTHEMA (red) and FEELING HOT (hot) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: MERCAPTOPURINE

Current Illness:

ID: 1567524
Sex: M
Age:
State: NH

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: complete bad reaction; rash itches and burns; rash all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (complete bad reaction), RASH PRURITIC (rash itches and burns) and RASH (rash all over the body) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION COMPLICATION (complete bad reaction), RASH PRURITIC (rash itches and burns) and RASH (rash all over the body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (complete bad reaction), RASH PRURITIC (rash itches and burns) and RASH (rash all over the body) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1567525
Sex: F
Age:
State: AR

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: lymph nodes on both arms are swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes on both arms are swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. Concurrent medical conditions included Chronic leukemia. On 25-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 LYMPHADENOPATHY (lymph nodes on both arms are swollen). At the time of the report, LYMPHADENOPATHY (lymph nodes on both arms are swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's concomitant medication included an unspecified infusion for chronic leukemia. Patient's lymph nodes on both arms were swollen about a week after vaccination. She did not took any treatment for the event.

Other Meds:

Current Illness: Chronic leukemia

ID: 1567526
Sex: F
Age: 66
State: PA

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

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

Lab Data:

Allergies:

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

Symptoms: moderate focal jaw pain on the side where she got the vaccine; flushing of the face; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (moderate focal jaw pain on the side where she got the vaccine), FLUSHING (flushing of the face) and DIZZINESS (dizziness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN JAW (moderate focal jaw pain on the side where she got the vaccine), FLUSHING (flushing of the face) and DIZZINESS (dizziness). At the time of the report, PAIN IN JAW (moderate focal jaw pain on the side where she got the vaccine), FLUSHING (flushing of the face) and DIZZINESS (dizziness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1567527
Sex: F
Age: 68
State: VA

Vax Date: 02/02/2021
Onset Date: 02/11/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Trouble thinking; Trouble talking; Whole body rash; A spontaneous report was received from a consumer concerning a 68 year-old, female patient, COVID-19 vaccine (mRNA-1273) received the first Moderna COVID-19 vaccine (mRNA-1273) on 02 Feb 2021. Patient stated after first Moderna vaccine she had a rash on day 9, Patient stated she received her second Moderna vaccine on 01 Mar 2021 and on day 12 she had a whole body rash. The patient's medical history, as provided by the reporter, immunocompromised . Concomitant medications reported included Antidepressant, Topamax, Zocor. Treatment received include Acterma Prednisone on 02 Feb 2021. Patient stated after first Moderna vaccine she had a rash on day 9, all around the injection site down arm above elbow. Patient stated she received her second Moderna vaccine on 01 Mar 2021 and on day 12 she had a whole body rash. Patient stated she visited her doctor on 15 Mar 2021. Patient stated healthcare professional (HCP) prescribed acterma and prednisone. Patient stated she is immunocompromised. Patient stated the only clear part on her body is the sole of her feet and eyes and arm at the injection site. Action taken with mRNA-1273 in response to the events was not applicable. The events, trouble thinking, trouble talking, rash all around injection site, immunocompromised were not resolved.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product onset of the event including evidence of re-challenge and excluding any other etiology, a causal relationship with the event cannot be excluded. Rash is consistent with the product safety profile.

Other Meds: TOPAMAX; ZOCOR

Current Illness: Immunocompromised (Patient stated she is immunocompromised)

ID: 1567528
Sex: M
Age: 52
State: TX

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of dyspnea (shortness of breath), pain in extremity (sore arm), peripheral swelling (swollen arm), pyrexia (low-grade fever) and headache in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Patient was negative for past history of COVID-19 diagnosis. On Mar 16, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 16, 2021, patient experienced dyspnea (shortness of breath), pain in extremity (sore arm), peripheral swelling (swollen arm), pyrexia (low-grade fever) and headache. The patient was treated with ibuprofen at an unspecified dose and frequency. At the time of the report, dyspnea (shortness of breath), pain in extremity (sore arm), peripheral swelling (swollen arm), pyrexia (low-grade fever) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1567529
Sex: F
Age:
State: VA

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

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

Lab Data:

Allergies:

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

Symptoms: patches quilt like on both arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (patches quilt like on both arms) 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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (patches quilt like on both arms). At the time of the report, RASH (patches quilt like on both arms) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. No treatment was taken by the patient for the event.

Other Meds:

Current Illness:

ID: 1567530
Sex: M
Age:
State: NY

Vax Date: 02/07/2021
Onset Date: 02/07/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), FATIGUE (fatigue) and HEADACHE (headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical information history was reported. Concomitant products included IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN (pain), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN (pain), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's concomitant medication also included an unspecified blood pressure medication. Treatment information was not provided.

Other Meds: IBUPROFEN; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1567531
Sex: F
Age:
State: OH

Vax Date: 02/18/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: red hive; pretty swollen; warm to touch; little sore; not feeling up to herself,doesn't feel not quite well; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red hive), SWELLING (pretty swollen), FEELING HOT (warm to touch), PAIN IN EXTREMITY (little sore) and MALAISE (not feeling up to herself,doesn't feel not quite well) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 031M20A) for COVID-19 vaccination. No medical information history was reported. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA), MONTELUKAST SODIUM (SINGULAIR), ALBUTEROL [SALBUTAMOL], SALBUTAMOL (ALBUTEROL HFA) and ELUXADOLINE (VIBERZI) for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced URTICARIA (red hive), SWELLING (pretty swollen), FEELING HOT (warm to touch), PAIN IN EXTREMITY (little sore) and MALAISE (not feeling up to herself,doesn't feel not quite well). At the time of the report, URTICARIA (red hive), SWELLING (pretty swollen), FEELING HOT (warm to touch), PAIN IN EXTREMITY (little sore) and MALAISE (not feeling up to herself,doesn't feel not quite well) outcome was unknown. Patient did not took any treatment for the events. This case was linked to MOD-2021-047754 (Patient Link).

Other Meds: LEXAPRO; ANORO ELLIPTA; SINGULAIR; ALBUTEROL [SALBUTAMOL]; ALBUTEROL HFA; VIBERZI

Current Illness:

ID: 1567532
Sex: M
Age:
State: PA

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (body aches), PYREXIA (fever of 103) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma and Crohn's disease. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN (body aches), PYREXIA (fever of 103) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (body aches) and PYREXIA (fever of 103) had resolved and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 103 (High) fever of 103F. On 15-Feb-2021, Heart rate: 85 (High) elevated heart rate of 85 bpm. 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: BREO ELLIPTA; PROAIR [SALBUTAMOL SULFATE]

Current Illness: Asthma; Crohn's disease

ID: 1567533
Sex: F
Age: 51
State: NJ

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little pain for 2 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 024M20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (little pain for 2 days). On 28-Jan-2021, PAIN (little pain for 2 days) had resolved. Not Provided No concomitant medications were provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-047936 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: The follow up received was NNI.

Other Meds:

Current Illness:

ID: 1567534
Sex: F
Age: 70
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: she still has some eruptions on her legs and stomach; headache; hives across her chest in the lung area, neck area, back and top of her arms and it was itching really bad; itching really bad; her face swelled up, like a big pumpkin; severe cramping in her back and some in her stomach; her whole left arm swelled up and was humongous; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her whole left arm swelled up and was humongous), URTICARIA (hives across her chest in the lung area, neck area, back and top of her arms and it was itching really bad), PRURITUS (itching really bad), SWELLING FACE (her face swelled up, like a big pumpkin) and MUSCLE SPASMS (severe cramping in her back and some in her stomach) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Kidney cancer, Solitary kidney, COPD, Asthma, Arthritis, Hypertension, Anxiety and Difficulty sleeping. Concomitant products included TRAMADOL for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PERIPHERAL SWELLING (her whole left arm swelled up and was humongous). On 04-Mar-2021, the patient experienced URTICARIA (hives across her chest in the lung area, neck area, back and top of her arms and it was itching really bad), PRURITUS (itching really bad), SWELLING FACE (her face swelled up, like a big pumpkin), MUSCLE SPASMS (severe cramping in her back and some in her stomach) and HEADACHE (headache). On an unknown date, the patient experienced RASH (she still has some eruptions on her legs and stomach). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 11-Mar-2021, PERIPHERAL SWELLING (her whole left arm swelled up and was humongous), URTICARIA (hives across her chest in the lung area, neck area, back and top of her arms and it was itching really bad), PRURITUS (itching really bad), SWELLING FACE (her face swelled up, like a big pumpkin), MUSCLE SPASMS (severe cramping in her back and some in her stomach) and HEADACHE (headache) had resolved. At the time of the report, RASH (she still has some eruptions on her legs and stomach) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's concomitant medication included unspecified medicines for heart, anxiety, sleep and high blood pressure.

Other Meds: TRAMADOL

Current Illness: Anxiety; Arthritis; Asthma; COPD; Difficulty sleeping; Hypertension; Kidney cancer; Solitary kidney

ID: 1567535
Sex: F
Age: 81
State: CA

Vax Date: 03/03/2021
Onset Date: 03/11/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Red Rash on the Left Upper Arm (About 5"); Itching Injection Site (About 5"); This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Rash on the Left Upper Arm (About 5")) and VACCINATION SITE PRURITUS (Itching Injection Site (About 5")) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash on the Left Upper Arm (About 5")) and VACCINATION SITE PRURITUS (Itching Injection Site (About 5")). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. On 12-Mar-2021, VACCINATION SITE PRURITUS (Itching Injection Site (About 5")) had resolved. On 15-Mar-2021, RASH ERYTHEMATOUS (Red Rash on the Left Upper Arm (About 5")) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information was received on 06-May-2021 added contact information and dose 2 received.

Other Meds:

Current Illness:

ID: 1567536
Sex: F
Age: 49
State: NY

Vax Date: 03/16/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Hot; Vomiting; Tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot), VOMITING (Vomiting), FATIGUE (Tired) and HEADACHE (headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032m20a) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING HOT (Hot), VOMITING (Vomiting), FATIGUE (Tired) and HEADACHE (headache). At the time of the report, FEELING HOT (Hot), VOMITING (Vomiting), FATIGUE (Tired) and HEADACHE (headache) outcome was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1567537
Sex: F
Age: 62
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm was sore), skin swelling (puffy in the area where shot was given), swelling (swollen), skin swelling (all puffy) and pain (sore) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 032M20A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. Concomitant products included vitamins (NOS) for an unknown indication. On Mar 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 8, 2021, patient experienced pain in extremity (arm was sore), skin swelling (puffy in the area where shot was given) and vaccination site induration (little hard). On Mar 17, 2021, patient experienced swelling (swollen), skin swelling (all puffy), pain (sore) and induration (all hard). At the time of the report, pain in extremity (arm was sore), skin swelling (puffy in the area where shot was given) and vaccination site induration (little hard) had resolved and swelling (swollen), skin swelling (all puffy), pain (sore) and induration (all hard) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Patient did not take any treatment for the events.

Other Meds: Vitamins (NOS)

Current Illness:

ID: 1567538
Sex: F
Age:
State: SC

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

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

Lab Data:

Allergies:

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

Symptoms: Lump injection site; Hard injection site; Itchy injection site; Redness injection site; Swollen injection site; Pain injection site; tired; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Lump injection site), INJECTION SITE INDURATION (Hard injection site), INJECTION SITE PRURITUS (Itchy injection site), INJECTION SITE ERYTHEMA (Redness injection site) and INJECTION SITE SWELLING (Swollen injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced INJECTION SITE MASS (Lump injection site), INJECTION SITE INDURATION (Hard injection site), INJECTION SITE PRURITUS (Itchy injection site), INJECTION SITE ERYTHEMA (Redness injection site), INJECTION SITE SWELLING (Swollen injection site), INJECTION SITE PAIN (Pain injection site), FATIGUE (tired) and NAUSEA (nausea). At the time of the report, INJECTION SITE MASS (Lump injection site), INJECTION SITE INDURATION (Hard injection site), INJECTION SITE PRURITUS (Itchy injection site), INJECTION SITE ERYTHEMA (Redness injection site), INJECTION SITE SWELLING (Swollen injection site), INJECTION SITE PAIN (Pain injection site), FATIGUE (tired) and NAUSEA (nausea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Outcome for the all the events has been updated from unknown to recovered and patient declined further follow-up

Other Meds:

Current Illness:

ID: 1567539
Sex: F
Age: 66
State: MI

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Labored breathing), HYPERHIDROSIS (Profusely sweating), CHILLS (Extreme chills) and VOMITING (vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. No medical information history was reported. Concomitant products included LIRAGLUTIDE (VICTOZA), APIXABAN (ELIQUIS), METOPROLOL, SERTRALINE, AMLODIPINE, BUPROPION, ATORVASTATIN, TRIAMTERENE, ACETAMIDE and GLIMEPIRIDE for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DYSPNOEA (Labored breathing), HYPERHIDROSIS (Profusely sweating), CHILLS (Extreme chills) and VOMITING (vomiting). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 01-Mar-2021, DYSPNOEA (Labored breathing), HYPERHIDROSIS (Profusely sweating), CHILLS (Extreme chills) and VOMITING (vomiting) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: VICTOZA; ELIQUIS; METOPROLOL; SERTRALINE; AMLODIPINE; BUPROPION; ATORVASTATIN; TRIAMTERENE; ACETAMIDE; GLIMEPIRIDE

Current Illness:

ID: 1567540
Sex: F
Age: 75
State: FL

Vax Date: 02/16/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.9,) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No medical history information was provided. Concomitant products included IBUPROFEN. On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (fever of 100.9,). At the time of the report, PYREXIA (fever of 100.9,) outcome was unknown. Unknown DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 101.0 (High) temperature now reads 101.0 on one thermometer and 100.0 on a different thermometer.. On 17-Mar-2021, Pyrexia: 100.9 (High) fever of 100.9. Reporter did not provide any other AE information. Action taken with mRNA-1273 in response to the events were not applicable.

Other Meds: IBUPROFEN

Current Illness:

ID: 1567541
Sex: F
Age: 60
State: KY

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Headache; Chills; Joint pain; Muscle pain; she get the second vaccine three months later; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she get the second vaccine three months later) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she get the second vaccine three months later). At the time of the report, HEADACHE (Headache), CHILLS (Chills) and ARTHRALGIA (Joint pain) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment information was given. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Significant follow up appended. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she get the second vaccine three months later) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she get the second vaccine three months later). At the time of the report, HEADACHE (Headache), CHILLS (Chills) and ARTHRALGIA (Joint pain) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment information was given. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Significant follow up appended.

Other Meds:

Current Illness:

ID: 1567542
Sex: F
Age:
State: MD

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOT FLUSH (Hot flashes), SLUGGISHNESS (Sluggish), ABDOMINAL DISCOMFORT (Swishy stomach), DIZZINESS (Dizzy) and PAIN IN EXTREMITY (Sore arm) in a 67-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 provided by the reporter. Concomitant products included LOSARTAN for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HOT FLUSH (Hot flashes), SLUGGISHNESS (Sluggish), ABDOMINAL DISCOMFORT (Swishy stomach), DIZZINESS (Dizzy), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain in her right arm) and NAUSEA (Nausea). On 06-Mar-2021, the patient experienced PARAESTHESIA (Tingling in both arms / Tingling in right leg / Tingling in the neck / Tingling in the back). The patient was treated with HYDROXOCOBALAMIN (VITAMIN B12 [HYDROXOCOBALAMIN]) for Symptomatic treatment, at an unspecified dose and frequency and VITAMIN C [ASCORBIC ACID] for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (Hot flashes), SLUGGISHNESS (Sluggish), ABDOMINAL DISCOMFORT (Swishy stomach), DIZZINESS (Dizzy), PAIN IN EXTREMITY (Sore arm), PARAESTHESIA (Tingling in both arms / Tingling in right leg / Tingling in the neck / Tingling in the back), MYALGIA (Muscle pain in her right arm) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood pressure measurement: high (High) High. On 06-Mar-2021, Glycosylated haemoglobin: elevated (High) Elevated.. On 06-Mar-2021, Heart rate: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information also included to take more fluids.

Other Meds: LOSARTAN

Current Illness:

ID: 1567543
Sex: F
Age: 66
State: CA

Vax Date: 03/08/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Felt little pain; Arm is swollen; Redness is getting bigger; Itchy around redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt little pain), PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness is getting bigger) and PRURITUS (Itchy around redness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. No medical history information was provided. Concomitant products included CALCIUM and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (Felt little pain), PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness is getting bigger) and PRURITUS (Itchy around redness). At the time of the report, PAIN (Felt little pain), PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness is getting bigger) and PRURITUS (Itchy around redness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included cold compress.

Other Meds: CALCIUM; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1567544
Sex: F
Age: 82
State: MD

Vax Date: 02/04/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Full body rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Full body rash) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. No medical history information was reported. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) and PREDNISONE for Eye abnormality NOS, APIXABAN (ELIQUIS), METOPROLOL, TIMOLOL, LATANOPROST, CALCIUM, COLECALCIFEROL (CALCIUM WITH D3), MAGNESIUM and SHARK CARTILAGE for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced RASH (Full body rash). The patient was treated with PARAFFIN, LIQUID, PETROLATUM, WOOL FAT (EUCERIN [PARAFFIN, LIQUID;PETROLATUM;WOOL FAT]) at an unspecified dose and frequency. At the time of the report, RASH (Full body rash) outcome was unknown. Not Provided Patient did not experience any itching or any other side effects just a rash all over her torso and down her arms and inner legs. She used Eucerin cream for rash. This case was linked to MOD-2021-047786 (Patient Link).

Other Meds: ELIQUIS; VALACYCLOVIR HCL; METOPROLOL; TIMOLOL; LATANOPROST; PREDNISONE; CALCIUM WITH D3; MAGNESIUM; SHARK CARTILAGE

Current Illness:

ID: 1567545
Sex: F
Age: 69
State: WA

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm Pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain) and HEADACHE (Headache). On 07-Mar-2021, PAIN IN EXTREMITY (Arm Pain) and HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was not provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1567546
Sex: U
Age:
State:

Vax Date: 03/14/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pain at injection iste; Swelling at injection site; Lightheadedness; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain at injection iste), VACCINATION SITE SWELLING (Swelling at injection site), DIZZINESS (Lightheadedness) and FATIGUE (Fatigue) 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 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection iste), VACCINATION SITE SWELLING (Swelling at injection site), DIZZINESS (Lightheadedness) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Pain at injection iste), VACCINATION SITE SWELLING (Swelling at injection site), DIZZINESS (Lightheadedness) and FATIGUE (Fatigue) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1567547
Sex: F
Age: 67
State: NY

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: High fasting blood sugar; Felt off; Couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (High fasting blood sugar), FEELING ABNORMAL (Felt off) and INSOMNIA (Couldn't sleep) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 029L20A) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus and Anxiety. Concomitant products included METFORMIN for Type 2 diabetes mellitus. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced HYPERGLYCAEMIA (High fasting blood sugar), FEELING ABNORMAL (Felt off) and INSOMNIA (Couldn't sleep). On 06-Mar-2021, HYPERGLYCAEMIA (High fasting blood sugar), FEELING ABNORMAL (Felt off) and INSOMNIA (Couldn't sleep) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Blood glucose: 180 mg/dl (High) The morning after receiving the vaccine patient's fasting blood sugars were "sky high", in the 180's, 174, 179 and it would last throughout the day as well.. Treatment information was not provided. Patient wears a diabetic sensor. Patient's normal fasting blood sugar is around 107. Patient noticed that fasting blood sugars altered with both the doses. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-047708 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Reporter contact information updated

Other Meds: METFORMIN

Current Illness: Anxiety; Type 2 diabetes mellitus

ID: 1567548
Sex: F
Age: 70
State: MO

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

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

Lab Data:

Allergies:

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

Symptoms: Did not get 2nd Vaccine as scheduled; rash head to toe/rash on chest/Rash over arms; Very bad itch; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Very bad itch), PRODUCT DOSE OMISSION ISSUE (Did not get 2nd Vaccine as scheduled), RASH (Rash) and RASH (rash head to toe/rash on chest/Rash over arms) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA AC), LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and METHOTREXATE SODIUM (MTX DURA) for an unknown indication, AVOBENZONE, OCTINOXATE (SUNSCREEN), FOLIC ACID, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CALCIUM. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PRURITUS (Very bad itch) and RASH (Rash). On 29-Mar-2021, the patient experienced RASH (rash head to toe/rash on chest/Rash over arms). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get 2nd Vaccine as scheduled). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 22-Apr-2021, RASH (rash head to toe/rash on chest/Rash over arms) had not resolved. At the time of the report, PRURITUS (Very bad itch) and PRODUCT DOSE OMISSION ISSUE (Did not get 2nd Vaccine as scheduled) had resolved and RASH (Rash) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication includes steroids Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Medical history, concomitant medication and new events were added

Other Meds: HUMIRA AC; SYNTHROID; MONTELUKAST; FLONASE ALLERGY RELIEF; MTX DURA; SUNSCREEN; FOLIC ACID; VITAMIN D 2000; CALCIUM

Current Illness: Rheumatoid arthritis

ID: 1567549
Sex: M
Age: 66
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: Swelling of his top lip; Swelling of his bottom lip; Rash on back of neck, arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling of his bottom lip), LIP SWELLING (Swelling of his top lip) and RASH (Rash on back of neck, arms and legs) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No medical history information was provided. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced RASH (Rash on back of neck, arms and legs). On 15-Mar-2021, the patient experienced LIP SWELLING (Swelling of his bottom lip). On 17-Mar-2021, the patient experienced LIP SWELLING (Swelling of his top lip). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 16-Mar-2021, LIP SWELLING (Swelling of his bottom lip) had resolved. At the time of the report, LIP SWELLING (Swelling of his top lip) and RASH (Rash on back of neck, arms and legs) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1567550
Sex: F
Age: 77
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: Itching all over the body; Worsened her allergies; Pain in arms; brain fogged; Felt sick; tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body), HYPERSENSITIVITY (Worsened her allergies), PAIN IN EXTREMITY (Pain in arms), FEELING ABNORMAL (brain fogged) and ILLNESS (Felt sick) 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. Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRURITUS (Itching all over the body), HYPERSENSITIVITY (Worsened her allergies), PAIN IN EXTREMITY (Pain in arms), FEELING ABNORMAL (brain fogged), ILLNESS (Felt sick) and FATIGUE (tired). On 08-Mar-2021, PAIN IN EXTREMITY (Pain in arms) had resolved. At the time of the report, PRURITUS (Itching all over the body), HYPERSENSITIVITY (Worsened her allergies), FEELING ABNORMAL (brain fogged), ILLNESS (Felt sick) and FATIGUE (tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information were provided. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Outcome of event fatigue was updated.

Other Meds: ZYRTEC ALLERGY

Current Illness: Allergy

ID: 1567551
Sex: F
Age: 31
State: PA

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Aug-2021. On 11-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications provided by the reporter. The patient gestation period was 17 weeks. Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Pregnancy data clean up

Other Meds: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS

Current Illness:

ID: 1567552
Sex: M
Age:
State: OR

Vax Date: 03/13/2021
Onset Date: 03/14/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Diarrhea; Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip; Hives broke out on blisters; Redness on fingers; Hives broke out with blisters, itching; Tired, wanted to sleep, fatigue again; Really hungry; R hand fingers and palms itching that come and go; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Really hungry), PRURITUS (R hand fingers and palms itching that come and go), DIARRHOEA (Diarrhea), PRURITUS (Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip) and BLISTER (Hives broke out on blisters) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LOSARTAN, METOPROLOL, AMLODIPINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced HUNGER (Really hungry), PRURITUS (R hand fingers and palms itching that come and go) and FATIGUE (Tired, wanted to sleep, fatigue again). On 16-Mar-2021, the patient experienced PRURITUS (Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip), BLISTER (Hives broke out on blisters), ERYTHEMA (Redness on fingers) and URTICARIA (Hives broke out with blisters, itching). On 17-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with HYDROCORTISONE (ITCH-X [HYDROCORTISONE]) for Itching, at an unspecified dose and frequency. At the time of the report, HUNGER (Really hungry), PRURITUS (R hand fingers and palms itching that come and go), DIARRHOEA (Diarrhea), PRURITUS (Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip), BLISTER (Hives broke out on blisters), ERYTHEMA (Redness on fingers), URTICARIA (Hives broke out with blisters, itching) and FATIGUE (Tired, wanted to sleep, fatigue again) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: unk (normal) blood pressure stable. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: LOSARTAN; METOPROLOL; AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1567553
Sex: F
Age: 17
State: CA

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: patient did not show up for her 2nd appointment; administered 1st dose of vaccine to a 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of vaccine to a 17 year old) and PRODUCT DOSE OMISSION ISSUE (patient did not show up for her 2nd appointment) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001b21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of vaccine to a 17 year old). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient did not show up for her 2nd appointment). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of vaccine to a 17 year old) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient did not show up for her 2nd appointment) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment details were not provided. patient presented herself for covid vaccination after making an online appointment where she attested that she was 18 years old to make this appointment. it was discovered that she was actually 17 years old when the informed consent form was scanned for billing purpose. at that point pharmacist called Moderna and spoke to an agent. it is my understanding that CDC did recomend use of moderna for 16-17 year old. and that second dose should be given as off label use. However patient did not show up for her 2nd appointment. Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: As reported: patient did not show up for her 2nd appointment.

Other Meds:

Current Illness:

ID: 1567554
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 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 FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1567555
Sex: F
Age: 78
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: DIscomfort; Felt a lump/ lump was the size of silver dollar; Really itchy and horrible; rash got larger and looked like "measles; rash, swelling and hurting at injection site; rash, swelling and hurting at injection site; rash, swelling and hurting at injection site; "Felt it throughout her whole body"; Pain above anklesand Pain to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL ("Felt it throughout her whole body"), PAIN (Pain above anklesand Pain to touch), DISCOMFORT (DIscomfort), NODULE (Felt a lump/ lump was the size of silver dollar) and PRURITUS (Really itchy and horrible) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M(??)A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cholesterol high. Concurrent medical conditions included Drug allergy (Naproxen,), Drug allergy (Codeine), Food allergy (Pineapple , Acidic fruits) and Drug allergy (allergic reaction to the Benadryl tablet). Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE) and ATORVASTATIN for an unknown indication. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL ("Felt it throughout her whole body") and PAIN (Pain above anklesand Pain to touch). On 16-Feb-2021, the patient experienced DISCOMFORT (DIscomfort), NODULE (Felt a lump/ lump was the size of silver dollar), PRURITUS (Really itchy and horrible), RASH (rash got larger and looked like "measles), VACCINATION SITE RASH (rash, swelling and hurting at injection site), VACCINATION SITE SWELLING (rash, swelling and hurting at injection site) and VACCINATION SITE PAIN (rash, swelling and hurting at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and IBUPROFEN (ADVIL 12 HOUR) at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL ("Felt it throughout her whole body"), PAIN (Pain above anklesand Pain to touch), DISCOMFORT (DIscomfort), NODULE (Felt a lump/ lump was the size of silver dollar), PRURITUS (Really itchy and horrible), VACCINATION SITE RASH (rash, swelling and hurting at injection site) and VACCINATION SITE PAIN (rash, swelling and hurting at injection site) outcome was unknown and RASH (rash got larger and looked like "measles) and VACCINATION SITE SWELLING (rash, swelling and hurting at injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-047860 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Added medical history. Treatment drug information is added.

Other Meds: DYAZIDE; ATORVASTATIN

Current Illness: Drug allergy (Naproxen,); Drug allergy (Codeine); Drug allergy (allergic reaction to the Benadryl tablet); Food allergy (Pineapple , Acidic fruits)

ID: 1567556
Sex: F
Age: 69
State: NY

Vax Date: 02/08/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Nausea; Fever of 102F; Body aches; Headaches; Vomited; She was really "put down"; Has barely eaten; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (She was really "put down"), DECREASED APPETITE (Has barely eaten), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever of 102F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (Chills). On 13-Mar-2021, the patient experienced ASTHENIA (She was really "put down"), DECREASED APPETITE (Has barely eaten), NAUSEA (Nausea), PYREXIA (Fever of 102F), MYALGIA (Body aches), HEADACHE (Headaches) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (She was really "put down"), DECREASED APPETITE (Has barely eaten), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches), HEADACHE (Headaches) and VOMITING (Vomited) outcome was unknown and PYREXIA (Fever of 102F) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: high (High) 102 F. The action taken with the drug in response to the event(s) was not applicable. This case was linked to MOD-2021-019543 (Patient Link).

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm