VAERS 2021 Database www.vaers.hhs.gov

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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: 1567707
Sex: F
Age: 68
State: GA

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: started to feel exteremely chilly; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (started to feel exteremely chilly) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (started to feel exteremely chilly). At the time of the report, CHILLS (started to feel exteremely chilly) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was taking concomitant medications (name not specified). No treatment was received.

Other Meds:

Current Illness:

ID: 1567708
Sex: F
Age: 52
State: OH

Vax Date: 02/11/2021
Onset Date: 03/12/2021
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: extreme headaches; nausea; chills; body aches; fever; exhaustion and fatigue; felt like somebody had beat me up; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (extreme headaches), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Lupus syndrome. Concomitant products included CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), DICLOFENAC, DULOXETINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FOLIC ACID, LEVOTHYROXINE, IBUPROFEN, ROPINIROLE, SUCRALFATE, SUMATRIPTAN, TIZANIDINE and VITAMIN D NOS. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (extreme headaches), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever), FATIGUE (exhaustion and fatigue) and FEELING ABNORMAL (felt like somebody had beat me up). The patient was treated with PANTOPRAZOLE ongoing since an unknown date at an unspecified dose and frequency. On 17-Mar-2021, HEADACHE (extreme headaches), NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever), FATIGUE (exhaustion and fatigue) and FEELING ABNORMAL (felt like somebody had beat me up) had resolved. Additional concomitant medications included Omega fish oil ,Benzoate, Hydrochloroquine No treatment was provided.

Other Meds: CALTRATE [CALCIUM CARBONATE]; DICLOFENAC; DULOXETINE; FLONASE [FLUTICASONE PROPIONATE]; FOLIC ACID; LEVOTHYROXINE; IBUPROFEN; ROPINIROLE; SUCRALFATE; SUMATRIPTAN; TIZANIDINE; VITAMIN D NOS

Current Illness:

ID: 1567709
Sex: M
Age: 69
State: TX

Vax Date: 03/03/2021
Onset Date: 03/10/2021
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: Light-headed/Dizzy; Weakness/ no energy; Clammy; Stomach tied up in knots; Thirsty; Random episodes of nausea/Felt like he was going to pass out; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light-headed/Dizzy), ASTHENIA (Weakness/ no energy), COLD SWEAT (Clammy), ABDOMINAL PAIN UPPER (Stomach tied up in knots) and THIRST (Thirsty) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M2077) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Light-headed/Dizzy), ASTHENIA (Weakness/ no energy), COLD SWEAT (Clammy), ABDOMINAL PAIN UPPER (Stomach tied up in knots), THIRST (Thirsty) and NAUSEA (Random episodes of nausea/Felt like he was going to pass out). At the time of the report, DIZZINESS (Light-headed/Dizzy), ASTHENIA (Weakness/ no energy), COLD SWEAT (Clammy), ABDOMINAL PAIN UPPER (Stomach tied up in knots), THIRST (Thirsty) and NAUSEA (Random episodes of nausea/Felt like he was going to pass out) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. These episode happened on 10-Mar-2021 and 16-Mar-2021. Concomitant products known to be used by the patient were Blood pressure medication, Cholesterol medication, Arthritis medication. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1567710
Sex: F
Age: 72
State: IL

Vax Date: 03/09/2021
Onset Date: 03/11/2021
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: Pain in lower right arm -when use it pain moved from lower right arm all the way to hand when use it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in lower right arm -when use it pain moved from lower right arm all the way to hand when use it) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in lower right arm -when use it pain moved from lower right arm all the way to hand when use it). At the time of the report, VACCINATION SITE PAIN (Pain in lower right arm -when use it pain moved from lower right arm all the way to hand when use it) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication were not provided.

Other Meds: SKYRIZI [RISANKIZUMAB RZAA]

Current Illness:

ID: 1567711
Sex: F
Age: 57
State: GA

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: 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: This spontaneous case reported by a patient, describes the occurrence of pain in extremity (pain in leg), pain (achy all over and now has subsided), pain in extremity (her arm is sore but not horrible), arthralgia (pain in hips) and injection site pain (injection site pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional events detailed below. The patient's past medical history included no adverse event. On Jan 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 9, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 9, 2021, patient experienced pain (achy all over and now has subsided), pain in extremity (her arm is sore but not horrible) and pyrexia (fever). On Feb 10, 2021, patient experienced pain in extremity (pain in leg), arthralgia (pain in hips) and injection site pain (injection site pain). At the time of the report, pain in extremity (pain in leg), pain in extremity (her arm is sore but not horrible), arthralgia (pain in hips) and injection site pain (injection site pain) outcome: unknown and pain (achy all over and now has subsided) and pyrexia (fever): resolving. Patient took Advil for her first dose and took 2 extra strength Tylenol after the second dose. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable. This case linked to MOD-2021-003479 (patient link).

Other Meds:

Current Illness:

ID: 1567712
Sex: F
Age: 64
State: FL

Vax Date: 03/16/2021
Onset Date: 03/16/2021
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: Stomach pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. Concomitant products included ATENOLOL, ENALAPRIL MALEATE (ENAPRIL), OMEPRAZOLE, EZETIMIBE, LORATADINE (LORATADIN) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No laboratory data was provided. No treatment information was provided.

Other Meds: ATENOLOL; ENAPRIL; OMEPRAZOLE; EZETIMIBE; LORATADIN; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1567713
Sex: F
Age:
State: PA

Vax Date: 01/28/2021
Onset Date: 02/25/2021
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: thinking its acid reflux; Burning in stomach; Hurting in stomach/some pain in stomach; Metallic taste in her mouth; She had some fever; Headache; Tiredness; Body aches; About 12 hours after receiving 2nd dose, her arm started to get sore; Stomach discomfort/feels discomfort and heaviness on top of the stomach; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (About 12 hours after receiving 2nd dose, her arm started to get sore), ABDOMINAL DISCOMFORT (Stomach discomfort/feels discomfort and heaviness on top of the stomach), GASTROOESOPHAGEAL REFLUX DISEASE (thinking its acid reflux), DYSPEPSIA (Burning in stomach) and ABDOMINAL PAIN UPPER (Hurting in stomach/some pain in stomach) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical information was provided by the reporter. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), LEVOTHYROXINE, MULTIVITAMIN [VITAMINS NOS] and FISH OIL for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (About 12 hours after receiving 2nd dose, her arm started to get sore), ABDOMINAL DISCOMFORT (Stomach discomfort/feels discomfort and heaviness on top of the stomach) and HEADACHE (Headache). 25-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth), PYREXIA (She had some fever), FATIGUE (Tiredness) and MYALGIA (Body aches). On 26-Feb-2021, the patient experienced DYSPEPSIA (Burning in stomach). 26-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Hurting in stomach/some pain in stomach). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (thinking its acid reflux). The patient was treated with FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency; OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at an unspecified dose and frequency and ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) at an unspecified dose and frequency. On 26-Feb-2021, PAIN IN EXTREMITY (About 12 hours after receiving 2nd dose, her arm started to get sore), HEADACHE (Headache), FATIGUE (Tiredness) and MYALGIA (Body aches) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach discomfort/feels discomfort and heaviness on top of the stomach), GASTROOESOPHAGEAL REFLUX DISEASE (thinking its acid reflux), DYSPEPSIA (Burning in stomach), DYSGEUSIA (Metallic taste in her mouth) and PYREXIA (She had some fever) outcome was unknown and ABDOMINAL PAIN UPPER (Hurting in stomach/some pain in stomach) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Endoscopy: unknown (Inconclusive) Unknown. It was reported that about 12 hours after receiving 2nd dose, patient arm started to get sore. She had some fever, headache and stomach discomfort, tiredness and body aches. After 24 hours later(26Feb2021), she only had stomach discomfort with burning and hurting in stomach. She feels discomfort and heaviness on top of the stomach. patient reported metallic taste in her mouth that started on 25-Feb-2021. She wants to know about commonly reported side effects It was reported that the patient experienced a lot of stomach problems, burning. She took a lot of medications. She went through tests, saw doctors. She said her symptoms didn't end a day or two after the vaccine and it is still a problem. She said it might have changed. She is on medication now. Ten days before second dose the symptoms went away. After the second dose, on the first day she had fever and wasn't feeling well. On the second day, problem came back, and it was worse. She had burning and some pain in stomach. She started taking antacids, tried several different medicines. A month into it, started taking Nexium over the counter. It helped a little bit. She went to GI doctor, did endoscopy, checked gall bladder. They put her on diet to see if it's gall bladder. Pain went away with diet. Now they're thinking its acid reflux. Treatment provided Tums, Milk of magnesia . Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-024653 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021 and included significant information such as New events were added, Treatment information about the patient was added, New lab test was added and details about doctor consultation was added.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-024653:1st dose

Other Meds: SINGULAIR; LEVOTHYROXINE; MULTIVITAMIN [VITAMINS NOS]; FISH OIL

Current Illness:

ID: 1567714
Sex: F
Age: 20
State: NC

Vax Date: 03/09/2021
Onset Date: 03/12/2021
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: hives; itching all over her chest, back, arms, legs, feet, everywhere; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and PRURITUS (itching all over her chest, back, arms, legs, feet, everywhere) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced URTICARIA (hives) and PRURITUS (itching all over her chest, back, arms, legs, feet, everywhere). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) and PRURITUS (itching all over her chest, back, arms, legs, feet, everywhere) 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 concomitant medication were provided by the reporter.

Other Meds:

Current Illness:

ID: 1567715
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Very cold; Body aches; Fever temperature of 101 F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Very cold), PAIN (Body aches), PYREXIA (Fever temperature of 101 F) and HEADACHE (Headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING COLD (Very cold), PAIN (Body aches), PYREXIA (Fever temperature of 101 F) and HEADACHE (Headache). At the time of the report, FEELING COLD (Very cold), PAIN (Body aches), PYREXIA (Fever temperature of 101 F) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Patient also mentioned that he has not had a temperature like this in years Treatment details was not provided.

Other Meds:

Current Illness:

ID: 1567716
Sex: M
Age: 55
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: soreness on the arm of the injection; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on the arm of the injection) and FATIGUE (felt tired) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal, Blood cholesterol abnormal and Prostate cancer. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness on the arm of the injection) and FATIGUE (felt tired). At the time of the report, VACCINATION SITE PAIN (soreness on the arm of the injection) and FATIGUE (felt tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included unspecified blood pressure and cholesterol medication. No treatment information was provided. The patient is going to have a surgery on 09-APR-2021.

Other Meds:

Current Illness: Blood cholesterol abnormal; Blood pressure abnormal; Prostate cancer

ID: 1567717
Sex: F
Age: 73
State: MA

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

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

Lab Data:

Allergies:

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

Symptoms: Scratchy Throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Scratchy Throat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. Concurrent medical conditions included Allergy (different underlying health problems and allergies). Concomitant products included MONTELUKAST, ATENOLOL, ALLOPURINOL, ACETAMINOPHEN, CALCIUM CARBONATE (TUMS 500 CALCIUM), FISH OIL, TRAMADOL, METFORMIN, AMLODIPINE, ESTRADIOL (ESTRADIOL ANTIBIOTICOS), LOTEPREDNOL ETABONATE and CITICOLINE for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced THROAT IRRITATION (Scratchy Throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat irritation, at a dose of UNK dosage form. On 28-Feb-2021, THROAT IRRITATION (Scratchy Throat) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included unspecified eye drops.

Other Meds: MONTELUKAST; ATENOLOL; ALLOPURINOL; ACETAMINOPHEN; TUMS 500 CALCIUM; FISH OIL; TRAMADOL; METFORMIN; AMLODIPINE; ESTRADIOL ANTIBIOTICOS; LOTEPREDNOL ETABONATE; CITICOLINE

Current Illness: Allergy (different underlying health problems and allergies)

ID: 1567718
Sex: F
Age: 49
State: MN

Vax Date: 03/14/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: dizziness,dizziness is worse; can't stand up; cannot eat; very weak; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness,dizziness is worse), BALANCE DISORDER (can't stand up), EATING DISORDER (cannot eat), ASTHENIA (very weak) and VOMITING (vomiting) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced BALANCE DISORDER (can't stand up), EATING DISORDER (cannot eat), ASTHENIA (very weak) and VOMITING (vomiting). On an unknown date, the patient experienced DIZZINESS (dizziness,dizziness is worse). At the time of the report, DIZZINESS (dizziness,dizziness is worse), BALANCE DISORDER (can't stand up), EATING DISORDER (cannot eat) and VOMITING (vomiting) outcome was unknown and ASTHENIA (very weak) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications taken by the patient were not provided. Patient had experienced dizziness on 16 Mar 2021 ant the dizziness was worse on 17 Mar 2021. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1567719
Sex: F
Age: 23
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 23-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and DOCOSAHEXAENOIC ACID (DHA) for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Oct-2020 and the estimated date of delivery was 02-Aug-2021. On 17-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-first week of the pregnancy. On 17-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Tests done was Ultrasounds, Anatomy scan and urinalysis (test results unknown). On 26 Nov 2020, Pregnancy test was Positive. No treatment medications reported.

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

Current Illness:

ID: 1567720
Sex: M
Age: 62
State: CT

Vax Date: 03/10/2021
Onset Date: 03/11/2021
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: Loss of sleep; Lymph node swelling; Injection site pain; Aches in joints/Aches in knees; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swelling), VACCINATION SITE PAIN (Injection site pain), ARTHRALGIA (Aches in joints/Aches in knees), CHILLS (Chills) and INSOMNIA (Loss of sleep) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included MONASCUS PURPUREUS (RED YEAST RICE), OMEPRAZOLE, LISINOPRIL, IBUPROFEN, FISH OIL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph node swelling), VACCINATION SITE PAIN (Injection site pain), ARTHRALGIA (Aches in joints/Aches in knees), CHILLS (Chills) and INSOMNIA (Loss of sleep). At the time of the report, LYMPHADENOPATHY (Lymph node swelling) outcome was unknown and VACCINATION SITE PAIN (Injection site pain), ARTHRALGIA (Aches in joints/Aches in knees), CHILLS (Chills) and INSOMNIA (Loss of sleep) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication also included coQ10. No treatment information was provided. Lymph node swelling had continued for 1 week.

Other Meds: RED YEAST RICE; OMEPRAZOLE; LISINOPRIL; IBUPROFEN; FISH OIL; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1567721
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1567722
Sex: F
Age: 29
State: CA

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck; Headache; chills; had a fever of 99.7; legs hurting,arms hurting; back hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs hurting,arms hurting), BACK PAIN (back hurting), RASH (rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck), HEADACHE (Headache) and CHILLS (chills) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sulfonamide allergy. Concomitant products included PROBIOTICS NOS for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs hurting,arms hurting), BACK PAIN (back hurting), HEADACHE (Headache), CHILLS (chills) and PYREXIA (had a fever of 99.7). On 13-Mar-2021, the patient experienced RASH (rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck). The patient was treated with PARACETAMOL (TYLENOL) on 12-Mar-2021 for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 13-Mar-2021 for Adverse event, at a dose of UNK dosage form. On 13-Mar-2021, PAIN IN EXTREMITY (legs hurting,arms hurting), BACK PAIN (back hurting), HEADACHE (Headache), CHILLS (chills) and PYREXIA (had a fever of 99.7) had resolved. On 14-Mar-2021, RASH (rashes on chest/ rashes on abdomen/ rashes on back/rashes on neck) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 99.7 (High) 99.7,Fever. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: PROBIOTICS NOS

Current Illness: Sulfonamide allergy

ID: 1567723
Sex: F
Age:
State: TX

Vax Date: 02/14/2021
Onset Date: 02/14/2021
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: Received the Moderna vaccine to 17 years old patient; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the Moderna vaccine to 17 years old patient) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included No adverse event (No medical history reported). On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the Moderna vaccine to 17 years old patient). On 14-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the Moderna vaccine to 17 years old patient) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No information on concomitant medication was provided. No treatment information was provided.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1567724
Sex: F
Age: 68
State: MI

Vax Date: 01/13/2021
Onset Date: 01/13/2021
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: fever; Chills; soreness; Achiness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), PYREXIA (fever), CHILLS (Chills) and ARTHRALGIA (soreness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PAIN (Achiness) and ARTHRALGIA (soreness). On 10-Feb-2021, the patient experienced PYREXIA (fever) and CHILLS (Chills). The patient was treated with IBUPROFEN for Fever, Chills and Ache, at a dose of 1 dosage form. On 14-Jan-2021, PAIN (Achiness) and ARTHRALGIA (soreness) had resolved. On 11-Feb-2021, PYREXIA (fever) and CHILLS (Chills) had resolved. No concomitant medication were reported The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable

Other Meds:

Current Illness:

ID: 1567725
Sex: F
Age:
State: NH

Vax Date: 01/25/2021
Onset Date: 01/25/2021
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: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm hurting), insomnia (unable to sleep), chills, myalgia (muscle pain) and fatigue in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional events detailed below. No medical history information reported. On Dec 28, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 25, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 25, 2021, patient experienced pain in extremity (arm hurting), insomnia (unable to sleep), chills, myalgia (muscle pain), fatigue, nausea and pyrexia (temperature 100 degrees). The patient was treated with ibuprofen at a dose of 1 dosage form. At the time of the report, pain in extremity (arm hurting), insomnia (unable to sleep), chills, myalgia (muscle pain), fatigue, nausea and pyrexia (temperature 100 degrees) outcome: unknown. For mRNA-1273 (Moderna COVID-19 vaccine), intramuscular, the reporter did not provide any causality assessments or concomitant medication use.

Other Meds:

Current Illness:

ID: 1567726
Sex: M
Age: 67
State:

Vax Date: 03/11/2021
Onset Date: 03/12/2021
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: cough; vomiting; fatigue; nausea; Chills; muscle aches; chills; sore left arm; joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (cough), PAIN IN EXTREMITY (sore left arm), ARTHRALGIA (joint pain), VOMITING (vomiting) and MYALGIA (muscle aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History Information was reported. Concomitant products included CLOPIDOGREL for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), ARTHRALGIA (joint pain), MYALGIA (muscle aches) and CHILLS (chills). On 16-Mar-2021, the patient experienced COUGH (cough), VOMITING (vomiting), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (Chills). The patient was treated with OMEPRAZOLE at an unspecified dose and frequency; PARACETAMOL at an unspecified dose and frequency; RIVAROXABAN at an unspecified dose and frequency; RUPATADINE at a dose of 10 mg and FLUTICASONE at a dose of 200 pg/ml twice a day. On 13-Mar-2021, PAIN IN EXTREMITY (sore left arm), ARTHRALGIA (joint pain), MYALGIA (muscle aches) and CHILLS (chills) had resolved. At the time of the report, COUGH (cough), VOMITING (vomiting), NAUSEA (nausea) and CHILLS (Chills) outcome was unknown and FATIGUE (fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Oxygen saturation: 90 or less (Low) oxygen levels went down up to 90 or less when he was standing up and 95/97 (Inconclusive) if he sits down levels go back to 95/97. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications include Blood Pressure Medication Doctor advised him on not taking the 2nd dose

Other Meds: CLOPIDOGREL

Current Illness:

ID: 1567727
Sex: F
Age: 38
State: TX

Vax Date: 03/05/2021
Onset Date: 03/05/2021
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: itches very bad; circular rash; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itches very bad), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE RASH (circular rash) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 11-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itches very bad) and VACCINATION SITE RASH (circular rash). At the time of the report, VACCINATION SITE PRURITUS (itches very bad), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE RASH (circular rash) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication use was provided No treatment of events was reported.

Other Meds:

Current Illness:

ID: 1567728
Sex: F
Age: 80
State:

Vax Date: 03/16/2021
Onset Date: 03/01/2021
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: Dizziness; Sore throat; Hot water hurt her skin; Arm is in so much pain the cannot move the arm.; Freezing cold at room temperature; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Hot water hurt her skin), PAIN IN EXTREMITY (Arm is in so much pain the cannot move the arm.) and FEELING COLD (Freezing cold at room temperature) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Hot water hurt her skin), PAIN IN EXTREMITY (Arm is in so much pain the cannot move the arm.), FEELING COLD (Freezing cold at room temperature) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (Sore throat), BURNING SENSATION (Hot water hurt her skin), PAIN IN EXTREMITY (Arm is in so much pain the cannot move the arm.), FEELING COLD (Freezing cold at room temperature) and FATIGUE (Fatigue) had not resolved. Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1567729
Sex: M
Age: 67
State: FL

Vax Date: 02/10/2021
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: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: exceed dosing interval; rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (exceed dosing interval) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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 HEART RATE INCREASED (rapid heart beat). On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (exceed dosing interval). At the time of the report, HEART RATE INCREASED (rapid heart beat) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (exceed dosing interval) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was mentioned. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1567730
Sex: F
Age:
State: OK

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: disoriented; forgetful; fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of DISORIENTATION (disoriented), MEMORY IMPAIRMENT (forgetful) and FATIGUE (fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced DISORIENTATION (disoriented), MEMORY IMPAIRMENT (forgetful) and FATIGUE (fatigue). At the time of the report, DISORIENTATION (disoriented), MEMORY IMPAIRMENT (forgetful) and FATIGUE (fatigue) 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 and treatment medications were reported. Patient was feeling better on 09-Mar-2021.

Other Meds:

Current Illness:

ID: 1567731
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Pregnant wife received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant wife received the vaccine) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The patient's past medical history included Miscarriage (Sometime in Oct-Nov 2020.). On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Feb-2021 and the estimated date of delivery was 17-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant wife received the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fourth week of the pregnancy. On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant wife received the vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Pregnancy test: positive positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication use was provided by the reporter. Patient tested positive for pregnant on 11-MAr-2021. Prenatal case has not been established. No treatment of events was reported. Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Internal review on 26-JUL-2021 resulted in update of Lab data,Gravida,Birth type and fetal outcome

Other Meds:

Current Illness:

ID: 1567732
Sex: F
Age:
State: GA

Vax Date: 03/02/2021
Onset Date: 03/02/2021
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: Hurt to move her arm; Got a little fever on it; Her arm was starting to get sore again where she got the shot; Her arm was real sore, then very painful; Her arm itched like crazy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm was real sore, then very painful), PRURITUS (Her arm itched like crazy), VACCINATION SITE WARMTH (Got a little fever on it), PAIN (Hurt to move her arm) and VACCINATION SITE PAIN (Her arm was starting to get sore again where she got the shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Itching. Concurrent medical conditions included Hypertension (HIgh blood pressure) and Hypercholesterolaemia (High cholesterol). On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Her arm was real sore, then very painful) and PRURITUS (Her arm itched like crazy). On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Her arm was starting to get sore again where she got the shot). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Got a little fever on it). On 14-Mar-2021, the patient experienced PAIN (Hurt to move her arm). On 17-Mar-2021, PAIN IN EXTREMITY (Her arm was real sore, then very painful), PRURITUS (Her arm itched like crazy), VACCINATION SITE WARMTH (Got a little fever on it), PAIN (Hurt to move her arm) and VACCINATION SITE PAIN (Her arm was starting to get sore again where she got the shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product used included high blood pressure medication NOS and high cholesterol medication NOS.

Other Meds:

Current Illness: Hypercholesterolaemia (High cholesterol); Hypertension (HIgh blood pressure)

ID: 1567733
Sex: F
Age:
State:

Vax Date: 03/17/2021
Onset Date: 03/17/2021
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: heart rate of 173; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate of 173) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HEART RATE INCREASED (heart rate of 173). At the time of the report, HEART RATE INCREASED (heart rate of 173) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Heart rate: 173 (Inconclusive) heart rate of 173. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication use was provided by the reporter. No treatment of events was reported.

Other Meds:

Current Illness:

ID: 1567734
Sex: F
Age:
State: NJ

Vax Date: 03/10/2021
Onset Date: 03/11/2021
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: she was not feeling well; she had chills which woke her up all night; she had chills which woke her up all night; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she was not feeling well), MIDDLE INSOMNIA (she had chills which woke her up all night) and CHILLS (she had chills which woke her up all night) 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 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (she was not feeling well), MIDDLE INSOMNIA (she had chills which woke her up all night) and CHILLS (she had chills which woke her up all night). On 12-Mar-2021, MALAISE (she was not feeling well), MIDDLE INSOMNIA (she had chills which woke her up all night) and CHILLS (she had chills which woke her up all night) had resolved. Action taken with mRNA-1273 in response to the event was not applicable. Treatment medicines were not reported. This case was linked to US-MODERNATX, INC.-MOD-2021-048160, MOD-2021-041860, MOD-2021-054920 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Follow up received on 22 Mar 2021 and contains no new information and Dates of events were reported one day earlier. Kept dates from original report; Sender's Comments: US-MODERNATX, INC.-MOD-2021-048160: MOD-2021-041860:Mother's Case MOD-2021-054920:Father's Case

Other Meds:

Current Illness:

ID: 1567735
Sex: F
Age: 58
State: FL

Vax Date: 03/12/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Cannot raise her arm up due to pain; Lump the size of a golf ball at the injection site; swelling seemed to be moving down her left side; Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side; Red at the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump the size of a golf ball at the injection site), SWELLING (swelling seemed to be moving down her left side), MOBILITY DECREASED (Cannot raise her arm up due to pain), VACCINATION SITE PAIN (Sore arm) and LYMPHADENOPATHY (Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 14-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump the size of a golf ball at the injection site), SWELLING (swelling seemed to be moving down her left side), LYMPHADENOPATHY (Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side) and VACCINATION SITE ERYTHEMA (Red at the injection site). On 17-Mar-2021, the patient experienced MOBILITY DECREASED (Cannot raise her arm up due to pain). The patient was treated with IBUPROFEN on 12-Mar-2021 at a dose of UNK dosage form. At the time of the report, VACCINATION SITE MASS (Lump the size of a golf ball at the injection site) and VACCINATION SITE PAIN (Sore arm) was resolving and SWELLING (swelling seemed to be moving down her left side), MOBILITY DECREASED (Cannot raise her arm up due to pain), LYMPHADENOPATHY (Lymph nodes started swelling under her left arm, swelling seemed to be moving her left side) and VACCINATION SITE ERYTHEMA (Red at the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided by the reporter.

Other Meds:

Current Illness:

ID: 1567736
Sex: F
Age: 64
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: stuffy nose; fever; headache; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (stuffy nose), PYREXIA (fever) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The patient's past medical history included COVID-19. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced NASAL CONGESTION (stuffy nose), PYREXIA (fever) and HEADACHE (headache). At the time of the report, NASAL CONGESTION (stuffy nose), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 100.2 f (High) 100.2 F.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication use was provided by the reporter. No treatment of events was reported.

Other Meds:

Current Illness:

ID: 1567737
Sex: F
Age: 49
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: cough; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and PAIN IN EXTREMITY (sore arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced COUGH (cough) and PAIN IN EXTREMITY (sore arm). At the time of the report, COUGH (cough) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1567738
Sex: F
Age: 68
State: AZ

Vax Date: 02/24/2021
Onset Date: 03/04/2021
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: very Weak; Infection on the arm; Welt arm; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very Weak), LOCALISED INFECTION (Infection on the arm), URTICARIA (Welt arm) and TREMOR (Shaking) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The patient's past medical history included Infection (Infection after Chemotherapy which was resolved) in November 2020 and Chemotherapy (Not Specified) in November 2020. Concurrent medical conditions included Cancer (Not Specified) and Red rash (Red rash all over the arms prior to vaccination and still going on). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Red rash. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ASTHENIA (very Weak), LOCALISED INFECTION (Infection on the arm), URTICARIA (Welt arm) and TREMOR (Shaking). At the time of the report, ASTHENIA (very Weak), LOCALISED INFECTION (Infection on the arm), URTICARIA (Welt arm) and TREMOR (Shaking) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Cancer (Not Specified); Red rash (Red rash all over the arms prior to vaccination and still going on)

ID: 1567739
Sex: F
Age: 72
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: arm swelled; deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest; started itching; she feels hazy, a little disoriented; allergic reaction; didn't feel well; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest), RASH PRURITIC (started itching), DISORIENTATION (she feels hazy, a little disoriented) and HYPERSENSITIVITY (allergic reaction) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030AZlA and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by reporter. No concomitant medication reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest), RASH PRURITIC (started itching), DISORIENTATION (she feels hazy, a little disoriented) and HYPERSENSITIVITY (allergic reaction). 10-Mar-2021, the patient experienced VACCINATION COMPLICATION (didn't feel well) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (deep red reaction that went down arm, redness is healing up on the arm but now is spreading to the middle of upper chest), RASH PRURITIC (started itching), HYPERSENSITIVITY (allergic reaction), VACCINATION COMPLICATION (didn't feel well) and FATIGUE (fatigue) outcome was unknown and DISORIENTATION (she feels hazy, a little disoriented) had not resolved. Not Provided Concomitant medications were not provided by the reporter. The patient went to an urgent care on 13MAR2021. Details about the visit were not provided.

Other Meds:

Current Illness:

ID: 1567740
Sex: F
Age: 73
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: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: sneezing; stuffiness; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing), NASAL CONGESTION (stuffiness) and VACCINATION SITE PAIN (Soreness in arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. 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 VACCINATION SITE PAIN (Soreness in arm). On 15-Mar-2021, the patient experienced SNEEZING (sneezing) and NASAL CONGESTION (stuffiness). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, SNEEZING (sneezing), NASAL CONGESTION (stuffiness) and VACCINATION SITE PAIN (Soreness in arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1567741
Sex: F
Age: 67
State: TX

Vax Date: 03/12/2021
Onset Date: 03/12/2021
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: Erythema, Pruritus

Symptoms: arm swelled up; arm swelled up, and was hot and heavy; arm swelled up, and was hot and heavy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up), FEELING HOT (arm swelled up, and was hot and heavy), LIMB DISCOMFORT (arm swelled up, and was hot and heavy) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The patient's past medical history included Dialysis since an unknown date. Concomitant products included HYDROXYZINE, ALLOPURINOL, RENA-VITE, VITAMINS NOS (GERITOL [VITAMINS NOS]) and LABETALOL HCL for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (Headache). On 13-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (arm swelled up), FEELING HOT (arm swelled up, and was hot and heavy) and LIMB DISCOMFORT (arm swelled up, and was hot and heavy). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 16-Mar-2021, PERIPHERAL SWELLING (arm swelled up), FEELING HOT (arm swelled up, and was hot and heavy) and LIMB DISCOMFORT (arm swelled up, and was hot and heavy) had resolved. At the time of the report, HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: HYDROXYZINE; ALLOPURINOL; RENA-VITE; GERITOL [VITAMINS NOS]; LABETALOL HCL

Current Illness: Dialysis

ID: 1567742
Sex: F
Age:
State: IN

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

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

Lab Data:

Allergies:

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

Symptoms: Teeth hurt; Could not get warm; Could not drink anything because water warm hit bad; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL DISCOMFORT (Teeth hurt), FEELING COLD (Could not get warm) and HYPOPHAGIA (Could not drink anything because water warm hit bad) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination. No relevant medical history was reported. Concomitant products included LOSARTAN, OMEPRAZOLE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN, VITAMIN B COMPLEX, ARMODAFINIL, VITAMIN C [ASCORBIC ACID], PROBIOTICS NOS and VITAMIN D NOS for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DENTAL DISCOMFORT (Teeth hurt), FEELING COLD (Could not get warm) and HYPOPHAGIA (Could not drink anything because water warm hit bad). The patient was treated with IBUPROFEN at a dose of UNK, q4h and PARACETAMOL (TYLENOL) 14-Mar-2021 at an unspecified dose and frequency. On 14-Mar-2021, DENTAL DISCOMFORT (Teeth hurt), FEELING COLD (Could not get warm) and HYPOPHAGIA (Could not drink anything because water warm hit bad) had resolved.

Other Meds: LOSARTAN; OMEPRAZOLE; ATORVASTATIN; ASPIRIN 81; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;; VITAMIN B COMPLEX; ARMODAFINIL; VITAMIN C [ASCORBIC ACID]; PROBIOTICS NOS; VITAMIN D NOS

Current Illness:

ID: 1567743
Sex: F
Age:
State:

Vax Date: 02/22/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Burning sensation; Itching on the left arm; Rash on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation), PRURITUS (Itching on the left arm) and RASH (Rash on the left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. No Medical History information was reported. On 22-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 BURNING SENSATION (Burning sensation), PRURITUS (Itching on the left arm) and RASH (Rash on the left arm). At the time of the report, BURNING SENSATION (Burning sensation), PRURITUS (Itching on the left arm) and RASH (Rash on the left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications was reported by the reporter No treatment medications was provided by the reporter.

Other Meds:

Current Illness:

ID: 1567744
Sex: F
Age:
State: NM

Vax Date: 01/27/2021
Onset Date: 02/28/2021
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: Lips started to swell/ lips are swollen; Lips crack; Lips bleed; Lips painful; Lips dry; Dehydrated to a point my skin of lips started to came out; Lips are red; Lips has blister; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lips started to swell/ lips are swollen), CHAPPED LIPS (Lips crack), LIP HAEMORRHAGE (Lips bleed), LIP PAIN (Lips painful) and LIP DRY (Lips dry; Dehydrated to a point my skin of lips started to came out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included FLUOXETINE, LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and VITAMIN D3 for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced LIP SWELLING (Lips started to swell/ lips are swollen), CHAPPED LIPS (Lips crack), LIP HAEMORRHAGE (Lips bleed), LIP PAIN (Lips painful), LIP DRY (Lips dry; Dehydrated to a point my skin of lips started to came out), LIP ERYTHEMA (Lips are red) and LIP BLISTER (Lips has blister). At the time of the report, LIP SWELLING (Lips started to swell/ lips are swollen), CHAPPED LIPS (Lips crack), LIP HAEMORRHAGE (Lips bleed), LIP PAIN (Lips painful), LIP DRY (Lips dry; Dehydrated to a point my skin of lips started to came out), LIP ERYTHEMA (Lips are red) and LIP BLISTER (Lips has blister) had not resolved. Treatment for the event included Chapstick and an unspecified Steroid cream, which the reporter stated does not help. Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Pictures added

Other Meds: FLUOXETINE; NP THYROID; VITAMIN D3

Current Illness:

ID: 1567745
Sex: M
Age:
State: IN

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: 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: been 47 days on the second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (been 47 days on the second dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (been 47 days on the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (been 47 days on the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Pharmacist called today, patient received 1st dose on 29Jan2021, She said the patient is 59 years old and had multiple health conditions so he was in and out of the hospital which caused a delay to his second shot. This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # not reported with no associated AEs. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up case received but it does not contain new information. Case is possible NNI; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # not reported with no associated AEs.

Other Meds:

Current Illness:

ID: 1567746
Sex: M
Age: 64
State:

Vax Date: 03/16/2021
Onset Date: 03/17/2021
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: Fever; chills; stomach ache; body ache; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills), ABDOMINAL PAIN UPPER (stomach ache), MYALGIA (body ache) and DECREASED APPETITE (no appetite) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for an unknown indication. The patient's past medical history included No adverse event. Concomitant products included ADALIMUMAB (HUMIRA), METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TAMSULOSIN and ROSUVASTATIN. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (chills), ABDOMINAL PAIN UPPER (stomach ache), MYALGIA (body ache) and DECREASED APPETITE (no appetite). At the time of the report, PYREXIA (Fever), CHILLS (chills), ABDOMINAL PAIN UPPER (stomach ache), MYALGIA (body ache) and DECREASED APPETITE (no appetite) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant drug included Humira -Injections every 15 days for Psoriasis, Metoprolol-For his heart, Rosuvastatin-For cholesterol Consent for safety follow up allowed.

Other Meds: HUMIRA; METOPROLOL; ASPIRIN (E.C.); TAMSULOSIN; ROSUVASTATIN

Current Illness:

ID: 1567747
Sex: F
Age:
State: MO

Vax Date: 03/12/2021
Onset Date: 03/12/2021
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: fever of 100.6; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches), PYREXIA (fever of 100.6) and CHILLS (chills) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced MYALGIA (muscle aches). On 16-Mar-2021, the patient experienced PYREXIA (fever of 100.6) and CHILLS (chills). On 15-Mar-2021, MYALGIA (muscle aches) had resolved. At the time of the report, PYREXIA (fever of 100.6) and CHILLS (chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 100.6 (High) 100.6. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1567748
Sex: F
Age:
State: MO

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of pleural effusion (lungs filling up with fluid), diarrhea (uncontrolled diarrhea), abdominal discomfort (uncontrolled bowel movements), decreased mobility (cannot move) and vomiting in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history information reported. On Mar 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 16, 2021, patient experienced pleural effusion (lungs filling up with fluid), diarrhea (uncontrolled diarrhea), abdominal discomfort (uncontrolled bowel movements), decreased mobility (cannot move) and vomiting. At the time of the report, pleural effusion (lungs filling up with fluid), diarrhea (uncontrolled diarrhea), abdominal discomfort (uncontrolled bowel movements), decreased mobility (cannot move) and vomiting outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessment, concomitant medication or treatment information. This case linked to MOD-2021-048046 (patient link).

Other Meds:

Current Illness:

ID: 1567749
Sex: M
Age: 66
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: red skin; dry skin; itchy skin; rash on legs; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red skin), DRY SKIN (dry skin), PRURITUS (itchy skin) and RASH (rash on legs) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis and Hypertension. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ERYTHEMA (red skin), DRY SKIN (dry skin), PRURITUS (itchy skin) and RASH (rash on legs). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (red skin), DRY SKIN (dry skin), PRURITUS (itchy skin) and RASH (rash on legs) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter.

Other Meds:

Current Illness: Arthritis; Hypertension

ID: 1567750
Sex: M
Age: 43
State: TX

Vax Date: 01/16/2021
Onset Date: 03/13/2021
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: received second dose 8 weeks after the first dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose 8 weeks after the first dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose 8 weeks after the first dose). On 13-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose 8 weeks after the first dose) had resolved. This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Not Provided) with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Not Provided) with no associated AEs.

Other Meds:

Current Illness:

ID: 1567751
Sex: F
Age: 71
State: CT

Vax Date: 02/20/2021
Onset Date: 02/20/2021
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: arm is still really bad, had excruciating pain in her bicep muscle in the arm; a couple days ago it started to get worse; put her on antibiotics in caseit was an infection; Doctor advised her that she did not get the second dose she has scheduled on saturday, as if it was a immune reaction; Has passed the window for the second dose; excruciating pain in her bicep muscle in the arm; (injection) it was way up from there,maybe 2 inches from my shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm is still really bad, had excruciating pain in her bicep muscle in the arm), PAIN (a couple days ago it started to get worse), INFECTION (put her on antibiotics in caseit was an infection), IMMUNE-MEDIATED ADVERSE REACTION (Doctor advised her that she did not get the second dose she has scheduled on saturday, as if it was a immune reaction) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE ((injection) it was way up from there,maybe 2 inches from my shoulder) in a 71-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 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE ((injection) it was way up from there,maybe 2 inches from my shoulder) and MYALGIA (excruciating pain in her bicep muscle in the arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm is still really bad, had excruciating pain in her bicep muscle in the arm), PAIN (a couple days ago it started to get worse), INFECTION (put her on antibiotics in caseit was an infection), IMMUNE-MEDIATED ADVERSE REACTION (Doctor advised her that she did not get the second dose she has scheduled on saturday, as if it was a immune reaction) and INTENTIONAL PRODUCT USE ISSUE (Has passed the window for the second dose). On 20-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE ((injection) it was way up from there,maybe 2 inches from my shoulder) had resolved. At the time of the report, PAIN IN EXTREMITY (arm is still really bad, had excruciating pain in her bicep muscle in the arm), PAIN (a couple days ago it started to get worse), INFECTION (put her on antibiotics in caseit was an infection), IMMUNE-MEDIATED ADVERSE REACTION (Doctor advised her that she did not get the second dose she has scheduled on saturday, as if it was a immune reaction), INTENTIONAL PRODUCT USE ISSUE (Has passed the window for the second dose) and MYALGIA (excruciating pain in her bicep muscle in the arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The symptoms (infection) started to get better while on antibiotics. However, on an unspecified date, the infection started to worsen. On an unknown date, the doctor advised to put ice and told the patient not to receive the second dose, as it was an immune reaction and could be worse on the second dose. On an unknown date, the patient scheduled her second dose appointment. She wanted to make sure if it is ok to get her second dose since her appointment is nowoutside the window. Concomitant medications were not provided. Treatment medications included antibiotics and ice. Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Event information updated

Other Meds:

Current Illness:

ID: 1567752
Sex: F
Age: 80
State: FL

Vax Date: 03/06/2021
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: It's got heat to it; Iiches; swelling in her injection site; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It's got heat to it), VACCINATION SITE PRURITUS (Iiches), VACCINATION SITE SWELLING (swelling in her injection site) and VACCINATION SITE ERYTHEMA (redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A2/A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (It's got heat to it), VACCINATION SITE PRURITUS (Iiches), VACCINATION SITE SWELLING (swelling in her injection site) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE WARMTH (It's got heat to it), VACCINATION SITE PRURITUS (Iiches), VACCINATION SITE SWELLING (swelling in her injection site) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information were provided by the reporter This case was linked to MOD21-056467, US-MODERNATX, INC.-MOD-2021-048101 (E2B Linked Report).; Sender's Comments: MOD21-056467: US-MODERNATX, INC.-MOD-2021-048101:Reporter case: wife

Other Meds:

Current Illness:

ID: 1567753
Sex: M
Age: 68
State: CA

Vax Date: 02/11/2021
Onset Date: 03/17/2021
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: whole arm was red; whole arm was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (whole arm was red) and VACCINATION SITE WARMTH (whole arm was red) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (whole arm was red) and VACCINATION SITE WARMTH (whole arm was red). At the time of the report, VACCINATION SITE ERYTHEMA (whole arm was red) and VACCINATION SITE WARMTH (whole arm was red) outcome was unknown. No concomitant and treatment information was provided by the reporter. This case was linked to MOD-2021-048102 (E2B Linked Report). This case was linked to MOD-2021-048102, MOD-2021-048808 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up document is received on 26-MAY-2021 and it doesn't have any new information; Sender's Comments: MOD-2021-048102:crosslink

Other Meds:

Current Illness:

ID: 1567754
Sex: F
Age: 17
State: GA

Vax Date: 03/17/2021
Onset Date: 03/17/2021
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: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: 17 Year Old Received Vaccine; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On 17 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 003A21A) intramuscularly for prophylaxis of COVID-19 infection. The patient received vaccine at the age of 17 Years. Laboratory details were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event was recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1567755
Sex: F
Age: 22
State:

Vax Date: 03/12/2021
Onset Date: 03/12/2021
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: sore arm; lost sense taste; cold; fever; muscle aches; nausea; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), AGEUSIA (lost sense taste), NASOPHARYNGITIS (cold), HEADACHE (headache) and FATIGUE (fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ZIPRASIDONE, CLONAZEPAM and LAMOTRIGINE (LAMICTAL) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (fatigue). On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), AGEUSIA (lost sense taste), NASOPHARYNGITIS (cold), PYREXIA (fever), MYALGIA (muscle aches) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), AGEUSIA (lost sense taste), NASOPHARYNGITIS (cold), HEADACHE (headache), FATIGUE (fatigue), PYREXIA (fever), MYALGIA (muscle aches) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD21-056649, US-MODERNATX, INC.-MOD-2021-048129 (E2B Linked Report).; Sender's Comments: MOD21-056649:Crosslink father case US-MODERNATX, INC.-MOD-2021-048129:Crosslinked daughter case

Other Meds: ZIPRASIDONE; CLONAZEPAM; LAMICTAL

Current Illness:

ID: 1567756
Sex: M
Age: 82
State: FL

Vax Date: 03/06/2021
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: arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A2/A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. concomitants medications were not reported no treatment medications were reported This case was linked to US-MODERNATX, INC.-MOD-2021-048097 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-048097:Reporter case: wife

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm