VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1178239
Sex: M
Age: 61
State: TX

Vax Date: 03/10/2021
Onset Date: 03/25/2021
Rec V Date: 04/07/2021
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: Swelling of groin and testicles; Swelling of groin and testicles; Pain on hands and feet; Weakness; Chills; Generalized pain; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized pain), SWELLING (Swelling of groin and testicles) and TESTICULAR SWELLING (Swelling of groin and testicles) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INSOMNIA (Insomnia). On 26-Mar-2021, the patient experienced PAIN (Generalized pain) (seriousness criterion medically significant), ASTHENIA (Weakness) and CHILLS (Chills). On 27-Mar-2021, the patient experienced SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant), TESTICULAR SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain on hands and feet). At the time of the report, PAIN (Generalized pain), INSOMNIA (Insomnia), ASTHENIA (Weakness) and CHILLS (Chills) was resolving and SWELLING (Swelling of groin and testicles), TESTICULAR SWELLING (Swelling of groin and testicles) and PAIN IN EXTREMITY (Pain on hands and feet) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1178240
Sex: F
Age:
State:

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

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: ugly allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (ugly allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (ugly allergic reaction) (seriousness criterion hospitalization). At the time of the report, HYPERSENSITIVITY (ugly allergic reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact.

Other Meds:

Current Illness:

ID: 1178241
Sex: M
Age: 89
State: TX

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 04/07/2021
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: liver level was up 1000 times what it normally is; pain in arm; a little bruising on that arm; pulled a muscle in the back of my thigh; calves and ankles are all swollen; hardly walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIVER INJURY (liver level was up 1000 times what it normally is) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in arm) and VACCINATION SITE BRUISING (a little bruising on that arm). On an unknown date, the patient experienced LIVER INJURY (liver level was up 1000 times what it normally is) (seriousness criterion medically significant), MUSCLE STRAIN (pulled a muscle in the back of my thigh), JOINT SWELLING (calves and ankles are all swollen) and GAIT INABILITY (hardly walk). At the time of the report, LIVER INJURY (liver level was up 1000 times what it normally is), VACCINATION SITE PAIN (pain in arm), VACCINATION SITE BRUISING (a little bruising on that arm), MUSCLE STRAIN (pulled a muscle in the back of my thigh), JOINT SWELLING (calves and ankles are all swollen) and GAIT INABILITY (hardly walk) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information included one dose of acetaminophen 500mg and heating pad. 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; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1178242
Sex: F
Age: 31
State: IL

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 04/07/2021
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: This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABORTION OF ECTOPIC PREGNANCY (Miscarriage) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypospadias on 15-Jun-2019 and Pregnancy (one). Concurrent medical conditions included Subfertility (Treated since 2018). On 04-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-Jan-2021 and the estimated date of delivery was 29-Oct-2021. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). On 05-Mar-2021, the patient experienced ABORTION OF ECTOPIC PREGNANCY (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fifth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Ectopic pregnancy. On 04-Mar-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, ABORTION OF ECTOPIC PREGNANCY (Miscarriage) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion.; Sender's Comments: This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion.

Other Meds:

Current Illness: Subfertility (Treated since 2018)

ID: 1178243
Sex: F
Age: 71
State: CA

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 04/07/2021
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: Little out of it in her head, very quick surge of pain on her left leg which is repeating; Left nose congestion; Left side of the face being numb; Eyebrows were kind of very heavy; Muscle aches; Temperature little high, heat was radiating to back of her head; A spontaneous report was received from a consumer concerning a 71-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced left nose congestion/ nose congestion, left side of the face being numb/ Hypoesthesia, eyebrows were kind of very heavy/asthenopia , little out of it in her head/adverse reaction, muscle aches/ myalgia, temperature little high,heat was radiating to back of her head/ pyrexia. The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter. On 25 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:016B21A ) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On unknown date, prior to receiving mRNA-1273, the patient felt left nose congestion, left side of the face being numb, eyebrows were kind of very heavy, little out of it in her head, heat was radiating to back of her head, muscle aches, temperature little high. Treatment for events included diphenhydramine HCl, acetylsalicylic acid. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, left nose congestion, left side of the face being numb, eyebrows were kind of very heavy, little out of it in her head, heat was radiating to back of her head, muscle aches, temperature little high were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1178244
Sex: F
Age: 39
State: OH

Vax Date: 12/23/2020
Onset Date: 01/14/2021
Rec V Date: 04/07/2021
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: Guillain-Barr? syndrome; Tingling and numb toes and fingers, which spread to elbows and knees; Tingling and numb toes and fingers , which spread to elbows and knees; Progressed to paralysis; Problems breathing on her own; A spontaneous report was received from a consumer concerning his relative a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling, numb toes and fingers which spread to elbows and knees, difficulty breathing progressed to paralysis. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2020, approximately three weeks prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient experienced tingling, numb toes and fingers, which spread to elbows and knees and progressed to paralysis which required hospitalization and patient was diagnosed with guillain-barr? syndrome. On 25 Jan 2021, the patient was intubated with mechanical breathing because she had problems breathing on her own. patient was hospitalized for a long-term acute care hospital. Treatment for the event included patient was intubated with mechanical breathing. The second dose of mRNA-1273 was discontinued in response to the events. The outcome of the events, tingling, numb toes and fingers which spread to elbows and knees, progressed to paralysis, guillain-barr? syndrome, was intubated with mechanical breathing and had problems breathing her own were not resolved.; Reporter'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. However, Further information is requested.

Other Meds:

Current Illness:

ID: 1178245
Sex: M
Age: 57
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
Hospital: Y

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: procedure in which his heart was cut from top to bottom/pacemaker dependent; fast heart rate; afib; red dots on both of his arms; rash on both arms; dizzy; sick; very weak/no energy; hard time walking; cannot do the simplest of tasks; flutter; A spontaneous report was received from a Consumer concerning herself, a 57-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, fast heart rate, cardiac pacemaker dependent, atrial fibrillation, red dots on both of his arms, rash on both arms, dizziness, sick, Atrial flutter, very weak and no energy, hard time walking, and cannot do the simplest of tasks. The patient's medical history included atrial fibrillation and had a pacemaker placed about 8-9 months ago. Products known to have been used by the patient, within two weeks prior to the event were blood pressure medication, antiarrhythmics. On 01 Mar 2021, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: 030m20a) via unknown route for prophylaxis of COVID-19 infection. On 01 Mar 2021, after vaccination, the patient developed red dots on both of his arms. For next two days, the patient had rash on both arms, was dizzy, felt sick, developed fast heart rate; went to hospital twice for heart rate either 07 Mar 2021 or 13 Mar 2021.During first visit to hospital, fast rate was brought under control, while in the second visit, the patient had a procedure in which his heart was cut from top to bottom and was made pacemaker dependent. The atrial fibrillation could not be controlled for 26 hours and had a flutter which was not identified and could not be controlled. Flutter returned after stopping amlodipine and hence patient was restarted on amlodipine. The patient now feels very weak, has a hard time walking, has no energy, cannot do the simplest of tasks, still experiences fast heart rate and flutter every now and then. No Laboratory investigations were provided. The Treatment information included pacemaker, amlodipine. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, fast heart rate, cardiac pacemaker dependent, atrial fibrillation, red dots on both of his arms, rash on both arms, dizziness, sick, atrial flutter, very weak and no energy, hard time walking, cannot do the simplest of tasks were unknown.

Other Meds:

Current Illness: Atrial fibrillation; Pacemaker insertion (cardiac) (pacemaker placed about 8-9 months ago.)

ID: 1178246
Sex: M
Age:
State:

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 04/07/2021
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: Bell's Palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No relevant medical history provided). On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1178247
Sex: F
Age: 50
State: CO

Vax Date: 03/24/2021
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
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: throat is bleeding; the left side of inner mouth from left molar to upper left tonsil is raw; glands swelled; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL HAEMORRHAGE (throat is bleeding) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no reported medical history). On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PHARYNGEAL HAEMORRHAGE (throat is bleeding) (seriousness criterion medically significant), STOMATITIS (the left side of inner mouth from left molar to upper left tonsil is raw) and LYMPHADENOPATHY (glands swelled). At the time of the report, PHARYNGEAL HAEMORRHAGE (throat is bleeding), STOMATITIS (the left side of inner mouth from left molar to upper left tonsil is raw) and LYMPHADENOPATHY (glands swelled) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment drug provided Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1178248
Sex: M
Age: 53
State: IA

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 04/07/2021
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: staph infection around the same time as getting the vaccine; Skin Sores looking like Chickenpox (Majority on Torso and groin area); Painful and Swollen Lymph Nodes (Groin and Arm pit ); Malaise; Sore left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (staph infection around the same time as getting the vaccine) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced MALAISE (Malaise) and ARTHRALGIA (Sore left shoulder). On 26-Mar-2021, the patient experienced SKIN LESION (Skin Sores looking like Chickenpox (Majority on Torso and groin area)) and LYMPHADENOPATHY (Painful and Swollen Lymph Nodes (Groin and Arm pit )). On an unknown date, the patient experienced STAPHYLOCOCCAL INFECTION (staph infection around the same time as getting the vaccine) (seriousness criterion medically significant). On 23-Mar-2021, MALAISE (Malaise) and ARTHRALGIA (Sore left shoulder) had resolved. At the time of the report, STAPHYLOCOCCAL INFECTION (staph infection around the same time as getting the vaccine) outcome was unknown and SKIN LESION (Skin Sores looking like Chickenpox (Majority on Torso and groin area)) and LYMPHADENOPATHY (Painful and Swollen Lymph Nodes (Groin and Arm pit )) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: New adverse event; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1178249
Sex: F
Age: 69
State: FL

Vax Date: 02/04/2021
Onset Date: 03/25/2021
Rec V Date: 04/07/2021
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: blacked out/felt going down; feeling weak/could not stand and walk; bumped on floor; dizziness; nausea; headache; fatigue; chills; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 10:55 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (felt going down), seriousness criterion medically significant), VACCINATION SITE PAIN, CHILLS, DIZZINESS,ASTHENIA (she could not stand) (she could not walk)(feeling weak), FALL(bumped on floor), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). On 29-Mar-2021, LOSS OF CONSCIOUSNESS (blacked out) (felt going down), ASTHENIA(she could not stand),(she could not walk)(feeling weak), FALL (bumped on floor), NAUSEA (nausea), HEADACHE (headache) ,VACCINATION SITE PAIN, CHILLS, DIZZINESSand FATIGUE (fatigue) had resolved. Concomitant medication: very low dose of cholesterol medication. This case was linked to MOD-2021-060481 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Drug allergy

ID: 1178250
Sex: F
Age: 51
State: NJ

Vax Date: 03/22/2021
Onset Date: 03/23/2021
Rec V Date: 04/07/2021
Hospital: Y

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: Convulsions; In and out of consciousness; extreme pain throughout the body; Vomiting; Inability to speak; Couldn't walk; Couldn't raise limbs; Sustained premature ventricular tachycardia; Heart collapsed to 20 BPM; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia), BRADYCARDIA (Heart collapsed to 20 BPM), SEIZURE (Convulsions), GAIT INABILITY (Couldn't walk), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs), SEIZURE (In and out of consciousness), APHASIA (Inability to speak), PAIN (extreme pain throughout the body) and VOMITING (Vomiting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No historical condition reported). On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia) (seriousness criteria hospitalization, medically significant and life threatening), BRADYCARDIA (Heart collapsed to 20 BPM) (seriousness criteria hospitalization, medically significant and life threatening), SEIZURE (Convulsions) (seriousness criteria hospitalization prolonged and medically significant), SEIZURE (In and out of consciousness) (seriousness criterion hospitalization prolonged), PAIN (extreme pain throughout the body) (seriousness criterion hospitalization prolonged) and VOMITING (Vomiting) (seriousness criterion hospitalization prolonged). 23-Mar-2021, the patient experienced GAIT INABILITY (Couldn't walk) (seriousness criterion hospitalization), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs) (seriousness criterion hospitalization) and APHASIA (Inability to speak) (seriousness criterion hospitalization). The patient was hospitalized on 23-Mar-2021 due to APHASIA, BRADYCARDIA, GAIT INABILITY, MUSCULOSKELETAL STIFFNESS and VENTRICULAR TACHYCARDIA. At the time of the report, VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia), BRADYCARDIA (Heart collapsed to 20 BPM), SEIZURE (Convulsions), GAIT INABILITY (Couldn't walk), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs), SEIZURE (In and out of consciousness), APHASIA (Inability to speak), PAIN (extreme pain throughout the body) and VOMITING (Vomiting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Heart rate: 20 (Low) 20 BPM. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VENTRICULAR TACHYCARDIA (Sustained premature ventricular tachycardia), BRADYCARDIA (Heart collapsed to 20 BPM), SEIZURE (Convulsions), GAIT INABILITY (Couldn't walk), MUSCULOSKELETAL STIFFNESS (Couldn't raise limbs), SEIZURE (In and out of consciousness), APHASIA (Inability to speak), PAIN (extreme pain throughout the body) and VOMITING (Vomiting) to be related.

Other Meds:

Current Illness:

ID: 1178251
Sex: F
Age: 55
State: CA

Vax Date: 02/19/2021
Onset Date: 03/18/2021
Rec V Date: 04/07/2021
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: Loss of consciousness; Lethargy; Feeling abnormal; Decreased Appetite; Dizziness; Abdominal pain upper; Fatigue; Headache; Nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PROGESTERONE, ESTRADIOL (ESTROGEN) and DULOXETINE for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), LETHARGY (Lethargy), FEELING ABNORMAL (Feeling abnormal), DECREASED APPETITE (Decreased Appetite), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Abdominal pain upper), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), LETHARGY (Lethargy), FEELING ABNORMAL (Feeling abnormal), DECREASED APPETITE (Decreased Appetite), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Abdominal pain upper), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Patient's treatment information include Tylenol for headache. This case was linked to MOD-2021-061582 (Patient Link).; 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 two days after second dose of vaccination, a causal relationship cannot be excluded. Further information has been requested

Other Meds: SYNTHROID; PROGESTERONE; ESTROGEN; DULOXETINE

Current Illness:

ID: 1178252
Sex: F
Age: 55
State: FL

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 04/07/2021
Hospital: Y

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: blood pressure went up high 200 systolic; body ache; soreness of left arm; chills; tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (blood pressure went up high 200 systolic) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included AMLODIPINE and METOPROLOL for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN (body ache), VACCINATION SITE PAIN (soreness of left arm), CHILLS (chills) and FATIGUE (tiredness). On 26-Mar-2021, the patient experienced HYPERTENSION (blood pressure went up high 200 systolic) (seriousness criterion hospitalization). The patient was hospitalized on 26-Mar-2021 due to HYPERTENSION. At the time of the report, HYPERTENSION (blood pressure went up high 200 systolic), PAIN (body ache), VACCINATION SITE PAIN (soreness of left arm), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood pressure measurement: (High) increased. On 26-Mar-2021, Electrocardiogram: (abnormal) abnormal. 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 these events, a causal relationship cannot be excluded.

Other Meds: AMLODIPINE; METOPROLOL

Current Illness:

ID: 1178253
Sex: F
Age: 31
State: OK

Vax Date: 03/13/2021
Onset Date: 03/13/2021
Rec V Date: 04/07/2021
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: Low grade ovarian cancer; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OVARIAN CANCER (Low grade ovarian cancer) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Ultrasound scan NOS (The results were reported as normal and clear.) on 04-Mar-2021. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 13-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 24-Dec-2020 and the estimated date of delivery was 30-Sep-2021. On 13-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 26-Mar-2021, the patient experienced OVARIAN CANCER (Low grade ovarian cancer) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the eleventh week of the pregnancy. On 13-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, OVARIAN CANCER (Low grade ovarian cancer) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This is a case of product exposure during pregnancy in a patient who was diagnosed with Ovarian Cancer after receiving the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy in a patient who was diagnosed with Ovarian Cancer after receiving the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient will continue to be contacted for further monitoring of AEs during the pregnancy.

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

Current Illness:

ID: 1178254
Sex: F
Age: 73
State: NY

Vax Date: 02/09/2021
Onset Date: 03/29/2021
Rec V Date: 04/07/2021
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: cellulitis; Redness of legs; swelling on the legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history.). On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant), ERYTHEMA (Redness of legs) and PERIPHERAL SWELLING (swelling on the legs). At the time of the report, CELLULITIS (cellulitis), ERYTHEMA (Redness of legs) and PERIPHERAL SWELLING (swelling on the legs) outcome was unknown. On 29 Mar 2021, the patient went to emergency room (ER) and was diagnosed with cellulitis. Treatment information was not provided. No relevant concomitant medications was provided. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1178255
Sex: F
Age: 63
State: MI

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 04/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/Her arm was hard and warm; itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site; itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/Her arm was hard and warm; itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site; Major depressive episode; fever; chills; headache; fatigue; A spontaneous report was received from a consumer concerning a 64 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/ pyrexia, chills, headache, fatigue, major depressive episode/ major depression, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site pruritus, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site induration, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site warmth, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site rash. The patient's medical history was reported by the reporter as patient had a major depression well controlled with medicine. Concomitant medications taken by the patient included duloxetine hydrochloride. On 15 Mar 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 044A21A) through unknown route at left arm for prophylaxis of COVID-19 infection. On 16 Mar 2021, patient developed fever (101.0 F for which she took an Aleve), chills for 24-36 hours, headache, fatigue for 3 -4 days. She took another Aleve the next day. On 20 Mar 2021 she had a major depressive episode. On 27 Mar 2021, she developed an itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site. Patient reported that she was doing a little better with the depression and the arm was hard and warm at the time of reporting too. The event major depressive episode was medically significant. Treatment activities for event was done with naproxen. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, fever, chills was resolved on 18 Mar 2021, headache, fatigue was resolved on 20 Mar 2021, itchy at injection site was resolved on 27 Mar 2021, rash at injection site was resolved on 28 Mar 2021, major depressive episode was recovering/resolving, hard, warm at injection site was not recovered/ not resolved.; 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: CYMBALTA

Current Illness: Major depression

ID: 1178256
Sex: F
Age: 83
State: ID

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 04/07/2021
Hospital: Y

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: tarry black diarrhea; swollen foot; vomiting; possible gout attack; possible cellulitis; shceduled to receive the second dose after 58 days; Runny nose; hard area at injection site; tender to touch the injection site; left arm swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GOUT (possible gout attack), CELLULITIS (possible cellulitis), FAECES DISCOLOURED (tarry black diarrhea), PERIPHERAL SWELLING (swollen foot) and VOMITING (vomiting) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CITALOPRAM, RIVASTIGMINE (EXELON [RIVASTIGMINE]), FAMOTIDINE, ASPIRIN [ACETYLSALICYLIC ACID], ZOLPIDEM TARTRATE (AMBIEN), XANTOFYL (LUTEIN OPT), KRILL OIL, CALCIUM, VITAMIN B3, VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and EVOLOCUMAB (REPATHA) for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced RHINORRHOEA (Runny nose), VACCINATION SITE INDURATION (hard area at injection site), VACCINATION SITE PAIN (tender to touch the injection site) and VACCINATION SITE SWELLING (left arm swelling). On 15-Feb-2021, the patient experienced FAECES DISCOLOURED (tarry black diarrhea) (seriousness criterion hospitalization), PERIPHERAL SWELLING (swollen foot) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced GOUT (possible gout attack) (seriousness criterion hospitalization), CELLULITIS (possible cellulitis) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shceduled to receive the second dose after 58 days). The patient was hospitalized for 8 days due to CELLULITIS, FAECES DISCOLOURED, GOUT, PERIPHERAL SWELLING and VOMITING. On 03-Feb-2021, RHINORRHOEA (Runny nose), VACCINATION SITE INDURATION (hard area at injection site), VACCINATION SITE PAIN (tender to touch the injection site) and VACCINATION SITE SWELLING (left arm swelling) had resolved. At the time of the report, GOUT (possible gout attack), CELLULITIS (possible cellulitis), FAECES DISCOLOURED (tarry black diarrhea), PERIPHERAL SWELLING (swollen foot) and VOMITING (vomiting) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shceduled to receive the second dose after 58 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was started on antibiotics and prednisone treatment for possible gout attack or cellulitis. No treatment information regarding other events was available.; Sender's Comments: This case of an 83-year-old female patient who experienced inappropriate schedule of vaccine administered after first dose of mRNA-1273 (58 days). Based on temporal association between mRNA-1273 use and onset of the events of runny nose, vaccination site induration, pain and swelling, a causal relationship cannot be excluded. There is not enough information to assess the other events due to lack of critical details in patient's medical history. Additional information is being requested.

Other Meds: CITALOPRAM; EXELON [RIVASTIGMINE]; FAMOTIDINE; ASPIRIN [ACETYLSALICYLIC ACID]; AMBIEN; LUTEIN OPT; KRILL OIL; CALCIUM; VITAMIN B3; VITAMIN C [ASCORBIC ACID]; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN E [TOCOPHEROL]; TUMS [CALCIUM CARBONATE]; RE

Current Illness:

ID: 1178257
Sex: M
Age: 68
State: CA

Vax Date: 03/08/2021
Onset Date: 03/16/2021
Rec V Date: 04/07/2021
Hospital: Y

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: Stroke; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No recorded medical history). On 08-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 CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged, medically significant and life threatening). The patient was hospitalized on 16-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) 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.

Other Meds:

Current Illness:

ID: 1178258
Sex: F
Age: 63
State: FL

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 04/07/2021
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: Blood clot in Left Arm; itchy rash from elbow to shoulder; lump on the underside of her biceps; nauseous; couldn't lift arm up; arm sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in Left Arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included CLONAZEPAM for Anxiety, STEROIDS for Back disorder, CITALOPRAM and MORPHINE SULFATE for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm sore at the injection site). On 24-Mar-2021, the patient experienced MOVEMENT DISORDER (couldn't lift arm up). On 25-Mar-2021, the patient experienced RASH PRURITIC (itchy rash from elbow to shoulder), MASS (lump on the underside of her biceps) and NAUSEA (nauseous). On 27-Mar-2021, the patient experienced THROMBOSIS (Blood clot in Left Arm) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot in Left Arm), RASH PRURITIC (itchy rash from elbow to shoulder), MASS (lump on the underside of her biceps), MOVEMENT DISORDER (couldn't lift arm up), NAUSEA (nauseous) and VACCINATION SITE PAIN (arm sore at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included Benadryl for symptoms and Eliquis for blood clot.; 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: CLONAZEPAM; CITALOPRAM; MORPHINE SULFATE; STEROIDS

Current Illness:

ID: 1178259
Sex: F
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: Patient's injection site has has become infected and that she has cellulitis; Brachial neuritis; Injection site has has become infected; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE CELLULITIS (Patient's injection site has has become infected and that she has cellulitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history 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 INJECTION SITE CELLULITIS (Patient's injection site has has become infected and that she has cellulitis) (seriousness criterion medically significant) with VACCINATION SITE INFECTION (Injection site has has become infected) and RADICULITIS BRACHIAL (Brachial neuritis). At the time of the report, INJECTION SITE CELLULITIS (Patient's injection site has has become infected and that she has cellulitis) and RADICULITIS BRACHIAL (Brachial neuritis) 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. Concomitant product use was not provided by the reporter. Treatment for the events included steroids. When the steroids are stopped, the patient's condition flares up again. Patient has been referred to a Neurologist for treatment. This case was linked to US-MODERNATX, INC.-MOD-2021-051579 (Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-051579: Crosslinked

Other Meds:

Current Illness:

ID: 1178260
Sex: F
Age: 37
State: PR

Vax Date: 01/04/2021
Onset Date: 02/02/2021
Rec V Date: 04/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and TOPIRAMATE (TOPAMAX) for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced TACHYCARDIA (Severe Tachycardia/ Still very tachycardia) and FEELING ABNORMAL (Felt a little weird). On 03-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), FATIGUE (Could not get up), ASTHMA (Asthma) and ASTHENIA (Could not get up). On 04-Feb-2021, the patient experienced CONTUSION (Bruise on her right and left leg) and VACCINATION COMPLICATION (Had a reaction to the vaccine). On 01-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg) (seriousness criterion medically significant). On an unknown date, the patient experienced HAEMOGLOBIN DECREASED (Hemoglobin decreased) and RED BLOOD CELL COUNT DECREASED (Red blood cells are low). At the time of the report, DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg), TACHYCARDIA (Severe Tachycardia/ Still very tachycardia), DYSPNOEA (Difficulty breathing), FEELING ABNORMAL (Felt a little weird), FATIGUE (Could not get up), ASTHMA (Asthma), CONTUSION (Bruise on her right and left leg), ASTHENIA (Could not get up), VACCINATION COMPLICATION (Had a reaction to the vaccine), HAEMOGLOBIN DECREASED (Hemoglobin decreased) and RED BLOOD CELL COUNT DECREASED (Red blood cells are low) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Haemoglobin: low gram per litre (Low) LOW. In March 2021, Red blood cell count: low cells per microlitre (Low) LOW. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment informations reported were Levalbuterol tartrate and Rivaroxaba 20 mg This case was linked to MOD-2021-059897 (Patient Link).

Other Meds: SYNTHROID; TOPAMAX

Current Illness:

ID: 1178261
Sex: F
Age:
State: CA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 04/07/2021
Hospital: Y

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: head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb, numbness to both hands; started feeling sweaty; shortness of breath; light headed; nausea; blood pressure drop to 40; The initial was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 23Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 05Jan2021 (Batch/Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included atrial fibrillation, thyroid problem, hearing problem from an unknown date and unknown if ongoing, Stroke like paralysis from 2014 to an unknown date, gallbladder removal in 2018. Concomitant medications included sotalol, taken for atrial fibrillation from Dec2019 and ongoing; levothyroxine taken for thyroid disorder from 2017 and ongoing; cyanocobalamin (B-12) taken for an unspecified indication from 2014 and ongoing; aspirin [acetylsalicylic acid], taken for an unspecified indication from 2014 and ongoing. The patient experienced 3-5 minutes after the first dose on 05Jan2021, started feeling sweaty, shortness of breath, light headed, nausea, numbness to both hands. Next day 06Jan2021, wake up with numbness to left hands, head aches, chills, weird feeling in head (back left side of head). This went on for about 2 weeks lasted 1 month got better as days went day. It was also reported that she experienced that her left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb for period of 2 weeks. Her blood pressure drop to 40 on 05Jan2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop to 40 on 05Jan2021, sars-cov-2 antibody test: 0 (came out 0 antibodies on my blood work had never been expose to anyone with Covid 19) on 24Nov2019, sars-cov-2 test: negative on 08Jan2021. The patient also reported that on 05Jan2021, she received the dose and had a reaction to it, but that same day her mother was taken to the hospital because she wasn't breathing well and she came out positive to Covid, she passed away 14 days after the patient took a test on Covid 08Jan2021 tested negative. She don't know if it was soon to be tested but other family member tested positive. The patient did not receive treatment for the events and was hospitalized due to the events. The patient did not recover from nausea, headache, chills while the outcome of the other events was unknown.

Other Meds: SOTALOL; LEVOTHYROXINE; B-12; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1178262
Sex: M
Age:
State: AL

Vax Date: 03/10/2021
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
Hospital: Y

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: fell out of his bed; her brother was incoherent when he was found by the ambulance staff; her brother was very weak at the time he was found; Her brother wasn't responsive in his hospital bed; her brother tried to get up from the floor and somehow wiggled under his bed and got stuck; had lost a lot of weight before his fall.; brother had some health problems recently; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6200; expiration date: Jun2021, via an unspecified route of administration, administered in left arm on 10Mar2021 10:00 as single dose for Covid-19 immunisation. Medical history included hypersensitivity and not feeling well. The patient's concomitant medications were not reported. The patient previously took Aleve and Advil and experienced allergy. It was reported that the patient took his first Pfizer COVID-19 Vaccine on Wednesday, 10Mar2021. On Monday, 15Mar2021, the ambulance staff found the patient, who had fallen on either Friday 12Mar2021 or Saturday 13Mar2021. The patient was very weak and incoherent at the time he was found. The patient was in bed and fell out of his bed. He tried to get up from the floor and somehow wiggled under his bed and got stuck. The ambulance staff estimated the patient was on the floor for 2 days before he was found. The patient doesn't drink, do drugs, or smoke. The patient may have a glass of wine every 6 months. It was reported that there was one time when the patient wasn't responsive in his hospital bed. The hospital staff shook her brother, massaged his hand, and yelled really loud in his ear before he became awake. The patient was discharged to a rehab center on 19Mar2021 and was going to be at the rehab center for 20 days. It was also reported that the patient had lost a lot of weight before his fall. The patient had some health problems recently. The outcome of the events weight loss and general discomfort was unknown. The outcome of other events was recovering. Follow up attempts needed. Further information is expected.

Other Meds:

Current Illness:

ID: 1178263
Sex: F
Age:
State: NY

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 04/07/2021
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: Dystonic reaction; Involuntary muscle movements and spasm; Involuntary muscle movements and spasm; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 23Mar2021 at 02:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included ethinylestradiol, norgestimate (MANUFACTURER UNKNOWN) taken for birth control. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced dystonic reaction and involuntary muscle movements and spasm on 23Mar2021 at 18:15. Therapeutic measures were taken as a result of the events, which included diphenhydramine (MANUFACTURER UNKNOWN) and lorazepam (MANUFACTURER UNKNOWN). The clinical outcome of dystonic reaction and involuntary muscle movements and spasm was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: NORGESTIMATE & ETHINYL ESTRADIOL

Current Illness:

ID: 1178264
Sex: M
Age:
State: TN

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 04/07/2021
Hospital: Y

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: Complex seizures; Explosive diarrhea; Profuse vomiting; Chills; sweats; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm, on 22Mar2021 at 09:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats on 22Mar2021 at 19:00. All of the events required hospitalization from an unspecified date to an unspecified date for one day. The patient underwent lab tests and procedures which included nasal swab: negative on 22Mar2021. Therapeutic measures were taken as a result of all of the events, which included intravenous fluids. The clinical outcome of complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats was recovered on an unspecified date. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: LISINOPRIL; ATORVASTATIN

Current Illness:

ID: 1178265
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 04/07/2021
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: Pooped massive amount of blood; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old female patient received bnt162b2 (BNT162B2), at the age of 21-years at vaccination, dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. On 24Mar2021 12:00, patient pooped massive amount of blood with outcome of unknown. Information about lot/batch has been requested.

Other Meds:

Current Illness:

ID: 1178266
Sex: M
Age:
State: PA

Vax Date: 03/23/2021
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
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: Numbness on side of face and cheek/numbness went from his cheek up on to the temple area and jaw area; Mouth pulls weird; Previous nerve damage in his neck that hadn't been acting up in about a year but it was acting up now; Previous nerve damage in his neck that hadn't been acting up in about a year but it was acting up now; Felt loopy; Some weird palsy going on in his face/mild palsy in the left side of the face/Felt like face was heavy on left side or drooping/left side of his face was sagging; This is a spontaneous report from a contactable consumer reporting for himself. A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), via an unspecified route of administration on 23Mar2021 14:40 at single dose for COVID-19 immunization. Medical history included he had some previous nerve damage in his neck that had not been acting up in about a year. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (Lot Number: EL9269) on 02Mar2021 for COVID-19 immunization. On 24Mar2021, patient had some facial numbness and mild palsy in the left side of the face. He stated he had some previous nerve damage in his neck that had not been acting up in about a year, but it was acting up then. He stated it was the feeling like when you go to sleep on something, and it felt heavier. He asked what he should do, if he should seek medical attention and for information on this. After providing information from the Prescribing information, he asked if the Bell's Palsy went away in these individuals in the clinical trials? He stated his wife just said that the left side of his face was sagging. He stated he did not think it was a stroke though because he could move that side of his face and can articulate everything. He felt loopy but did not feel like it was a stroke. Patient reported that basically he felt numbness on the side of his face and cheek. There were reactions when he smiled, it seemed a little bit off. There was a weird feeling and numbness in his face. The numbness went from his cheek up on to the temple area and jaw area, the numbness was primarily on the left side of his face. Patient had nerve damage in his neck already. Patient wanted to know if he should go somewhere with it, was it ok, what was going on with the numbness in his face. Patient thought the numbness in his face and cheek had worsened. Felt like face was heavy on that side or drooping: Caller reported that looking in mirror, the left side of his face did not react the same. Patient's face felt like it was heavy or drooping on the left side, but that it pulls up higher. Patient reported that his face looked ok. Mouth pulls weird: Patient reported that this could be from his prior nerve damage, it was like he had got some weird palsy going on in his face. Patient stated that he just wanted someone to tell him dude wait it out, go to the emergency room, go to the doctor. Patient inquired if the facial numbness was because he had prior nerve condition and if the Covid-19 vaccine had exacerbated his existing nerve condition. The outcome of the events were unknown.

Other Meds:

Current Illness:

ID: 1178267
Sex: M
Age:
State: FL

Vax Date: 02/06/2021
Onset Date: 02/08/2021
Rec V Date: 04/07/2021
Hospital: Y

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: He had 2 seizures that following Monday, 08 Feb 2021 and another seizure on Friday, 12 Feb 2021.; discovered he had COVID; discovered he had COVID; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) at age of 61 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received his first dose of Pfizer's COVID vaccine on 06Feb2021. He had 2 seizures that following Monday, 08Feb2021 and another seizure on Friday, 12Feb2021. He also stated he discovered he had COVID. He was at the hospital for the seizures and diagnosed with Covid. He was due for the second dose which was supposed to be given the third week. He he spoke to the nurses there and they advised him not to do anything until after 90 days or something like that. He was told by the doctor that his second dose should be delayed until 30 to 90 days and heard from Department of Health that he had up to 42 days that he'll be ok. He stated that he just spoke to themDepartment of Health. He stated that they said after 40 or 42 some odd days, and there was an extra 7 days of leeway, he could get the second dose. He stated that his 42 days was up either today (24Mar2021) or yesterday (23Mar2021). He had an opportunity this Friday (26Mar2021) to get the second shot. He had to get the shot at the same location. He was tired of this. The patient stated when should he take the second shot? Should he wait the 90 days? He stated his primary said to see a neurologist, but he didn't see them until 05May2021 and the neurologist said they couldn't say anything because he was a new patient until they see him, so they say to go to his primary care. Dates for tested positive for covid after first dose of Covid Vaccine was unspecified. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1178268
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: passed out; feel faint; This is a spontaneous report from a non-contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient felt faint and passed out after receiving dose, pharmacist asking if need to re administer although received dose. The outcome of the events was unknown. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1178270
Sex: F
Age:
State: NJ

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 04/07/2021
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: Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination); Severe headache; Muscle aches; Chills; Fatigue; This is a spontaneous report received from a contactable pharmacist reporting for herself. A 63-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534), via an unspecified route of administration on 23Mar2021 10:00 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medications included calcium carbonate (CALTRATE), ascorbic acid, retinol, tocopherol (OCUVITE). Historical Vaccine included first dose of BNT162B2 (Lot number EN6203) on 23Mar2021 at 10:00 AM for COVID-19 immunization. The patient experienced Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination), Severe headache, Muscle aches, Chills and Fatigue on 23Mar2021 20:00. Treatment received for event headache included Tylenol 1grm at 9:30 am 3/24. The outcome of the events were resolving. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported event parosmia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: CALTRATE [CALCIUM CARBONATE]; OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]

Current Illness:

ID: 1178271
Sex: F
Age:
State: FL

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 04/07/2021
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: This is a spontaneous report received from a contactable Consumer, the patient. A 53-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, lot number, expiration date: not available) via an unspecified route of administration on left arm on 24Mar2021 09:15 at single dose for COVID-19 immunisation. The patient's medical history included Gastroparesis, allergies to medications, food, or other products: latex, yeast, wheat, guafanisen and Dextromethorphan. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:15 AM, patient experienced anaphylaxis within minutes of having the injection and began to feel flushing down throat, then down to chest. That was concerning but when suddenly, patient got really hot, ripped her mask off, and she realized that she was having difficulty breathing and it got worse as time went on, it was resulted in Emergency room/department or urgent care. Patient received Epi-pen, Benedryl, fluids as the treatment for the events. The outcome for the events was recovered on an unspecified date. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1178272
Sex: F
Age:
State: KS

Vax Date: 03/17/2021
Onset Date: 03/21/2021
Rec V Date: 04/07/2021
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: Sore throat; body ache; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unknown route of administration on 17Mar2021 at 10:00 AM (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Mar2021 at 03:00, the patient experienced sore throat and body ache. The seriousness criteria includes prolonged hospitalization. The patient did not receive any treatment for the events. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1178273
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: diminished alertness/clouded headedness; mental acuity reduced; reduced attention to details; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced diminished alertness/clouded headedness, mental acuity reduced, and reduced attention to details on an unspecified date. The clinical outcome of the events was recovered on an unspecified date. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1178274
Sex: F
Age:
State: NJ

Vax Date: 03/01/2021
Onset Date: 03/24/2021
Rec V Date: 04/07/2021
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: patient experienced headache; This is a spontaneous report received from a contactable nurse. A 88-year-old non-pregnant female patient received BNT162B2 (Solution for injection) via intramuscular route on an unknown date in Mar2021 (second dose) at an unknown dose, single for COVID-19 immunization. Relevant medical history included glaucoma. Historical vaccine included BNT162B2 in Mar2021 for Covid-19 immunization at the age of 88-years. The concomitant medications were not reported. Prior and since the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021, patient experienced headache. The outcome of the event was not resolved. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1178275
Sex: F
Age:
State: FL

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 04/07/2021
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: Mild syncope; Mild syncope; Low grade fever; Arm soreness 1st 24 hours; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN9581), via an unspecified route of administration in left arm on 02Mar2021 13:30 (at the age of 69-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's first dose of bnt162b2 (lot not reported) (at the age of 68-years-old) in left arm on 01Feb2021 at 14:00 for Covid 19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have other vaccines within 4 weeks prior to the COVID vaccine. Medical history included mild syncope episodes and pacemaker. The patient had no allergies to medications, food, or other products. Concomitant medications included alondranate, calcium, metropolol and an unspecified multi vitamin. The patient experienced arm soreness in the first 24 hours on 02Mar2021. Mild syncope and low grade fever 20 days after dose 2 (on 21Mar2021 at 13:00). The treatment received for the adverse events was paracetamol (TYLENOL). The outcome of all events was recovered on 03Mar2021 for pain in extremity and in Mar2021 for the rest of the events.

Other Meds: ALENDRONATE; CALCIUM; METOPROLOL

Current Illness:

ID: 1178276
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/22/2021
Rec V Date: 04/07/2021
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: decrease in fetal movements; body aches; decrease in fetal movements; slight headache; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and fetus/baby. This is the mother report. A 30-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 22Mar2021 at 5:30, the patient experienced decrease in fetal movements, body aches and had a slight headache. The mother reported she became pregnant while taking bnt162b2. The mother was 37 Weeks pregnant at the onset of the event. The mother was due to deliver on 10Apr2021. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovering. Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021326788 same report/drug, mother/child case

Other Meds:

Current Illness:

ID: 1178277
Sex: M
Age:
State: CO

Vax Date: 02/06/2021
Onset Date: 02/15/2021
Rec V Date: 04/07/2021
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: Deep vein thrombosis in the left calf; This is a spontaneous report received from a contactable consumer (patient). A 73-year-old male patient received the second single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 06Feb2021 (Lot Number: EM9810), at the age of 73 years old, for COVID-19 immunisation. The patient had previously received the first single dose of BNT162b2 in the left arm on 16Jan2021 (lot number: EL8482). The patient had not received any other vaccines within 4 weeks prior to the BNT162b2 administration. Prior to vaccination, the patient had never been diagnosed with COVID-19. The patient's medical history included essential thrombocythaemia and benign prostatic hyperplasia. There were no allergies to report. Concomitant medications included hydroxyurea, simvastatin, mirtazapine, and acetylsalicylic acid (ASPIRIN). The patient stated developing deep vein thrombosis in the left calf on 15Feb2021, at 06:00 (10 days after 2nd shot), requiring a visit to ER. The patient was treated with enoxaparin (LOVENOX), followed by dabigatran etexilate (PRADAXA). Since the vaccination, the patient not been tested for COVID-19. The patient was recovering from the event. Follow-up Information has been requested.

Other Meds: HYDROXYUREA; SIMVASTATIN; MIRTAZAPINE; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1178278
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: was "almost like cellulitis."; arm "turned beet red"; This is a spontaneous report from a contactable consumer reported for her friend. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. he patient reported "almost like cellulitis" (medically significant) on an unspecified date with outcome of unknown ,and arm "turned beet red" on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1178279
Sex: F
Age:
State: NC

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 04/07/2021
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: face felt like plastic; Acute pain in base/spine of neck; dizziness; difficulty breathing & swallowing; difficulty breathing & swallowing; nausea; metallic taste in mouth; double vision; This is a spontaneous report from a contactable consumer. A 49-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 18Mar2021 at 08:15 (Batch/Lot Number: EP7534) as a single dose at the age of 49, for Covid-19 immunisation. Medical history included juvenile- als, and a sulfa allergy. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 18Mar2021, after use of product patient developed Acute pain in base/spine of neck, dizziness, difficulty breathing & swallowing, nausea, metallic taste in mouth, face felt like plastic, double vision. The patient was not hospitalized nor was treatment received for the events. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19. Additional Information has been requested.

Other Meds:

Current Illness:

ID: 1178281
Sex: F
Age:
State: OK

Vax Date: 03/09/2021
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
Hospital: Y

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: O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen; inflammation in the lower lungs that was rubbing on her diaphragm; Pneumonia; Cough/bad cough/dry cough; Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage; gastroenteritis; short of breath; she wasn't breathing deep; feels like she doesn't have any energy; feeling bad; nauseated/felt sick to stomach; ate about half of her breakfast, this lasted for several days, she wouldn't eat much; This is a spontaneous report from a contactable consumer (patient's husband) via Pfizer. This consumer reported similar event for two patients. This is the first of two reports. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206, expiry date: unknown), via an unspecified route of administration, on 09Mar2021, as single dose, for COVID-19 immunisation. Medical history included exposure to SARS-COV-2 on 02Mar2021 (reported as "daughter tested positive for COVID on 02Mar2021, patient had been around their daughter and their daughter's husband, they went out to eat with them on the night of 02Mar2021"). Concomitant medication included esomeprazole sodium (NEXIUM) taken for an unspecified indication, start and stop date were not reported. On 09Mar2021, the patient received her first shot. About 20 minutes after she took the shot, she started feeling bad and became nauseated/felt sick to stomach. On 09Mar2021, the top part of her stomach would hurt, and she started developing a cough. On 11Mar2021, the patient felt like she doesn't have any energy. The coughing went pretty bad so on 12Mar2021, the patient took a COVID-19 PCR test and it came back negative. The patient kept having a bad cough so then they went to the doctor where they put the patient on prednisone 20 mg and amoxicillin 875 mg on 12Mar2021. On 16Mar2021, the patient went to the family doctor and the doctor put the patient on azithromycin and gave her a steroid shot. Then the patient kept coughing and her stomach was hurting right at the bottom of her rib cage. The patient was never getting better or anything. So, on 18Mar2021, the patient had COVID-19 Virus test where they swabbed her nose and the test came back negative. The patient was taken to the hospital on 19Mar2021 at 11:30 where they did an x-ray of the patient's lungs and her O2 level was 82-86 sitting in the bed (also reported as 84-86 so she was put on oxygen), performed CT scan of her lungs and it looked like there was inflammation in the lower lungs that was rubbing on her diaphragm, and performed Chest CT which determined pneumonia. That night they did another COVID-19 virus test where they went really deep and it came back negative. The patient was admitted to the hospital on the night of 19Mar2021. The patient was given IV ceftriaxone, IV azithromycin, azithromycin (also reported as Zythromax), one breathing treatment, and they said they may have to send the patient home with some oxygen. It was also reported that on 19Mar2021, the patient did really good with coughing, she didn't cough that much. The patient had a dry cough that wasn't productive at all. The patient acted kind of short of breath because she wasn't breathing deep because of the pain in the top part of her stomach, but the reporter doesn't believe it was true shortness of breath. When the patient got out of the hospital on 22Mar2021, she didn't need to come home with the oxygen. The patient's oxygen level is running pretty good at the time of the report, in the lower 90s (Mar2021). The patient was on Decadron 6 mg for 5 days and she's doing pretty good, she still has a little bit of a cough. It was also reported that in Mar2021, the patient only ate about half of her breakfast, this lasted for several days, she wouldn't eat much. The patient pretty much recovered from the nausea. When she ate, it felt like everything would make it to her stomach and just sit there. The emergency room doctor said it could be from gastroenteritis, also they gave the patient several rounds of Protonix. The patient usually takes Nexium every night. The doctor felt that this event could very well be from the vaccine. The reporter asked if the patient could get the second shot on 30Mar2021. The patient was recovering from "Cough/bad cough/dry cough", "Stomach pain/top part of her stomach would hurt/stomach was hurting right at the bottom of her rib cage", and "O2 level was 82-86/ Oxygen level was like 84 or 86 so she was put on oxygen"; has recovered from "nauseated/felt sick to stomach" on an unspecified date. The outcome of the events "inflammation in the lower lungs that was rubbing on her diaphragm", pneumonia, "feeling bad", "ate about half of her breakfast, this lasted for several days, she wouldn't eat much", "feels like she doesn't have any energy", "gastroenteritis", "short of breath" and "she wasn't breathing deep" was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329963 Same reporter, drug and event; different patient

Other Meds: NEXIUM [ESOMEPRAZOLE SODIUM]

Current Illness:

ID: 1178282
Sex: M
Age:
State: CA

Vax Date: 03/03/2021
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
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: Collapse of lung; Diarrhea; very weak; lost his appetite; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered on right arm on 03Mar2021 (Batch/Lot Number: EL9261) at single dose (at the age of 78 years old) for COVID-19 immunisation. The patient medical history included had vascular problems in his legs, and his legs were very clogged. The doctors couldn't do anything and tried to do a catheterization. Thyroid was not okay, and now his doctor increased his thyroid medication. The reporter blamed the hospital for doing something wrong when her husband was there the last time. She said the hospital made a mistake and gave her husband the wrong medication. She said the first time her husband was at the hospital, the hospital didn't give her husband his thyroid medicine. She said the second time, the hospital gave her husband the wrong dose of medication. Concomitant medications were not reported. The patient previously took BNT162B2 (lot number: EN9581) dose 1 on 10Feb2021 for COVID-19 immunisation. The patient previously took flu vaccines in Sep2020. On Mar2021, the reporter's husband was okay at first. She said now her husband had diarrhea and pooped in his clothes. She said her husband was very weak and lost his appetite. She clarified her husband's symptoms started probably 2 weeks ago, and her husband was worse, and like a different person now. She said her husband used to eat at the table, and now he just sits in his chair, and after 5:00PM he wants to go to bed. She said she was not sure if her husband's symptoms were related to the COVID-19 Vaccine. She said her husband was supposed to have heart bypass surgery on Monday (22Mar2021), and his surgeon called on Saturday night (20Mar2021) and called off her husband's surgery. She said the surgeon said her husband had a collapsed lung. She said her husband had a chest x-ray in late Feb2021 and his lungs were clear. She said everything that happened to her husband, happened after he had his second dose of the COVID-19 Vaccine. She said she was not sure if her husband's collapsed lung (19Mar2021) was related to his second COVID-19 Vaccine. She said before getting the COVID-19 Vaccine, her husband did not have a problem with his lungs. She said her husband's surgeon can't figure out why her husband's lung collapsed. She said she can't prove his collapsed lung was a side effect of the COVID-19 Vaccine, but her husband never had sick lungs in his life. She said she knows her husband doesn't have the COVID-19 Virus because he had to be tested on Saturday (20Mar2021) for the COVID-19 Virus before he could have his surgery on Monday (22Mar2021). She said her husband's COVID-19 Virus test was negative Saturday, but he has all these problems. The patient's wife was afraid to give her husband Pepto Bismol, so she didn't give her husband anything. She said her husband has an appointment on Thursday (25Mar2021) with his primary care doctor to talk about his symptoms. The outcome of collapsed lung was unknown and other events were not recovered.

Other Meds:

Current Illness:

ID: 1178283
Sex: F
Age:
State: FL

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

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: Anaphylactic reaction; choking; could not breathe; legs have been red; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (wife). A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date were unknown) via an unspecified route of administration as single dose for COVID-19 immunisation. The reporter stated that the patient never had allergies, not until she took the Pfizer covid-19 vaccine. Concomitant medications were not reported. On an unspecified date, the patient had an Anaphylactic reaction after first dose and started choking and could not breathe. The reporter also stated they gave her two shots in her legs of Adrenaline right after first dose of covid-19. The reporter then stated his wife went to the hospital and was prescribed medication which than gave her allergies and her legs have been red since taking medication. Treatment was received for the events, Anaphylactic reaction, started choking and could not breathe. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1178284
Sex: F
Age:
State: TX

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 04/07/2021
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: This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 20Mar2021 08:30 as a single dose for COVID-19 immunisation. Medical history included cystitis interstitial and allergies: cat and bee stings. Concomitant medications included prednisone epinephrine, and chlorphenamine maleate (ANTIHISTAMIN) taken. Patient was not pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID prior to vaccination. After about 30 minutes, on 20Mar2021 09:00 AM, the patient experienced tongue started swelling and would not subside. She tried antihistamine all day with no success. She went to Urgent Care and received steroid shot and was prescribed prednisone that same evening. She was told to return if symptoms not improved in three days. The patient returned on Monday evening and was sent to the ER. She was diagnosed with Angioedema and given more antihistamines and steroid shot and epinephrine in IV. The patient was currently monitoring and seeing an allergist to follow up. Her tongue was still not back to normal. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of tongue started swelling and would not subside was not recovered, and of angioedema was unknown. The events were reported as non-serious. The patient had not been been tested for COVID-19 since the vaccination. No follow-up attempts are possible; information on the batch/lot number cannot be obtained.

Other Meds: PREDNISONE; EPINEPHRINE; ANTIHISTAMIN

Current Illness:

ID: 1178285
Sex: U
Age:
State: OH

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 04/07/2021
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: Arrhythmia episode; This is a spontaneous report from a contactable consumer (patient). A 68-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205), via an unspecified route of administration, on 03Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history included occasional palpitation episodes which has been self-terminating. The patient's concomitant medications were not reported. The patient had the first COVID-19 shot and had some questions about possible side effect from that. The patient was a healthy person but in the last several years I have had occasional palpitation episodes which has been self-terminating. Anyway, the day after the patient's first COVID-19 shot (04Mar2021), the patient had arrhythmia episode and that was unusual for the patient and it lasted till 3:00 PM. The patient didn't have in several months and since then, the patient had four more episodes. Now, the only thing the patient wanted to mention is that it (arrhythmia) started on 04Mar2021 and on 05Mar2021, the patient started to take unspecified (as voice not clear), so that is going on. The patient had the second shot scheduled this afternoon, so the patient's question is if it is safe to get that or should the patient be suspicious about these episodes. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1178286
Sex: F
Age:
State: WI

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

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: My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown. Information on the lot/batch number has been requested.

Other Meds: LEVOTHYROXINE; CHOLESTAT [ATORVASTATIN CALCIUM]; PANTOPRAZOLE; FLOXAZOLE; ASPIRIN [ACETYLSALICYLIC ACID]; AMITIZA; ALPHA LIPOIC ACID; BACLOFEN; ZENIX [LINEZOLID]; CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE

Current Illness:

ID: 1178287
Sex: M
Age:
State: MA

Vax Date: 03/06/2021
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
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: blood became a clot; pimple; This is a spontaneous report received from a Pfizer sponsored program received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2 reported as Pfizer Covid-19 vaccine), dose 1 via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he received Pfizer Covid-19 vaccine first dose on 06Mar2021, and second dose will be on Saturday 27Mar2021. While showering, he broke his pimple on Mar2021 then tried to remove it using the tissue and the blood became a clot. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1178288
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: he has thrombosis in leg; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient himself) reported that a male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included metastatic cancer in the lungs (he's taking chemotherapy) and heart problems from an unknown date. The patient's concomitant medications were not reported. The patient was due the next day for the 2nd dose of the Pfizer vaccine. He was asking if he can take his pre-scheduled medication, especially he's taking chemotherapy because he has metastatic cancer in the lungs. Due also to the nature of him having heart problems, he had thrombosis in leg and he's taking blood thinner since an unspecified date. He was asking if he should stop the medication or if he can take the blood thinner before the 2nd dose. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1178289
Sex: F
Age:
State: IL

Vax Date: 03/01/2021
Onset Date: 03/02/2021
Rec V Date: 04/07/2021
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: Un usual Hair loss; Chills; Fever; Vomiting; Lack of Energy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 01Mar2021 10:50 (Batch/Lot Number: EN6205) as SINGLE DOSE for covid-19 immunisation. Medical history included mild COPD from 2015 and ongoing, non-smoking, ongoing sinus issues, COVID-19 from Nov2020 to an unknown date. The patient's concomitant medication was none. The patient received dose 1 of vaccine on 08Feb021 11:00AM at Right Arm via Intramuscular (lot number: EM9810) and experienced Fever, Chills, Vomiting, Lack of Energy, Headache. On 02Mar2021 13:00, the patient experienced Fever, Chills, Vomiting, Lack of Energy. The events were assessed as serious, disabling. Treatment Received includes Advil. Also, for approximately two weeks after 2nd shot, the patient had unusual Hair loss. The outcome of the events Fever, Chills, Vomiting, Lack of Energy was recovered on 04Mar2021; outcome oof unusual hair loss was unknown.

Other Meds:

Current Illness: COPD (Mild COPD,Non smoking); Sinus disorder (Sinus issues)

ID: 1178290
Sex: M
Age:
State: OR

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
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: Atrial Fibrillation; increase in heart rate; fatigue; Headache; muscle pain; This is a spontaneous report received from a Pfizer sponsored program received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2 reported as Pfizer COVID-19 Vaccine), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he was experiencing atrial fibrillation, an increase in heart rate, fatigue, headache, and muscle pain on Mar2021. He mentioned that he is scheduled for the second dose on 26Mar2021 and inquired if he can still continue the 2nd dose of the vaccine. He also inquired if the symptoms would worsen after the second dose of the vaccine. The outcome of the events was unknown. Information on lot/batch number was requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm