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**
PLEASE CHECK BACK SOON
Download the files above while you wait.






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: 1161239
Sex: F
Age: 35
State: WI

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 04/02/2021
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: Bactrim

Symptom List: Dysphagia, Epiglottitis

Symptoms: Symptoms started upon wakening the morning after getting the Moderna vaccine. Symptoms include a headache, nausea, fever/chills, and pain at injection site. Vitals stable.

Other Meds: Atorvastatin 10 mg HS, Insulin isophane (NPH) SQ 4 units AM/PM,

Current Illness:

ID: 1161914
Sex: U
Age: 72
State: VA

Vax Date: 04/04/2016
Onset Date:
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-APR-2016, the patient was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).

Other Meds:

Current Illness:

ID: 1161916
Sex: F
Age:
State: NE

Vax Date: 04/21/1994
Onset Date: 05/01/1994
Rec V Date: 04/02/2021
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: she started having seizures / still currently gets seizures; This spontaneous report as received from a patient's mother refers to a currently 28-year-old female patient. Her concurrent conditions included hypothyroidism. The patient's concomitant therapies included methsuximide (CELONTIN), levetiracetam(KEPPRA) and "Selbatol". There was no information regarding her medical history. The patient had none drug reactions or allergies. On an unknown date, the patient was was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, route of administration, indication, lot # and expiration date were not reported) for prophylaxis, without any reactions. On 21-APR-1994, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot# 1603W has been verified to be not valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (dose, route of administration and expiration date were not reported) for vaccination. On the same date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, route of administration, indication, lot # and expiration date were not reported) for prophylaxis. On 01-MAY-1994, the patient started having seizures. She still currently got seizures and was taking seizure medications. The patient did not have seizures prior to taking the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The patient sought medical attention on an unknown date. The reporter stated that she reported this in the past (initial version was not found). The outcome of seizure was reported as not recovered. The causality assessment between the events and the suspect therapies was not provided. Upon internal review, the event of seizures was determined to be medically significant.

Other Meds: CELONTIN; KEPPRA

Current Illness: Hypothyroidism

ID: 1161921
Sex: F
Age:
State: TN

Vax Date: 03/01/2018
Onset Date:
Rec V Date: 04/02/2021
Hospital: Y

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: her heart went back into afib one; feeling tired; numbness in her hands and fingers; tingling in her hands and fingers; lower back pain on the right side/lower back starts to hurt sometimes; weakness in legs/legs are weak; shortness of breath; feeling off; black eye; This is an initial solicited report from a non-Pfizer sponsored program, from a contactable consumer, based on information received by Pfizer. This 79-year-old female patient was involved in a patient support program. The patient received apixaban. The report describes a case of fatigue (feeling tired), hypoaesthesia (numbness in her hands and fingers), paraesthesia (tingling in her hands and fingers), back pain (lower back pain on the right side/lower back starts to hurt sometimes) and muscular weakness (weakness in legs/legs are weak). The occurrence of additional non-serious events is detailed below. The patient's past medical history included High frequency ablation and Hospitalisation. In March 2018, the patient started apixaban (Oral), (unspecified dose, twice a day). On an unknown date, the patient experienced fatigue (feeling tired), hypoaesthesia (numbness in her hands and fingers), paraesthesia (tingling in her hands and fingers), back pain (lower back pain on the right side/lower back starts to hurt sometimes), muscular weakness (weakness in legs/legs are weak), dyspnoea (shortness of breath) and feeling abnormal (feeling off). The action taken with apixaban (Oral) was unknown. At the time of the report, fatigue, hypoaesthesia, paraesthesia, back pain, muscular weakness, dyspnoea and feeling abnormal outcome was unknown. For apixaban (Oral), the reporter did not provide any causality assessments. Patient received apixaban for the indication of Atrial fibrillation. The consumer reported that in Mar-2018 during a trip with her daughter, she began feeling tired and her legs hurt. When she returned home, she was hospitalized and diagnosed with Atrial Fibrillation. Follow-up (18Mar2021): This is a follow-up solicited report from a non-Pfizer sponsored program, from a contactable consumer, based on information received by Pfizer license party for apixaban. This 79-year-old female patient was involved in a patient support program. The patient received APIXABAN. The report describes a case of ATRIAL FIBRILLATION (her heart went back into afib one). The occurrence of additional non-serious events is detailed below Co-suspect products included Covid-19 Vaccine. The patient's past medical history included High frequency ablation and Hospitalization. Concurrent medical conditions included AFib. In March 2018, the patient started APIXABAN (Oral), (unspecified dose, twice a day). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seriousness criterion medically significant), FATIGUE (feeling tired), HYPOAESTHESIA (numbness in her hands and fingers), PARAESTHESIA (tingling in her hands and fingers), BACK PAIN (lower back pain on the right side/lower back starts to hurt sometimes), MUSCULAR WEAKNESS (weakness in legs/legs are weak), DYSPNOEA (shortness of breath), FEELING ABNORMAL (feeling off) and EYE CONTUSION (black eye). The patient was treated with Surgery (heart monitor) for Atrial fibrillation. The action taken with APIXABAN(Oral) was unknown. At the time of the report, ATRIAL FIBRILLATION, FATIGUE, HYPOAESTHESIA, PARAESTHESIA, BACK PAIN, MUSCULAR WEAKNESS, DYSPNOEA, FEELING ABNORMAL and EYE CONTUSION outcome was unknown. The patient stated that she had the coronavirus Pfizer vaccine and a few days later she had a black eye. The patient was concerned about this because she takes Eliquis so she asked a healthcare professional for advice they then informed her that the vaccine had caused her black eye. She was told that she cannot miss her second vaccine and that she might have to stop Eliquis. Patient was concerned about having to stop and had some questions. The patient reported that, she had been on Eliquis for a while and she had been doing just fine. She recently took the Pfizer Covid vaccine and a week or two later she developed a "black eye". She described the color around her eye as eggplant purple. She remembered her mother would have blood vessels burst around her eye, so at first, she thought nothing of it. She said the day before yesterday she went with her daughter while she got the Moderna Covid vaccine. She asked the nurse administering her daughters Moderna Covid vaccine if the Pfizer vaccine could cause black eyes. The patient said the nurse did some research and told her the the Pfizer vaccine was known to cause hemorrhaging, and that the vaccine caused the black eye. The nurse told the patient she should go to her HCP as soon as possible and get blood work done. The patient did not say anything else was abnormal about her blood work. She told the HCP what happened to her eye after she was given the Pfizer Covid vaccine. The HCP told her that no matter what the patient should get the second Pfizer vaccine, even if she had to stop the Eliquis for a few days. The patient said she did not want to stop the Eliquis because she has been doing wonderful on the medication and did not think the Eliquis was the cause of the black eye. She said she will have a talk with her normal primary care doctor as well as her cardiologist. The patient said she rather not get the second covid then stop the Eliquis. The patient started Eliquis two years ago after her heart went into "full afib" she had an ablation procedure and they shocked her heart three times to get it back into rhythm. Since starting the Eliquis the patient said her heart went back into afib one time. She wore a heart monitor and her heart went back into sinus rhythm on its own. She also mentioned that her HCP prescribed her a diuretic but she said she has a terrible reaction to it. She was prescribed the diuretic to help with the swelling around her ankles. She said the diuretic was also to help "keep congestion from her heart". The diuretic makes her feel "terrible" so her HCP allows her to cut the pill in half or quarters and take as needed to keep swelling down. She said the diuretic makes her feel faint and she even passed out one time while walking in the mall. She said she has not taken it in a while. The patient said she had a lot of allergies to medications, to many to list. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Prothrombin time: 16.2 seconds. For APIXABAN(Oral), the reporter did not provide any causality assessments. Patient received apixaban for the indication of Atrial fibrillation. The consumer reported that in Mar-2018 during a trip with her daughter, she began feeling tired and her legs hurt. When she returned home, she was hospitalized and diagnosed with Atrial Fibrillation. The strength of Eliquis was 5 mg. Most recent follow up information received on 18-Mar-2021 from Non-Health Professional incorporated above includes : New events added, lad data, concomitant drugs and narrative updated.; Sender's Comments: BMS Medical Evaluation Comment: This 79-year-old patient had atrial fibrillation after therapy with apixaban. Elderly age and underlying atrial fibrillation can be associated with increased risk of arrhythmias and based on the absence of etiological plausibility; the reported event is considered not related to apixaban.

Other Meds: POTASSIUM; CHLORTALIDONE; VITAMINS NOS; PROBIOTICS NOS

Current Illness: AFib

ID: 1161925
Sex: F
Age: 67
State: FL

Vax Date: 08/25/2020
Onset Date:
Rec V Date: 04/02/2021
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: Bilateral Sensorineural Hearing Loss; Bilateral Tinnitus; Right ear pain; Pressure on ears; This case was reported by a lawyer and described the occurrence of sensorineural hearing loss in a 56-year-old female patient who received Herpes zoster (Shingrix) for muscle pain. The initial information was received on 31 March 2021 via medical record (case is now medically confirmed). The current condition includes Nonsmoker, Patient suffered with Bilateral Sensorineural Hearing Loss and Bilateral Tinnitus. The patient was used Shingrix 0.5 ml via Intramuscular route on 27 August 2020. According to MR patient had odynophagia (pain while swallowing) Patient was reported since August 25 had series of adverse effects includes loss hearing and tinnitus, later she experienced terrible pressure on her ear.

Other Meds:

Current Illness: Pre-diabetes

ID: 1161927
Sex: F
Age:
State: UT

Vax Date:
Onset Date: 03/04/2021
Rec V Date: 04/02/2021
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: SWOLLEN THROAT; HEART RACING; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 220 kilograms, and height was 54 inches. The patient's past medical history included hormone replacement therapy, and concurrent conditions included thyroid disorder, anxiety, depression, arthritis, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient had no known allergies or history of drug abuse or illicit drug usage. The patient received COVID-19 vaccine AD26.COV2.S (suspension for injection, intramuscular, batch number: Unknown) dose not reported, on 04-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that the patient was on unspecified hormone replacement therapy medication, thyroid medication, a blood thinner ,antianxiety and antidepressant medications, pre diabetes medications, and arthritis medication. On 04-MAR-2021, the subject experienced swollen throat and heart racing and was admitted to emergency room. On 04-MAR-2021, the subject also experienced headache. No further information provided. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 04-MAR-2021, and had not recovered from swollen throat, and heart racing. The reporter assessed the events as related to COVID-19 vaccine AD26.COV2.S This report was serious (Hospitalization Caused / Prolonged) for swollen throat and heart racing.; Sender's Comments: Swollen throat, headache and heart racing . This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship. There are no other factors more likely to be associated with the event(s) than the drug.

Other Meds:

Current Illness: Abstains from alcohol; Anxiety; Arthritis; Depression; Hormone replacement therapy; Non-smoker; Thyroid disorder

ID: 1161928
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 03/06/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: CHEST TIGHTNESS; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, alcohol use (socially), no smoking, and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, administered on 06-MAR-2021;11:00 am, into left arm, for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced chest tightness and shortness of breath. Patient complained of chest tightness which began approx. 2 min after injection. Patient also stated that he had to breathe slowly and "not heavy", and felt short of breath. The dose of covid-19 vaccine ad26.cov2.s was not changed. The patient had not recovered from chest tightness, and shortness of breath. This report was serious (Other Medically Important Condition).; Sender's Comments: Chest tightness, and shortness of breath. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.

Other Meds:

Current Illness: Alcohol use (Socially); Nonsmoker; Pollen allergy

ID: 1161929
Sex: U
Age:
State: MN

Vax Date:
Onset Date: 03/06/2021
Rec V Date: 04/02/2021
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: VOMITING; SEVERE SHAKING; HIGH HEART RATE; FEVER OVER 100.2; This spontaneous report received from a health care professional . The patient's weight, height, and medical history were not reported. It was not asked if the patient had any allergies. It was unknown if the patient consume alcohol, smoke and if there was any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021; 04.45 pm, vaccination site not reported, for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 06-MAR-2021, the patient experienced vomiting, severe shaking, high heart rate, and fever over 100.2. Patient was given injection around 4.45 pm on 05-MAR-2021 and adverse events of severe shaking, fever over 100.2, high heart rate and vomiting started about 45 minutes ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, severe shaking, and fever over 100.2, and the outcome of high heart rate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: Vomiting, severe shaking, high heart rate, and fever over 100.2.. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship. There are no other factors more likely to be associated with the event(s) than the drug.

Other Meds:

Current Illness:

ID: 1161930
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 03/05/2021
Rec V Date: 04/02/2021
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: INCREASED HEART RATE; BREATHING INCREASE; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021; 08:40 am, into left arm, for covid-19 prevention. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the patient experienced increased heart rate and breathing increase. Patient had covid screening a couple of days ago and it was negative. Patient reported that she got the shot at about 20 minutes to 9 am today and was fine till after dinner around 1:30 and her heart rate increased by 10 beats per minute (bpm) and she had increased breathing. Patient wanted to know if that was a bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, and breathing increase on 05-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: Increased heart rate, and breathing increase. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.

Other Meds:

Current Illness:

ID: 1161931
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 03/06/2021
Rec V Date: 04/02/2021
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: FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021, vaccination site was not reported, for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 06-MAR-2021, the patient experienced fever. Patient reported that she received the covid vaccination last night around midnight. Next morning patient started to have a fever. Patient was referred to seek medical advice from health care practitioner as patient asked what she should take for fever, as health care practitioner know her medical history. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was serious (Other Medically Important Condition).; Sender's Comments: Pyrexia. This event(s) is labeled and is therefore considered potentially related.

Other Meds:

Current Illness:

ID: 1161933
Sex: M
Age:
State: UT

Vax Date:
Onset Date: 03/06/2021
Rec V Date: 04/02/2021
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: DIFFICULTY BREATHING; FAST HEARTBEAT; DIZZINESS; WEAKNESS; WEIRD FEELING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 to Left Arm for covid-19 vaccination. No concomitant medications were reported. On 06-MAR-2021 (at night), the patient experienced difficulty breathing, fast heartbeat, dizziness, weakness, and weird feeling. Symptoms have not worsened or improved since onset. The patient stated that "he doesn't feel that bad, but feels weird, like he is in the water." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty breathing, fast heartbeat, dizziness, weakness, and weird feeling (outcome also reported as unknown). This report was serious (Other Medically Important Condition).; Sender's Comments: Difficulty breathing, fast heartbeat, dizziness, weakness, and weird feeling. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are no other factors more likely to be associated with the event(s) than the drug.

Other Meds:

Current Illness:

ID: 1161934
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 03/05/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: FEVER; HEART RATE INCREASED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route and batch number: Unknown) dose was not reported, administered on 05-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the patient experienced fever and heart rate increased. Her heart rate was115 beats per minute even at rest. Treatment medications included paracetamol for fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and heart rate increased was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: Fever and heart rate increased. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship. There are no other factors more likely to be associated with the event(s) than the drug.

Other Meds:

Current Illness:

ID: 1161936
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 03/11/2021
Rec V Date: 04/02/2021
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: PASSED OUT; LIGHT HEADED; SHIVERING; HARD TIME REGULATING ITS TEMPERATURE; SENSITIVE SKIN; This spontaneous report received from a female of unspecified age reporting on self via social media. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced sensitive skin. On an unspecified date, the patient stated that the side effects for her were bad but short lived, got light headed and passed out in her kitchen, if she felt light headed, sat or lay down so she could not fall, her body also had a hard time regulating its temperature (temperature regulation disorder). The patient was shivering uncontrollably for about an hour, and then overheated very quickly under all blankets. On 11-MAR-2021 the patient mentioned that her skin feel sensitive, otherwise she was fine. She got the shot yesterday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, was recovering from shivering, and sensitive skin, the outcome of passed out and temperature regulation disorder was not reported. The reporter considered the causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder as related. Company causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder was possible This report was serious (Other Medically Important Condition).; Sender's Comments: 20210322217-JANSSEN COVID-19 VACCINE-Passed out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1161937
Sex: F
Age:
State: NV

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SEIZURE; FLU LIKE SYMPTOMS (CHILLS, HIGH TEMPERATURE, FEELS HOT,STUFFY NOSE); This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. No concomitant medications were reported. On MAR-2021,On an unspecified date, the patient experienced seizure, shaking, chills, high temperature, feels hot, and stuffy nose. patient daughter report she was suffering from seizure symptoms include extremely stiff ,extreme dizziness, shaking, and eyes rolling in back of head, also reported her mother did not lost consciousness and has been coherent .Daughter stated symptoms seem almost like a stroke ,upon follow call she clarify about seizure which is subsided. seizure occurred 3 times over past 5 days prior to call (first night of vaccine, next morning, and reporting day.) Daughter also reported mother had flu-like symptoms for the first 3 days after vaccine, including chills, high temperature, feels hot, and stuffy nose, but these have resolved. Daughter reports mother has not had symptoms like these prior to vaccine. she also report pharmacist who gave vaccine is aware of symptoms. patient body temperature was high, patient not performed covid 19 test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms ( chills, high temperature, feels hot ,stuffy nose.), and the outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0: 20210322863-Covid-19 Vaccine Ad26.Cov2.S-Seizure. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1161938
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/02/2021
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: UNABLE TO ACHIEVE OR MAINTAIN AN ERECTION; FEMINIZATION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received JNJ78436735 (Ad26.COV2.S)(suspension for injection, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in MAR-2021, the patient was unable to achieve or maintain an erection as well as feminization (making him 5'3" and giving him small hands). The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The outcome of the unable to achieve or maintain an erection and feminization was not reported. This report was serious (Other Medically Important Condition). Version created to amend previously reported information on 11-MAR-2021. Upon review, the following information was amended: outcome was updated from possible to not reported in narrative. Null flavor unknown selected for batch no.; Sender's Comments: v1: Version created to amend outcome in narrative. 20210324270-Covid-19 vaccine ad26.cov2.s-Erectile dysfunction. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1161939
Sex: U
Age:
State: VA

Vax Date:
Onset Date: 03/11/2021
Rec V Date: 04/02/2021
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: FAINTING; LOSS OF CONSCIOUSNESS; HYPOTENSION; This spontaneous report received from a health care professional concerned multiple patients. Initial information was processed along with the additional information received on 17-MAR-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The nurse reported on 11-MAR-2021. two patients had hypotensive episodes and fainted in clinic. On 11-MAR-2021, the patients experienced loss of consciousness. On an unspecified date, the patients had fainted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of consciousness, hypotension and fainting was not reported. The reporter provided causality between covid-19 vaccine ad26.cov2.s and loss of consciousness, hypotension, fainting was possible. This report was serious (Other Medically Important Condition).; Reporter's Comments: This case contains multiple patients.; Sender's Comments: V0: 20210324277- Covid-19 vaccine ad26.cov2.S- loss of consciousness, hypotension, fainting. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Other Meds:

Current Illness:

ID: 1161941
Sex: M
Age:
State: LA

Vax Date:
Onset Date: 03/10/2021
Rec V Date: 04/02/2021
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: FELT BILATERAL LUNG CONGESTION; BILATERAL SIDE PAIN; VOMITING; DIFFICULTY BREATHING; PAIN WHEN BREATHS; FEVER OF 100 F; FATIGUE; MISSED WORK TODAY; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021 (mentioned as yesterday), the symptoms of the patient started, and he missed work today (loss of personal independence in daily activities) and left arm pain (painful L arm) because he was not feeling well. The reporter advised him to contact his primary care provider, but he said he called and they are not able to see him without an appointment also advised him to seek medical attention by going to the emergency room. The patient agrees to go to the Emergency Room. On 11-MAR-2021, the patient experienced bilateral side pain (flank pain), vomiting, felt bilateral lung congestion (lung congestion), difficulty breathing, fever of 100 F, fatigue, pain when breaths (painful respiration). Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 100 f, had not recovered from bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, and pain when breaths, and the outcome of missed work today was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever of 100 f and missed work today as possible. Company causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever of 100 f and of missed work today as possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210325415- Covid-19 vaccine ad26.cov2.S- bilateral lung congestion. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1161942
Sex: M
Age:
State: AR

Vax Date:
Onset Date: 03/09/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: RASH ON ARMS AND HANDS; EXTREME PAIN IN BOTH HANDS AND ARMS; SEIZURE; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient is not on any medication and has no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. patient got the Janssen Covid shot on March 9th Tuesday and then experienced headache started same day and Wednesday10th march, took Tylenol and headache recovered, then seizure on 11th mar, went to the ER and spoke to the doctor on reporting day. consumer also started patient experiencing rash and extreme pain on both arms and hands on reporting day 12th mar and getting worse. On 09-MAR-2021, the subject experienced headache Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, and headache, and had not recovered from rash on arms and hands, and extreme pain in both hands and arms. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210325468 - Covid-19 Vaccine Ad26.Cov2.S - Seizure. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1161944
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/03/2021
Rec V Date: 04/02/2021
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: FEELS BAD; Initial information received on 03-MAR-2021 was processed with additional information received on 09-MAR-2021. The case was reassessed as serious based upon new information received on 09-MAR-2021. This spontaneous case was received from a patient and concerned a 76 year old female. The patient's weight was reported as 90 kilograms, and height was not reported. The patient's concurrent conditions included pulmonary arterial hypertension. The patient received treatment with COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported; the Company is unable to perform follow-up to request batch/lot numbers), dose was not reported for prophylactic vaccination on 02-MAR-2021. The concomitant medications included macitentan and apixaban. On 03-MAR-2021, the patient reported feeling bad after taking the COVID shot and was considering going to the hospital. On an unspecified date in MAR-2021, the patient was hospitalized. No details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feels bad was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210108619.; Sender's Comments: V0 A 76-year-old female patient reported feeling bad next day after receiving Janssen COVID-19 Vaccine Ad26.COV2.S (suspension for injection, route of administration not reported) for prophylactic vaccination. The patient's concurrent conditions included pulmonary arterial hypertension. concomitant medications, and details of the event were not reported. On an unspecified date the patient was hospitalized. This case has insufficient information to make a meaningful medical assessment.

Other Meds: ELIQUIS; MACITENTAN

Current Illness: Pulmonary arterial hypertension

ID: 1161946
Sex: M
Age:
State: MD

Vax Date:
Onset Date: 03/10/2021
Rec V Date: 04/02/2021
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: DEHYDRATED/ DIZZY SPELLS IN MORNING; VERTIGO; This spontaneous report received from a patient concerned a 65 year old male. The patient's weight was 238 pounds, and height was 155.7 centimeters. The patient's concurrent conditions included abstains from alcohol, non-smoker, and cholesterol, and other pre-existing medical conditions included no known allergy and no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 09-MAR-2021 13:00 at left arm for prophylactic vaccination. The batch number was not reported in follow-up information. Concomitant medications included atorvastatin to control cholesterol. On 10-MAR-2021, the patient experienced vertigo. On 12-MAR-2021, the patient was dehydrated (dizzy spells) in morning. And patient took IV treatment for dehydration. Laboratory data (dates unspecified) included: Blood test (NR: not provided) all good. It was reported that the patient was not ill at the time of vaccination. The patient did not have pre-existing acute illness 30 days prior to vaccination. The patient did not have history of hospitalization in last 30 days prior to vaccination. The patient did not have any family history of any disease (relevant to vaccination) or allergy. It was also stated that the product was properly stored from receipt to administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, and the outcome of dehydrated/ dizzy spells in morning was not reported. This report was serious (Other Medically Important Condition). Additional information was received as follow-up 30/MAR/2021. The following information was updated and incorporated into the case narrative: Patient demographic (height, weight, age), medical history, lab test, reporter (contact), concomitant medication, event of dehydration/dizzy spell in morning and administered IV treatment for dehydration.; Sender's Comments: V1 20210327793-covid-19 vaccine ad26.cov2.s.-Dehydration. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds: ATORVASTATIN

Current Illness: Abstains from alcohol; Blood cholesterol abnormal; Non-smoker

ID: 1161947
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/02/2021
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: STROKE; BLINDNESS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested On MAR-2021, the subject experienced stroke. On MAR-2021, the subject experienced blindness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and blindness was not reported. The reporter did not report causality between covid-19 vaccine ad26.cov2.s and stroke ,blindness .Company causality between covid-19 vaccine ad26.cov2.s and stroke and blindness was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210331088-Covid-19 vaccine ad26.cov2.s-Stroke , Blindness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1161948
Sex: M
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 04/02/2021
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: Unevaluable event

Symptoms: SEIZURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, after administration of vaccine the patient started having a seizure and ended up going to hospital (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210333412 - JANSSEN COVID-19 VACCINE Ad26.COV2.S - Seizure. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabelled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1161949
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/02/2021
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: SEIZURE/CONVULSION; LOW BLOOD PRESSURE; SORE ARM; FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN)) dose was not reported, administered on 16-MAR-2021 at 17:00 in the right deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 20-MAR-2021,The caller called to report that her daughter developed some rare side effects. The patient reported that she got the shot on 16-MAR-2021 and went home and went to bed at 23:15 PM experienced convulsing/seizure, chills, shaking, low blood pressure, heart rate increased. The police came to take her to the Emergency room. The patient was hospitalized on 16-MAR-2021. On an unspecified date in MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 70/20 mmHg, 80/30 mmHg, and Heart rate (NR: not provided) 110 OR 115 BPM. The patient has no fever then was given an unspecified IV. At 06:00 On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 98/38 mmHg, COVID-19 virus test (NR: not provided) NEGATIVE, CT scan (NR: not provided) NORMAL, Echocardiogram (NR: not provided) FINE, and Echocardiography (NR: not provided) FINE. Overall she took 6 Liters of IV fluid. The patient was discharged on 17-MAR-2021 at 14:00PM. The duration of hospitalization was two days. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 120/90 mmHg, and Heart rate (NR: not provided) 70 BPM. On an unspecified date, the patient experienced dizzy, lethargic, sore arm and fever. The patient gave permission to speak with her doctor who treated her there and was told to follow up with Primary Care Physician which she did on 18-MAR-2021. No medications were given at discharge. According to her, Blood pressure and Heart Rate was normal when she saw her Primary Care Physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking on 19-MAR-2021, low blood pressure and heart rate increased on 18-MAR-2021, was recovering from, chills and the outcome of, convulsing/seizure, dizzy, sore arm, lethargic and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210339790 - COVID-19 VACCINE AD26.COV2.S - Seizure, Blood Pressure Low. This event(s) is considered Unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1161950
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 03/22/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: BLOOD SUGAR LEVEL INCREASED; VOMITING 10 TIMES; CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's past medical history included type-1 diabetes for last 32 years, taking insulin Humalog 15 iu bd and Lancetan 40 iu once daily, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug use, no alcohol consumption and no smoking. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808609) dose was not reported, frequency 1 total, administered on 20-MAR-2021 09:00 for prophylactic vaccination on right arm. Concomitant medications included insulin lispro for type 1 diabetes, and plantago major extract. Blood Sugar level was tested on (Saturday) March 20, 2021 with test result 86, (Sunday) March 21, 2021 with test result 79 and 106 and (Monday morning at 7 am) March 22, 2021 with test result 286 On 22-MAR-2021, the patient experienced blood sugar level increased. On 22-MAR-2021, the patient experienced vomiting, chills, nausea and headache. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the nausea, vomiting, headache, chills and blood sugar level increased was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210342051-COVID-19 VACCINE AD26.COV2.S - Blood Sugar Level Increased. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.

Other Meds: LANCETAN; HUMALOG

Current Illness: Abstains from alcohol; Diabetes mellitus insulin-dependent (Type-1 Diabetic for last 32 yearsTaking Insulin Humalog 15 IU BD and Lancet 40 IU Once Daily); Non-smoker

ID: 1161951
Sex: U
Age:
State: NM

Vax Date:
Onset Date: 03/22/2021
Rec V Date: 04/02/2021
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: ADMINISTERED VACCINE OUT OF TEMPERATURE RANGE; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The reporter stated that, on 22-MAR-2021, they administered 2 doses of product to the 2 patients at their facility, However these 2 doses was exposed at the room temperature for more than 2 hours recommended (10-15 mins past the recommended 2 hours) (administered vaccine out of temperature range). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine out of temperature range was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210343668-covid-19 vaccine ad26.cov2.s-administered vaccine out of temp range. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1161952
Sex: M
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 04/02/2021
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: WAS NOT ABLE TO WALK; NEUROLGICAL PROBLEMS WITH HIS LEGS; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight was 90.5 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included warfarin. On an unspecified date, the patient experienced possible reaction to the Covid vaccine, patient was not able to walk and neurolgical problems with his legs. The patient was hospitalized since 14-MAR-2021. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neurolgical problems with his legs and was not able to walk was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210132481, 20201218555, 20201109402, 20201033394, A-NJ2017-162166, A-US2016-145072, A-NJ2016-130161, A-US2015-129188, A-US2014-94192, A-US2019-188952 and A-NJ2014-109450.; Sender's Comments: V0: 20210343964-COVID-19 VACCINE AD26.COV2.S - Was Not Able To Walk, Neurological Problems With His Legs. This event(s) is considered Unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: WARFARIN

Current Illness: Primary pulmonary hypertension

ID: 1161953
Sex: F
Age:
State: AK

Vax Date:
Onset Date: 03/22/2021
Rec V Date: 04/02/2021
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: ACHES; CHEST PAIN; FEVER; SORENESS AT INJECTION SITE; STIFFNESS; WEAKNESS ON THE ENTIRE LEFT SIDE OF BODY; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 196 pounds, and height was 63 inches. The patient's concurrent conditions included sulfas allergy, penicillin allergy and alcohol consumption. The patient does not smoke and does not have any drug abuse or illicit drug usage. The patient stated that she has a general good health. The patient received COVID-19 vaccine AD26.COV2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on left deltoid on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the patient experienced weakness on the entire left side of her body. On the same day, the patient experienced stiffness, fever, and soreness at injection site and also recovered from the left side body weakness. On 23-MAR-2021, the subject experienced aches and chest pain. The action taken with COVID-19 vaccine AD26.COV2.s was not applicable. The patient recovered from weakness on the entire left side of body on 22-MAR-2021, was recovering from soreness at injection site, aches, stiffness, and chest pain, and had not recovered from fever. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210345029-Covid-19 Vaccine Ad26.Cov2.S - Weakness On The Entire Left Side Of Her Body. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness: Alcohol use (She consumes alcohol on holidays.); Non-smoker; Penicillin allergy; Sulfonamide allergy

ID: 1161954
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/02/2021
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: RAISED BLOOD SUGAR TO DANGEROUS HIGH LEVEL, 400 AND GOING STRAIGHT UP; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry date: UNKNOWN) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, after vaccination the patient did not have any flu reaction but the vaccine raised blood sugar to dangerous high level. It was 400 and going straight up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of raised blood sugar to dangerous high level, 400 and going straight up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210347311-JANSSEN COVID-19 VACCINE Ad26.COV2. S - Blood sugar increased. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1161955
Sex: F
Age:
State: IN

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/02/2021
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: ARRHYTHMIA; COMPLEX MIGRAINE; BP BOUNCING HIGH AND LOW; TROUBLE MOVING LEGS AND NO STRENGTH; TIRED; EXTREMELY WEAK; TEMPERATURE ELEVATED; ELEVATED BLOOD PRESSURE; TROUBLE WITH ARM HARDLY USE ARM; GROIN PAIN; MUSCLE ACHE; COULDN'T SLEEP; UNABLE TO WALK; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's past medical history included bulbar polio diagnosed at age 15, and concurrent conditions included seasonal allergy, non-smoker, and high blood pressure. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at right arm. No concomitant medications were reported. On 12-MAR-2021, Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) NEGATIVE. On 13-MAR-2021, the patient experienced temperature elevated. On 14-MAR-2021 (Sunday) and 15-MAR-2021 (Monday), she felt bad and had elevated blood pressure (BP) and temperature. On 16-MAR-2021 (Tuesday), she felt lot better but by afternoon, she experienced loss of sight in right saw round circle with black triangle and her BP was 130/111 (77- heart rate (HR)). She developed arrhythmias. Her daughter and husband took her to the hospital. The hospital staff was concern about stroke. Her magnetic resonance imaging (MRI) and two computerized axial tomography (CAT) scans, one with iodine was performed and confirmed that she did not had stroke. Her BP was bouncing around high and low. She had trouble in moving legs were not working no strength. At one point her heavy muscle couldn't move. She reported that her BP was erratic, she was conscious but not mentally functioning, which was hard to explain. She was sent back to do scan with iodine, as health care professional was concern with blockage. Later, her MRI was performed. She started getting better and on the same day she was released from hospital after about 7 -8 hours. After coming home, she felt tired. She was diagnosed with complex migraine. On 26-MAR-2021, she started having trouble with arm and leg and she could not sleep. On 27-MAR-2021, her last muscle ache. Her BP elevated again and can hardly use her right arm. On 28-MAR-2021, her left leg was not in shape, trouble using right arm, groin area muscle is giving out with sharp pains. Treatment medications (dates unspecified) included: amlodipine, acetylsalicylic acid, and metoprolol. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arrhythmia on 16-MAR-2021, and temperature elevated, and unable to walk, had not recovered from elevated blood pressure, trouble moving legs and no strength, complex migraine, muscle ache, groin pain, and BP bouncing high and low, and the outcome of extremely weak, trouble with arm hardly use arm, tired and couldn't sleep was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arrhythmia, Complex migraine, Temperature elevated, Trouble moving legs and no strength, Tired. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Elevated Blood pressure, BP bouncing high and low. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY of High blood pressure. V0: 20210353871-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Extremely Weak. This event(s) is labeled and is therefore considered potentially related.

Other Meds:

Current Illness: Blood pressure high; Non-smoker; Seasonal allergy

ID: 1161956
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/26/2021
Rec V Date: 04/02/2021
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: BODY ACHES; LETHARGY; CHILLS; INJECTION SITE PAIN; FEVER; This spontaneous report received from a patient concerned a 58 year old (White, not Hispanic or Latino) female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination on Right deltoid. No concomitant medications were reported. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced lethargy. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced injection site pain. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and chills, and had not recovered from body aches, injection site pain, and lethargy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210354457-Covid-19 vaccine ad26.cov2.s-Bodyache, Lethargy,. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210354457-Covid-19 vaccine ad26.cov2.s-chills, injection site pain and fever. This event(s) is labeled and is therefore considered potentially related.

Other Meds:

Current Illness:

ID: 1161958
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/02/2021
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: CHOLERA; SORE ARM; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the patient experienced cholera, sore arm, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sore arm and cholera was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210355547-Covid-19 vaccine ad26.cov2.s-Cholera. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1161959
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/27/2021
Rec V Date: 04/02/2021
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: SEVERE ANAPHYLACTIC REACTION; This solicited report received from a patient via RRA-4549: PriCara social media Account concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer, and immunocompromised. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 27-MAR-2021, the patient experienced severe anaphylactic reaction and went twice to emergency room by an ambulance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe anaphylactic reaction was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and severe anaphylactic reaction as related. Company causality between covid-19 vaccine ad26.cov2.s, and severe anaphylactic reaction was related. This report was serious (Other Medically Important Condition).; Sender's Comments: Covid-19 vaccine ad26.cov2.s-Severe anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness: Cancer; Immunocompromised

ID: 1161960
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 03/27/2021
Rec V Date: 04/02/2021
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: FEELING HOT; SWEAT; TOOTHACHE; HEART RACING; FEVER; POUNDING HEAD; TENSION IN NECK; SORENESS IN BODY; SORE ARM; FEELING ROOM ON FIRE/PARANOIA/SEEING SPIDER/POSSIBLE HALLUCINATION; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, high blood pressure, and depression. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: unknown) dose was not reported, administered on 27-MAR-2021 on right arm for prophylactic vaccination. Concomitant medications included tramadol for fibromyalgia. On 27-MAR-2021, the patient experienced possible hallucination, tension in neck, soreness in body, sore arm and pounding head. On 28-MAR-2021, the patient experienced heart racing, toothache, fever and feeling hot and sweat. Treatment medications included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible hallucination, paranoia, heart racing, seeing spiders, tension in neck, soreness in body, feeling hot, felt like room was on fire, sore arm, fever, and pounding head on 29-MAR-2021, and sweat, and the outcome of toothache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210356720-COVID-19 VACCINE AD26.COV2.S-Possible hallucination. This event is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds: TRAMADOL

Current Illness: Blood pressure high; Depression; Fibromyalgia

Date Died:

ID: 1161961
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/02/2021
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: DEATH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin)total 1 dose, start therapy date were not reported for prophylactic vaccination. The Batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced death. On an unspecified date, the patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210356723- Covid-19 vaccine ad26.cov2.s-Death. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1161962
Sex: U
Age:
State: CA

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 04/02/2021
Hospital: Y

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: SEVERE VERY DANGEROUS IMMUNE RESPONSE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced severe, very dangerous immune response. On an unspecified date the patient was hospitalized for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe, very dangerous immune response. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210357960-Covid-19 vaccine ad26.cov2.s - severe, very dangerous immune response. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

Date Died: 03/29/2021

ID: 1161963
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/02/2021
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: DEATH; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced confirmed covid-19 infection. On 29-MAR-2021, the subject experienced death. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. On 29-MAR-2021, the subject died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patient died from unknown cause of death, and the outcome of confirmed covid-19 infection was not reported. It was unknown if an autopsy was performed This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210358262-COVID-19 VACCINE AD26.COV2.S- Death, Confirmed Covid-19 Infection. This event(s) is considered Unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1161964
Sex: U
Age:
State: NJ

Vax Date:
Onset Date: 03/29/2021
Rec V Date: 04/02/2021
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: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient had no known drug or non-drug allergy. The patient had no history of drug abuse or illicit drug use. The patient was non-smoker and non-alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the patient experienced suspected immunological vaccine failure. Laboratory data included: Antibody test (NR: not provided) Negative Antibodies (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210358301-Covid-19 vaccine ad26.cov2.s-Suspected Immunological Vaccination Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1161966
Sex: M
Age:
State: IN

Vax Date:
Onset Date: 03/18/2021
Rec V Date: 04/02/2021
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: HIGH BLOOD PRESSURE; CHILLS; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 18-MAR-2021, the patient experienced high blood pressure. On 18-MAR-2021, the patient experienced chills. On 18-MAR-2021, the patient experienced fever. Laboratory data included: Blood pressure (NR: not provided) 189/101, and Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high blood pressure, fever and chills was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210358958-COVID-19 VACCINE AD26.COV2.S-High blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1161967
Sex: F
Age:
State:

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

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: HOSPITALIZED AFTER FIRST DOSE; This spontaneous report received from a consumer via a company representative concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced hospitalized after first dose, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalized after first dose was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210400286-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Hospitalization. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1161968
Sex: U
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 04/02/2021
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: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 66 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, were not reported for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s more than 3 weeks ago. The batch number was not reported and has been requested. No concomitant medications were reported. On an unknown date, the patient experienced suspected immunological vaccine failure. The patient had no side effects. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative, SARS-CoV-2 IgG antibody test (NR: not provided) negative, and SARS-CoV-2 IgM antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210400318-covid-19 vaccine ad26.cov2.s -Suspected Immunological failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1161969
Sex: F
Age:
State: ME

Vax Date:
Onset Date: 03/23/2021
Rec V Date: 04/02/2021
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: SEIZURE; This spontaneous report received from a consumer concerned a 94 year old female. The patient's weight was 135 pounds, and height was 60 inches. The patient's past medical history included heart rate, oxalate and polysorbate sensitivity, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on the left arm. No concomitant medications were reported. On 23-MAR-2021, the patient experienced seizure, had to be taken by ambulance to hospital and was hospitalized for 5 days. She was in ICU for 3 days. On 26-MAR-2021, Laboratory data included: MRI (NR: not provided) MRI showed no damage Mitral Valve Regurgitation. The Patient was discharged on 27-Mar-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from seizure. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210400319- JANSSEN COVID-19 VACCINE Ad26.COV2. S- Seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1161970
Sex: U
Age:
State: UT

Vax Date:
Onset Date: 03/30/2021
Rec V Date: 04/02/2021
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: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 38-year-old not Hispanic or Latino, of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) once a total dose was not reported, administered on 23-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported by patient that on 30-MAR-2021, the patient had no antibodies found in bloodstream (suspected immunological vaccine failure). On 30-MAR-2021, Laboratory data included: SARS-CoV-2 IgM antibody test negative, no antibodies found in bloodstream, and Viral PCR test negative means no virus found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210401325-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1161971
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/31/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: vasovagal syncope; This spontaneous report received from a health care professional concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no significant past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, a couple minutes later of vaccination, patient experienced vasovagal syncope for which a Code Blue was called by clinic staff. 911 was also called. Patient was evaluated by ED physician on scene at the clinic, where patient had regained consciousness and responded to questions. The patient was then transported to emergency department next door by the emergency department staff where patient was monitored and ultimately discharged home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal syncope on 2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210401417 -COVID-19 VACCINE AD26.COV2.S-VASOVAGAL SYNCOPE. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event

Other Meds:

Current Illness:

ID: 1161973
Sex: F
Age: 78
State: LA

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 04/02/2021
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: Cellulitis flare up; A spontaneous report was received from a Pharmacist concerning a 78 year ? old female patient, who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Cellulitis flared up. The patient's medical history included Cellulitis for 15 Years. No relevant concomitant medications were provided. On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced cellulitis that was aggravated after vaccination. The event cellulitis was considered medically significant. No Laboratory details were provided. The Treatment medication included Cephalexin 500 mg twice a day. Action taken with mRNA-1273 in response to the other events was unknown. At the time of this report, the outcome of the event, Cellulitis aggravated was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Cellulitis (Cellulitis for 15 years.)

ID: 1161974
Sex: M
Age: 65
State: FL

Vax Date: 01/04/2021
Onset Date: 01/21/2021
Rec V Date: 04/02/2021
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: Left eye was not closing; Left face drooping; Extreme pain behind his left ear; Can't blink; A spontaneous report was received from a consumer concerning a 65-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left side of his face was drooping/facial paralysis, extreme pain behind his left ear/ear pain, can't blink/corneal reflex decreased, and his left eye was not closing/eye movement disorder. The patient's medical history included COPD, congestive heart disease and chronic problems with his back. No relevant concomitant medications were reported. On 4 Jan 2021, 17 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021 the patient had an unexpected reaction. He got up that morning and felt fine, but as the day went on, he noticed that when he spoke, the left side of his mouth was not moving, then he noticed his left eye was not closing and that side of his face was drooping. He was not in any pain at that point. He made an appointment to see his general doctor the next day, 22 Jan 2021, after the exam he was diagnosed him with Bell's Palsy (BP) and referred him to a neurologist and ophthalmologist. The earliest he could see the ophthalmologist back was next week and he could not get the neuro to call him back. His doctor prescribed him prednisone which he completed after 7 days but said the BP symptoms have not improved. Then on Saturday, 30 Jan 2021, he started feeling extreme pain behind his left ear. Everyday the pain got worse. His pain medications were not helping the pain behind his left ear. He could not see out of his left eye and he could not blink. The event left side of his face was drooping was considered as medically significant. Action taken with mRNA-1273 in response to the events left side of his face was drooping, extreme pain behind his left ear, can't blink, and his left eye was not closing was not provided. The events left side of his face was drooping, extreme pain behind his left ear, can't blink, and his left eye was not closing was not reported.; 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. Further information has been requested.

Other Meds:

Current Illness: Back disorder; Congestive heart failure; COPD

ID: 1161975
Sex: M
Age: 66
State: CO

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 04/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Swollen lip; Rash over their body (it itches bad); Heartbeat fast; Difficulty breathing; Had all of the symptoms of an allergic reaction; Dizziness; Weakness; Swelliness of their face, hand and feet; A spontaneous report was received from a healthcare professional concerning a 66-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had all of the symptoms of an allergic reaction, rash over their body, it itches bad (hypersensivity), dizziness, weakness (asthemia), swelliness of their face, difficulty breathing (dyspnea), heart beat fast (heartbeats increased), swollen lip, feet and hand swolle up. The patient's medical history was not provided. Concomitant medications reported were metformin, carvedilol, atorvastatin, aspirin, citalopram. On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection. On 5 Feb 2021, the patient experienced the event(s) had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast. On 19 Feb 2021, the patient experienced the event(s) swollen lip, feet and hand swolle up. Treatment details included Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast, swollen lip, feet and hand swolle up was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded

Other Meds: METFORMIN; CARVEDILOL; ATORVASTATIN; ASPIRIN (E.C.); CITALOPRAM

Current Illness:

ID: 1161976
Sex: M
Age: 73
State: ND

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 04/02/2021
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: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Dizzy; Disorientated; Can't balance, fell several times; fell several times; A spontaneous report was received from a consumer and confirmed by a healthcare provided concerning a 73-year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness, disorientation and balance issues falling several times. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly on unknown arm for prophylaxis of COVID-19 infection. On 16-FEB-2021, it was reported that the patient was dizzy, disorientated, couldn't balance and fell several times. On 17-FEB-2021, the patient was admitted to the hospital. Laboratory reports were not provided. Treatment information was not reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1161977
Sex: F
Age: 66
State: VA

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 04/02/2021
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: Unsteady/had to hold onto the wall to keep upright; Forever to write a simple email/weired things; No appetite but able to eat after 10 pm; Slept and woke up delirious; Woke up with 101.6 degrees fever; Tremendous itching; Soreness/pain; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Slept and woke up delirious) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 016M20A) 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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness/pain) and SWELLING (Swelling). On 25-Jan-2021, the patient experienced PRURITUS (Tremendous itching). On 19-Feb-2021, the patient experienced DELIRIUM (Slept and woke up delirious) (seriousness criterion medically significant), GAIT DISTURBANCE (Unsteady/had to hold onto the wall to keep upright), ABNORMAL BEHAVIOUR (Forever to write a simple email/weired things), DECREASED APPETITE (No appetite but able to eat after 10 pm) and PYREXIA (Woke up with 101.6 degrees fever). On 19-Feb-2021, DELIRIUM (Slept and woke up delirious), GAIT DISTURBANCE (Unsteady/had to hold onto the wall to keep upright), ABNORMAL BEHAVIOUR (Forever to write a simple email/weired things), DECREASED APPETITE (No appetite but able to eat after 10 pm) and PYREXIA (Woke up with 101.6 degrees fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness/pain) and SWELLING (Swelling) outcome was unknown and PRURITUS (Tremendous itching) was resolving. No relevant concomitant medications were reported. Treatment for events included 3 paracetamol.; Reporter's Comments: This case concerns a 66 Y/O F with a serious unexpected event of delirium, and nonserious unexpected abnormal behavior, pain in extremity, pruritus, and expected swelling and pyrexia. Serious event onset was 2 days after second dose mRNA-1273. Delirium resolved. Based on 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: 1161978
Sex: F
Age:
State: NM

Vax Date:
Onset Date:
Rec V Date: 04/02/2021
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: Chest congestion; Nose congestion; A spontaneous report was received from a consumer concerning a female (age not provided) who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced nose congestion (nasal congestion) and chest congestion (lower respiratory tract infection). The patient's medical history was not provided. Concomitant medication was not provided by the reporter. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) via intramuscular route for COVID-19 infection prophylaxis. After receiving the first dose, the patient reported experiencing nose and chest congestion. No treatment information was provided. No additional details were reported. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, nose and chest congestion, was unknown..; Reporter's Comments: This case concerns a female of unknown age with a serious unexpected event of Lower respiratory tract infection and nonserious unexpected Nasal congestion. Event onset with unknown latency after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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: 1161979
Sex: M
Age: 65
State: FL

Vax Date: 01/12/2021
Onset Date:
Rec V Date: 04/02/2021
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: autoimmune disorder which is Poly myalgia Rheumatica; having discomfort in my shoulders/started started noticing discomfort in hips and thighs; mostly about discomfort in lower extremities; Could not even get out of my bed at one point a; Joint pain; A spontaneous report was received from a physician concerning himself, a 65-years-old, male patient who experienced joint pain, having discomfort in my shoulders, started noticing discomfort in hips and thighs, mostly about discomfort in lower extremities, autoimmune disorder which is poly myalgia rheumatica and could not even get out of my bed at one point. The patient's medical history included neurological issues. Concomitant product use was not provided by the reporter. On 12 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 lot number 012L20A for prophylaxis of COVID-19 infection. On 12 Jan 2021, the patient reported discomfort in his shoulder and discomfort in his hips and thighs. Patient found out that it was an autoimmune disorder which was polymyalgia rheumatica. Treatment for the event included high dose steroid. Action taken with mRNA-1273 in response to the events was unknown. The outcome of all the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm