VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1449537
Sex: M
Age:
State: MA

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 07/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: crohn's flare up and was out of work for a month; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021), via an unspecified route of administration on 24Mar2021 (at the age of 54-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included crohn's disease (diagnosed over 20 years ago), acid reflux (esophageal). The patient concomitant medications included mesalazine (LIALDA) (MANUFACTURER UNKNOWN), via an unspecified route of administration at unspecified date at 1.2 g, daily (per day) for crohn's disease; omeprazole (PRILOSEC) (MANUFACTURER UNKNOWN), via an unspecified route of administration at unspecified date at 20 mg, once a day for acid reflux (esophageal). On an unspecified date, the patient experienced crohn's flare up and was out of work for a month, joint pain. The patient is calling about the covid vaccine. The patient was weaning off some of the medications with the doctor permission, Lialda. The patient can't remember when symptoms started to return but it closely corresponded with when the patient was vaccinated. The patient had a Crohn's flare up and was out of work for a month. Lialda lot, NDC, and expiration date not probed as it is not a Pfizer product. The patient has been seeing his GI doctor for the treatment of his flare up. The patient is getting close to getting his Crohn's back into remission, his blood work yesterday showed that it is almost there. Event: The patient is unsure when the symptoms started coming on. The joint pain started right around the first dose and then he got the second shot in the middle of April. The symptoms were getting increasingly worse at the end of May and then the middle of May is when they started changing up the mediations. The patient also had blood work on 27May2021. The clinical outcome of the joint pain was unknown and crohn's flare up and was out of work for a month was recovering.

Other Meds: LIALDA; PRILOSEC [OMEPRAZOLE]

Current Illness: Crohn's disease (Diagnosed over 20 years ago.)

ID: 1449538
Sex: M
Age:
State: KY

Vax Date: 06/02/2021
Onset Date: 06/11/2021
Rec V Date: 07/06/2021
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: some possible increase in heat exhaustion; kind of like a heat stroke; This is a spontaneous report from a Pfizer sponsored program . This case is for 1 of 4 patient whose demographic was available. A contactable (Physician) reported that a 24-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot: EW0180) via deltoid alternating on 02Jun2021 (at the age of 24-year-old) at 08:00 as single dose for COVID-19 immunization/ Health force protection. Medical history and concomitant medications were not reported. The patient historical vaccine reported was bnt162b2 (Lot: unknown) via deltoid alternating on 10May2021 (at the age of 24-year-old) at 06:54 as single dose for COVID-19 immunisation. The patient was in the emergency room and discharged from the emergency room. No history of allergic reaction to any kind of vaccines was reported. Caller was a military physician and had reported some of his men (referring to military people) were actually experiencing some difficulty in carrying out their usual military exercises as compared to before. He mentioned some possible increase in heat exhaustion, but he is not positive that it is caused by the vaccine. In line with this, he would like to have some information in regards precaution that may be aware of regarding an increase in heat exhaustion after "x" amount of days after getting the vaccine. Over-all there were 28 people reporting this side effect after getting their second dose on 06Jun2021. A bunch of other factors probably played a role. Kind of chasing a wild goose. The caller wanted to make sure. The caller reported he has not seen anything else in his research other than a couple reports of pericarditis in young men. The caller wants to make sure there is no reason to be concerned. The caller states the event was probably heat and humidity related issue, peoples conditioning. The caller was the officer assigned to investigate the situation. The caller wanted to make sure he was not missing anything and was doing his due diligence. The caller would like to know any recommendations, the caller stated he has not seen taking it easy for longer than a week or two after receiving the Pfizer Covid Vaccine. The caller stated part of the exercises was the 12-mile march, part of exercises called EID, a bunch of tasks the persons perform. During the 12-mile March 28 folks kind of fell out with heat exhaustion. Generally speaking, with this kind of exaggerated heat exhaustion, to have 28 persons experience was a large number for the caller. The caller states this has gone away for the patient after the patient was discharged from the emergency room. The patient was doing fine. The caller stated the patient has recovered completely. The caller stated he feels pretty good about doing the Pfizer Covid Vaccines every 3-4 weeks in terms of once a person starts the Pfizer Covid Vaccines. The patient had elevated CK that went all the way up to 1,683. The patient had an AKI of 2.2, creatinine of 2.2, normalized on 15Jun2021 back down to 1.1. The CK down trending by 17Jun2021. Outcome of the events was recovered on an unspecified date in Jun2021. Causality: The caller stated the event was not a direct correlation, more of an indirect kind of thing that just popped up. Whether the event is a thing or more of like, a bunch of other reasons the caller can think of that this could happen including heat and humidity. Information on the lot/batch number is available. Other information is expected.; Sender's Comments: Based on the information provide in the narrative, the causal association between the suspect drug and the events cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021755866 Same reporter/ drug/ AE, different patient

Other Meds:

Current Illness:

ID: 1449539
Sex: M
Age:
State: NJ

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 07/06/2021
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: lost a lot of blood, there was excess bleeding at the injection site; This is a spontaneous report from a contactable consumer (wife). A 73-year-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: E19126, Expiration date: unknown) via an unspecified route of administration on 23Jan2021 (at the age of 73-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jan2021, patient experienced lost a lot of blood, there was excess bleeding at the injection site. Reporter called for her husband reporting on the Covid 19 vaccine and who wants to know if he should get a third dose of the vaccine. Reported that when he received the 2nd dose the patient lost a lot of blood, there was excess bleeding at the injection site. Because of this, she was questioning if he needs a third dose. Reporter stated that the tech put the needle in and afterward states that he was the 3rd patient that had blood spew out of the injection site. No other information provided for this statement as the reporter declined to complete the report. It was explained the bleeding lasted about an hour, it was not a lot but shot right out of the puncture, where the jab was at the injection site. There was no investigation assessment provided. The outcome of event was recovered on 23Jan2021. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1449540
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Patient got a blood transfusion on 17May2021 due to low iron.; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received first dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Solution for Injection), via an unspecified route on an unknown date as a dose 1 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient got a blood transfusion on 17MAY2021 due to low iron. Patient wanted to know if there will be a potential contraindication for a blood transfusion patient to get the 2nd dose of the BNT162B2 (Pfizer BioNTech Covid-19 Vaccine). Patient underwent for lab test and procedure which included iron test result was low. The clinical outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected. ; Sender's Comments: Based on current information available, the event low iron mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2. Relevant medical history and concurrent disease are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1449542
Sex: F
Age:
State: CA

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 07/06/2021
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: She was advise to go to the ER because it could be a stroke.; Tingling in her arms post vaccination/ tingling started in her face and then spread; Her right eye lid was drooping a little.; She noticed a pressure on her chest including panic attacks and anxiety.; She noticed a pressure on her chest including panic attacks and anxiety.; She noticed a pressure on her chest including panic attacks and anxiety.; Soreness in arm; Lump; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional from Pfizer sponsored program. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EN6207 ), dose 1 via an unspecified route of administration, administered in top of the Arm Left on 17Mar2021 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in top of the Arm Right on 08Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Prior vaccinations within 4 weeks were None. Reporter then stated she did not receive any of the vaccines and she thinks she just had the tests to confirm you had it. Medical history included pain in extremity and visual impairment. There were no concomitant medications. The patient experienced she was advise to go to the ER because it could be a stroke on an unspecified date, tingling in her arms post vaccination/ tingling started in her face and then spread ( It was within 48 to 72 hours of receiving the vaccine). it initially started at the jaw bone and down into her arm midway to forearm then continued to left side of hip and down leg and stopped right above her knee, her right eye lid was drooping a little, she noticed a pressure on her chest including panic attacks and anxiety, soreness in arm, lump. It was reported that reporter has asked certain questions Has Pfizer provided a statement on the need for a booster dose (3rd dose)? Is Pfizer investigating the need for a booster dose. My pediatrician told me the vaccine is only 95 % effective against the variant. Response: The emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine has been expanded to include individuals 12 to 15 years of age. In the Phase 3 pivotal trial, there were 2,260 individuals in this age group who received either the vaccine or placebo. The dose in 12 to 15 years of age is the same dose as currently available for adults (30 mcg per 0.3 mL dose as a series of two doses). Topline results showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and the vaccine was also generally well-tolerated. These individuals will continue to be monitored for an additional two years after their second dose. Also, Pfizer has submitted this information for publication in a scientific journal for peer-review and potential publication. Pfizer and BioNTech started a Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in children aged 5 to 11 years. This is part of the Phase 1/2/3 dose-escalation study in healthy children 6 months to 11 years was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine on a two-dose schedule (approximately 21 days apart) in three age groups:o 5 to 11 yearso 2 to 5 yearso 6 months to 2 yearsAdditional information about the study can be found at www.clinicaltrials.gov under the identifier NCT04816643. The Pfizer-BioNTech COVID-19 Vaccine is not authorized for use in individuals less than 12 years of age. References:Pfizer-BioNTech COVID-19 Vaccine EUA Prescribing Information Pfizer-BioNTech COVID-19 Vaccine Authorized Product Monograph. Pfizer Press Pelease. withheld 10May2021.Pfizer-BioNTech COVID-19 Vaccine. Data on file (155). Pfizer. The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On February 25, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It is important to have a vaccine technology that allows us to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against. While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we are taking multiple steps to be ready in case a strain becomes resistant to the vaccine. The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine is not approved. She had asked her doctor confirmed the vaccine can cause demyelination in adults post vaccination. Response: There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech. She asked What are the ingredients of the vaccine. Response: Informed caller to retrieve the list of ingredients on the following website. Sending the attached document via e-mail for reference. She was sure she does not have a stroke . Response was sent tot her to speak to her HCP. Reporter stated she had the adverse events after both the first and second doses. The outcome of she was advise to go to the ER because it could be a stroke on an unspecified date, tingling in her arms post vaccination/ tingling started in her face and then spread. it initially started at the jaw bone and down into her arm midway to forearm then continued to left side of hip and down leg and stopped right above her knee, She noticed a pressure on her chest including panic attacks and anxiety , Soreness in arm and Lump was unknown. The outcome of Her right eye lid was drooping a little was not recovered. She has to see when she goes to the doctor next week.

Other Meds:

Current Illness:

ID: 1449543
Sex: F
Age:
State: VA

Vax Date: 06/23/2021
Onset Date:
Rec V Date: 07/06/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: it was 106 fever; She is just very sick; Cough; Nausea; I vomited twice; Diarrhea; Muscle pain; Weakness; cold; she was not well; This is a spontaneous report from contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on 23Jun2021 as dose 2 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that patient was very sick now. She had the second Pfizer, she had bad reaction. It was 106 fever all night and she was not well. Patient was vomiting a lot yesterday when she came back and since then fever went up till 104 and she was taking Tylenol to put her cold down. Patient turned to develop the symptoms. patient had cough, fever, nausea, vomited twice, diarrhoea, muscle pain everywhere, had weakness all in 2021 and then you know by the time I am going to bed the fever was 102.7 so I took Tylenol and then I kept checking my temperature. The outcome of events was unknown. Information about batch/lot number has been requested

Other Meds:

Current Illness:

ID: 1449544
Sex: F
Age:
State: NV

Vax Date: 12/29/2020
Onset Date: 01/01/2021
Rec V Date: 07/06/2021
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: the patient got COVID and didn't got the second dose. The patient went back on 06Jun and got another dose.; Had her first dose 29Dec2020 and a week or two later got Covid; Had her first dose 29Dec2020 and a week or two later got Covid; This is a spontaneous report from a contactable pharmacist. An unspecified age female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient had her first does on 29Dec2020 and a week or two later got COVID and didn't got the second dose. The patient went back on 06Jun2021 and received another dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The reporter stated: the patient was here in currently day to got the second dose from the Jun2021 series. And the reporter wanted to known whether that dose could be given. The outcome of COVID and drug ineffective was recovered in 2021 and the outcome of inappropriate schedule of vaccine administration was unknown. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.

Other Meds:

Current Illness:

ID: 1449545
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 07/06/2021
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: Heart fluttering; Severe headache neck pain shoulder pain jaw pain; Severe headache neck pain shoulder pain jaw pain; Severe headache neck pain shoulder pain jaw pain/Joint pain; Severe headache neck pain shoulder pain jaw pain; Teeth pain tingling in left fingers; Teeth pain tingling in left fingers; Fatigue; lot of pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. No concomitant medications were reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization and experienced no events. On an unspecified date after second COVID vaccine, the patient experienced heart fluttering, severe headache, neck pain, shoulder pain, jaw pain, teeth pain, tingling in left fingers, joint pain, fatigue and nausea. Patient reported that it was the first day and patient felt well enough to do anything after receiving the vaccination. Patient had a lot of pain with the vaccine. Events took place after use of product. The clinical outcome of the events was reported as unknown. Information on the Batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1449546
Sex: F
Age:
State: NJ

Vax Date: 06/03/2021
Onset Date: 06/13/2021
Rec V Date: 07/06/2021
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: Crohn's flare including severe bloating and constipation; This is a spontaneous report from a contactable consumer(patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0177 and expiration date: not reported), via an unspecified route of administration, on Left Arm, on 03Jun2021 at 11:00 (at the age of 39-year-old), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization at Pharmacy or Drug Store. Medical history included ongoing Crohn's disease. No past drug event has been reported. Concomitant medication included hydrochlorothiazide. The patient was not pregnant at the time of vaccination. Patient doesn't have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19 and after the vaccination patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jun2021 (10 days post vaccine), the patient experienced Crohn's flare including severe bloating and constipation and lasted for approximately 2 weeks. The outcome of the events was recovered on Jun2021.

Other Meds: HYDROCHLOROTHIAZIDE

Current Illness: Crohn's disease

ID: 1449547
Sex: F
Age:
State: NC

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 07/06/2021
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: Her doctor now says she has pericarditis due to the shot.; she had felt real bad; all over pain; vomiting; This is a spontaneous report from two contactable consumers. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 10Jun2021 as dose number unknown, single, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had not been tested for COVID-19 prior vaccination and post vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 10Jun2021, the patient felt real bad after the injection with vomiting and all over pain. The doctor said she has pericarditis due to the shot. The patient visited emergency room/physician office due to the events. Therapeutic measures (unspecified) were taken as a result of the events. The outcome for the events were not recovered. Information on Lot/Batch information has been requested.

Other Meds:

Current Illness:

ID: 1449549
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 07/06/2021
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: can not walk yet without walker; Initial information was received on 21-Jun-2021 regarding an unsolicited valid serious case from a consumer or non-healthcare professional. This case involves an elderly male patient who can not walk yet without walker (gait inability) after he received FLUVIRIN [INFLUENZA VACCINE INACT SAG 3V], ZOSTAVAX and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect ZOSTAVAX not produced by Sanofi Pasteur [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient received a dose of suspect FLUVIRIN [INFLUENZA VACCINE INACT SAG 3V] not produced by Sanofi Pasteur [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a serious cannot walk yet without walker (gait inability) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, ZOSTAVAX and FLUVIRIN [INFLUENZA VACCINE INACT SAG 3V]. This event was assessed as medically significant and was leading to disability. Details of laboratory data were not reported. It was not reported if the patient received a corrective treatment for the events. At the time of reporting, the event outcome was unknown. Information on batch number is requested.; Sender's Comments: This case involves an elderly male patient who experienced gait inability (unknown latency) after vaccination with FLUZONE HIGH DOSE, ZOSTAVAX (not produced by Sanofi Pasteur) and FLUVIRIN (not produced by Sanofi Pasteur). The time to onset was unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccines cannot be assessed.

Other Meds:

Current Illness:

ID: 1449550
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/06/2021
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: Slight reaction to type HIB vaccine just a mild one; Initial information was received on 25-Jun-2021 regarding an unsolicited valid non-serious case received from a patient. This case involves a male patient (unknown age) who experienced slight reaction to type HIB vaccine just a mild one (vaccination complication) while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious slight reaction to type HIB vaccine just a mild one (vaccination complication) (unknown latency) following the administration of HIB (PRP/T) VACCINE. The reporter wants to know that if he can get the Pfizer vaccine and if any common ingredients with type B HIB vaccine. It is unknown if patient's physician provided consent to be contacted. It was unknown if the patient experienced any additional symptoms/events. Details of laboratory data were not reported. It was not reported if the patient received a corrective treatment. At the time of report, the outcome of event was unknown. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1449551
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/06/2021
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: severe anaphylactic reaction to the influenza vaccine; Initial information received on 25-Jun-2021 regarding an unsolicited valid serious case received from a physician. This case involves an unknown age female patient who experienced severe anaphylactic reaction (anaphylactic reaction), while she received INFLUENZA VACCINE and TOZINAMERAN [PFIZER BIONTECH Coronavirus disease (COVID-19) VACCINE]. The patient's medical treatments, vaccinations, concomitant medications and family history were not provided. At the time of the event, the patient had ongoing medical history of allergy to iodine and penicillin (Drug hypersensitivity). On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer and a dose of suspect PFIZER BIONTECH COVID-19 VACCINE not produced by Sanofi Pasteur (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination respectively. On an unknown date, the patient experienced a serious severe anaphylactic reaction to the influenza vaccine (anaphylactic reaction) (unknown latency) following the administration of INFLUENZA VACCINE and PFIZER BIONTECH COVID-19 VACCINE. This event was assessed as medically significant. It is unknown if the patient experienced any additional symptoms/ event. It is unknown if there were lab data/ results available. Caller states that he is an Infectious Disease physician who is calling today in regards to the Pfizer (COVID-19) vaccine and his wife. He goes on to states that is wife has an allergy to iodine and penicillin and has previously had a severe anaphylactic reaction to the influenza vaccine. He states that since she has had these allergies and reactions in the past he is looking into some research to see if he would recommend his wife to get the vaccine. He is asking for any information regarding the administration of the vaccine in 4 smaller doses rather than the current two dose series that is recommended. He reports that he understands the information may be limited and just wanted to check and see if there had been in studies done in this case. Adverse Event recognized after the call of wife having reaction to flu vaccine in the past. Electronic-transmitting information. Response: Spoke from attached documents regarding the Health Care Professional (HCP) inquiry. Advised that there is limited information on this topic but relayed that there are currently ongoing trials for pediatric patients that are being studies with a variety of different dosage amounts that may be helpful for him. Disclaimers provided. Reporter was very thankful and happy to receive any information. Sharing information via email per HCP request. Request Name: PFIZER-BIONTECH (COVID-19) VACCINE Question: Pfizer has done a wonderful job being able to develop and supply a safe and very much effective vaccine in such a short amount of time based on previous vaccine and timelines. This has been so important and helpful for our country and I just want to thank Pfizer. Age group actually not provided. It is unknown if patient's physician provided consent to be contacted. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome of event was unknown. Information on the batch number was requested for this case.; Sender's Comments: This case concerns an unknown age female patient who experienced severe anaphylactic reaction after vaccination with INFLUENZA VACCINE produced by unknown manufacturer and PFIZER BIONTECH Coronavirus disease (COVID-19) VACCINE not produced by Sanofi Pasteur. The time to onset is unknown. The patient has a known allergy to iodine and penicillin, and other medical history and lab tests was not reported. Based upon the reported information, the role of the suspect vaccines cannot be individually assessed.

Other Meds:

Current Illness: Iodine allergy; Penicillin allergy

ID: 1449705
Sex: U
Age:
State: WA

Vax Date: 09/18/2008
Onset Date: 09/18/2008
Rec V Date: 07/06/2021
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: No additional adverse events reported; the student had received MMRV/PROQUAD; the student is missing their MMR; This spontaneous report was received from a nurse referring to her student of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 18-SEP-2008, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # reported as 0392X but upon internal validation established as 660654/0392X, expiration date was reported as unknown, but upon internal validation established as 05-MAR-2010, 0.5 milliliter) subcutaneously for prophylaxis. The patient was missing the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (0.5 ml, subcutaneous; strength, lot# and expiration date were not reported) vaccine on the document (product dose omission issue). It was reported that the dose of varicella virus vaccine live (oka/merck)(VARIVAX) should have been received with the vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on the same date. It was unknown if documented incorrectly and the patient had received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, route, lot# and expiration date were not reported) (wrong product administered). No additional adverse events were reported.

Other Meds:

Current Illness:

ID: 1449706
Sex: F
Age: 0
State: CA

Vax Date: 06/18/2021
Onset Date: 06/18/2021
Rec V Date: 07/06/2021
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: multiple doses of ROTATEQ had partially sealed foil pouches/ 1 dose of ROT ATEQ that experienced PQC was administered to a patient on 18JUN2021; No additional information provided; 1 dose of ROT ATEQ that experienced PQC was administered to a patient on 18JUN2021; This spontaneous report was received from a nurse referring to a 4-month old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, it was noticed that multiple doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had partially sealed foil pouches. There were 19 doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# T033634, expiration date 16-MAR-2022) were affected. On 18-JUN-2021, one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# T033634, expiration date 16-MAR-2022, 1 dosage form; strength and dose detail were not reported) that experienced product quality complaint was administered to the patient orally as routine vaccination (product container seal issue and poor quality product administered). No additional information was reported. The product was available for return.

Other Meds:

Current Illness:

ID: 1449707
Sex: U
Age:
State: MT

Vax Date: 06/23/2021
Onset Date: 06/23/2021
Rec V Date: 07/06/2021
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: No additional adverse effect reported; VARlVAX that underwent a temperature excursion was administered; This spontaneous report as received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On 23-JUN-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T035400, was confirmed to be valid, expiration date 16-OCT-2022 (strength, exact dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine was stored in 42.9 degrees Fahrenheit for 216h. Data logger was involved. There were no previous excursions reported.

Other Meds:

Current Illness:

ID: 1449708
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/06/2021
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: I got both my shingles shots / I've had horrible pain in my arm / My arm hasn't been the same since; This case was reported by a consumer via media and described the occurrence of pain in arm in a 50-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient. The patient received 1st dose of Shingles vaccine and experienced horrible pain in arm. This case has been linked with US2021AMR140659,reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR140659:

Other Meds:

Current Illness:

ID: 1449709
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 05/24/2021
Rec V Date: 07/06/2021
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: SHORTNESS OF BREATHE; LOSS OF SENSATION LEFT SIDE; STRONG SHIVER; This spontaneous report received from a patient concerned a male 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, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced strong shiver. On 28-JUN-2021, the subject experienced shortness of breathe. On 28-JUN-2021, the subject experienced loss of sensation left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strong shiver, and was recovering from shortness of breathe, and loss of sensation left side. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Other Meds:

Current Illness:

ID: 1449710
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: DIZZINESS/LIGHT HEADEDNESS; BLURRY VISION; DIFFICULTY BREATHING; DISORIENTATION; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-JUN-2021 15:35 for prophylactic vaccination. The batch number is unknown and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness/light headedness, blurry vision, difficulty breathing, disorientation, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness/light headedness, blurry vision, difficulty breathing, headache and disorientation was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1449711
Sex: M
Age:
State:

Vax Date:
Onset Date: 06/23/2021
Rec V Date: 07/06/2021
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: CONGESTION; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUN-2021, the subject experienced congestion. On 23-JUN-2021, the subject experienced chills. On 23-JUN-2021, the subject experienced fatigue. On 23-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the congestion, chills, fatigue and headache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1449712
Sex: U
Age:
State: OH

Vax Date:
Onset Date: 06/30/2021
Rec V Date: 07/06/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 30-JUN-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 30-JUN-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1449713
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: POTENTIALLY EXPIRED VACCINE ADMINISTERED; INCORRECT PRODUCT STORAGE; This case, from the same reporter is linked to 20210704358. This spontaneous report received from a pharmacist concerned a 64 year old male. 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, route of admin not reported, batch number: 1816022 expiry: 15-AUG-2021) dose was not reported, administered on 01-JUL-2021 11:50:00 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced potentially expired vaccine administered. On 01-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potentially expired vaccine administered and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210704358.

Other Meds:

Current Illness:

ID: 1449714
Sex: F
Age:
State: DE

Vax Date:
Onset Date: 05/04/2021
Rec V Date: 07/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: HYPERTENSIVE CRISIS DURING HER PERIODS; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight was 215 pounds, and height was 66 inches. The patient's concurrent conditions included hypertension, chronic kidney disease, left breast cancer, seasonal allergies (mold), non smoker, and non alcohol user. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included biotin for drug used for unknown indication, hydrochlorothiazide for drug used for unknown indication, pyridoxine hydrochloride for drug used for unknown indication, valsartan for drug used for unknown indication, vitamins nos for drug used for unknown indication, and withania somnifera for drug used for unknown indication. On 04-MAY-2021, the subject experienced hypertensive crisis during her periods. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hypertensive crisis during her periods. This report was non-serious.

Other Meds: VITAMIN B6; DIOVAN; HYDROCHLOROTHIAZIDE; BIOTIN; ASHWAGANDHA [WITHANIA SOMNIFERA]; MULTIVITAMIN [VITAMINS NOS]

Current Illness: Abstains from alcohol; Breast cancer; Chronic kidney disease; Hypertension; Non-smoker; Seasonal allergy (Seasonal allergies (mold))

ID: 1449715
Sex: M
Age:
State: IN

Vax Date:
Onset Date: 07/02/2021
Rec V Date: 07/06/2021
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: FELT DIZZINESS; SORENESS IN RIGHT ARM; WEAKNESS IN RIGHT LEG AND RIGHT ARM / CAN'T PICK UP ANYTHING OVER 5 POUNDS; SORENESS AT INJECTION SITE TRAVELLED DOWN RIGHT ARM; NAUSEOUS; This spontaneous report received from a patient concerned a 56 year old male. 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, route of admin not reported, batch number: 1821281, and expiry: 06-SEP-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced felt dizziness. On 02-JUL-2021, the subject experienced soreness in right arm. On 02-JUL-2021, the subject experienced weakness in right leg and right arm / can't pick up anything over 5 pounds. On 02-JUL-2021, the subject experienced soreness at injection site travelled down right arm. On 02-JUL-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt dizziness on 02-JUL-2021, and had not recovered from soreness at injection site travelled down right arm, nauseous, weakness in right leg and right arm / can't pick up anything over 5 pounds, and soreness in right arm. This report was non-serious.

Other Meds:

Current Illness:

ID: 1449716
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/06/2021
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: SECONDARY EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, 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 secondary effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of secondary effects was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Other Meds:

Current Illness:

ID: 1449717
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: HORRIBLE REACTION TO J AND J FOR AN ACQUAINTANCE OF MINE; SCARY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported 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 an unspecified date, the subject experienced horrible reaction to j and j for an acquaintance of mine, and scary. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the horrible reaction to j and j for an acquaintance of mine and scary was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1449718
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 07/06/2021
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: SORES IN MOUTH; 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, 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 sores in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sores in mouth was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1449719
Sex: M
Age:
State: FL

Vax Date: 03/04/2021
Onset Date: 06/12/2021
Rec V Date: 07/06/2021
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: temperarily lost sight in left eye; This spontaneous case was reported by a patient and describes the occurrence of BLINDNESS TRANSIENT (temperarily lost sight in left eye) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Knee replacement (Right knee replacement surgery) in 2017. Concurrent medical conditions included Blood pressure high since 2014 and Benign prostatic hypertrophy since 2000. Concomitant products included TAMSULOSIN, LOSARTAN and NIFEDIPINE for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021 at 12:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021 at 2:30 AM, the patient experienced BLINDNESS TRANSIENT (temperarily lost sight in left eye) (seriousness criterion medically significant). On 12-Jun-2021, BLINDNESS TRANSIENT (temperarily lost sight in left eye) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jun-2021, Computerised tomogram: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BLINDNESS TRANSIENT (temperarily lost sight in left eye) to be possibly related. Patient's treatment product details not provided. It was ambiguously reported that outcome of the event was resolved on 12-Jun-2021 and unknown. The first event occurred the day after the first vaccine shot the left toe swelled and the swelling and pain worked its way into the lower leg. Required a doctor visit, ultra sound and xray did not show any damage to the toe, foot or leg. Blood tests showed uric acid levels in the high end of the normal range. After treatment in office with an injection the pain and swelling subsided. No long term effects from this event. The second event occurred after the second vaccine shot. Two weeks after the second shot was administered (Saturday 6/12/21), temporarily lost sight in my left eye while driving. Went to the ER for treatment. Assement showed no retinal detachment. On Monday visited family doctor and she recommended that patient see by an eye doctor and ordered some additional blood tests blood tests. Family doctor appointment for follow up visit scheduled for 7/28/21. Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested. This case was linked to MOD-2021-040178, MOD-2021-245133 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds: TAMSULOSIN; LOSARTAN; NIFEDIPINE

Current Illness: Benign prostatic hypertrophy; Blood pressure high

ID: 1449720
Sex: F
Age: 38
State: CO

Vax Date: 05/01/2021
Onset Date: 07/02/2021
Rec V Date: 07/06/2021
Hospital:

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

Lab Data:

Allergies: Penicillin, Ceclor, Sulfa

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

Symptoms: I had bleeding for my period 5 days earlier the month of my second vaccine. I subsequently got pregnant that month and miscarried at 5 weeks.

Other Meds: B-12 500mcb d3 4000 iu liquid Slow release iron 50mg Pre natal with DHA Benedryl 50 mg Ambien 10mg - on occasion CoQ10 DHEA

Current Illness: None

ID: 1449721
Sex: F
Age: 57
State: TX

Vax Date: 07/02/2021
Onset Date: 07/03/2021
Rec V Date: 07/06/2021
Hospital:

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

Lab Data:

Allergies: Penicillin, sulfa and albuterol

Symptom List: Nausea

Symptoms: Swelling in arm, fever up to 39C, no appetite, decline and pain all over body, partial paralysis of face right side.

Other Meds:

Current Illness: Hypertensive

ID: 1449722
Sex: M
Age: 17
State: AL

Vax Date: 07/05/2021
Onset Date: 07/05/2021
Rec V Date: 07/06/2021
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: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient received pfizer covid vaccine in left deltoid. 5 minutes after shot he complained of visual changes. He sat down and said he could not see then lost conciousness and had mild convulsions for about 10 seconds. He regained counciousness but still could not see. pupals very dialated. 911 was called. Patient had temp of 97.8 and osat of 99. vision loss continued for 10-15 minutes but patient was concious. EMTs arrived on scene. blood glucose 102, BP 92/46. very low. recommended he go to ER.

Other Meds:

Current Illness:

ID: 1449723
Sex: F
Age: 40
State: VA

Vax Date: 04/09/2021
Onset Date: 04/17/2021
Rec V Date: 07/06/2021
Hospital:

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

Lab Data:

Allergies: n/a

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

Symptoms: Shingles developed after the first round of vaccine. I was treated with anti-virals.

Other Meds: Levothyroxine

Current Illness: n/a

ID: 1449724
Sex: M
Age: 40
State: IL

Vax Date: 12/01/2020
Onset Date: 05/01/2021
Rec V Date: 07/06/2021
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: family stress; depression; drug effect decreased; Walking difficulty; Rheumatoid arthritis flare up; Activities of daily living impaired; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. No Medical History information was reported. In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. In May 2021, the patient experienced FAMILY STRESS (family stress) and DEPRESSION (depression). In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired), THERAPEUTIC PRODUCT EFFECT DECREASED (drug effect decreased) and GAIT DISTURBANCE (Walking difficulty). The patient was treated with METHOTREXATE at a dose of 1 dosage form. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired), THERAPEUTIC PRODUCT EFFECT DECREASED (drug effect decreased) and GAIT DISTURBANCE (Walking difficulty) had not resolved and FAMILY STRESS (family stress) and DEPRESSION (depression) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1449725
Sex: F
Age: 62
State: CA

Vax Date: 06/22/2021
Onset Date: 06/22/2021
Rec V Date: 07/06/2021
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: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient is still experiencing severe pain on injection site area. "COVID ARM" symptoms.

Other Meds:

Current Illness:

ID: 1449726
Sex: M
Age: 51
State: CA

Vax Date: 06/28/2021
Onset Date: 06/28/2021
Rec V Date: 07/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1449727
Sex: M
Age: 14
State: TX

Vax Date: 07/05/2021
Onset Date: 07/05/2021
Rec V Date: 07/06/2021
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: Systemic: Fainting / Unresponsive-Medium, Additional Details: Pharmacy administered vaccine & followed normal routine, including keeping a hand on pt the whole time until finished pt slumped over & rolled to his left & rolled out of chair onto the ground, on his stomach. He didnt hit the wall or the chair. Father & I both knelt to ground to roll him to his side and he immediately came to & sat up against wall. Dad said he had not had anything to eat any time recently, unconcerned & proceded to move to the next child, who was too scared to do it.

Other Meds:

Current Illness:

ID: 1449728
Sex: M
Age:
State:

Vax Date: 05/01/2021
Onset Date: 05/25/2021
Rec V Date: 07/06/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Paralysed; Seizure; Stroke; Atrial fibrillations; Heart Palpitaion; Breathing Became shallow; Brain fog; Swelling in his feet; Uncontrollable spasms; Migrains; Tinnitus; Tremors; Overall body pain; Dizziness; Rash throughout Body; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralysed), SEIZURE (Seizure), CEREBROVASCULAR ACCIDENT (Stroke), ATRIAL FIBRILLATION (Atrial fibrillations), PALPITATIONS (Heart Palpitaion), HYPOPNOEA (Breathing Became shallow), CONFUSIONAL STATE (Brain fog), PERIPHERAL SWELLING (Swelling in his feet), MUSCLE SPASMS (Uncontrollable spasms), MIGRAINE (Migrains), TINNITUS (Tinnitus), TREMOR (Tremors), PAIN (Overall body pain), DIZZINESS (Dizziness) and RASH (Rash throughout Body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No Medical History information was reported. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PARALYSIS (Paralysed) (seriousness criteria hospitalization and medically significant), SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant), CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), ATRIAL FIBRILLATION (Atrial fibrillations) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Heart Palpitaion) (seriousness criterion hospitalization), HYPOPNOEA (Breathing Became shallow) (seriousness criterion hospitalization), CONFUSIONAL STATE (Brain fog) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Swelling in his feet) (seriousness criterion medically significant), MUSCLE SPASMS (Uncontrollable spasms) (seriousness criterion medically significant), MIGRAINE (Migrains) (seriousness criterion medically significant), TINNITUS (Tinnitus) (seriousness criterion medically significant), TREMOR (Tremors) (seriousness criterion medically significant), PAIN (Overall body pain) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and RASH (Rash throughout Body) (seriousness criterion medically significant). At the time of the report, PARALYSIS (Paralysed), SEIZURE (Seizure), CEREBROVASCULAR ACCIDENT (Stroke), ATRIAL FIBRILLATION (Atrial fibrillations), PALPITATIONS (Heart Palpitaion), HYPOPNOEA (Breathing Became shallow), CONFUSIONAL STATE (Brain fog), PERIPHERAL SWELLING (Swelling in his feet), MUSCLE SPASMS (Uncontrollable spasms), MIGRAINE (Migrains), TINNITUS (Tinnitus), TREMOR (Tremors), PAIN (Overall body pain), DIZZINESS (Dizziness) and RASH (Rash throughout Body) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported . Treatment information was not provided. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1449729
Sex: F
Age: 39
State: MS

Vax Date: 06/02/2021
Onset Date: 06/02/2021
Rec V Date: 07/06/2021
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: pneumonia; upper respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant) and UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection). At the time of the report, PNEUMONIA (pneumonia) and UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) outcome was unknown. Treatment medication used as Steroids and Antibiotics. Concomitant medication information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1449730
Sex: M
Age: 75
State: FL

Vax Date: 03/26/2021
Onset Date: 04/26/2021
Rec V Date: 07/06/2021
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: grand mal seizures; blacks out momentarily; difficulty of breathing; teeth clenching; eyes shifting to the right side; movement in chest; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures), LOSS OF CONSCIOUSNESS (blacks out momentarily), DYSPNOEA (difficulty of breathing), SEIZURE (teeth clenching) and SEIZURE (eyes shifting to the right side) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Myelodysplastic syndrome in November 2020 and Brain stem hematoma (A brain surgery in feb2021 where a left cranial flap was done for another brain hematoma.) in February 2021. Concomitant products included AZACITIDINE (VIDAZA) for White blood cell count abnormal. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (blacks out momentarily) (seriousness criterion medically significant), DYSPNOEA (difficulty of breathing) (seriousness criterion medically significant), SEIZURE (teeth clenching) (seriousness criterion medically significant), SEIZURE (eyes shifting to the right side) (seriousness criterion medically significant) and CHEST DISCOMFORT (movement in chest). The patient was hospitalized from 01-May-2021 to 06-May-2021 due to GENERALISED TONIC-CLONIC SEIZURE. The patient was treated with LACOSAMIDE at a dose of 200 mg twice a day and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) ongoing since an unknown date at a dose of 1500 mg twice a day. On 03-May-2021, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (blacks out momentarily), DYSPNOEA (difficulty of breathing), SEIZURE (teeth clenching), SEIZURE (eyes shifting to the right side) and CHEST DISCOMFORT (movement in chest) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had same experience on 26Apr2021 (6:00am) and 30 apr20219(5:30pm), his had a grand mal seizure. Emergency medical technician (EMT) was called and he was brought to the hospital and was released after a few hours.Patient had also experience on 01 May 2021, he had 3 episodes of grand mal seizures while still at the ER. Because there was no room available, he was transferred to another hospital. Also same experience on 2 and 3 may 2021.He has a ready donor for a transplant at a medical center but since he has is still having the seizures the doctors will not do it; surgery on 02Jan2021 for a subdural hematoma (not brain surgery but they had to access the bleed through his groin. Company comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds: VIDAZA

Current Illness:

ID: 1449731
Sex: F
Age: 60
State: PA

Vax Date: 04/05/2021
Onset Date:
Rec V Date: 07/06/2021
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: Admitted to the hospital for low sodium; Malaise; Night sweats; fever; Swollen glands; Numb fingers and toes; Cramp to right lower leg; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD SODIUM DECREASED (Admitted to the hospital for low sodium), MALAISE (Malaise), NIGHT SWEATS (Night sweats), PYREXIA (fever) and LYMPHADENOPATHY (Swollen glands) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD SODIUM DECREASED (Admitted to the hospital for low sodium) (seriousness criterion hospitalization prolonged), MALAISE (Malaise) (seriousness criterion hospitalization prolonged), NIGHT SWEATS (Night sweats) (seriousness criterion hospitalization prolonged), PYREXIA (fever) (seriousness criterion hospitalization prolonged), LYMPHADENOPATHY (Swollen glands) (seriousness criterion hospitalization prolonged), HYPOAESTHESIA (Numb fingers and toes) and MUSCLE SPASMS (Cramp to right lower leg). The patient was hospitalized on 15-May-2021 due to BLOOD SODIUM DECREASED, LYMPHADENOPATHY, MALAISE, NIGHT SWEATS and PYREXIA. The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) at a dose of 1 dosage form and SODIUM CHLORIDE at a dose of 1 dosage form. At the time of the report, BLOOD SODIUM DECREASED (Admitted to the hospital for low sodium), MALAISE (Malaise), NIGHT SWEATS (Night sweats), PYREXIA (fever), LYMPHADENOPATHY (Swollen glands), HYPOAESTHESIA (Numb fingers and toes) and MUSCLE SPASMS (Cramp to right lower leg) outcome was unknown. Concomitant medication was not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1449732
Sex: F
Age: 25
State: CA

Vax Date: 06/25/2021
Onset Date: 06/25/2021
Rec V Date: 07/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Convulsions; Patient is experiencing a possible vaccine reaction; This spontaneous case was reported by a nurse and describes the occurrence of SEIZURE (Convulsions) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant). 25-Jun-2021, the patient experienced VACCINATION COMPLICATION (Patient is experiencing a possible vaccine reaction). The patient was treated with LORAZEPAM (ATIVAN) 25-Jun-2021 for Convulsion, at a dose of 2 mg. At the time of the report, SEIZURE (Convulsions) was resolving and VACCINATION COMPLICATION (Patient is experiencing a possible vaccine reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. Lab Data: results pending. It was reported that in the emergency room they have treated the patient with 2mg of Ativan, with improving results, from convulsing to subtle shakes. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1449733
Sex: M
Age: 73
State: CO

Vax Date: 04/20/2021
Onset Date:
Rec V Date: 07/06/2021
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: black blood cloth on the left foot; legs numbed/from the head half the body was numb; after the vaccine felt very sick; head feels like it explodes,it hurts daily; has Cramps on the left foot, all the night; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (black blood cloth on the left foot) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (black blood cloth on the left foot) (seriousness criterion medically significant), HYPOAESTHESIA (legs numbed/from the head half the body was numb), MALAISE (after the vaccine felt very sick), HEADACHE (head feels like it explodes,it hurts daily) and MUSCLE SPASMS (has Cramps on the left foot, all the night). At the time of the report, THROMBOSIS (black blood cloth on the left foot), HYPOAESTHESIA (legs numbed/from the head half the body was numb), MALAISE (after the vaccine felt very sick), HEADACHE (head feels like it explodes,it hurts daily) and MUSCLE SPASMS (has Cramps on the left foot, all the night) outcome was unknown. No concomitant product information was provided. No treatment information was provided. 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 This case was linked to MOD-2021-237381 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested

Other Meds:

Current Illness:

ID: 1449734
Sex: M
Age: 34
State: CA

Vax Date: 04/09/2021
Onset Date: 05/01/2021
Rec V Date: 07/06/2021
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: Really sick\sicker than dogs; Breathing very fast; In bed for 3 week; Like he's hyperventilating; Can't catch his breath\like he is hyperventilating\very short of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Can't catch his breath\like he is hyperventilating\very short of breath), ILLNESS (Really sick\sicker than dogs) and RESPIRATORY RATE INCREASED (Breathing very fast) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017Z21A and 031BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ACETYLCYSTEINE (N-ACETYLCYSTEINE), PAROXETINE, LISINOPRIL, METOPROLOL, LEVOTHYROXINE, LORAZEPAM, BUPRENORPHINE and RISPERIDONE for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced ILLNESS (Really sick\sicker than dogs) (seriousness criterion medically significant). In May 2021, the patient experienced DYSPNOEA (Can't catch his breath\like he is hyperventilating\very short of breath) (seriousness criterion medically significant), RESPIRATORY RATE INCREASED (Breathing very fast) (seriousness criterion medically significant), BED REST (In bed for 3 week) and HYPERVENTILATION (Like he's hyperventilating). At the time of the report, DYSPNOEA (Can't catch his breath\like he is hyperventilating\very short of breath), ILLNESS (Really sick\sicker than dogs), RESPIRATORY RATE INCREASED (Breathing very fast), BED REST (In bed for 3 week) and HYPERVENTILATION (Like he's hyperventilating) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was not given. Patient's son received the second dose of Moderna COVID-19 vaccine on 7-May-2021 and now was sicker than dogs, very short of breath, can't catch breath. The patient was living with that type of breathing, like hyperventilating. This has been going on since second Moderna shot. Right after taking the second dose, patient started feeling really sick and in bed for about 3 weeks. Starting from about a month ago, started breathing very fast. Seen by a physician, but not hospitalized or administered any specific treatment for these symptoms. 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. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious. Further information has been requested. This case was linked to MOD-2021-237424 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious. Further information has been requested.

Other Meds: N-ACETYLCYSTEINE; PAROXETINE; LISINOPRIL; METOPROLOL; LEVOTHYROXINE; LORAZEPAM; BUPRENORPHINE; RISPERIDONE

Current Illness:

ID: 1449735
Sex: F
Age: 73
State: VA

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 07/06/2021
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: Abnormal looking lymph nodes with necrosis; Tenderness and itchiness on the lymph nodes that went away but "came back"; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NECROSIS (Abnormal looking lymph nodes with necrosis) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced LYMPH NODE PAIN (Tenderness and itchiness on the lymph nodes that went away but "came back"). In March 2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). On 18-Mar-2021, the patient experienced NECROSIS (Abnormal looking lymph nodes with necrosis) (seriousness criterion medically significant). In March 2021, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) had resolved. At the time of the report, NECROSIS (Abnormal looking lymph nodes with necrosis) and LYMPH NODE PAIN (Tenderness and itchiness on the lymph nodes that went away but "came back") outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Mammogram: negative (Negative) Negative. Patient had a biopsy and magnetic resonance imaging done on her breast tissue. The biopsy results were inconclusive. No treatment information was provided. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. 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. This case was linked to MOD-2021-237379 (Patient Link).

Other Meds:

Current Illness:

ID: 1449736
Sex: F
Age: 69
State: NY

Vax Date: 02/18/2021
Onset Date: 03/01/2021
Rec V Date: 07/06/2021
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: myocarditis; Patient received 2nd dose 23 days after the first; a little sensitivity if she touched the injection site; heavy pressured feeling on her chest; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMINS NOS for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced CHEST DISCOMFORT (heavy pressured feeling on her chest). On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 23 days after the first) and VACCINATION SITE DYSAESTHESIA (a little sensitivity if she touched the injection site). At the time of the report, MYOCARDITIS (myocarditis), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 23 days after the first), VACCINATION SITE DYSAESTHESIA (a little sensitivity if she touched the injection site) and CHEST DISCOMFORT (heavy pressured feeling on her chest) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was given. Patient had on allergy pills as concomitant medication. Company Comment: 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. This case was linked to MOD-2021-237410 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1449737
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 07/06/2021
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: fainting; Severe vertigo; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (fainting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant) and VERTIGO (Severe vertigo). At the time of the report, SYNCOPE (fainting) and VERTIGO (Severe vertigo) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. No relevant concomitant medications were reported. Lab details were not provided. Action taken with mRNA-1273 in response to the events was not Applicable. Company Comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1449738
Sex: M
Age:
State: FL

Vax Date: 03/04/2021
Onset Date: 05/25/2021
Rec V Date: 07/06/2021
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: four 2 liters of pee flushed out of body; A-fib; 25 pound water weight gain; dry cough with phlegm; feeling tired; Water blisters on leg where skin was coming off; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (A-fib), FLUID RETENTION (25 pound water weight gain), URINE OUTPUT INCREASED (four 2 liters of pee flushed out of body) and PRODUCTIVE COUGH (dry cough with phlegm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 5A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high. Concomitant products included IBUPROFEN, POTASSIUM and OMEPRAZOLE for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLISTER (Water blisters on leg where skin was coming off). On 13-Jun-2021, the patient experienced PRODUCTIVE COUGH (dry cough with phlegm) (seriousness criterion hospitalization prolonged). On 23-Jun-2021, the patient experienced ATRIAL FIBRILLATION (A-fib) (seriousness criteria hospitalization prolonged and medically significant) and FLUID RETENTION (25 pound water weight gain) (seriousness criterion hospitalization prolonged). On 27-Jun-2021, the patient experienced FATIGUE (feeling tired). On an unknown date, the patient experienced URINE OUTPUT INCREASED (four 2 liters of pee flushed out of body) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 23-Jun-2021 to 26-Jun-2021 due to ATRIAL FIBRILLATION, FLUID RETENTION, PRODUCTIVE COUGH and URINE OUTPUT INCREASED. The patient was treated with GUAIFENESIN (MUCINEX) for Cough, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) for Cough, at an unspecified dose and frequency. On 26-Jun-2021, FLUID RETENTION (25 pound water weight gain) had resolved. At the time of the report, ATRIAL FIBRILLATION (A-fib), URINE OUTPUT INCREASED (four 2 liters of pee flushed out of body) and BLISTER (Water blisters on leg where skin was coming off) outcome was unknown and PRODUCTIVE COUGH (dry cough with phlegm) and FATIGUE (feeling tired) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information included blood pressure medication. Treatment information included Blood thinner (not specified) for A-fib. The patient reported four 2 liters of pee flushed out of his body where he went from 259 pounds upon admission to 226 pounds on 27June2021. The patient had an appointment with his cardia doctor for the A-fib 06july2021. Action taken with M-RNA-1273 (Moderna Covid-19 Vaccine) in response to the event was not applicable. Company Comment : Very limited information regarding these events have been provided at this time. The long latency period and patient's history of high blood pressure may be confounding factors to the events. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. The long latency period and patient's history of high blood pressure may be confounding factors to the events. Further information has been requested.

Other Meds: IBUPROFEN; POTASSIUM; OMEPRAZOLE

Current Illness:

ID: 1449739
Sex: F
Age: 64
State: IN

Vax Date: 03/13/2021
Onset Date:
Rec V Date: 07/06/2021
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: convulsion; aches; This spontaneous case was reported by a patient and describes the occurrence of SEIZURE (convulsion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (convulsion) (seriousness criterion medically significant). an unknown date, the patient experienced MYALGIA (aches). The patient was treated with Surgery (Heart Surgery) for Seizure. At the time of the report, SEIZURE (convulsion) and MYALGIA (aches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment for the events included was heart surgery, received 3 stents and physical therapy. The patient was taken to the hospital. 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. This case was linked to MOD-2021-237450 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received on 28-JUN-2021 contains non-significant information. Batch number /Lot number added; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1449740
Sex: F
Age: 59
State: MA

Vax Date: 12/28/2020
Onset Date: 01/25/2021
Rec V Date: 07/06/2021
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: Liver cancer after second dose 90 cist; Diabetes diagnosis/diabetic from a time that coincides whit the first shoot; High blood pressure (200); Lump Under Arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jun-2021 and was forwarded to Moderna on 26-Jun-2021. This spontaneous case was reported by a health care professional and describes the occurrence of HEPATIC CYST (Liver cancer after second dose 90 cist) and DIABETES MELLITUS (Diabetes diagnosis/diabetic from a time that coincides whit the first shoot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HERBAL EXTRACT NOS, HOMEOPATHICS NOS (SIMILASAN), MONTELUKAST SODIUM (SINGULAIR), EPINEPHRINE and LORATADINE for Allergy, SALBUTAMOL (ALBUTEROL HFA) for Asthma, HYDROCHLOROTHIAZIDE for Blood pressure fluctuation, MULTIVITAMIN & MINERAL for an unknown indication. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced HEPATIC CYST (Liver cancer after second dose 90 cist) (seriousness criterion disability), DIABETES MELLITUS (Diabetes diagnosis/diabetic from a time that coincides whit the first shoot) (seriousness criterion medically significant), HYPERTENSION (High blood pressure (200)) and VACCINATION SITE LYMPHADENOPATHY (Lump Under Arm). At the time of the report, HEPATIC CYST (Liver cancer after second dose 90 cist), DIABETES MELLITUS (Diabetes diagnosis/diabetic from a time that coincides whit the first shoot), HYPERTENSION (High blood pressure (200)) and VACCINATION SITE LYMPHADENOPATHY (Lump Under Arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: abnormal (abnormal) Blood sugar was not under control.. On an unknown date, Blood pressure measurement: high- 200 (High) Blood pressure high. On an unknown date, Glycosylated haemoglobin: high (High) Diabetic. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication include CPAP machine used for Apnea. The treatment information was not provided. Action taken with mRNA-1273 in response to the events was not Applicable. Company Comment: 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. This case was linked to MOD-2021-237510, MOD-2020-001691 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested

Other Meds: HYDROCHLOROTHIAZIDE; SIMILASAN; ALBUTEROL HFA; SINGULAIR; EPINEPHRINE; LORATADINE; MULTIVITAMIN & MINERAL

Current Illness:

ID: 1449741
Sex: M
Age: 52
State: OK

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 07/06/2021
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: Heart enzyme elevated; Small blood clot; Chest pain; Soreness; Low grade fever; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated) and THROMBOSIS (Small blood clot) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 020B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical history was provided. Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated) (seriousness criterion medically significant), THROMBOSIS (Small blood clot) (seriousness criterion medically significant), CHEST PAIN (Chest pain), MYALGIA (Soreness), PYREXIA (Low grade fever) and FATIGUE (Fatigue). The patient was treated with APIXABAN (ELIQUIS) for Thrombosis, at an unspecified dose and frequency. At the time of the report, MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated), THROMBOSIS (Small blood clot), CHEST PAIN (Chest pain), MYALGIA (Soreness), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) found a clot in his right lung.. On an unknown date, Myocardial necrosis marker increased: increased (High) increased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Labs include ultrasound, chest x-ray ,strep tests whose results are not provided. 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. This case was linked to MOD-2021-237494 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LOSARTAN; SIMVASTATIN

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm