VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1757846
Sex: M
Age: 86
State: MD

Vax Date: 12/31/2020
Onset Date:
Rec V Date: 10/04/2021
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: Not immunocompromised; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Not immunocompromised) and VACCINATION SITE PAIN (Pain at the injection site) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 032L20A and 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Not immunocompromised) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, OFF LABEL USE (Not immunocompromised) had resolved and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. Concomitant medications were not reported. Treatment medications were not reported. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up document received contains Initiative.

Other Meds:

Current Illness:

ID: 1757847
Sex: F
Age: 17
State: OK

Vax Date: 08/11/2021
Onset Date: 09/19/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: Test Date: 20210428; Test Name: pregnancy test; Test Result: Positive; Result Unstructured Data: positive

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Moderna Vaccine under age 18; Inappropriate schedule of vaccine administered; Maternal exposure during pregnancy.; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine under age 18), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy.) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Mar-2021 and the estimated date of delivery was 24-Dec-2021. On 19-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine under age 18), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy.). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-seventh week of the pregnancy. On 19-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy.) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Vaccine under age 18) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Pregnancy test: positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Relevant concomitant medications were not reported. Treatment information was not provided This case concerns a 17-year-old female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy and inappropriate age at vaccine administration with no associated AEs. The patient received the first dose of mRNA-1273 at approximately 21 weeks of pregnancy, and second dose at approximately 27 weeks. Rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 COVID-19 Vaccine in not affected by this report This case was linked to MOD-2021-283972 (Patient Link). Sender's Comments: This case concerns a 17-year-old female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy and inappropriate age at vaccine administration with no associated AEs. The patient received the first dose of mRNA-1273 at approximately 21 weeks of pregnancy, and second dose at approximately 27 weeks. Rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 COVID-19 Vaccine in not affected by this report

Other Meds:

Current Illness:

ID: 1757848
Sex: M
Age:
State: CA

Vax Date: 09/12/2021
Onset Date: 09/19/2021
Rec V Date: 10/04/2021
Hospital: Y

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: Test Date: 20210916; Test Name: Low Blood sugar; Result Unstructured Data: Low blood sugar (Below 50)

Allergies:

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

Symptoms: Mild urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Mild urinary tract infection) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced URINARY TRACT INFECTION (Mild urinary tract infection) (seriousness criterion hospitalization). At the time of the report, URINARY TRACT INFECTION (Mild urinary tract infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, Blood glucose: low (Low) Low blood sugar (Below 50). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter. Reporter stated that on 19-SEP-2021 patient was taken to the emergency room and found out that patient had mild urinary tract infection and a dirty diaper. Company Comment: This case concerns a 92-year-old, male patient with no relevant medical history, who experienced the unexpected event of urinary tract infection. The event occurred approximately 8 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 92-year-old, male patient with no relevant medical history, who experienced the unexpected event of urinary tract infection. The event occurred approximately 8 days after the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1757849
Sex: F
Age:
State: OH

Vax Date: 08/11/2021
Onset Date: 08/31/2021
Rec V Date: 10/04/2021
Hospital: Y

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

Lab Data: Test Date: 20210902; Test Name: Blood potassium; Result Unstructured Data: 4.2; Test Date: 20210902; Test Name: blood pressure; Result Unstructured Data: 138/70 mmHg; Test Date: 20210903; Test Name: blood pressure; Result Unstructured Data: 129/60 mmHg; Test Date: 20210902; Test Name: Blood sodium; Result Unstructured Data: 138; Test Date: 20210902; Test Name: body temperature; Result Unstructured Data: 36.4 degrees Celsius; Test Date: 20210903; Test Name: body temperature; Result Unstructured Data: 36.6 degrees Celsius; Test Date: 20210902; Test Name: Computerised tomogram head; Result Unstructured Data: no definite acute intracranial mass or hemorrhage; Test Date: 20210902; Test Name: hemoglobin; Result Unstructured Data: 12.1; Test Date: 20210902; Test Name: heart rate; Result Unstructured Data: 77/min; Test Date: 20210903; Test Name: heart rate; Result Unstructured Data: 64 /min; Test Date: 20210903; Test Name: Oxygen saturation; Result Unstructured Data: 96 percent; Test Date: 20210902; Test Name: Pain assessment; Result Unstructured Data: 10/10 headache; Test Date: 20210902; Test Name: Physical examination; Result Unstructured Data: positive for headache and nausea and negative for abdominal pain, diarrhea and vomiting. The subject was positive for Reynaud's and had slight kyphosis and consolidated lung sound; Test Date: 20210903; Test Name: Physical examination; Result Unstructured Data: normocephalic, atraumatic and tachycardiac; Test Date: 20210902; Test Name: respiratory rate; Result Unstructured Data: 18/min; Test Date: 20210902; Test Name: white blood cells; Result Unstructured Data: 4.9

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Severe intractable headache; nausea; myalgias; fatigue; Low grade fever / temperature: 36.4 degrees Celsius,; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Severe intractable headache) in a 66-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. Co-suspect product included non-company product RALINEPAG for Pulmonary arterial hypertension. The patient's past medical history included Diastolic dysfunction, Acne (took tetracycline for acne) in 1969, Diverticulitis in 2004, Hiatus hernia in 2004, Cough, Tonsillectomy in 1964, Laparoscopy in 1994, Female sterilisation in 1995, Colonoscopy on 08-Jul-2016 and Oesophagogastroduodenoscopy on 08-Jul-2016. Family history included Migraine (family history of migraine (mother, maternal grandmother, sister and son)) since 1970, Osteoarthritis (Mother, maternal grandmother, maternal grandfeather) since 2015 and Caffeine consumption (Rarely) since an unknown date. Concurrent medical conditions included Depression since 1996, Gastrooesophageal reflux disease since 2004, Shortness of breath since 2018, Headache (had an onset in May 2021 and on 22 Jul 2021) since May 2021, Drug allergy (Rituxan (rituximab) allergy led to angioedema, chills, joints pain, shortness of breath and headache), Drug allergy (nitrate analogues.), Alcohol use (2 glass of wine (2 standard drink or equivalent) per week), Basedow's disease since 1994, Sjogren's syndrome since 1994, Raynaud's phenomenon since 2008, Systemic scleroderma (Progressive or Diffuse) since 2010, Menopausal symptoms since 2006, Osteopenia since 2006, Supraventricular extrasystoles since 2013, Rhinitis allergic since 2015, Intervertebral disc degeneration since 2015, Diastolic dysfunction since 2016, Radiculopathy since 18-Apr-2016, Interstitial lung disease since 2018, Pulmonary arterial hypertension (WHO 1 PAH associated with systemic sclerosis (scleroderma) since 27-Nov-2018, Constipation and Scleroderma since 12-Mar-2019. Concomitant products included PARACETAMOL (TYLENOL) for Adverse event, CICLOSPORIN (RESTASIS), FISH OIL (FISH OIL OMEGA 3), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM CARBONATE AND VITAMIN D), DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LIDOCAINE (LIDODERM), MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]), METOPROLOL TARTRATE (LOPRESSOR) from 27-Aug-2018 to an unknown date, AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]) from 14-Oct-2019 to an unknown date, DENOSUMAB (PROLIA) from 11-Apr-2021 to an unknown date, FAMOTIDINE (PEPCID [FAMOTIDINE]) from 23-Sep-2021 to an unknown date, BOSWELLIA SERRATA RESIN, CURCUMA LONGA ROOT, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX JOINT HEALTH TRIPLE STRENGTH + TURMERIC), LISINOPRIL from 18-Jul-2021 to 16-Aug-2021, MACROGOL 3350 (MIRALAX) from 20-Jan-2020 to an unknown date, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) from 24-Jun-2021 to an unknown date, AZITHROMYCIN (ZITHROMAX) from 22-Jul-2021 to an unknown date, DEXLANSOPRAZOLE (DEXILANT) from 24-Jun-2021 to an unknown date, FUROSEMIDE (LASIX [FUROSEMIDE]) from 03-Aug-2021 to an unknown date, GABAPENTIN (NEURONTIN) from 08-Mar-2021 to an unknown date, LOPERAMIDE HYDROCHLORIDE (IMODIUM A-D) from 09-Aug-2021 to an unknown date, MACITENTAN (OPSUMIT) from 07-May-2021 to an unknown date, MULTIVITAMIN WITH MINERALS from 16-Jan-2021 to an unknown date, TADALAFIL (ADCIRCA) from 05-May-2021 to an unknown date, TRAMADOL from 20-Aug-2021 to an unknown date, CELECOXIB (CELEBREX) and NINTEDANIB for an unknown indication. On 11-Aug-2021, the patient started RALINEPAG (unknown route) at an unspecified dose. On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced HEADACHE (Severe intractable headache) (seriousness criterion hospitalization), NAUSEA (nausea), MYALGIA (myalgias), FATIGUE (fatigue) and PYREXIA (Low grade fever / temperature: 36.4 degrees Celsius,). The patient was hospitalized from 03-Sep-2021 to 03-Sep-2021 due to HEADACHE. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date at a dose of 4 milligram; ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 02-Sep-2021 for Adverse event, at an unspecified dose and frequency; OXYCODONE on 03-Sep-2021 for Adverse event, at an unspecified dose and frequency; TRAMADOL HYDROCHLORIDE (ULTRAM [TRAMADOL HYDROCHLORIDE]) on 02-Sep-2021 for Adverse event, at an unspecified dose and frequency; MAGNESIUM SULFATE (intravenous) on 02-Sep-2021 for Adverse event, at an unspecified dose and frequency; DROPERIDOL on 02-Sep-2021 for Adverse event, at an unspecified dose and frequency; PROCHLORPERAZINE MALEATE (COMPAZINE [PROCHLORPERAZINE MALEATE]) (intravenous) on 02-Sep-2021 for Adverse event, at an unspecified dose and frequency; ENOXAPARIN on 03-Sep-2021 for Adverse event, at an unspecified dose and frequency and FUROSEMIDE on 03-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 03-Sep-2021, HEADACHE (Severe intractable headache) had resolved. At the time of the report, NAUSEA (nausea) had not resolved and MYALGIA (myalgias), FATIGUE (fatigue) and PYREXIA (Low grade fever / temperature: 36.4 degrees Celsius,) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Blood potassium: 4.2 (normal) 4.2. On 02-Sep-2021, Blood pressure measurement: 138/70 mmhg. (abnormal) 138/70 mmHg. On 02-Sep-2021, Blood sodium: 138 (normal) 138. On 02-Sep-2021, Body temperature: 36.4 degrees celsius (normal) 36.4 degrees Celsius. On 02-Sep-2021, Computerised tomogram head: normal (normal) no definite acute intracranial mass or hemorrhage. On 02-Sep-2021, Haemoglobin: 12.1 (normal) 12.1. On 02-Sep-2021, Heart rate: 77/min (normal) 77/min. On 02-Sep-2021, Pain assessment: 10/10 headache (abnormal) 10/10 headache. On 02-Sep-2021, Physical examination: abnormal (abnormal) positive for headache and nausea and negative for abdominal pain, diarrhea and vomiting. The subject was positive for Reynaud's and had slight kyphosis and consolidated lung sound. On 02-Sep-2021, Respiratory rate: 18/min (normal) 18/min. On 02-Sep-2021, White blood cell count: 4.9 (normal) 4.9. On 03-Sep-2021, Blood pressure measurement: 129/60 mmhg (abnormal) 129/60 mmHg. On 03-Sep-2021, Body temperature: 36.6 degrees celsius (normal) 36.6 degrees Celsius. On 03-Sep-2021, Heart rate: 64 /min (normal) 64 /min. On 03-Sep-2021, Oxygen saturation: 96 percent (normal) 96 percent. On 03-Sep-2021, Physical examination: normocephalic, atraumatic and tachycardiac (abnormal) normocephalic, atraumatic and tachycardiac. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HEADACHE (Severe intractable headache) to be possibly related. No further causality assessments were provided for NAUSEA (nausea), MYALGIA (myalgias), FATIGUE (fatigue) and PYREXIA (Low grade fever / temperature: 36.4 degrees Celsius,). On 02-Sep-2021, the patient went to the emergency room (ER) and various evaluations were performed. On 03-Sep-2021, the patient was admitted for further observation and was treated. On the same day, the patient was discharged from the hospital with normal functional and mental status. The patient was completely free from headache. Company comment: This report concerns a 66 year old female subject with relevant medical history of pulmonary arterial hypertension, headaches and migraines who experienced a serious unexpected event of headache and was hospitalized. The event occurred one day after vaccination with the booster dose (third dose) of mRNA-1273. The headache was associated with nausea and the subject additionally experienced non-serious events of pyrexia, fatigue and myalgia. The diagnostic evaluation for the event headache was found to be normal. The re-challenge was as

Other Meds: RESTASIS; FISH OIL OMEGA 3; CALCIUM CARBONATE AND VITAMIN D; VOLTAREN [DICLOFENAC SODIUM]; FLONASE [FLUTICASONE PROPIONATE]; LIDODERM; CELLCEPT [MYCOPHENOLATE MOFETIL]; LOPRESSOR; ASTELIN [AZELASTINE HYDROCHLORIDE]; PROLIA; PEPCID [FAMOTIDI

Current Illness: Alcohol use (2 glass of wine (2 standard drink or equivalent) per week); Basedow's disease; Caffeine consumption (Rarely); Constipation; Depression; Diastolic dysfunction; Drug allergy (Rituxan (rituximab) allergy led to angioedema, chills, joints pain, shortness of breath and headache); Drug allergy (nitrate analogues.); Gastrooesophageal reflux disease; Headache (had an onset in May 2021 and on 22 Jul 2021); Interstitial lung disease; Intervertebral disc degeneration; Menopausal symptoms; Migraine (family history of migraine (mother, maternal grandmother, sister and son)); Osteoarthritis (Mother, maternal grandmother, maternal grandfeather); Osteopenia; Pulmonary arterial hypertension (WHO 1 PAH associated with systemic sclerosis (scleroderma); Radiculopathy; Raynaud's phenomenon; Rhinitis allergic; Scleroderma; Shortness of breath; Sjogren's syndrome; Supraventricular extrasystoles; Systemic scleroderma (Progressive or Diffuse)

ID: 1757850
Sex: F
Age: 41
State: PR

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: Test Date: 20210829; Test Name: Blood pressure; Result Unstructured Data: High; Test Date: 20210913; Test Name: Blood pressure; Result Unstructured Data: Blood pressure was OK

Allergies:

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

Symptoms: Chest pain; While she talks, she feels like gasping for air/felt lack of air she had to breathe through her mouth to get air in; Weakness; Felt like someone was rubbing her legs (like pressure); Throat pain; Felt pain like needles stabbing her in the neck area; Vomiting; Feeling feverish; Nausea; trouble concentrating/could not focus; Felt febrile (like burning inside but without actual temperature); Extreme tiredness; Feeling like fainting; High blood pressure; had to leave work because of her symptoms; intestines were "all swollen"; Pain in the arm of the injection; Difficulty to pee; Irregular heartbeat; Wasn't able to sleep; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling like fainting), DYSPNOEA (While she talks, she feels like gasping for air/felt lack of air she had to breathe through her mouth to get air in), PAIN IN EXTREMITY (Pain in the arm of the injection), DYSURIA (Difficulty to pee) and HEART RATE IRREGULAR (Irregular heartbeat) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heartbeats irregular and Iodine allergy (Allergic to the iodine contrast, they are still trying to figure out how to do it). On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm of the injection), DYSURIA (Difficulty to pee), HEART RATE IRREGULAR (Irregular heartbeat), INSOMNIA (Wasn't able to sleep) and HEADACHE (Headache). On 27-Aug-2021, the patient experienced GASTROINTESTINAL INFLAMMATION (intestines were "all swollen"). On 28-Aug-2021, the patient experienced DIZZINESS (Feeling like fainting), HYPERTENSION (High blood pressure), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to leave work because of her symptoms) and FATIGUE (Extreme tiredness). On 29-Aug-2021, the patient experienced DISTURBANCE IN ATTENTION (trouble concentrating/could not focus) and FEELING HOT (Felt febrile (like burning inside but without actual temperature)). On 30-Aug-2021, the patient experienced NECK PAIN (Felt pain like needles stabbing her in the neck area), VOMITING (Vomiting), PYREXIA (Feeling feverish) and NAUSEA (Nausea). On 31-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Throat pain). On 02-Sep-2021, the patient experienced LIMB DISCOMFORT (Felt like someone was rubbing her legs (like pressure)). On 04-Sep-2021, the patient experienced ASTHENIA (Weakness). On 06-Sep-2021, the patient experienced DYSPNOEA (While she talks, she feels like gasping for air/felt lack of air she had to breathe through her mouth to get air in). On 16-Sep-2021, the patient experienced CHEST PAIN (Chest pain). At the time of the report, DIZZINESS (Feeling like fainting), PAIN IN EXTREMITY (Pain in the arm of the injection), DYSURIA (Difficulty to pee), HEART RATE IRREGULAR (Irregular heartbeat), INSOMNIA (Wasn't able to sleep), GASTROINTESTINAL INFLAMMATION (intestines were "all swollen"), HYPERTENSION (High blood pressure), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to leave work because of her symptoms), DISTURBANCE IN ATTENTION (trouble concentrating/could not focus), NECK PAIN (Felt pain like needles stabbing her in the neck area), OROPHARYNGEAL PAIN (Throat pain), LIMB DISCOMFORT (Felt like someone was rubbing her legs (like pressure)), CHEST PAIN (Chest pain), FEELING HOT (Felt febrile (like burning inside but without actual temperature)), ASTHENIA (Weakness), VOMITING (Vomiting), HEADACHE (Headache), PYREXIA (Feeling feverish) and NAUSEA (Nausea) outcome was unknown and DYSPNOEA (While she talks, she feels like gasping for air/felt lack of air she had to breathe through her mouth to get air in) and FATIGUE (Extreme tiredness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, Blood pressure measurement: high (High) High. On 13-Sep-2021, Blood pressure measurement: normal (normal) Blood pressure was OK. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. On 15-Sep-2021 patient had headache, felt a lack of air, low intensity and her heartbeat was still irregular, medium. On 16-Sep-2021, the patient felt irregular heartbeat, low intensity. On 17-Sep-2021, the patient felt chest pain, lack of air - low intensity. On 19-Sep-2021, the patient felt irregular heartbeat - low intensity. On20-Sep-2021, the patient felt lack of air - high intensity. On 21-Sep-2021, the patient felt lack of air - medium. The patient was worried that the second dose will make everything even worse, went to a cardiologist and talked with an internist by the phone. They took some blood work and a chest X-ray. Also, they ordered a CT scan of her lungs, results were not reported. Treatment information was not provided.

Other Meds:

Current Illness: Heartbeats irregular; Iodine allergy (Allergic to the iodine contrast, they are still trying to figure out how to do it.)

ID: 1757851
Sex: F
Age: 29
State: PR

Vax Date: 07/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/04/2021
Hospital: Y

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: palpitations; can't breath properly; Patient was crying; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations) and DYSPNOEA (can't breath properly) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016c21a and 036c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced PALPITATIONS (palpitations) (seriousness criteria hospitalization and medically significant), DYSPNOEA (can't breath properly) (seriousness criteria hospitalization and medically significant) and CRYING (Patient was crying). The patient was hospitalized on sometime in September 2021 due to DYSPNOEA and PALPITATIONS. The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of in the hospital. At the time of the report, PALPITATIONS (palpitations), DYSPNOEA (can't breath properly) and CRYING (Patient was crying) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Company Comment - This case concerns a 29-year-old female patient with no relevant medical history, who experienced serious, unlisted, events of palpitations and dyspnoea. The event occurred at unknown duration after 2nd dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the 2nd dose of Moderna COVID-19 Vaccine. Event seriousness assessed based on the limited information available, however, more information is expected for further assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 29-year-old female patient with no relevant medical history, who experienced serious, unlisted, events of palpitations and dyspnoea. The event occurred at unknown duration after 2nd dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the events occurred after the 2nd dose of Moderna COVID-19 Vaccine. Event seriousness assessed based on the limited information available, however, more information is expected for further assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds: SYNTHROID

Current Illness:

ID: 1757852
Sex: U
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: Vaccine went through excursion in freezer twice and administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went through excursion in freezer twice and administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went through excursion in freezer twice and administered to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went through excursion in freezer twice and administered to patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided by the reporter. No Treatment information was reported. She actually called last Thursday to cancel this inquiry. Her pharmacist on duty and she had a miscommunication. The sensor, to her understanding was not in correct position and was not collecting the data of the vaccine temperature. She was originally under the impression that the freezer had not been closed for the entire day. She had called in last Wednesday about a possible excursion, but called back Thursday to cancel it when she spoke more to her pharmacist that was on duty the day in question and learned that what she thought had happened did not happen. So sorry for the confusion. Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Non Significant Follow up received and checked medication error On 28-Sep-2021: Non Significant follow up received and appended

Other Meds:

Current Illness:

ID: 1757853
Sex: M
Age: 41
State: LA

Vax Date: 03/19/2021
Onset Date: 04/01/2021
Rec V Date: 10/04/2021
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: Excruciating chest pain that doesn't come from food, alcohol, or vigorous exercise; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Excruciating chest pain that doesn't come from food, alcohol, or vigorous exercise) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 045A21A) for COVID-19 vaccination. Concurrent medical conditions included Sleep apnea. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced CHEST PAIN (Excruciating chest pain that doesn't come from food, alcohol, or vigorous exercise). At the time of the report, CHEST PAIN (Excruciating chest pain that doesn't come from food, alcohol, or vigorous exercise) had not resolved. No concomitant medication provided. No treatment medication provided.

Other Meds:

Current Illness: Sleep apnea

ID: 1757854
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling unwell) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling unwell). At the time of the report, MALAISE (feeling unwell) outcome was unknown. Not Provided No concomitant medication was provided No treatment received by the patient This case was linked to MOD-2021-330232 (Patient Link).

Other Meds:

Current Illness:

ID: 1757855
Sex: F
Age: 41
State: ID

Vax Date: 08/24/2021
Onset Date: 09/24/2021
Rec V Date: 10/04/2021
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: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired second dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091B21A and 047B21A) for COVID-19 vaccination. medical History not reported. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired second dose). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received an expired second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. NO treatment Drug was reported

Other Meds: TYLENOL.

Current Illness:

ID: 1757856
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: discomfort in her hands; pains; very tired; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (discomfort in her hands), PAIN (pains) and FATIGUE (very tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (discomfort in her hands), PAIN (pains) and FATIGUE (very tired). At the time of the report, LIMB DISCOMFORT (discomfort in her hands), PAIN (pains) and FATIGUE (very tired) outcome was unknown. No concomitant medications were not reported. No treatment medications were not provided.

Other Meds:

Current Illness:

ID: 1757857
Sex: M
Age: 71
State: MD

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 10/04/2021
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: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. Concomitant products included TELMISARTAN, ROSUVASTATIN CALCIUM, DUTASTERIDE, ALFUZOSIN HYDROCHLORIDE, VITAMIN D NOS, ZINC and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 07-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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No treatment medications were reported. This case was linked to MOD-2021-330549, MOD-2021-330449 (Patient Link).

Other Meds: TELMISARTAN; ROSUVASTATIN CALCIUM; DUTASTERIDE; ALFUZOSIN HYDROCHLORIDE; VITAMIN D NOS; ZINC; ASPIRIN [ACETYLSALICYLIC ACID.]

Current Illness:

ID: 1757858
Sex: F
Age: 27
State: AL

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: Test Name: heart rate; Result Unstructured Data: heart rate was 130 to 145 at rest heart rate increased

Allergies:

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

Symptoms: Product dose omission issue; Pericarditis; Pericardial effusion; Tachycardia; feeling miserable; shortness of breath; This spontaneous case was reported by a nurse and describes the occurrence of PERICARDITIS (Pericarditis) and PERICARDIAL EFFUSION (Pericardial effusion) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (COVID-19 infection) and COVID-19 virus test positive (Prior to vaccine). In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant), PERICARDIAL EFFUSION (Pericardial effusion) (seriousness criterion medically significant), TACHYCARDIA (Tachycardia), FEELING ABNORMAL (feeling miserable) and DYSPNOEA (shortness of breath). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Product dose omission issue). In March 2021, PERICARDITIS (Pericarditis), PERICARDIAL EFFUSION (Pericardial effusion), FEELING ABNORMAL (feeling miserable) and DYSPNOEA (shortness of breath) had resolved. At the time of the report, TACHYCARDIA (Tachycardia) had not resolved and PRODUCT DOSE OMISSION ISSUE (Product dose omission issue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 130-145 (High) heart rate was 130 to 145 at rest heart rate increased. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant was provided. The patient developed the adverse reaction the very next day of her 1st dose, and so she has not gotten her 2nd dose yet. On the next day of her 1st dose, she was feeling miserable and heart rate was 130 to 145 at rest and developed shortness of breath and pain which felt like having a heart attack. The patient still having episodes of tachycardia. The patient was on some medications, but not anymore. Reportedly, the patient did not experienced symptoms like this before receiving the Moderna COVID-19 vaccine. This case concerns a 27 year old female with a history of COVID-19 infection in Dec 2019 who experienced the serious listed AESI of Pericarditis and serious unlisted event of Pericardial effusion and the non-serious unlisted event of Product dose omission issue. The events reportedly occurred the day after the first dose of mRNA-1273 in Dec 2020. Re-challenge is not applicable as this is dose 1. The patient as not had dose 2 yet. Benefit -risk relationship is not affected by this report.; Sender's Comments: This case concerns a 27 year old female with a history of COVID-19 infection in Dec 2019 who experienced the serious listed RA of Pericarditis and serious unlisted event of Pericardial effusion and the non-serious unlisted event of Product dose omission issue. The events reportedly occurred the day after the first dose of mRNA-1273 in Dec 2020. Re-challenge is not applicable as this is dose 1. The patient as not had dose 2 yet. Benefit -risk relationship is not affected by this report.

Other Meds:

Current Illness:

ID: 1757859
Sex: M
Age: 74
State: PA

Vax Date: 02/17/2021
Onset Date: 09/18/2021
Rec V Date: 10/04/2021
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: Pain in my upper right arm, shoulder, and into my neck; Pain in my upper right arm, shoulder, and into my neck; Pain in my upper right arm, shoulder, and into my neck; Soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness around the injection site), PAIN IN EXTREMITY (Pain in my upper right arm, shoulder, and into my neck), ARTHRALGIA (Pain in my upper right arm, shoulder, and into my neck) and NECK PAIN (Pain in my upper right arm, shoulder, and into my neck) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness around the injection site). On 19-Sep-2021, the patient experienced PAIN IN EXTREMITY (Pain in my upper right arm, shoulder, and into my neck), ARTHRALGIA (Pain in my upper right arm, shoulder, and into my neck) and NECK PAIN (Pain in my upper right arm, shoulder, and into my neck). The patient was treated with HYDROCODONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Soreness around the injection site), PAIN IN EXTREMITY (Pain in my upper right arm, shoulder, and into my neck), ARTHRALGIA (Pain in my upper right arm, shoulder, and into my neck) and NECK PAIN (Pain in my upper right arm, shoulder, and into my neck) outcome was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1757860
Sex: F
Age: 80
State: FL

Vax Date: 03/01/2021
Onset Date: 04/04/2021
Rec V Date: 10/04/2021
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: All covered in hives/doctor said that it was the worse case of hives doctor had seen; Awful; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (All covered in hives/doctor said that it was the worse case of hives doctor had seen) and FEELING ABNORMAL (Awful) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced URTICARIA (All covered in hives/doctor said that it was the worse case of hives doctor had seen) and FEELING ABNORMAL (Awful). At the time of the report, URTICARIA (All covered in hives/doctor said that it was the worse case of hives doctor had seen) and FEELING ABNORMAL (Awful) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. Patient took 2 medicines orally and 1 injection to treat symptoms . Patient did not know what was taken but one of these was an antihistamine.

Other Meds:

Current Illness:

ID: 1757861
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: how long side effects last; patient pregnant received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (how long side effects last) and MATERNAL EXPOSURE DURING PREGNANCY (patient pregnant received the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced VACCINATION COMPLICATION (how long side effects last) and MATERNAL EXPOSURE DURING PREGNANCY (patient pregnant received the vaccine). At the time of the report, VACCINATION COMPLICATION (how long side effects last) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (patient pregnant received the vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication list was not provided. Treatment information was not provided. This prospective pregnancy spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced unexpected event of maternal exposure during pregnancy with associated unexpected event of vaccination complication, described as side effects. The associated event occurred after Spikevax however, the exact time to onset was unknown since there is lack of information regarding number of doses and dates of administration. Rechallenge was unknown due to lack of key information regarding Spikevax administration (number of doses and exact dates of administration). The benefit-risk relationship of drug is not affected by this report Reporter did not allow further contact; Sender's Comments: This prospective pregnancy spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced unexpected event of maternal exposure during pregnancy with associated unexpected event of vaccination complication, described as side effects. The associated event occurred after Spikevax however, the exact time to onset was unknown since there is lack of information regarding number of doses and dates of administration. Rechallenge was unknown due to lack of key information regarding Spikevax administration (number of doses and exact dates of administration). The benefit-risk relationship of drug is not affected by this report

Other Meds:

Current Illness:

ID: 1757862
Sex: M
Age:
State: SC

Vax Date: 09/12/2021
Onset Date: 09/01/2021
Rec V Date: 10/04/2021
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: Itching in different parts of the body/Itching started/other arm/now it is on the waist; Arm Hurt; Did not feel well; Headache; General Aches/Pain; Itching in arm below the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in different parts of the body/Itching started/other arm/now it is on the waist), PAIN IN EXTREMITY (Arm Hurt), MALAISE (Did not feel well), HEADACHE (Headache) and MYALGIA (General Aches/Pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PRURITUS (Itching in different parts of the body/Itching started/other arm/now it is on the waist), PAIN IN EXTREMITY (Arm Hurt), MALAISE (Did not feel well), HEADACHE (Headache), MYALGIA (General Aches/Pain) and VACCINATION SITE PRURITUS (Itching in arm below the elbow). At the time of the report, PRURITUS (Itching in different parts of the body/Itching started/other arm/now it is on the waist) had not resolved and PAIN IN EXTREMITY (Arm Hurt), MALAISE (Did not feel well), HEADACHE (Headache), MYALGIA (General Aches/Pain) and VACCINATION SITE PRURITUS (Itching in arm below the elbow) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication list was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1757863
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: palpitations; hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations) and DYSPNOEA (hard time breathing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (palpitations) and DYSPNOEA (hard time breathing). At the time of the report, PALPITATIONS (palpitations) and DYSPNOEA (hard time breathing) had not resolved. Not Provided no concomitant mediations are provided. treatment to the events not reported. patient experienced having a hard time breathing and palpitation for 2 days, until now.

Other Meds:

Current Illness:

ID: 1757864
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: Diarrhea; Stomach distress; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Stomach distress) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Stomach distress). At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Stomach distress) outcome was unknown. Concomitant product use was not provided. Treatment information was not provided. This case was linked to MOD-2021-331183 (Patient Link).

Other Meds:

Current Illness:

ID: 1757865
Sex: F
Age:
State: NJ

Vax Date: 01/20/2021
Onset Date: 09/01/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: Sinuses hurting; This spontaneous case was reported by a consumer and describes the occurrence of SINUS PAIN (Sinuses hurting) 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 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced SINUS PAIN (Sinuses hurting). At the time of the report, SINUS PAIN (Sinuses hurting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive. No Concomitant medication was reported No treatment Drug was reported

Other Meds:

Current Illness:

ID: 1757866
Sex: F
Age: 79
State: NY

Vax Date: 09/25/2021
Onset Date: 09/25/2021
Rec V Date: 10/04/2021
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: Shaking of legs; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking of legs) and NAUSEA (Nausea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. Concomitant products included ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN COMPOUND [ACETYLSALICYLIC ACID;ASCORBIC ACID]) for Anticoagulant therapy, ATORVASTATIN for Cholesterol, FUROSEMIDE (FUROSIMIDE) for Hypertension. On 25-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Sep-2021, the patient experienced TREMOR (Shaking of legs) and NAUSEA (Nausea). At the time of the report, TREMOR (Shaking of legs) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Carbetolol is used as concomitant medication for hypertension. No treatment information is provided.

Other Meds: FUROSIMIDE; ATORVASTATIN; ASPIRIN COMPOUND [ACETYLSALICYLIC ACID;ASCORBIC ACID.]

Current Illness:

ID: 1757867
Sex: F
Age: 41
State:

Vax Date: 08/29/2021
Onset Date: 09/05/2021
Rec V Date: 10/04/2021
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: Fever; Soreness in the muscles of the left upper arm; Covid arm; Tenderness in the left upper arm; Lethargic; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash) and PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash), PYREXIA (Fever) and MYALGIA (Soreness in the muscles of the left upper arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm), TENDERNESS (Tenderness in the left upper arm), LETHARGY (Lethargic), RASH (Rash), PYREXIA (Fever) and MYALGIA (Soreness in the muscles of the left upper arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant drug was not reported. Treatment medication included topical spray of all natural mint and eucalyptus and anti-allergic medications to alleviate the symptoms. It was reported that patient was supposed to take second dose on 26-SEP-2021.

Other Meds:

Current Illness:

ID: 1757868
Sex: M
Age:
State: MA

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 10/04/2021
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: Received dose from a vial that was punctured for more than 12hs; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. it was reported that Moderna COVID-19 vaccine was given outside the recommended time frame, more than 12 hours post vial puncture. vial was kept at recommended temperature of 2-8 C before administration. No treatment medication reported by the reporter. This case was linked to MOD-2021-295452, MOD-2021-331621 (Patient Link).

Other Meds:

Current Illness:

ID: 1757869
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: Reporter states that after second shot patient had high fever and the arm swelled up,; Reporter states that after second shot patient had high fever and the arm swelled up,; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Reporter states that after second shot patient had high fever and the arm swelled up,) and VACCINATION SITE SWELLING (Reporter states that after second shot patient had high fever and the arm swelled up,) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Reporter states that after second shot patient had high fever and the arm swelled up,) and VACCINATION SITE SWELLING (Reporter states that after second shot patient had high fever and the arm swelled up,). At the time of the report, PYREXIA (Reporter states that after second shot patient had high fever and the arm swelled up,) and VACCINATION SITE SWELLING (Reporter states that after second shot patient had high fever and the arm swelled up,) outcome was unknown. No concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-331759 (Patient Link).

Other Meds:

Current Illness:

ID: 1757870
Sex: M
Age: 81
State: FL

Vax Date: 09/22/2021
Onset Date: 09/22/2021
Rec V Date: 10/04/2021
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: Lungs inflammation/it's swelling all around the heart; Arm swelled up; High fever; Not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONITIS (Lungs inflammation/it's swelling all around the heart), PERIPHERAL SWELLING (Arm swelled up), PYREXIA (High fever) and EXTRA DOSE ADMINISTERED (Not immunocompromised) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced PNEUMONITIS (Lungs inflammation/it's swelling all around the heart), PERIPHERAL SWELLING (Arm swelled up), PYREXIA (High fever) and EXTRA DOSE ADMINISTERED (Not immunocompromised). On 22-Sep-2021, EXTRA DOSE ADMINISTERED (Not immunocompromised) had resolved. At the time of the report, PNEUMONITIS (Lungs inflammation/it's swelling all around the heart) and PERIPHERAL SWELLING (Arm swelled up) outcome was unknown and PYREXIA (High fever) had resolved. No concomitant medications were provided. No treatment medications were reported. The patient had high fever last only one day arm swelled up and lungs inflammation. The doctor thought it was pneumonia, but the fever went away after one day, it was swelling all around the heart. This case was linked to MOD-2021-331716 (Patient Link).

Other Meds:

Current Illness:

ID: 1757871
Sex: F
Age: 73
State: WV

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 10/04/2021
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: Dizziness; My arm hurt hurt real good; Loss of appetite; I wanted to sleep a lot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (My arm hurt hurt real good), DECREASED APPETITE (Loss of appetite) and HYPERSOMNIA (I wanted to sleep a lot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high and Diabetes. Concomitant products included INSULIN for Diabetes. On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (My arm hurt hurt real good), DECREASED APPETITE (Loss of appetite) and HYPERSOMNIA (I wanted to sleep a lot). At the time of the report, DIZZINESS (Dizziness), PAIN IN EXTREMITY (My arm hurt hurt real good), DECREASED APPETITE (Loss of appetite) and HYPERSOMNIA (I wanted to sleep a lot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient has a lot of side effects with medicines. Moreover, when she take her insulin shot, it puts her out and go right to sleep. No treatment information was provided. Sender's Comments: This case concerns a 73-year-old, female patient with history of hypertension and diabetes non relevant for the case, who experienced the unexpected non-serious adverse event of special interest of hypersomnia. The event occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the event occurred after the first dose and there is no information about the second. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.

Other Meds: INSULIN.

Current Illness: Blood pressure high; Diabetes.

ID: 1757872
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: Pharmacies gives the 3rd dose to not immunocompromised people; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Pharmacies gives the 3rd dose to not immunocompromised people) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Pharmacies gives the 3rd dose to not immunocompromised people). At the time of the report, OFF LABEL USE (Pharmacies gives the 3rd dose to not immunocompromised people) had resolved. No concomitant product information was provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1757873
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/01/2021
Rec V Date: 10/04/2021
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: Product temperature excursion issue; vaccine administered to patients that was exposed to temperatures outside of the recommended storage per Fact Sheet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (vaccine administered to patients that was exposed to temperatures outside of the recommended storage per Fact Sheet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (vaccine administered to patients that was exposed to temperatures outside of the recommended storage per Fact Sheet). In September 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (vaccine administered to patients that was exposed to temperatures outside of the recommended storage per Fact Sheet) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were not reported. No treatment medications were not provided. Frozen vaccine stored Minimum: -12 degree C, Maximum: -23 degree C. Multiple episodes of temperature fluctuation for 15-90 minutes each day from 01-Sep-2021 to 16-Sep-2021 due to freezer cycling and needing defrosted. Expired vaccine was used on 02-Sep2021 for 11 patients and on 16-Sep-2021 for 18 patients. This lot expires 24-Sep2021.

Other Meds:

Current Illness:

ID: 1757874
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: Very bad edma; This spontaneous case was reported by a nurse and describes the occurrence of OEDEMA (Very bad edma) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OEDEMA (Very bad edma). At the time of the report, OEDEMA (Very bad edma) 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 were provided. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow up received on 30 sep 2021: contains no new information.

Other Meds:

Current Illness:

ID: 1757877
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/04/2021
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: me too i dd twice this year with no adverse event; Initial information received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from via consumer non health care professional (under reference number: US-SA-SAC20210929000207). This case involves Adult and unknown gender patient who was administered an extra dose INFLUENZA VACCINE (extra dose administered). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. It was case of an actual medication error due to extra dose administered (latency: same day). It was reported that "Hello, The following potential OSF has been found as a public comment on an Influencer post related to Flu Shot Fridays. Product name was not provided. Since this is a public post on the Sanofi flu shot campaign Flu Shot Friday we are assuming the consumer is referring to the Sanofi flu vaccine". At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.)

Other Meds:

Current Illness:

ID: 1757878
Sex: F
Age:
State: WI

Vax Date: 09/23/2021
Onset Date: 09/23/2021
Rec V Date: 10/04/2021
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: first dose leaked during administration with no adverse event; vaccine leaked between the syringe and needle during administration( plunger rob) with no adverse event; Initial information was received on 28-Sep-2021 regarding an unsolicited valid non-serious case from other health professional Information (under reference-00788891). This case involves a female patient (over the age of 65) who was vaccinated INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], but first dose leaked during administration and vaccine leaked between the syringe and needle during administration (plunger rob) (underdose and syringe issue). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 23-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ704AA, expiry date-30-Jun-2022) via intramuscular route in the deltoid NOS. It was an actual medication error due to vaccine underdose and syringe leak (same day latency). It was reported "a female patient over the age of 65 received a second dose of Fluzone High-Dose, as the first dose leaked during administration. The patient received a second dose of the vaccine, as she received a partial dose. The vaccine leaked between the syringe and needle during administration (plunger rob). She stated that the needle was attached properly, with no apparent defects to the syringe". At time of reporting, no adverse event was reported.

Other Meds:

Current Illness:

ID: 1757879
Sex: M
Age: 47
State: MI

Vax Date: 08/28/2021
Onset Date: 08/29/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: None

Allergies: None

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

Symptoms: Severe tinnitus and loss of hearing in right ear. Moderate tinnitus in left ear.

Other Meds: None

Current Illness: None

ID: 1757880
Sex: F
Age: 20
State: MO

Vax Date: 10/03/2021
Onset Date: 10/04/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: None.

Allergies: NKA.

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

Symptoms: 1:00am headache body and joint pain dizziness cold and clammy temperature 100.2 weakness unable to stand.

Other Meds: None.

Current Illness: None.

ID: 1757881
Sex: F
Age: 22
State:

Vax Date: 09/02/2021
Onset Date: 09/03/2021
Rec V Date: 10/04/2021
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: waking up abruptly with an extremely high heart rate and heart palpitations.

Other Meds:

Current Illness:

ID: 1757882
Sex: F
Age: 24
State: MI

Vax Date: 09/28/2021
Onset Date: 09/30/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: EKG (normal), CBCD, CMP, thyroid labs (all normal.)

Allergies: Penicillin.

Symptom List: Erythema, Pruritus

Symptoms: Shortness of breath, heart palpitations, extreme fatigue, migraine.

Other Meds: Nurtec; Fish oil; Multivitamin.

Current Illness:

ID: 1757883
Sex: F
Age: 38
State: NY

Vax Date: 09/30/2021
Onset Date: 10/01/2021
Rec V Date: 10/04/2021
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: Ekg clear 10/1/2021 Given 2 bags IV, zolfran, benadryl, and steroid Blood work taken, low potassium and magnesium

Allergies: Pine nuts Penicillin Sulfa

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

Symptoms: Nausea, vomiting, hands and feet cramped and stiff, stomach tightness and pain, dehydrated, ended up in ER

Other Meds: Multivitamin Took humira week before

Current Illness: None

ID: 1757884
Sex: F
Age: 36
State: WI

Vax Date: 10/02/2021
Onset Date: 10/02/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: N/a

Allergies: Sulfasalazine

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

Symptoms: Significant Right arm pain Deep bone/joint pain Muscle pain Fatigue Mild headache Heartburn

Other Meds: Lialda, Concerta, prenatal multivitamin, l-tyrosine, gabapentin, zolpidem, doxylamine, melatonin, iron

Current Illness: N/a

ID: 1757887
Sex: F
Age: 14
State: IN

Vax Date: 10/03/2021
Onset Date: 10/03/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: None

Allergies: None

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Throwing up, fever.

Other Meds: None

Current Illness: None

ID: 1757889
Sex: F
Age: 22
State: WV

Vax Date: 09/24/2021
Onset Date: 10/03/2021
Rec V Date: 10/04/2021
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: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Red swollen lump at injection site. Very tender. She is going to doctor to make sure its not a blood clot.

Other Meds:

Current Illness:

ID: 1757890
Sex: F
Age: 35
State: NV

Vax Date: 10/03/2021
Onset Date: 10/03/2021
Rec V Date: 10/04/2021
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: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild.

Other Meds:

Current Illness:

ID: 1757891
Sex: F
Age: 17
State: MD

Vax Date: 10/03/2021
Onset Date: 10/03/2021
Rec V Date: 10/04/2021
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: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild.

Other Meds:

Current Illness:

ID: 1757892
Sex: M
Age: 32
State: CT

Vax Date: 10/02/2021
Onset Date: 10/02/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: Chest pain, body aches, chills. Advil helped the chills and body aches but not the chest pain.

Other Meds: None

Current Illness: None

ID: 1757893
Sex: M
Age: 40
State:

Vax Date: 06/01/2021
Onset Date: 06/30/2021
Rec V Date: 10/04/2021
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: Headaches

Other Meds:

Current Illness:

ID: 1757894
Sex: M
Age: 35
State: CA

Vax Date: 10/02/2021
Onset Date: 10/02/2021
Rec V Date: 10/04/2021
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: Error: Wrong Dose of Vaccine - Too Low-

Other Meds:

Current Illness:

ID: 1757895
Sex: F
Age: 62
State: NJ

Vax Date: 09/30/2021
Onset Date: 09/30/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: Nonr

Allergies: None

Symptom List: Vomiting

Symptoms: Red arm rash size of baseball. Itching and pain at injection site, pain in lymp node under arm, body aches, fever and chills. Still not resolved after 4 days

Other Meds: Claritin, multi vitamin, probiotic

Current Illness: None

ID: 1757896
Sex: F
Age: 51
State: VA

Vax Date: 10/03/2021
Onset Date: 10/03/2021
Rec V Date: 10/04/2021
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: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Medium, Additional Details: Approximately 5 minutes after administration patient appeared "clammy" upon asking patient how she felt she reported feeling very hot and nauseous. Patient initially reported reservations about getting the shot prior to administration and was "very nervous about having to get it." Roughly 10 minutes after administration patient was getting short of breath, breathing rapidly, and appeared very distraught. Told patient epipen was available and patient requested it, breathing became easier after.

Other Meds:

Current Illness:

ID: 1757897
Sex: F
Age: 36
State: IL

Vax Date: 10/02/2021
Onset Date: 10/02/2021
Rec V Date: 10/04/2021
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: Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium

Other Meds:

Current Illness:

ID: 1757898
Sex: F
Age: 80
State: FL

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/04/2021
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: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1757899
Sex: F
Age: 49
State: OK

Vax Date: 09/30/2021
Onset Date: 09/30/2021
Rec V Date: 10/04/2021
Hospital:

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

Lab Data: None

Allergies: Na

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

Symptoms: Extreme swelling to left underarm(lymph node) hardness and swelling noted first evening of shot. Tenderness to left groin area Numbness and weakness to left hand and fingers especially fifth finger. Fever blister formed On bottom lip. Underarm swollen and warm. No low grade temp notes but I do not experience elevated temps when sick as a general rule.

Other Meds: Vit c,d,k

Current Illness: No

ID: 1757900
Sex: F
Age: 37
State: KY

Vax Date: 10/02/2021
Onset Date: 10/03/2021
Rec V Date: 10/04/2021
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: Eurythamyacin

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

Symptoms: Severe lump, redness and itching at injection site. Hot to the touch and extremely sore. No other side effects. Tylenol for arm pain.

Other Meds: Latuda

Current Illness: Active covid infection from 9/06 to 9/22

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am