VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

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

Incidents per State

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

Date Died: 06/12/2021

ID: 1483629
Sex: F
Age:
State:

Vax Date: 03/29/2021
Onset Date:
Rec V Date: 07/18/2021
Hospital: Y

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: Neurologic damage (Shaking/memory/speech/motorskills); DVT; Afib; Secondary hlh; Cytokine Storm; This is a spontaneous report from a Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Mar2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number: unknown), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient experienced neurologic damage (Shaking/memory/speech/motorskills), DVT, Afib, secondary hlh, cytokine storm on 2021. The patient was hospitalized for neurologic damage (Shaking/memory/speech/motorskills), dvt, Afib, Secondary hlh and cytokine storm from 12Apr2021 to an unknown date. The patient underwent lab tests and procedures which included platelet count: 15,000. The patient died on 12Jun2021. It was not reported if an autopsy was performed. The outcome of all the events was Fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.,Linked Report(s) : US-PFIZER INC-2021879892 same source, different reporter/ patient; Reported Cause(s) of Death: The Pfizer shots killed my beautiful mother

Other Meds:

Current Illness:

ID: 1483630
Sex: F
Age:
State: NY

Vax Date: 07/10/2021
Onset Date: 07/10/2021
Rec V Date: 07/18/2021
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: Second dose: very hard to lift her left arm up; Second dose: challenging to shower or even put a shirt on; Second dose: can barely do anything with her left arm; Second dose: her mother had to help put her underwear on this morning; Second dose: muscle pain; Second dose: excruciating pain in her left shoulder where she received the vaccine injection; Second dose: excruciating pain in her left shoulder where she received the vaccine injection; This is a spontaneous report from a contactable consumer. A 32-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0198), via an unspecified route of administration in left deltoid on 10Jul2021 at 13:45 (age at the time of vaccination was 32-year-old) as single dose for COVID-19 immunization. The patient's medical history included ovarian cyst, soreness in her arm. In Dec2019, the patient received a yellow fever, hepatitis a, and typhoid vaccine. The patient did not receive any other vaccine within four weeks prior to the first administration of COVID-19 vaccine. The patient's concomitant medication included unspecified birth control medication, multivitamin. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0180) via an unspecified route of administration on 19Jun2021 as single dose for COVID-19 immunization. On 10Jul2021 at around 13:45, the patient received second dose of vaccine drug and at evening on Saturday, the patient experienced excruciating pain in her left shoulder where the patient received the vaccine injection. The patient would not too worried about it because that was listed as a side effect but now it was Monday, 12Jul2021 and she was still having pain. It was very hard to lift her left arm up. It was challenging to shower or even put a shirt on. The patient can barely do anything with her left arm. The patient's mother had to help put her underwear on this morning. The patient was wanting additional information regarding this side effect. From her understanding the patient should have expected side effects for 24 to 48 hours and they did mention muscle pain. But she could not lift her arm without excruciating pain. The patient not needed emergency room or physician office visit. The outcome of the events was activities of daily living impaired, and myalgia was unknown and rest all other events not recovered.

Other Meds:

Current Illness:

ID: 1483631
Sex: F
Age:
State: NJ

Vax Date: 04/06/2021
Onset Date:
Rec V Date: 07/18/2021
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: started menstruating; This is a spontaneous report from a contactable consumer or other non-health care professional. A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/ Batch Number: Not reported), dose 2 via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previously patient received first dose of BNT162B2 (Lot/ Batch Number: Not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The patient experienced started menstruating on an unspecified date. The patient was 18 months post menopause and menstruating started exactly three weeks after her first dose. Patient underwent lab tests and procedures which included tests was biopsy of uterus were negative on an unspecified date. Upon follow-up general company information was reported. Patient stated Does the vaccine have anything to do regarding this. Thanking you advance for looking into this matter. The outcome of the event was unknown. Information regarding lot/batch number has been requested

Other Meds:

Current Illness:

ID: 1483632
Sex: F
Age:
State: NJ

Vax Date: 04/08/2021
Onset Date: 07/06/2021
Rec V Date: 07/18/2021
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: Sars-cov-2 test positive: positive on 07Jul2021; sars-cov-2 test positive: positive on 07Jul2021; Cough; Fever; Congestion; Headache; SOB; Fatigue / tired; Dose 1 08Apr2021 / Dose 2 08Apr2021; This is a spontaneous report from a contactable other Health Care Professional. A 44-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736 and Expiry date: Unknown) via an unspecified route of administration on 08Apr2021 (age at the time of vaccination was 50-year-old) as single, first dose via an unspecified route of administration on 08Apr2021, (Lot Number: GN6204 and Expiry date: Unknown) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed COVID prior to the vaccination. On 06Jul2021, the patient experienced cough, fever, congestion, headache, fatigue, tired and SOB (shortness of breath). On 07Jul2021, the patient underwent COVID-19 test and resulted positive. The adverse events resulted in doctor or other healthcare professional office/clinic and Emergency room/department or urgent care visit. The patient received unspecified antibiotics and steroids as treatment medication for the events.; Sender's Comments: Based on Plausible association, there is a casual relationship between the suspected drug BNT162b2 and the reported events COVID-19 along with Drug Ineffective.

Other Meds:

Current Illness:

ID: 1483633
Sex: F
Age:
State: FL

Vax Date: 04/29/2021
Onset Date: 07/07/2021
Rec V Date: 07/18/2021
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: COVID-19 confirmed by positive COVID-19 test; thought she had pneumonia or bronchitis; Caller states she would have reported within 24 hours, but she just did not feel well enough.; thought she had pneumonia or bronchitis; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER8736), via an unspecified route in the right arm on 29Apr2021 at 08:00 (at the age of 44-years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: GN6204), via an unspecified route in the left arm on 08Apr2021 at 08:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jul2021, the patient experienced and went to urgent care, she thought she had pneumonia or bronchitis, they did a rapid test and the rapid test came back positive and that day, she went to the store drive-thru to get a molecular test and on 10Jul2021, the molecular test came back positive but they didn't specify if it was the variant or not. Patient stated that she would have reported within 24 hours, but she just did not feel well enough and she is perfectly healthy, she's not on any medications. The patient visited to physician office and not went to emergency room. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1483634
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date: 07/09/2021
Rec V Date: 07/18/2021
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: received both doses of the Pfizer Covid-19 vaccine in Apr2021 and tested positive for Covid-19 on 09Jul2021; received both doses of the Pfizer Covid-19 vaccine in Apr2021 and tested positive for Covid-19 on 09Jul2021; This is a spontaneous report from a contactable consumer. A 78-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Apr2021 as dose 1, single for COVID-19 immunization. The caller reported that the patient (husband) received both doses of the Pfizer COVID-19 vaccine on an unspecified date in Apr2021 and tested positive for Covid-19 on 09Jul2021. Caller was asking how the variant type of the COVID-19 was tested for after being vaccinated against Covid-19 and testing positive. Caller asked if her husband could have given COVID-19 to their grandkids who stayed with them that weekend. Caller asked if you would get less sick and be less contagious if you were vaccinated. Caller was asking if she should isolate from her husband who was COVID-19 positive. Caller asked if there was any proof that mild cases of COVID-19 were not transmissible or transmissible. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 09Jul2021. Outcome of the events was reported as unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1483635
Sex: F
Age:
State: IN

Vax Date: 05/25/2021
Onset Date:
Rec V Date: 07/18/2021
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: On an unknown date after the first injection of the pfizer covid-19 vaccine, the patient got COVID-19 infection.; On an unknown date after the first injection of the pfizer covid-19 vaccine, the patient got COVID-19 infection.; This is a spontaneous report received from a contactable pharmacist via Pfizer Sponsored Program. A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number and Expiration date was not reported), via an unspecified route of administration on 25May2021 as a single dose for covid-19 immunization. On an unspecified date in 2021, after the first injection of the Pfizer covid-19 vaccine, the patient got COVID-19 infection. On 16Jun2021, the patient was treated with monoclonal antibodies for the COVID-19 infection. It was reported that, patient is scheduled to get their second dose of the product today (as per report 12Jul2021). However, the patient took a medication for COVID on 16Jun2021, and reporter wanted to confirm if the patient could safely get the second dose of the vaccine today (12Jul2021). The reporter assessed the event as non serious. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on known safety profile and plausible temporal relationship, a possible causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 1483636
Sex: F
Age:
State: MD

Vax Date: 07/05/2020
Onset Date: 07/10/2020
Rec V Date: 07/18/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Bell's palsy; Sore throat; This is a spontaneous report from a contactable Physician. A 13-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number: LSW0196) via an unspecified route of administration on 05Jul2020 (at the age of 13-year-old) as single dose for COVID-19 immunisation. The patient's medical history, concomitant medications or past drug history were not reported. On 10Jul2020 (Saturday), the patient experienced sore throat and on 11Jul2020, patient experienced numbness of face on Sunday and was diagnosed with Bell's palsy. The patient was started on unspecified steroids as treatment medication after Bell's palsy diagnosis. The parent still wants child to receive second dose of vaccine and asked if this was okay. The outcome of the events was unknown.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Bell's Palsy cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1483637
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 07/09/2021
Rec V Date: 07/18/2021
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: patient developed COVID-19 infection after being vaccinated; patient developed COVID-19 infection after being vaccinated; This is a spontaneous report from a contactable physician. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unknown date in 2021, as unknown dose number, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Jul2021, patient developed COVID-19 infection after being vaccinated. Adverse event (AE) resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive treatment in response to the event. Outcome of the event was not resolved. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Covid 19 and suspect drug BNT162B2 cannot be excluded

Other Meds:

Current Illness:

ID: 1483638
Sex: F
Age:
State:

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 07/18/2021
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: Caller states she and her husband received their 2nd Pfizer vaccine dose in June, 90 days after first dose; dying septic; I had an echocardiogram and one of my cardiac arteries is 90% blocked and could this be the vaccine; had trouble with breathing worse after 2nddose of vaccine; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Jun2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6200, Expiry date: 30Jun2021), dose 1 via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation and experienced Covid and trouble breathing. The patient stated, she and her husband received their 2nd Pfizer vaccine dose in Jun, 90 days after first dose. She had trouble with breathing worse after 2nd dose of vaccine (In 2021). She had an echocardiogram and one of her cardiac arteries was 90% blocked (in 2021) and could this be the vaccine. She stated this was not blocked 1.5 yrs. ago. Her cardiologist said it was highly unusual to get blockage this soon. Could the vaccine cause blockage in her arteries. The patient wrote a letter to Pfizer asking if this could cause the blockage and no one wrote back. She wants answers. She would send another letter and if no one answers me this time, she would go to the Television (TV) and media and report Pfizer. She has been bounced between offices 2-3 times today. This was taking hours and is ridiculous. She said after her second COVID Vaccination she was dying septic (in 2021) of the (voice not clear) she doesn't know what that was. She says that one of her arteries was 90 percent blocked now in her heart and she was wanting to know if this vaccine could've had anything to do with it. She wanted to speak to someone. Her question when she first roll back way back then, could the shot cause COVID. They still haven't answered that question but now happened was she had been on wound healers (voice not clear) and have been having problems' (not clarified further hence not captured as event) and she went in for a catheterization the other day and they found that one of her arteries was 90 percent blocked and it was not blocked at all a year and a half ago. So, the doctors wondering why (incomplete sentence). The outcome of event had trouble with breathing worse after 2nddose of vaccine was not recovered and outcome of all other events was unknown. Follow-up attempts are needed. Further information is requested.

Other Meds:

Current Illness:

ID: 1483639
Sex: F
Age:
State: IN

Vax Date: 06/04/2021
Onset Date:
Rec V Date: 07/18/2021
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: after the first dose had broken out into hives from head to toe; This is a spontaneous report from a Pfizer sponsored program. A contactable Other Health Professional reported for a 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left deltoid on 04Jun2021 (at age of 12-year-old) (Batch/Lot Number: EW0186) as single dose for covid-19 immunisation. There was no medical history. The concomitant medications were not reported. The patient got the first dose of the Pfizer covid vaccine and after the first dose had broken out into hives from head to toe. They treated her with Benadryl but she is not better and therefore they will prescribe steroids. The outcome of the event was not recovered.; Sender's Comments: The causal association of the event urticaria in relation to suspected drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be totally excluded based on known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1483640
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and then via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, all for covid-19 immunization. Medical history and concomitant medications were not reported. The patient was fully vaccinated and had been for just about six months. The patient recently tested positive for COVID. Whom should the patient send this information to, to better support the need for a third vaccine. Also, if there somewhere the patient can get his/her blood drawn to distinguish which variant he/she was exposed to, further support scientific study and research. Please keep him/her informed. The patient was a withheld and did not mind contributing to this research. The patient underwent lab tests and procedures which included tested positive for COVID on an unknown date. The outcome of event was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the temporal relationship the causal role between the events Drug ineffective and COVID-19 cannot be fully excluded. However the possibility of Covid being an intercurrent condition cannot be ruled out.

Other Meds:

Current Illness:

ID: 1483642
Sex: U
Age:
State:

Vax Date: 07/05/2021
Onset Date: 07/05/2021
Rec V Date: 07/18/2021
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: were given expired pentacel vaccinations with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional and physician via medical information (Reference number- 00669898) and transmitted to Sanofi on 06-Jul-2021. This case is linked with 2021SA225602. This case involves an infant patient (gender not reported) who received expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccinations (expired product administered). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On 05-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number: UJ325AA, expiry date not reported] via an intramuscular route at right thigh for prophylactic vaccination (expired product administered) (latency: on the same day). It was a case of actual medication error due to expired vaccine used. At the time of report, no adverse event was reported. It was reported that "Medical assistant calling to report that (3) patients were given expired PENTACEL vaccinations on 5Jul2021. Caller stated that all the vaccines were given intramuscularly in the right thigh. linked to case : 2021SA225602 and linked to Inquiry Number: 00669898 Case created for 2nd patient It is unknown if the patient experienced any additional symptoms/events." This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2021SA225602: 00669898:

Other Meds:

Current Illness:

ID: 1483645
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: patient did not remember states he forgets sometimes; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (patient) via Medical Information (Reference number- 00661430) and transmitted to Sanofi on 29-Jun-2021. This case involves a 24 year old male patient who said that he did not remember states, he forgets sometimes (Memory impairment) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On an unknown date in last year the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination On an unknown date the patient developed a non-serious patient did not remember states he forgets sometimes (memory impairment) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Additionally it was reported as Caller wants to know the side effects of tenivac and does it cause cancer or male infertility? Also wants to know about flublok hat he took last year and if it causes cancer or male infertility? Caller hasn't taken Tenivac and was given the name by the pharmacy he may get the vaccine from but has taken Flublok last year. Caller mentions he is not attempting to conceive nor has he had any symptoms but just asking the question. Caller feels testing should be done on all the vaccines for male infertility. Additional Description of event Adverse events :Caller mentions during the conversation that he didn't remember providing his email and states he forgets sometimes. Caller didn't mention any side effects of the Flublok and isn't trying to conceive. Caller mentions having the CoVid (corona virus disease) vaccine but didn't say which one. No relevant laboratory data was provided. It was not reported if the patient received a corrective treatment for the event At time of reporting, the outcome was unknown for the event There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1483648
Sex: F
Age: 17
State: IL

Vax Date: 06/30/2021
Onset Date: 06/30/2021
Rec V Date: 07/18/2021
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: seizure; Initial information regarding an unsolicited valid serious case from a pharmacist via Regulatory Authority (Reference number- 00663747) and transmitted to Sanofi on 30-Jun-2021. This case involves a 17-years old female patient who experienced seizure, while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported, and patient received no concomitant vaccines. On 30-Jun-2021, the patient received 0.5 ml total (once) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6828AB and expiration date: 09-Jan-2022) via intramuscular route in the left deltoid muscle for prophylactic vaccination. On 30-Jun-2021, the patient developed a serious, seizure, same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Seriousness criteria was assessed as medically significant as per important medical event Regulatory Authority list. It was reported "pharmacist ask about seizure as a potential side effect". It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment. At the time of report, the outcome of the event was unknown.; Sender's Comments: This case concerns a 17-years old female patient who had seizure same day following vaccination with MENACTRA. The time to onset is compatible. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1483650
Sex: F
Age:
State: TX

Vax Date: 06/23/2021
Onset Date:
Rec V Date: 07/18/2021
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: The patient was missing the second dose, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00667193) and transmitted to Sanofi on 02-Jul-2021. This case involves a 27-year-old female patient who missed the second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (product dose omission issue). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 23-Jun-2021, the patient received 1 mL of 1st dose of suspect RABIES (HDC) VACCINE (lot T1C66 and expiry date : 17-Jun-2022) via an unknown route in an unknown administration site for unknown indication but missed to receive the second dose on 30-Jun-2021 (product dose omission issue). It was reported that "RPh (registered pharmacist) intern is calling to see what the scheduling for the IMOVAX vaccine is." This was a case of actual medication error due to missed dose (latency unknown). At time of reporting, no adverse events were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1483651
Sex: F
Age: 1
State: TX

Vax Date: 07/02/2021
Onset Date: 07/02/2021
Rec V Date: 07/18/2021
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: only the diluent portion of Pentacel was administered to patient, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health professional via Global Medical Information (GMI) (Reference number- 00667263) and transmitted to Sanofi on 02-Jul-2021 and live follow up received on 06-Jul-2021. This case involves a 14-months old female patient who only had the diluent portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE INJECTION [PENTACEL] was administered (product preparation error) on 02-Jul-2021 (lot number: U6940BA and expiry date: 21-May-2022) at a dose of 0.5 ml via unknown route in the left thigh for prophylactic vaccination. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medications and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEP [HEPATITIS B VACCINE]). It was a case of an off-label use and active ingredient not added to diluent (latency same day). At the time of report, no adverse event was reported. It was unknown if there were lab data/results available. Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: PREVNAR 13; ROTAVIRUS VACCINE; HEP [HEPATITIS B VACCINE]

Current Illness:

ID: 1483662
Sex: F
Age: 0
State: WV

Vax Date: 07/02/2021
Onset Date: 07/02/2021
Rec V Date: 07/18/2021
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: administered expired Pentacel because the expiration date on the box was confusing, with no reported adverse event; Initial information was received on 07-Jul-2021 regarding an unsolicited valid non-serious case from other health professional in the (GMI Inquiry number: 00672437). This case involves a four-month-old female patient who experienced administration of expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension For Injection) because the expiration date on the box was confusing (expired product administered). Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation and ROTAVIRUS VACCINE for Immunisation. On 02-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number: UJ350AAA, expiry date: 22-Jun-2021] via an intramuscular route at left thigh for prophylactic vaccination. Description: The caller reported that two patients were administered expired Pentacel because the expiration date on the box was "confusing". The caller wanted to know what they need to do now, for those patients. It was a case of actual medication error due to expired vaccine used. At the time of report, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: SAD20210707001286:

Other Meds: PNEUMOCOCCAL CONJUGATE VACCINE; ROTAVIRUS VACCINE

Current Illness:

ID: 1483663
Sex: M
Age: 33
State: MO

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 07/18/2021
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: A patient received an expired Adacel vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (Reference number- 00672539) and transmitted to Sanofi on 07-Jul-2021. This case involves a 33-year-old male patient who received an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 07-Jul-2021, the patient received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6378AA and expiry date: 04-Jul-2021) via an intramuscular route in the right deltoid for prophylactic vaccination (expired product administered). It was reported that "Caller states that she gave an Adacel vaccine to a male patient because the patient stepped on a nail. She states that over the weekend the expired vaccines were not pulled out due to the holiday and she did not pay attention to the expiration date before vaccinating the patient. The nurse states that the patient did not experience any other AE's (adverse event) as a result of this. Pasteur AE Reporting." There were no lab data/results available. It was a case of actual medication error due to expired vaccine used (latency same day). At time of reporting, no adverse events were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1483667
Sex: F
Age: 36
State: OR

Vax Date: 07/13/2021
Onset Date: 07/13/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies: Sulfa Dairy Soy Cranberry

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

Symptoms: Nausea, achy, chills, fever, headache, tiredness All lasted approximately 24 hours

Other Meds: Buspirone Bupropion Lamotrigine Hydroxyzine Multivitamin

Current Illness: None

ID: 1483668
Sex: M
Age: 0
State:

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 07/18/2021
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: administering Pentacel today that was not reconstituted (only liquid was administered, not powder)v with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Global Medical Information (GMI) (Reference number- 00672844) and transmitted to Sanofi on 07-Jul-2021 in United States. This case involved a 6 month old male patient who administering pentacel today that was not reconstituted (only liquid was administered, not powder) (product preparation issue) while receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL]. Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination. On 07-Jul-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Frequency: once) (lot U694DBA) via unknown route in the right thigh for prophylactic vaccination. On 07-JUL-2021 the patient developed a non-serious when administering pentacel today that was not reconstituted (only liquid was administered, not powder) (product preparation issue) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE. This was an actual medication error case due to inappropriate reconstitution technique (latency was same day). Additionally it was reported that the caller wanted to know how long they need to wait before starting the series over for this patient. The call became disconnected while the caller was holding and an outbound call was made and the MIA (manufacturing / importers authorisation) continued the call. The call was transferred from MIA. PENTACEL was administered incorrectly. At the time of reporting, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: PREVNAR; HEPATITIS B VACCINE; ROTAVIRUS VACCINE

Current Illness:

ID: 1483670
Sex: U
Age:
State: OR

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: diluent portion of Pentacel has been administered without being mixed with the powder (HIB) / no AE; Initial information received on 08-Jul-2021 regarding an unsolicited valid non-serious case received from a pharmacist via call center via Global Medical Information (reference number- 00674315). This case involves a patient of (unknown demographics) who inadvertently received dtap ipv from Pentacel without reconstituting with HIB (product preparation issue) when received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]. The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination. It was an actual medication error case due to inappropriate reconstitution technique (latency: same day). ''It was reported that while doing his inventory, he noticed that a diluent was missing. They are in the process of verifying which patient was immunized last week with only the DTAP-IPV portion.'' At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1483671
Sex: U
Age:
State: MI

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 07/18/2021
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: The patient received an expired dose of Act-Hib vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via global medical information (GMI) (Reference number- 00674336) and transmitted to Sanofi on 08-Jul-2021. This case involves a patient with unknown demographics who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). Medical history, medical treatment, vaccination, family history and concomitant medications were not reported. On 08-Jul-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE [lot UJ327AA, expiry date: 28-Jun-2021, diluent expiration date: 30-Sep-2021, other dosing details were not reported] for prophylactic vaccination. (expired product administered) (Latency: on the same day) It was a case of actual medication error due to expired vaccine used. It was reported that, reporter did not have any additional information, she was handed a box and requested to make call regarding validity of vaccine. (reporter wanted to know if this vaccine is considered viable or not) At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1483673
Sex: F
Age: 1
State: WI

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 07/18/2021
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: expired pentacel was administered to patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (nurse) and physician via global medical information (GMI) (Reference number- 00674667) and transmitted to Sanofi on 08-Jul-2021. This case involves a 19-month-old female patient who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). Medical history, medical treatment, vaccination and family history were not reported. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13),MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) and HEPATITIS A VACCINE. On 07-Jul-2021, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB [Pentacel] VACCINE (total, lot UJ336AAA and Expiry date- 05-Jul-2021) via an unknown route at the right vastus lateralus site for prophylactic vaccination (expired product administered) (latency: on the same day). It was a case of actual medication error due to expired vaccine used. At the time of report, reporter was asked for any adverse event to watch for and what should they do. At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: PREVNAR 13; MMRVAXPRO; HEPATITIS A VACCINE

Current Illness:

ID: 1483674
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: A patient received ACT-HIB VACCINE which was not mixed with the diluent, no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Global Medical Information (Reference number- 00674736) and transmitted to Sanofi on 08-Jul-2021. This case involves a patient (unknown demographics) who received HIB (PRP/T) VACCINE [ACT-HIB] which was not mixed with the diluent (product preparation issue). The patient's medical history, past 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 and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination which was not mixed with the diluent (product preparation issue). It was reported that "The caller wanted to know what to do from here. Pharmacist reported ActHIB was administered with diluent other than what was provided with vaccine''. It was a case of actual medication error due to Inappropriate reconstitution technique (latency same day). At time of reporting, no adverse events were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1483675
Sex: M
Age: 18
State: PA

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 07/18/2021
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: patient was given Menactra in the left deltoid in error, instead of the intended meningococcal B vaccine, with no reported adverse event; Initial information was received on 09-Jul-2021 regarding an unsolicited valid non-serious case from other health professional (GMI Inquiry number: 00675660). This case involves 18-year-old male patient who was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in the left deltoid in error, instead of the intended meningococcal b vaccine (wrong product administered). It was a case of actual medication error due to wrong vaccine administered. On an unknown date, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number: U6690AA, expiry date: 23-Aug-2021] via an unknown route at left deltoid for prophylactic vaccination. At the time of report, no adverse event reported. Description: Yesterday, 08Jul2021, a patient was given Menactra in the left deltoid in error, instead of the intended meningococcal B vaccine. o Treatment NA o Dose # if series Yesterday's dose was an accidental, extra third dose of Menactra. The patient's two prior doses of MCV4 vaccine were in 2014 and Jun2020. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1483676
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: severe anaphylactic reaction /allergic reaction; suffering with the pain,she can only spend 20 minutes at a time on each of her shoulders; she wakes up screaming; Initial information received on 09-Jul-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional via Media Information (under reference 00676037). This case involves a 82 years old female patient who had severe anaphylactic reaction /allergic reaction (anaphylactic reaction), was suffering with the pain, she can only spend 20 minutes at a time on each of her shoulders (arthralgia) and she wakes up screaming (screaming), after receiving INFLUENZA VACCINE. The patient had an eye problem; she stated that she had an eye exam with dye and two minutes later experienced an allergic reaction and has a heart issue and cancer. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. In 2008, the patient received a 0.5 ml dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient had severe anaphylactic reaction /allergic reaction (anaphylactic reaction, unknown latency, medically significant), which required an emergency room visit. On an unknown date, the patient was suffering with the pain; she states she wakes up screaming (screaming, unknown latency, non serious) and can only spend 20 minutes at a time on each of her shoulders (arthralgia, unknown latency, non serious). It was reported that, patient was unable to identify what vaccine she had; she wants the COVID (coronavirus disease) vaccine; however, she was unsure about the components in the vaccine and wants to identify what exactly caused her anaphylactic reaction. Caller was not able to recall what shot was given. She stated that her doctors were ambivalent to her taking the Covid vaccine, and indicated that she wanted the Moderna vaccine; but her heart doctor was against her taking it saying "no way", her internal medicine doctor was fine with her taking the vaccine, and her eye doctor was against it due to her eye issue. Relevant laboratory test results included: On an unknown date: a skin test for the Covid (coronavirus disease) vaccine was done and reported that she may not have an allergic reaction. It was not reported if the patient received a corrective treatment. At time of reporting, the patient did not recover from the event arthralgia, while the outcome was unknown for other two reported events. Information on the batch number to be requested for this case.; Sender's Comments: This case involves a 82 years old female patient who presented with severe anaphylactic reaction, arthralgia and screaming, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. The patient' s medical history included an eye problem; allergy to dye and has a heart issue and cancer. Further information regarding other 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 vaccine cannot be assessed.

Other Meds:

Current Illness: Allergy to chemicals (she had an eye exam with dye and two minutes later experienced an allergic reaction); Cancer; Heart disorder

ID: 1483678
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: expired PENTACEL was accidentally administered to a patient with no reported adverse event; Initial information was received on 09-Jul-2021 regarding an unsolicited valid non-serious case from a pharmacist in the United States (GMI Inquiry number: 00676148). This case involves a patient (age and gender not reported) who was administered with expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was accidentally administered (expired product administered). Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. It was a case of actual medication error due expired vaccine used. At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information on batch number for this case.

Other Meds:

Current Illness:

ID: 1483687
Sex: F
Age:
State: VI

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm pain and swelling; Arm pain and swelling; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. It was reported that the patient had no allergies to medications, food, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 18Mar2021, the patient experienced arm pain and swelling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the adverse events was reported as no. The clinical outcome of the events arm pain and swelling was recovered on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1483713
Sex: F
Age: 33
State: OR

Vax Date: 04/08/2021
Onset Date: 04/12/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Nausea

Symptoms: Unusual and extremely heavy vaginal bleeding with clots. Now occurs every month for 2-3 weeks. Previous menses only happened 3-4 times a year for four days and was very light.

Other Meds: Xanax, Zoloft, multivitamin, iron

Current Illness: None

ID: 1483714
Sex: M
Age: 44
State: OH

Vax Date: 07/16/2021
Onset Date: 07/17/2021
Rec V Date: 07/18/2021
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: blood on toilet paper after bowel movement-Mild

Other Meds:

Current Illness:

ID: 1483715
Sex: F
Age: 25
State: MA

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt prone to fainting due to vagal-vasal response. she expected it, her mom was with her. she did faint for about 30-40 seconds and then came to.

Other Meds:

Current Illness:

ID: 1483716
Sex: F
Age: 58
State: NY

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 07/18/2021
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: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1483717
Sex: F
Age: 18
State: NJ

Vax Date: 07/16/2021
Onset Date: 07/17/2021
Rec V Date: 07/18/2021
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: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium

Other Meds:

Current Illness:

ID: 1483718
Sex: F
Age: 30
State: VA

Vax Date: 06/26/2021
Onset Date: 07/03/2021
Rec V Date: 07/18/2021
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: Systemic: Tinnitus-Severe

Other Meds:

Current Illness:

ID: 1483719
Sex: M
Age: 28
State:

Vax Date: 07/16/2021
Onset Date: 07/17/2021
Rec V Date: 07/18/2021
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: Ceclor

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

Symptoms: Light headedness, fever, muscle aches, headache. Began approximately 12 hours after dose was administered. Prevented returning to work or any strenuous physical activity?have not waned noticeably now 34 hours after vaccination.

Other Meds: None

Current Illness: None

ID: 1483720
Sex: M
Age: 47
State: PA

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Weakness-Medium, Additional Details: Patient stated he had a fear of needles at the start of the interaction. Was fine right after the injection, then after I completed the immunization for the person he came in with, he fainted. Was out for approx. 30 sec, then awoke. I provided a bottle of water, and ice pack. They sat for 20mins, walked around the store for a bit, then left. He was accompanied by a female who he lived with.

Other Meds:

Current Illness:

ID: 1483721
Sex: M
Age: 57
State: FL

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 07/18/2021
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: Error: Incorrect Reconstitution-

Other Meds:

Current Illness:

ID: 1483722
Sex: F
Age: 59
State: FL

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Error: Incorrect Reconstitution-

Other Meds:

Current Illness:

ID: 1483723
Sex: F
Age: 21
State: NJ

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 07/18/2021
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: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1483724
Sex: M
Age: 38
State: NC

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 07/18/2021
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: Error: Wrong Dose of Vaccine - Too Low-

Other Meds:

Current Illness:

ID: 1483725
Sex: M
Age: 25
State: AL

Vax Date: 07/16/2021
Onset Date: 07/16/2021
Rec V Date: 07/18/2021
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: Systemic: Fainting / Unresponsive-Medium

Other Meds:

Current Illness:

ID: 1483726
Sex: F
Age: 52
State: MA

Vax Date: 06/22/2021
Onset Date: 06/22/2021
Rec V Date: 07/18/2021
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: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Weakness-Mild, Additional Details: Following patients first dose of Pfizer, she reported a it swelled up like a "large marble". She reported redness that went all the way down her arm and it took about 1 week for pain and redness to improve. There still is a hard node under her skin at the site where vaccine was administered. Patient came in for second dose and reported these symptoms from 6/22. Instructed patient to follow up with PCP and to monitor.

Other Meds:

Current Illness:

ID: 1483727
Sex: F
Age: 47
State: OH

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 07/18/2021
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: NKDA

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Menstrual cycle stoped for 2 months returning with a massive heavy flow. My cycles usually run 3 to 3 1/2 day and now I have a full 7 day cycle with extreme heavy flow! I also experience Brain fog along with muscles in fingers, thumb and arm twich intermittently.

Other Meds: Zyrtec allergy medicine

Current Illness: None

ID: 1483728
Sex: F
Age: 70
State: CA

Vax Date: 06/24/2021
Onset Date: 06/24/2021
Rec V Date: 07/18/2021
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: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: On the first shot, pt has constant sholder/neck pain from shot and still continued after 3 weeks when recieving the 2nd shot (on opposite arm). She says the left arm pain is getting better, but it still has pain. On the second shot, the pain subsided after 3 days.

Other Meds:

Current Illness:

ID: 1483729
Sex: M
Age: 50
State: CO

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 07/18/2021
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: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium

Other Meds:

Current Illness:

ID: 1483730
Sex: F
Age: 21
State: TX

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Systemic: Dizziness / Lightheadness-Mild, Systemic: left hand felt numb-Mild, Additional Details: light headed right after vaccine. offered and accepted water. observed her for 20minutes. left arm numb. mother was here. offered to call emergency services. pt said no. mother took her home for further observation. checked on her at 8pm. she was back to normal

Other Meds:

Current Illness:

ID: 1483731
Sex: M
Age: 32
State: NJ

Vax Date: 05/25/2021
Onset Date: 06/12/2021
Rec V Date: 07/18/2021
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: One time Oxycontin rash

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Hives. Red bumps that are itchy. Recurring daily in the morning, occurring in various areas of body. Sometimes it skips a few days. Rash disappears after 3 hours, I guess. One instance happened after I applied a sunscreen before sun exposure- a hives reaction appeared where i applied the sunscreen product, arms, legs, head, neck, and shoulders.

Other Meds: Adderall XR (generic) Lamotrigine Vitamin B12 sublingual

Current Illness:

ID: 1483732
Sex: F
Age: 33
State: OR

Vax Date: 02/25/2021
Onset Date: 06/16/2021
Rec V Date: 07/18/2021
Hospital: Y

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

Lab Data:

Allergies: Na

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

Symptoms: I was pregnant due October 26th 2021. This was my second pregnancy. My first, I went 42+ weeks and ended up having a csection. I ended up delivering my second born on 7/6/2021. He was 24 weeks old and 700 grams.

Other Meds: Prenantals, iron, vit. D, 50 mg Zoloft

Current Illness: Na

ID: 1483733
Sex: F
Age: 70
State: FL

Vax Date: 03/23/2021
Onset Date: 03/26/2021
Rec V Date: 07/18/2021
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: Sulfa

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

Symptoms: Body and joint aches Previously taken Acetaminophen, Naproxin, currently taking MethylPredniSolone dose pack

Other Meds: Ropinirole. Venlafaxine. Lisinopril. Calcium Citrate +3D. Magnesium Glycinate

Current Illness: None

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm