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: 1560541
Sex: F
Age: 61
State: PA

Vax Date: 02/08/2021
Onset Date:
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: lightheadedness; Diarrhea; Dizziness; Nauseous; Chills; A spontaneous report was received from a consumer concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nauseous, chills, diarrhea, dizziness, lightheadedness. The patient's medical history was not provided. Concomitant medications reported were acetaminophen, levothyroxine, fluticasone proprionate, fluticasone proprionate and salmeterol xinafoate, multivitamin for drug use for unknown indication. On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the events nauseous, Chills, diarrhea, dizziness, lightheadedness. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, nauseous, chills, diarrhea, dizziness, lightheadedness were unknown.

Other Meds: TYLENOL; LEVOTHYROXINE; FLONASE ALLERGY RELIEF; ADVAIR; MULTIVITAMIN & MINERAL

Current Illness:

ID: 1560542
Sex: F
Age: 64
State: PA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
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: back was burning; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and BURNING SENSATION (back was burning) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Radioactive iodine in November 2020. Concomitant products included ALPRAZOLAM, APIXABAN (ELIQUIS), METOPROLOL, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), SIMVASTATIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 10-Feb-2021, the patient experienced BURNING SENSATION (back was burning). On 30-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, BURNING SENSATION (back was burning) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Updated outcome of event back was burning from unknown to recovered and patient declined further follow-up.

Other Meds: ALPRAZOLAM; ELIQUIS; METOPROLOL; PRILOSEC [OMEPRAZOLE]; SIMVASTATIN; SYNTHROID

Current Illness:

ID: 1560543
Sex: M
Age: 91
State: CA

Vax Date: 02/05/2021
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: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Achilles tendon was affected; his balance was affected; he was put him in a wheel chair; Cant move his ankle to any degree; worsened conditions after taking the Moderna vaccine; his right ankle and foot has swollen up; leg is swollen from the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (his right ankle and foot has swollen up), PERIPHERAL SWELLING (leg is swollen from the vaccine), TENDON INJURY (Achilles tendon was affected), BALANCE DISORDER (his balance was affected) and GAIT DISTURBANCE (he was put him in a wheel chair) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 05-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 JOINT SWELLING (his right ankle and foot has swollen up) and PERIPHERAL SWELLING (leg is swollen from the vaccine). On an unknown date, the patient experienced TENDON INJURY (Achilles tendon was affected), BALANCE DISORDER (his balance was affected), GAIT DISTURBANCE (he was put him in a wheel chair), JOINT INJURY (Cant move his ankle to any degree) and CONDITION AGGRAVATED (worsened conditions after taking the Moderna vaccine). At the time of the report, JOINT SWELLING (his right ankle and foot has swollen up), TENDON INJURY (Achilles tendon was affected), BALANCE DISORDER (his balance was affected), JOINT INJURY (Cant move his ankle to any degree) and CONDITION AGGRAVATED (worsened conditions after taking the Moderna vaccine) had not resolved and PERIPHERAL SWELLING (leg is swollen from the vaccine) and GAIT DISTURBANCE (he was put him in a wheel chair) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2021: No specific follow-up information recorded. On 20-Apr-2021: Follow up received, Updated - Events tab; Events added: Achilles tendon was affected (Tendon injury); his balance was affected (Balance disorder); put him in a wheelchair (Gait disturbance). Patient mentioned that his Achilles tendon was affected and put him in a wheelchair, and it has affected his balance. He believes that if he falls, he will die or will die from the escalation of swelling or blood clot. On 23-Apr-2021: Follow up received on: 23-Apr-2021Outcome for event "worsened conditions after taking the Moderna vaccine" updated to "Not Recovered/Not Resolved"

Other Meds:

Current Illness:

ID: 1560544
Sex: F
Age: 60
State: NY

Vax Date: 01/04/2021
Onset Date: 01/04/2021
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: Tired; Arm hurting; Achy all over body; Fever 100F; Nausea; Vomiting; Felt like have QVID all over again; headache; Tingling in cheek; Sinuses opened Up; Felt like her lungs were opened up (Similar to having Albuterol nebulizer treatment); A spontaneous report was received from a healthcare professional concerning a 60-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tingling in cheek, felt like her lungs were opened up (similar to having albuterol nebulizer treatment), sinuses opened up, headache, tired, arm hurting, achy all over body, fever 100f, nausea and vomiting, fatigue, felt like have qvid all over again. The patient's medical history was not provided. No relevant concomitant medications were reported. On 4 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026L20A) Intramuscularly for prophylaxis of COVID-19 infection. On 4 Jan 2021, the patient experienced the event(s) tingling in cheek, felt like her lungs were opened up (similar to having albuterol nebulizer treatment), sinuses opened up. On 5 Jan 2021, the patient experienced the event(s) headache, tired, arm hurting, achy all over body, fever 100f, nausea and vomiting, fatigue, felt like have qvid all over again. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 20 Jan 2021 the outcome of event(s), tingling in cheek, felt like her lungs were opened up (similar to having albuterol nebulizer treatment), sinuses opened up, headache, tired, arm hurting, achy all over body, fever 100f, nausea and vomiting, fatigue, felt like have qvid all over again was resolved.

Other Meds:

Current Illness:

ID: 1560545
Sex: F
Age:
State: AZ

Vax Date: 01/21/2021
Onset Date: 01/25/2021
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: Painful Shoulder; Hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful Shoulder) and DRY SKIN (Hot) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Painful Shoulder) and DRY SKIN (Hot). At the time of the report, PAIN IN EXTREMITY (Painful Shoulder) and DRY SKIN (Hot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1560546
Sex: F
Age: 44
State: IL

Vax Date: 01/10/2021
Onset Date: 01/11/2021
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: Tiredness; Soreness; A spontaneous report was received from a healthcare professional concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tiredness / fatigue and soreness/ pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 7 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient experienced the events, tiredness and soreness. Treatment details included Tylenol and Advil. Action taken with mRNA-1273 in response to the events was not reported. On 12 Jan 2021 the outcome of events, tiredness and soreness was resolved.

Other Meds:

Current Illness:

ID: 1560547
Sex: M
Age:
State: MO

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: stuffy nose/nose congestion; body aches; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose/nose congestion), PAIN (body aches), PYREXIA (fever) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. no medical history was provided by reporter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced NASAL CONGESTION (stuffy nose/nose congestion), PAIN (body aches), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, NASAL CONGESTION (stuffy nose/nose congestion), PAIN (body aches), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication were included blood pressure medicine, cholesterol medicine. This case was linked to MOD-2021-033551 (Patient Link).

Other Meds:

Current Illness:

ID: 1560548
Sex: F
Age:
State: GA

Vax Date: 02/15/2021
Onset Date: 02/16/2021
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: severely sick; no energy to get up; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (severely sick), ASTHENIA (no energy to get up), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Concomitant products included COLECALCIFEROL (VITAMIN D 3), ACETYLSALICYLIC ACID (ASPIRIN 81) and LEVOFLOXACIN (LEFOX [LEVOFLOXACIN]) for an unknown indication. On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ILLNESS (severely sick), ASTHENIA (no energy to get up), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (severely sick), ASTHENIA (no energy to get up), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Patient was having cholesterol medicine at night and Cholesterol injection every other week on Tuesday as concomitant medication. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.

Other Meds: VITAMIN D 3; ASPIRIN 81; LEFOX [LEVOFLOXACIN]

Current Illness:

ID: 1560549
Sex: M
Age: 63
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Small spots at the injection site; Hardness at the injection site; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (Small spots at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE PAIN (Injection site pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE DISCOLOURATION (Small spots at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE PAIN (Injection site pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE DISCOLOURATION (Small spots at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE PAIN (Injection site pain) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product use was reported This case was linked to MOD21-027217 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: received on 22-APR-2021 and does not contain any new information; Sender's Comments: MOD21-027217:

Other Meds:

Current Illness:

ID: 1560550
Sex: F
Age: 78
State: NC

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Sore arm; Pain in my legs when I walk or sit down; Hurts a lot; Knot at the injection site, it was red; It was red; Low grade fever; muscle pain; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events low grade fever/pyrexia, sore arm/pain in extremity, knot at the injection site/vaccination site induration, red/vaccination site erythema, pain in my legs when i walk or sit down/pain, muscle pain/myalgia, hurts a lot/pain. The patient's medical history was not provided. Concomitant medications reported were gabapentin used for unknown indication. On 7 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. No adverse events were reported related to the first dose of the vaccine. On 3 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch:028L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 3 Feb 2021, the patient experienced the events low grade fever, sore arm, knot at the injection site, red, pain in legs when she walked or sat down, muscle pain, hurt alot. Treatment details included aspirin with acetaminophen. Since the patient received both the planned doses of the vaccine, action taken with mRNA-1273 in response to the events was not applicable. The outcome of events low grade fever, sore arm, knot at the injection site, red, pain in my legs when i walk or sit down, muscle pain, hurts alot was unknown on 8 Feb 2021.

Other Meds: GABAPENTIN

Current Illness:

ID: 1560551
Sex: F
Age: 68
State: FL

Vax Date: 12/30/2020
Onset Date: 12/31/2020
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: Rash on her upper thighs and upper arms/continued to have rash since its first appearance even until today; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her upper thighs and upper arms/continued to have rash since its first appearance even until today) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029K20A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced RASH (Rash on her upper thighs and upper arms/continued to have rash since its first appearance even until today). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash on her upper thighs and upper arms/continued to have rash since its first appearance even until today) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1560552
Sex: F
Age: 66
State: IL

Vax Date: 02/01/2021
Onset Date: 02/04/2021
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: Covid-19; Fever 102 F; Very Fatigue; Under weather; Cough; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cough, very fatigue, under weather, fever 102 f, covid-19. The patient's medical history was not provided. No relevant concomitant medications were reported. On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 4 Feb 2021, the patient experienced the event cough. On 6 Feb 2021, the patient experienced the events very fatigue, under weather. On 7 Feb 2021, the patient experienced the events fever 102 f. On 9 Feb 2021, the patient experienced the event covid-19.Consumer visited HCP. HCP recommended over the counter medications to treat symptoms. Treatment details included acetaminophen, azithromycin, mucinex, Ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. On 5 Feb 2021 the outcome of event, cough was resolved. The outcome of events, very fatigue, under weather, fever 102 f, covid-19 was unknown.

Other Meds:

Current Illness:

ID: 1560553
Sex: F
Age: 63
State: MN

Vax Date: 01/29/2021
Onset Date: 02/09/2021
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: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Hypersensitivity cutaneous reaction; Red rash on the inside of her forearm; Itchy rash on the inside of her forearm; Look like mosquito bumps or hives; "Finger tingling"; "Rashes" started popping up in different areas (including the left arm, face, jawline, body) and "alongside her rear"; Chills; Redness; Intense itching; A spontaneous report was received from a nurse concerning a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypersensitivity reaction, red rash, itchy rash, hives, tingling, rash all over, chills, redness and itching. The patient's medical history, as provided by the reporter, includes hypertension, and shingles. Concomitant medications reported includes HCTZ. On 29 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09 Feb 2021 she experienced red and itchy rash on the inside of her forearm, that lasted one-half hour and resolved. For the past 3 days she reported to have rash on left arm, face, jawline and body. She reported intense itching and redness (that last for 15-20 minutes) associated with the rash looks like hives (that last for about 45 minutes and resolved). She started feeling chills and thingling. She called her HCP. She was diagnosed with known delayed hypersensitivity cutaneous reaction after receiving Moderna's COVID-19 vaccine. Treatment for the events include Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The events red rash, itchy rash, hives, redness, itching, rash were resolved. The events chills, tingling, hypersensitivity reaction were unknown at the time of report.

Other Meds: HCTZ

Current Illness:

ID: 1560554
Sex: F
Age:
State: NY

Vax Date: 02/06/2021
Onset Date: 02/06/2021
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: Rash; Burning; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and BURNING SENSATION (Burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. 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 RASH (Rash) and BURNING SENSATION (Burning). At the time of the report, RASH (Rash) and BURNING SENSATION (Burning) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications was not reported. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1560555
Sex: F
Age:
State: MN

Vax Date: 01/25/2021
Onset Date: 01/29/2021
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: severe headache; neck ache; excessive sweating; fatigue; weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), NECK PAIN (neck ache), HYPERHIDROSIS (excessive sweating), FATIGUE (fatigue) and ASTHENIA (weakness) 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (severe headache), NECK PAIN (neck ache), HYPERHIDROSIS (excessive sweating), FATIGUE (fatigue) and ASTHENIA (weakness). At the time of the report, HEADACHE (severe headache), NECK PAIN (neck ache), HYPERHIDROSIS (excessive sweating), FATIGUE (fatigue) and ASTHENIA (weakness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560556
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Adverse rash on his foot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Adverse rash on his foot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. NO Medical History Information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Adverse rash on his foot). At the time of the report, RASH (Adverse rash on his foot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Feb-2021 and was forwarded to Moderna on 09-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Adverse rash on his foot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. NO Medical History Information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Adverse rash on his foot). At the time of the report, RASH (Adverse rash on his foot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1560557
Sex: M
Age: 70
State: FL

Vax Date: 02/02/2021
Onset Date: 02/07/2021
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: vaccinated and 5 days later got COVID; Flu positive; Feeling bad; seemed like cold; felt sleepy; Regular Dry Cough; whizzing that turns up during bedtime; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (seemed like cold), SOMNOLENCE (felt sleepy), COUGH (Regular Dry Cough) and WHEEZING (whizzing that turns up during bedtime) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (seemed like cold), SOMNOLENCE (felt sleepy), COUGH (Regular Dry Cough) and WHEEZING (whizzing that turns up during bedtime). On 08-Feb-2021, the patient experienced COVID-19 (vaccinated and 5 days later got COVID) and INFLUENZA (Flu positive). The patient was treated with OSELTAMIVIR PHOSPHATE (TAMIFLU) at an unspecified dose and frequency; DOXYCYCLINE at an unspecified dose and frequency and IPRATROPIUM BROMIDE (ATROVENT) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling bad), NASOPHARYNGITIS (seemed like cold), SOMNOLENCE (felt sleepy), COUGH (Regular Dry Cough), WHEEZING (whizzing that turns up during bedtime), COVID-19 (vaccinated and 5 days later got COVID) and INFLUENZA (Flu positive) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 22-APR-2021 and does not contain any new information

Other Meds:

Current Illness:

ID: 1560558
Sex: F
Age: 79
State: CO

Vax Date: 02/10/2021
Onset Date: 02/10/2021
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: Bad headache; Body Aches; Really Tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache), MYALGIA (Body Aches) and FATIGUE (Really Tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Bad headache), MYALGIA (Body Aches) and FATIGUE (Really Tired). At the time of the report, HEADACHE (Bad headache), MYALGIA (Body Aches) and FATIGUE (Really Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560559
Sex: F
Age: 83
State: HI

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Her left arm and her shoulders muscles was sore for a few days; Her left arm and her shoulders muscles was sore for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her left arm and her shoulders muscles was sore for a few days) and ARTHRALGIA (Her left arm and her shoulders muscles was sore for a few days) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient's past medical history included Breast cancer. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her left arm and her shoulders muscles was sore for a few days) and ARTHRALGIA (Her left arm and her shoulders muscles was sore for a few days). At the time of the report, PAIN IN EXTREMITY (Her left arm and her shoulders muscles was sore for a few days) and ARTHRALGIA (Her left arm and her shoulders muscles was sore for a few days) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24-JUN-2021 and contains non-significant information.

Other Meds:

Current Illness:

ID: 1560560
Sex: F
Age: 76
State: MA

Vax Date: 02/08/2021
Onset Date: 02/08/2021
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: Uncomfortable from elbow to top of the shoulder; Arm is sore; (Arm) warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore), FEELING HOT ((Arm) warm) and FEELING ABNORMAL (Uncomfortable from elbow to top of the shoulder) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore) and FEELING HOT ((Arm) warm). On 11-Feb-2021, the patient experienced FEELING ABNORMAL (Uncomfortable from elbow to top of the shoulder). At the time of the report, PAIN IN EXTREMITY (Arm is sore), FEELING HOT ((Arm) warm) and FEELING ABNORMAL (Uncomfortable from elbow to top of the shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560561
Sex: F
Age: 42
State: OH

Vax Date: 02/01/2021
Onset Date: 02/01/2021
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: site of injection is itching; site of injection developed red mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (site of injection developed red mark) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (site of injection developed red mark). At the time of the report, VACCINATION SITE PRURITUS (site of injection is itching) and VACCINATION SITE ERYTHEMA (site of injection developed red mark) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications reported were Benadryl Benadryl, Cortisone cream Cortisone cream for drug use for unknown indication. Treatment details included Benadryl, Cortisone Cream.

Other Meds:

Current Illness:

ID: 1560562
Sex: M
Age:
State: VA

Vax Date: 02/11/2021
Onset Date: 02/11/2021
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: He seems confused than normal; slept all day after getting home; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (He seems confused than normal) and SOMNOLENCE (slept all day after getting home) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. Concurrent medical conditions included Dementia. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CONFUSIONAL STATE (He seems confused than normal) and SOMNOLENCE (slept all day after getting home). At the time of the report, CONFUSIONAL STATE (He seems confused than normal) and SOMNOLENCE (slept all day after getting home) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness: Dementia

ID: 1560563
Sex: M
Age: 48
State: NJ

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported Treatment details included paracetamol 650 mg. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1560564
Sex: F
Age:
State:

Vax Date: 01/27/2021
Onset Date:
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: Redness of neck; Had COVID arm; Itching neck; Chills; Confusion; Redness of face; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness of neck), RASH ERYTHEMATOUS (Had COVID arm), PRURITUS (Itching neck), CHILLS (Chills) and CONFUSIONAL STATE (Confusion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 an unknown date, the patient experienced ERYTHEMA (Redness of neck), RASH ERYTHEMATOUS (Had COVID arm), PRURITUS (Itching neck), CHILLS (Chills), CONFUSIONAL STATE (Confusion) and ERYTHEMA (Redness of face). At the time of the report, ERYTHEMA (Redness of neck), RASH ERYTHEMATOUS (Had COVID arm), PRURITUS (Itching neck), CHILLS (Chills), CONFUSIONAL STATE (Confusion) and ERYTHEMA (Redness of face) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560565
Sex: F
Age: 79
State: TX

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Swelling; Turned red and currently a still swollen; Fever in arm and hot to the touch; Uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling), ERYTHEMA (Turned red and currently a still swollen), FEELING HOT (Fever in arm and hot to the touch) and DISCOMFORT (Uncomfortable) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20a and 037k20a) for COVID-19 vaccination. The patient's past medical history included Hypertension since an unknown date and High cholesterol since an unknown date. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling), ERYTHEMA (Turned red and currently a still swollen), FEELING HOT (Fever in arm and hot to the touch) and DISCOMFORT (Uncomfortable). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling), ERYTHEMA (Turned red and currently a still swollen), FEELING HOT (Fever in arm and hot to the touch) and DISCOMFORT (Uncomfortable) had resolved. Reported Concurrent medications including Blood pressure and cholesterol medications. This case was linked to MOD21-025114 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received on 22 Apr 2021 included Updated outcome of the event peripheral swelling, erythema, feeling hot and discomfort from unknown to resolved. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2021 and was forwarded to Moderna on 10-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling), ERYTHEMA (Turned red and currently a still swollen), FEELING HOT (Fever in arm and hot to the touch) and DISCOMFORT (Uncomfortable) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20a and 037k20a) for COVID-19 vaccination. The patient's past medical history included Hypertension since an unknown date and High cholesterol since an unknown date. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling), ERYTHEMA (Turned red and currently a still swollen), FEELING HOT (Fever in arm and hot to the touch) and DISCOMFORT (Uncomfortable). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling), ERYTHEMA (Turned red and currently a still swollen), FEELING HOT (Fever in arm and hot to the touch) and DISCOMFORT (Uncomfortable) had resolved. Reported Concurrent medications including Blood pressure and cholesterol medications. This case was linked to MOD21-025114 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received on 22 Apr 2021 included Updated outcome of the event peripheral swelling, erythema, feeling hot and discomfort from unknown to resolved.

Other Meds:

Current Illness: High cholesterol; Hypertension

ID: 1560566
Sex: M
Age: 73
State: CO

Vax Date: 02/10/2021
Onset Date: 02/10/2021
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: shaking; bad headache; chills; fever; nausea; aching muscles; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea) in a 73-year-old male patient who received mRNA-1273 (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Feb-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced TREMOR (shaking), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aching muscles). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (shaking), HEADACHE (bad headache), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and MYALGIA (aching muscles) outcome was unknown. No concomitant medication provided.

Other Meds:

Current Illness:

ID: 1560567
Sex: F
Age: 47
State: CO

Vax Date: 02/09/2021
Onset Date: 02/10/2021
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: severe chills; stomach issues; Nausea; tightness; sharp pains in/near shoulder blades; runny nose; she had a little bit of a fever of 101.5F at 4AM. It has dropped to 99.7F and at the time of the call it is 99.6F; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (severe chills), GASTRIC DISORDER (stomach issues), NAUSEA (Nausea), DISCOMFORT (tightness) and ARTHRALGIA (sharp pains in/near shoulder blades) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (severe chills), GASTRIC DISORDER (stomach issues), NAUSEA (Nausea), DISCOMFORT (tightness), ARTHRALGIA (sharp pains in/near shoulder blades), RHINORRHOEA (runny nose) and PYREXIA (she had a little bit of a fever of 101.5F at 4AM. It has dropped to 99.7F and at the time of the call it is 99.6F). At the time of the report, CHILLS (severe chills), GASTRIC DISORDER (stomach issues), NAUSEA (Nausea), DISCOMFORT (tightness), ARTHRALGIA (sharp pains in/near shoulder blades), RHINORRHOEA (runny nose) and PYREXIA (she had a little bit of a fever of 101.5F at 4AM. It has dropped to 99.7F and at the time of the call it is 99.6F) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant Concomitant product medication was provided by reporter.

Other Meds:

Current Illness:

ID: 1560568
Sex: F
Age: 44
State: OH

Vax Date: 02/10/2021
Onset Date: 02/11/2021
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: Headache; Fatigue; Muscle pain; Joint pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1560569
Sex: F
Age:
State:

Vax Date:
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: RA

Lab Data:

Allergies:

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

Symptoms: Rash on chest and neck; Delayed reaction; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on chest and neck) and SKIN REACTION (Delayed reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on chest and neck) and SKIN REACTION (Delayed reaction). At the time of the report, RASH (Rash on chest and neck) and SKIN REACTION (Delayed reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1560570
Sex: F
Age: 51
State: NJ

Vax Date: 01/09/2021
Onset Date: 01/16/2021
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: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: itchiness; Negative rapid test and antigen test; rash started on feet and legs then moved to torso and the rest of body except the face; fever 101.5 F; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), SARS-COV-2 TEST NEGATIVE (Negative rapid test and antigen test), RASH (rash started on feet and legs then moved to torso and the rest of body except the face), PYREXIA (fever 101.5 F) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PRURITUS (itchiness), SARS-COV-2 TEST NEGATIVE (Negative rapid test and antigen test), RASH (rash started on feet and legs then moved to torso and the rest of body except the face), PYREXIA (fever 101.5 F) and NAUSEA (nausea). At the time of the report, PRURITUS (itchiness), SARS-COV-2 TEST NEGATIVE (Negative rapid test and antigen test), RASH (rash started on feet and legs then moved to torso and the rest of body except the face), PYREXIA (fever 101.5 F) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment details included Benadryl, PREDNISONE . Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1560571
Sex: F
Age: 66
State: FL

Vax Date: 02/09/2021
Onset Date: 02/09/2021
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: Fibromyalgia; Arm Pain - Near Injection Site/ Soreness - Near Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FIBROMYALGIA (Fibromyalgia) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site/ Soreness - Near Injection Site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Fibromyalgia. Concomitant products included ALPRAZOLAM, OXYCODONE HYDROCHLORIDE (OXYCONTIN), OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]), GABAPENTIN, MIRTAZAPINE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN LOW) and METOPROLOL for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm Pain - Near Injection Site/ Soreness - Near Injection Site). On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia). At the time of the report, FIBROMYALGIA (Fibromyalgia) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site/ Soreness - Near Injection Site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 23APR2021, patient stated that she is in hospital and rehab after 1st dose and updated the 2nd dose details and states she fell a lot of additional pain.

Other Meds: ALPRAZOLAM; OXYCONTIN; PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]; GABAPENTIN; MIRTAZAPINE; ATORVASTATIN; ASPIRIN LOW; METOPROLOL

Current Illness: Fibromyalgia

ID: 1560572
Sex: F
Age:
State:

Vax Date: 02/11/2021
Onset Date: 02/11/2021
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: spike in her blood sugar glucose for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (spike in her blood sugar glucose for 3 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetic and Diabetes. On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (spike in her blood sugar glucose for 3 days). At the time of the report, BLOOD GLUCOSE INCREASED (spike in her blood sugar glucose for 3 days) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood glucose increased: (High) Spike in her blood sugar glucose. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness: Diabetes

ID: 1560573
Sex: F
Age: 56
State: NY

Vax Date: 12/29/2020
Onset Date: 12/29/2020
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: Induration circular area redness; Induration circular area redness; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Induration circular area redness) and INDURATION (Induration circular area redness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 in April 2020. Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]), KETOROLAC TROMETHAMINE (TORADOL), MORPHINE and IBUPROFEN for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2020, the patient experienced ERYTHEMA (Induration circular area redness) and INDURATION (Induration circular area redness). On 01-Jan-2021, ERYTHEMA (Induration circular area redness) and INDURATION (Induration circular area redness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-024639 (Patient Link).

Other Meds: ZOFRAN [ONDANSETRON]; TORADOL; MORPHINE; IBUPROFEN

Current Illness:

ID: 1560574
Sex: F
Age: 60
State:

Vax Date: 01/26/2021
Onset Date: 01/27/2021
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: fever; sneezing runny nose; sneezing runny nose; headache; diarrhea; vomit; fatigue body ache; fatigue body ache; rash on stomach (upper leg, calf, private area); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (sneezing runny nose), SNEEZING (sneezing runny nose), DIARRHOEA (diarrhea), PYREXIA (fever) and RASH (rash on stomach (upper leg, calf, private area)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart attack in 2000 and Knee surgery NOS. Concurrent medical conditions included Hypertension, Obesity and Arthritis. Concomitant products included MELOXICAM (MOBIC) and ACETAMINOPHEN for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced RASH (rash on stomach (upper leg, calf, private area)). On 01-Feb-2021, the patient experienced FATIGUE (fatigue body ache) and MYALGIA (fatigue body ache). On 05-Feb-2021, the patient experienced VOMITING (vomit). On 06-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 07-Feb-2021, the patient experienced HEADACHE (headache). On 08-Feb-2021, the patient experienced RHINORRHOEA (sneezing runny nose) and SNEEZING (sneezing runny nose). On 10-Feb-2021, the patient experienced PYREXIA (fever). On 31-Jan-2021, RASH (rash on stomach (upper leg, calf, private area)) had resolved. On 07-Feb-2021, DIARRHOEA (diarrhea) had resolved. On 09-Feb-2021, RHINORRHOEA (sneezing runny nose) and SNEEZING (sneezing runny nose) had resolved. At the time of the report, PYREXIA (fever), FATIGUE (fatigue body ache), MYALGIA (fatigue body ache), VOMITING (vomit) and HEADACHE (headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Consulted Jan 27 and 28 Jan: Medicine prescribed by physician follow adverse events include Zyrtec daily four days and Benadryl daily four days.

Other Meds: MOBIC; ACETAMINOPHEN

Current Illness:

ID: 1560575
Sex: F
Age:
State: OK

Vax Date: 01/22/2021
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: The patient has severe pain on the back of the arm under her breast to her neck; The patient has severe pain on the back of the arm under her breast to her neck; The patient has severe pain on the back of the arm under her breast to her neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (The patient has severe pain on the back of the arm under her breast to her neck), NECK PAIN (The patient has severe pain on the back of the arm under her breast to her neck) and BREAST PAIN (The patient has severe pain on the back of the arm under her breast to her neck) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZOA) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-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 PAIN IN EXTREMITY (The patient has severe pain on the back of the arm under her breast to her neck), NECK PAIN (The patient has severe pain on the back of the arm under her breast to her neck) and BREAST PAIN (The patient has severe pain on the back of the arm under her breast to her neck). The patient was treated with KETOROLAC for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (The patient has severe pain on the back of the arm under her breast to her neck), NECK PAIN (The patient has severe pain on the back of the arm under her breast to her neck) and BREAST PAIN (The patient has severe pain on the back of the arm under her breast to her neck) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by investigator. Patient used ketorolac 1 tablet by mouth every 6 hours as needed for pain for 5 days.

Other Meds:

Current Illness:

ID: 1560576
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Having some difficulties with her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Having some difficulties with her arm at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (Having some difficulties with her arm at the injection site). At the time of the report, VACCINATION SITE DISCOMFORT (Having some difficulties with her arm at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1560577
Sex: F
Age:
State: PA

Vax Date: 02/06/2021
Onset Date: 02/06/2021
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: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: essential tremor gone; Sore Arm; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (essential tremor gone), PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient's past medical history included Essential tremor (Suffering from Essential tremors for about 5 years) since an unknown date. Concomitant products included LOSARTAN, DIGOXIN, BUMETANIDE and WARFARIN for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and HEADACHE (Headache). On 08-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (essential tremor gone). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (essential tremor gone), PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2021 and was forwarded to Moderna on 09-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (essential tremor gone), PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient's past medical history included Essential tremor (Suffering from Essential tremors for about 5 years) since an unknown date. Concomitant products included LOSARTAN, DIGOXIN, BUMETANIDE and WARFARIN for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and HEADACHE (Headache). On 08-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (essential tremor gone). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (essential tremor gone), PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided.

Other Meds: LOSARTAN; DIGOXIN; BUMETANIDE; WARFARIN

Current Illness: Essential tremor (Suffering from Essential tremors for about 5 years)

ID: 1560578
Sex: F
Age: 72
State: CA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
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: Itching on right arm; Pain at injection site; Vaccination site urticaria; Swelling at injection site; Exhausted; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Exhausted), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer, Brain tumor, Immunocompromised and Surgery (on left hand). On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION COMPLICATION (Exhausted), FATIGUE (Fatigue), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE URTICARIA (Vaccination site urticaria). On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching on right arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Exhausted), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE URTICARIA (Vaccination site urticaria) outcome was unknown. Unknown The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product use was reported ; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1560579
Sex: F
Age: 56
State: MA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
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: Breathing problem but not bad enough to stop her from going on with her day // 1st dose; Lump on the lymph node on her neck // 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing problem but not bad enough to stop her from going on with her day // 1st dose) and LYMPHADENOPATHY (Lump on the lymph node on her neck // 1st dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No medical history information was provided. Concomitant products included LEVOTHYROXINE for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DYSPNOEA (Breathing problem but not bad enough to stop her from going on with her day // 1st dose) and LYMPHADENOPATHY (Lump on the lymph node on her neck // 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Breathing problem but not bad enough to stop her from going on with her day // 1st dose) and LYMPHADENOPATHY (Lump on the lymph node on her neck // 1st dose) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. This case was linked to MOD-2021-027216 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: NNI pertaining to case. Updated patient's contact information.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1560580
Sex: F
Age: 75
State: IL

Vax Date: 01/27/2021
Onset Date: 02/10/2021
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: Runny Nose; Sneezing; Scratchy Throat; Cough; Hardness - Near Injection Site; Rash - Inside of Right Forearm; Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Soreness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (Runny Nose), SNEEZING (Sneezing), THROAT IRRITATION (Scratchy Throat), COUGH (Cough) and VACCINATION SITE INDURATION (Hardness - Near Injection Site) in a 75-year-old female patient who received mRNA-1273 (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RHINORRHOEA (Runny Nose), SNEEZING (Sneezing), THROAT IRRITATION (Scratchy Throat), COUGH (Cough), VACCINATION SITE INDURATION (Hardness - Near Injection Site), RASH (Rash - Inside of Right Forearm), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PAIN (Soreness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE (CORTIZONE-10 [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Runny Nose), SNEEZING (Sneezing), THROAT IRRITATION (Scratchy Throat), COUGH (Cough), VACCINATION SITE INDURATION (Hardness - Near Injection Site), RASH (Rash - Inside of Right Forearm), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PAIN (Soreness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) had not resolved. Not Provided The action taken with mRNA-1273 (Intramuscular) was unknown. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1560581
Sex: F
Age: 56
State: AZ

Vax Date: 02/02/2021
Onset Date: 02/02/2021
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: dizziness; fever; chills; nausea; vomiting; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and VOMITING (vomiting) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headache) and MYALGIA (body ache). At the time of the report, DIZZINESS (dizziness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headache) and MYALGIA (body ache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1560582
Sex: F
Age: 25
State: CA

Vax Date: 01/19/2021
Onset Date: 01/25/2021
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: Low fever; Big hard lump and rash at injection site; Big hard lump and rash at injection site; Itcy at inejction site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big hard lump and rash at injection site), VACCINATION SITE RASH (Big hard lump and rash at injection site), VACCINATION SITE PRURITUS (Itcy at inejction site) and PYREXIA (Low fever) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025j20-2A) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE MASS (Big hard lump and rash at injection site), VACCINATION SITE RASH (Big hard lump and rash at injection site) and VACCINATION SITE PRURITUS (Itcy at inejction site). On 31-Jan-2021, the patient experienced PYREXIA (Low fever). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Big hard lump and rash at injection site), VACCINATION SITE RASH (Big hard lump and rash at injection site), VACCINATION SITE PRURITUS (Itcy at inejction site) and PYREXIA (Low fever) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1560583
Sex: F
Age: 72
State: NC

Vax Date: 02/03/2021
Onset Date: 02/03/2021
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: dry heaves; fever; headache; joints and muscle aches; joints and muscle aches; chills; vomiting; slight diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), PYREXIA (fever), HEADACHE (headache), MYALGIA (joints and muscle aches) and ARTHRALGIA (joints and muscle aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced RETCHING (dry heaves), PYREXIA (fever), HEADACHE (headache), MYALGIA (joints and muscle aches), ARTHRALGIA (joints and muscle aches), CHILLS (chills), VOMITING (vomiting) and DIARRHOEA (slight diarrhea). On 06-Feb-2021, RETCHING (dry heaves), PYREXIA (fever), HEADACHE (headache), MYALGIA (joints and muscle aches), ARTHRALGIA (joints and muscle aches), CHILLS (chills), VOMITING (vomiting) and DIARRHOEA (slight diarrhea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1560584
Sex: F
Age: 75
State: IA

Vax Date: 01/28/2021
Onset Date: 01/28/2021
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: Swelling; Itchiness; Arm was warm to touch; soreness; Redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (soreness), ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (Itchiness) and FEELING HOT (Arm was warm to touch) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 immunisation. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (soreness) and ERYTHEMA (Redness). On 06-Feb-2021, the patient experienced SWELLING (Swelling), PRURITUS (Itchiness) and FEELING HOT (Arm was warm to touch). The patient was treated with CORTISONE at an unspecified dose and frequency. On 29-Jan-2021, PAIN (soreness) and ERYTHEMA (Redness) had resolved. At the time of the report, SWELLING (Swelling), PRURITUS (Itchiness) and FEELING HOT (Arm was warm to touch) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1560585
Sex: F
Age: 56
State: MI

Vax Date: 02/10/2021
Onset Date: 02/11/2021
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: Site of injection swelling; Pain on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Site of injection swelling) and VACCINATION SITE PAIN (Pain on the site of injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Site of injection swelling) and VACCINATION SITE PAIN (Pain on the site of injection). At the time of the report, VACCINATION SITE SWELLING (Site of injection swelling) and VACCINATION SITE PAIN (Pain on the site of injection) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1560586
Sex: F
Age: 70
State:

Vax Date: 01/29/2021
Onset Date:
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: Hives; Itchy; Redness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PRURITUS (Itchy) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L2019) for COVID-19 vaccination. The patient's past medical history included No adverse event (Medical history was not reported). On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), PRURITUS (Itchy) and ERYTHEMA (Redness). The patient was treated with HYDROCORTISONE (topical) for Itchy, at a dose of UNK dosage form. At the time of the report, URTICARIA (Hives), PRURITUS (Itchy) and ERYTHEMA (Redness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication use was not provided. Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: Follow-up received on 12-FEB-2021.Patient demographics, Vaccine information which includes date of first dose, batch number, Route of administration were added.Treatment information and new events which includes Itchiness, Redness were added.

Other Meds:

Current Illness:

ID: 1560587
Sex: M
Age:
State: FL

Vax Date: 02/07/2021
Onset Date: 02/08/2021
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: Diarrhea; Stomach hurt; Neck hurt; Shoulders hurt; Nausea; Very weak; Lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Very weak), LETHARGY (Lethargic), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt) and NECK PAIN (Neck hurt) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ASTHENIA (Very weak) and LETHARGY (Lethargic). On 09-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt), NECK PAIN (Neck hurt), ARTHRALGIA (Shoulders hurt) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Very weak), LETHARGY (Lethargic), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach hurt), NECK PAIN (Neck hurt), ARTHRALGIA (Shoulders hurt) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1560588
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: Vaccination site lymphadenopathy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Vaccination site lymphadenopathy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Vaccination site lymphadenopathy). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Vaccination site lymphadenopathy) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1560589
Sex: M
Age: 75
State: NJ

Vax Date: 01/28/2021
Onset Date: 01/28/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1560590
Sex: F
Age:
State: FL

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: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: nauseous; discomfort; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) and DISCOMFORT (discomfort) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-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 NAUSEA (nauseous) and DISCOMFORT (discomfort). The patient was treated with FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, NAUSEA (nauseous) and DISCOMFORT (discomfort) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm