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

ID: 1489856
Sex: M
Age:
State: FL

Vax Date: 04/16/2021
Onset Date: 07/01/2021
Rec V Date: 07/21/2021
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: Got 2 doses of the vaccine tested positive with the COVID-19 Virus; breakthrough infection/patient was just diagnosed last week Friday; Got 2 doses of the vaccine tested positive with the COVID-19 Virus; breakthrough infection/patient was just diagnosed last week Friday; Patient not feeling good; Severe Cold and Flu; Severe Cold and Flu; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6208), dose 1 via intramuscular route, administered in arm left on 26Mar2021 at 09:30 (at the age of 48-year-old) as dose 1, single and dose 2 (Batch/Lot Number: ER8729) via intramuscular route, administered in arm right on 16Apr2021 at 09:30 (at the age of 48-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included Levocetirizine as allergy medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Jul2021, the patient experienced got 2 doses of the vaccine tested positive with the covid-19 virus; breakthrough infection/ patient was just diagnosed last week Friday and on an unspecified date in 2021, the patient not feeling good, severe cold and flu. The clinical course of the events was reported as: he mentioned that he got 2 doses of the vaccine and he was really glad to have the vaccine but unfortunately after that (incomplete sentence), well actually he got the 1st dose last 26Mar and the 2nd dose last 16Apr but unfortunately after a month he was tested positive with the COVID-19 Virus. He stated, he got diagnosed just last week and his shot were between 26Mar and 16Apr of this year and he did not have COVID before this ever. He stated that right now (as reported) since he was not feeling good he had some over the counter medication but when he first came down with this (COVID-19 Virus), the only thing I was taking was allergy medication. I take Levocetirizine (Intent: treatment), 5 mg and I take I once a day in the evening. Laboratory test: included sars-cov-2 test: positive on an unspecified date in Jul2021 and he stated, not for at least, he wanted to say 4 or 5 months, it was the last time he had lab test. Treatment in response to events: he stated, yes, he started on Nyquil and Dayquill and they were severe cold and flu. He took some Aspirin also. He added, that was everything, he just wanted to call and let Pfizer know what happened to see if they ever wanted more information. The outcome of the events was unknown. Product quality complaints: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the formulated drug product lot EN5329. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.

Other Meds: LEVOCETIRIZINE

Current Illness:

ID: 1489857
Sex: M
Age:
State:

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 07/21/2021
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: Rash on his arm; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported) via an unspecified route of administration on Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on his arm on Jul2021. The patient unsure if this has something to do with the vaccine or not and want to clarify if rashes on the arm is a common side effect. Patient also wanted to know, is still safe to get a second dose of BNT162B2. The outcome of the events was unknown. No follow-up attempts are possible; No further information is expected.

Other Meds:

Current Illness:

ID: 1489858
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: shingles; This is a spontaneous report from a non-contactable consumer (patient daughter) received via a sales representative. A 40-year-old 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 an unspecified date, as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient experienced shingles after second dose of COVID vaccine on an unspecified date. The outcome for the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1489859
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: Experiencing headache; Super congestion; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The consumer stated that the patient was supposed to get his second dose of vaccine on Monday (12Jul2021) but he had been experiencing headache and super congestion since an unspecified day. On 15Jul2021, the patient did not have fever and his temperature was 98.7 in the morning. The consumer wanted to know if congestion was part of the side effects of the COVID vaccine. The outcome of the events was not recovered. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1489860
Sex: F
Age:
State:

Vax Date: 06/22/2021
Onset Date:
Rec V Date: 07/21/2021
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: her SED rate went from 30 to 130; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 22Jun2021 as dose 1, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 12Jul2021, as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had a blood test done before she received the vaccine. On an unspecified date of 2021, patient had another blood test done after she received the vaccine, and her erythrocyte sedimentation rate (SED) went from 30 to 130. Patient questioned that, has this happened before and was informed that there was no information regarding a change in lab results with the Pfizer Covid-19 vaccine, Survey offered. The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1489861
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: seizure; Initial information received on 12-Jul-2021 regarding an unsolicited valid serious case received from a pharmacist via call center via Regulatory Authority (Reference number- 00676744). This case involves an female patient (unknown demographics) who experienced seizure when received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's past medical history, vaccination, concomitant and family history were not provided. Past vaccination include ADACEL 10 years ago for prophylactic vaccination and did not have any side effect or seizures attack related to the vaccine for the past 10 years. On an unknown date, the patient received a booster dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS 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 developed a serious seizure (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. Laboratory details were not reported. It was reported that ''what to advise patient after informing her medical provider? does patient have to undergo tests through provider to rule out any adverse reaction from the vaccine due to her current seizure disorder. If Pharmacist calls in verify if asking of drug interactions between Adacel and Keppra.'' The patient was treated with LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) 500 mg for her seizures. The event outcome was unknown for seizure. Batch number has been requested for suspect product for this case.; Sender's Comments: This case concerns a unknown age old female patient who presented with seizure after vaccination with ADACEL. The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1489862
Sex: M
Age: 0
State: IL

Vax Date: 07/12/2021
Onset Date: 07/12/2021
Rec V Date: 07/21/2021
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: A child received an expired dose of ACTHIB yesterday with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via nurse via regulatory authority (Reference number- 00678904) and transmitted to Sanofi on 12-Jul-2021. This case involves a 2 months old male patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] yesterday (Expired product administered) Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccination. On 12-Jul-2021, the patient received a first dose of suspect HIB (PRP/T) VACCINE (lot UJ359AA, expiry date: 11-Jul-2021) (Diluent- Lot: U6872AA, Expiration date: 01-Feb-2022, dose of diluent 0.6 ml) via intramuscular route in the left thigh for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used (latency same day). It was reported that "Nurse called to report that an expired dose of a vaccine had been administered today (12JUL2021). The vaccine expired 11-Jul-2021. The caller would like to know if this dose is valid or if the child should be revaccinated?" 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: ROTATEQ; PREVNAR; PEDIARIX

Current Illness:

ID: 1489865
Sex: M
Age:
State: FL

Vax Date: 07/12/2021
Onset Date: 07/12/2021
Rec V Date: 07/21/2021
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: male patient was accidently given Tenivac instead of TDap with no adverse event; Initial information received on 13-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an adult male patient in his 40's who was accidently given DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [TDAP]. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 12-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number and expiry date: not reported) (Frequency: once) instead of TDAP not produced by Sanofi Pasteur via an unknown route at an unknown administration site (Wrong product administered) for prophylactic vaccination. It was an actual medication error case due to Wrong vaccine administered (latency on same day). It was reported that "Practitioner reported that a patient was accidently given TD instead of TDap on yesterday. Caller would like to know when can TDap now be administered to this patient. The Practitioner reported that the patient that received the Tenivac and not the ordered Tdap is in their 40s and is a male and that the dose of TDap was ordered was to be able to be near a newborn. The Practitioner was not able to provide any more information for this report due to not being in the clinic". At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1489866
Sex: M
Age: 40
State: TX

Vax Date: 07/13/2021
Onset Date: 07/13/2021
Rec V Date: 07/21/2021
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: 40 year old male patient administered expired diluent with no adverse event; Initial information received on 13-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 40 year old male patient who was vaccinated with an expired diluent dose of suspect YELLOW FEVER VACCINE - US [YF-VAX]. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 13-Jul-2021, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US (lot number: UJ386AA and expiry date: 22-Aug-2022, Diluent Lot number: U6309AA and expiry date: 30-Jun-2021) (Frequency: once) via an subcutaneous route in the left arm (Expired product administered) for prophylactic vaccination. It was an actual medication error case due to Expired medical agent used (latency on same day). At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1489867
Sex: M
Age: 17
State: VA

Vax Date: 06/16/2021
Onset Date: 06/16/2021
Rec V Date: 07/21/2021
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: 17 year old male patient was inadvertently administered an expired dose of Menactra with no reported AE; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case received from a consumer in the United States. This case involves a 17 year old male patient who was inadvertently administered an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. Patient received no concomitant vaccines. Medical history, medical treatment, concomitant medication, and family history were not provided. On 16-Jun-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6365AA and expiry date: 24-Sep-2020) via an intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency on same day). It was reported that "Caller stated the vaccine is expired and they administered it to a patient. Caller wants to know how effective the vaccine is, if they needed to give the vaccine to the patient again, or would they need to wait. Reported stated that as of today (14 Jul 2021) the patient has not reported any adverse effects from having received the expired vaccine." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1489868
Sex: U
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: IMOVAX for pre-exposure, incorrect schedule, dose on day 0, day 3, and day 7, no AE; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case from a pharmacist via Global Media Information (under reference number: 00681667). This case involves a patient of unknown age and gender patient who received RABIES (HDC) VACCINE [IMOVAX RABIES]'s incorrect schedule; that is on day 0, day 3, and day 7. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient received first, second and third dose of suspect RABIES (HDC) VACCINE (lot number and expiration date not reported) via unknown route in an unknown administration site for pre-exposure immunization on day 0, day 3 and day 7 respectively (dates unknown) (inappropriate schedule of product administration). It was an actual medication error case due to inappropriate schedule vaccine administered. It was reported: "Pharmacist asked about the dosing series of IMOVAX for pre-exposure. An incorrect schedule was given to a patient. Patient was given a dose on day 0, day 3, and day 7. They are wondering if a 4th dose should be given, or would the patient be fully protected already. Pharmacist does not have the patient information at the moment." At time of reporting, it was unknown whether the patient had any adverse event or not. 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 the batch number for this case.

Other Meds:

Current Illness:

ID: 1489869
Sex: F
Age: 11
State: KS

Vax Date: 07/13/2021
Onset Date: 07/13/2021
Rec V Date: 07/21/2021
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: 11 year old female patient inadvertently given DAPTACEL instead of a TDAP vaccine with no reported adverse event; 11 year old female patient inadvertently given DAPTACEL vaccine with no reported adverse event; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 year old female patient who was inadvertently given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [TDAP]. Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation. On 13-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5774AA and expiry date: 18-Sep-2022) (Frequency: once) via an intramuscular route in the right arm instead of TDAP not produced by Sanofi Pasteur (lot number and expiry date: not reported) via an unknown route at an unknown administration site (Wrong product administered and Product administered to patient of inappropriate age) for prophylactic vaccination. It was an actual medication error case due to Wrong vaccine administered and inappropriate age at vaccine administration (latency on same day). It was reported that "Patient age greater than one year enter as two month, four month, etc. Many pediatric vaccines need month for age. Pregnancy: not applicable, Last menstrual period, Due date, AE (adverse event) symptoms or no AE, If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food and drug administration) requirement. Reporter relationship: HCP (health care professional) Product used: Used First time product used: Yes". At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: MENINGOCOCCAL VACCINE; HPV VACCINE

Current Illness:

ID: 1489870
Sex: F
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: inadvertently given an expired dose of Imovax Rabies with no reported adverse event; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case from a nurse. This case involves an unknown age female patient who was inadvertently given an expired dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (expired product administered). The patient's past medical history included cat bite. The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received an expired dose of suspect RABIES (HDC) VACCINE (lot number not reported via unknown route in unknown administration site for post exposure immunization (expired product administered). It was reported that, "A patient was bitten by a cat and presented at the clinic on June 30th. She was inadvertently given an expired dose of Imovax Rabies. My colleague called, the patient was re-vaccinated with unexpired vaccine, on the same day. She also received immunoglobulin on that day. Today, she is back, 14 days later. How should I proceed with the series? Should I start over or give the day 3 dose?" It was a case of actual medication error due to expired vaccine used (latency same day). 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. There will be no information available on the lot number for this case.

Other Meds:

Current Illness:

ID: 1489871
Sex: F
Age: 0
State: IN

Vax Date: 07/14/2021
Onset Date: 07/14/2021
Rec V Date: 07/21/2021
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: Expired PENTACEL was administered to a patient 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- 00682124) and transmitted to Sanofi on 14-Jul-2021. This case involved 4 month old female patient who administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL] (expired product administered) Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); HEPATITIS B VACCINE and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (reported as ROTOTECK) for prophylactic vaccination. On 14-Jul-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ341AAA and expiry date: 22-jun-2021) (Frequency: one) (strength: standard) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered) It was reported that, "RMA (Registered Medical Assistant) stated that she accidentally gave an expired Pentacel injection to a patient today because she looked at the Pentacel wrong. Caller asked what she should do". It was an actual medication error case (expired vaccine used) (latency same day) At time of reporting, no adverse event 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; HEPATITIS B VACCINE; ROTATEQ

Current Illness:

ID: 1489872
Sex: M
Age: 68
State:

Vax Date: 07/15/2021
Onset Date: 07/15/2021
Rec V Date: 07/21/2021
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: expired dose of ACT HIB had be administered with no reported adverse event; 68 year old patient administred ACT-HIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and pharmacist via Global Medical Information (Reference number- 00684494) and transmitted to Sanofi on 15-Jul-2021. This case involved a 68 year old male patient who administered expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (product administered to patient of inappropriate age and expired product administered) Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On 15-Jul-2021, the patient received 0.5ml dose of suspect HIB (PRP/T) VACCINE (lot: UJ328AB and expiry date: 30-Jun-2021) (Frequency = once) (Strength = standard) via intramuscular route in the right deltoid for prophylactic vaccination (product administered to patient of inappropriate age and expired product administered) It was reported that, "the caller stated that an expired dose of ACT HIB had be administered. What are our recommendations"? This case was an actual medication error (expired vaccine used and Inappropriate age at vaccine administration) (latency same day) At the time of reporting, no adverse event 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: 1490017
Sex: U
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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 AE reported. No PQC reported.; ROTATEQ had been administered to a patient since the excursion occured; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant therapy was not provided. On an unspecified date in 2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # T039454 has been verified to be a valid lot number, expiration date reported as 14-DEC-2021; strength, dose and route were not reported) for prophylaxis. The vaccine had been stored under 0.3 degree Celsius for 11 hours, 0.4 degree Celsius for 11 hours and 0.6 degree Celsius for 3 hours, recorded by digital data logger. The reporter was told that the vaccine was still viable. There was no previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported.

Other Meds:

Current Illness:

ID: 1490018
Sex: U
Age:
State: OH

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 07/21/2021
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: No additional AE reported; An expired dose of VARIVAX was administered; This spontaneous report was received from a health care professional concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided. On 07-JUL-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliters, lot S020465 expiration date 02-JUL-2021 (route of administration was not provided) as prophylaxis. Caller provided information from the post expiry memo. No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1490019
Sex: U
Age:
State:

Vax Date: 07/12/2021
Onset Date: 07/12/2021
Rec V Date: 07/21/2021
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: No additional AE reported; adult patient located at an offsite facility received a pediatric dose of RECOMBIVAX HB.; adult patient located at an offsite facility received a pediatric dose of RECOMBIVAX HB.; This spontaneous report as received from a pharmacist refers to an adult patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-JUL-2021, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.

Other Meds:

Current Illness:

ID: 1490020
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Suspected vaccination failure; GOT shingles / nearly died and was in ICU for weeks; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization, GSK medically significant and life threatening) and shingles (serious criteria hospitalization and life threatening). On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The reporter stated that, the patient nearly died and was in intensive care unit for weeks. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR156171, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR156171:same reporter

Other Meds:

Current Illness:

ID: 1490021
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 06/15/2021
Rec V Date: 07/21/2021
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: RIGHT HAND FELT GREASY AND THEN FELT STICKY NEED TO CLEAN HAND SEVERAL TIMES A DAY; INSECURE FEELING DUE TO MUSCLE WEAKNESS (DIFFICULT TO TAKE A DECISION TO WALK FROM THE DINING TABLE TO THE BATHROOM OR OTHER AREAS); WEAKNESS INVOLVING WHOLE BODY; HAD PROBLEMS WHILE SPEAKING; RIGHT HAND AND LEG NUMBNESS; PARALYSIS RIGHT HALF OF THE BODY; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included back injury, and pain due to back injury, and concurrent conditions included symptoms of covid-19 (runny nose). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 03-JUN-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, at 21: 30 the patient experienced paralysis right half of the body and paralysis of the right leg. Did not feel any pain of previous back injury once the paralysis happened. On 16-JUN-2021, at 05:30- 06 the patient had problems while speaking, right hand and leg numbness and at unspecified time patient had trouble walking, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), tongue numbness, right arm weakness and sometimes left arm weakness and weakness that started on the right side and then involving whole body. On 19-JUN-2021, the patient felt right hand greasy and then felt sticky need to clean hand several times a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paralysis right half of the body, and paralysis of the right leg on 15-JUN-2021 lasted about 15 minutes, and had not recovered from had problems while speaking, weakness that started on the right side and then involving whole body, trouble walking, right hand and leg numbness, right hand felt greasy and then felt sticky need to clean hand several times a day, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), right arm weakness and sometimes left arm weakness, and tongue numbness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210731397-covid-19 vaccine ad26.cov2.s-Hemiplegia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Pain trauma activated; Runny nose

ID: 1490022
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: OVERDOSE; OFF LABEL USE; This spontaneous report received from a consumer 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: unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced overdose, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from off label use, and overdose. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.

Other Meds:

Current Illness:

ID: 1490023
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/08/2021
Rec V Date: 07/21/2021
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: CHEST PRESSURE; INVOLUNTARY MOVEMENTS OF HEAD, ARMS AND LEGS; CHILLS; TIREDNESS; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced tiredness. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 18-APR-2021, the subject experienced chest pressure. On 18-APR-2021, the subject experienced involuntary movements of head, arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, tiredness, muscle aches, and fever on 11-APR-2021, and had not recovered from chest pressure, and involuntary movements of head, arms and legs. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1490024
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 07/21/2021
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: SEIZURES; MINOR INJURIES; BRUISES WITH RUG BURN; FALLING ON THE CARPET; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 210 pounds, and height was 76 inches. The patient's concurrent conditions included alcohol use occasional, and non-smoker, and the patient had no known allergies and no history of drug abuse or illicit drug use. Patient had no history of epilepsy as well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 12-APR-2021, after six days of vaccination patient started experiencing seizures. Patient's wife found patient in office face down laying on stomach and was unconscious. In less than two minutes patient woke up confused, and disoriented. Patient had suffered some minor injuries, and bruises with rug burn due to falling on the carpet. Patient was taken to the urgent care on 12-APR-2021. Since 12-APR-2021 patient had five more seizures. On 12-APR-2021, Laboratory data included: Electrocardiogram (EKG) (NR: not provided) within normal range. On 26-APR-2021, Laboratory data included: Blood lactate dehydrogenase (NR: not provided) within normal range, Complete blood count (CBC) (NR: not provided) within normal range, Chest X-ray (NR: not provided) within normal range, Emergency room Magnetic resonance imaging (MRI) (NR: not provided) within normal range, and Troponin (NR: not provided) within normal range. On 09-JUN-2021, Laboratory data included: Electroencephalogram (EEG) (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, minor injuries, bruises with rug burn and falling on the carpet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738406-covid-19 vaccine ad26.cov2.s- seizures. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Alcohol use (Occasional); Non-smoker

ID: 1490025
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 04/03/2021
Rec V Date: 07/21/2021
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: OVERALL ACHINESS IN UPPER BODY; LABORED BREATHING; EXTREME PAIN IN JOINTS/PAIN IN RIGHT WRIST/SHOULDER PAIN/ELBOW PAIN; This spontaneous report received from a patient concerned a 48 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: 180869 and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced overall achiness in upper body. On 03-APR-2021, the subject experienced labored breathing. On 03-APR-2021, the subject experienced extreme pain in joints/pain in right wrist/shoulder pain/elbow pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from labored breathing, overall achiness in upper body, and extreme pain in joints/pain in right wrist/shoulder pain/elbow pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1490026
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 07/16/2021
Rec V Date: 07/21/2021
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: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 40 year old White and Not Hispanic or Latino female. 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: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 16-JUL-2021, the patient was tested positive for COVID-19 (suspected COVID-19 infection and suspected clinical vaccination failure). The patient was close to someone who had COVID-19 with mild symptoms of a runny nose and cough. The symptoms were mild and patient got tested because she had children at home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected COVID-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738685-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1490027
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: BODY ACHES; FELT BLAH; 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, 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 body aches, and felt blah. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and felt blah. This report was non-serious. This case, from the same reporter is linked to 20210740692.

Other Meds:

Current Illness:

ID: 1490028
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 07/02/2021
Rec V Date: 07/21/2021
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: VACCINE ADMINISTERED TO 16 YEAR OLD PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no medical history. the patient have no history of drug abuse or illicit drug usage.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 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced vaccine administered to 16 year old subject. On 02-JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to 16 year old patient was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1490029
Sex: M
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/21/2021
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: UNDER MINIMUM CONDITIONS; 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: Unk) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced under minimum conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from under minimum conditions. This report was non-serious. This case, from the same reporter is linked to 20210743283.

Other Meds:

Current Illness:

ID: 1490030
Sex: F
Age: 63
State: CA

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 07/21/2021
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: Swelling of upper airways (lips, tongue, throat,uvula or larynx); Angioedema; Allergic reaction; Mild tongue swelling; Weird sensation in tongue; Glands were swollen; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Angioedema) and RESPIRATORY TRACT OEDEMA (Swelling of upper airways (lips, tongue, throat,uvula or larynx)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) 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 05-Apr-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction), SWOLLEN TONGUE (Mild tongue swelling), PARAESTHESIA ORAL (Weird sensation in tongue), LYMPHADENOPATHY (Glands were swollen) and FATIGUE (Fatigue). On 05-Apr-2021 at 10:25 AM, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). On an unknown date, the patient experienced RESPIRATORY TRACT OEDEMA (Swelling of upper airways (lips, tongue, throat,uvula or larynx)) (seriousness criterion medically significant). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) (oral) on 05-Apr-2021 at a dose of 10 mg once a day. On 05-Apr-2021 at 11:05 AM, ANGIOEDEMA (Angioedema) had resolved. At the time of the report, RESPIRATORY TRACT OEDEMA (Swelling of upper airways (lips, tongue, throat,uvula or larynx)) had resolved, ALLERGY TO VACCINE (Allergic reaction), SWOLLEN TONGUE (Mild tongue swelling) and LYMPHADENOPATHY (Glands were swollen) had not resolved and PARAESTHESIA ORAL (Weird sensation in tongue) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Blood pressure measurement: 100/73 (Low) 100/73 and 109/77 (Low) 109/77. On 04-May-2021, Heart rate: 65 (Inconclusive) 65 and 66 (Inconclusive) 66. On 04-May-2021, Respiratory rate: 12 (Inconclusive) 12 and 12 (Inconclusive) 12. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. On 04-Apr-2021 at 10:25 a.m Patient vitals were Heart rate 65.,resiratory rate 12 and blood pressure of 100/73. On 04-Apr-2021 at 10:35 a.m. Patient vitals were Heart rate 66, respiratory rate 12 and blood pressure 109/77.On 05-Apr-2021 at 10:25 a.m Patient had Angioedema. It resolved after 40 minutes at 11:05 a.m. The first observation of angioedema was mild tongue swelling followed by swelling of upper airways(lips, tongue, throat, uvula or larynx ).Patient went to Doctor's office/ urgent care /return to vaccine clinic and Follow up with Allergist on 14-04-2021. Treatment for the event included cetirizine (Zyrtec). 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. Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up information received on 20MAY2021 contains no new information. On 14-Jul-2021: Follow-up information was received: Patient demographics, lab data, vaccine batch number, treatment drug and new events Angioedema, Airway edema and Fatigue were added. This case was upgraded from non-serious to serious due to the addition of new events angioedema and airway edema; 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: 1490031
Sex: F
Age: 57
State: FL

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 07/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Unfortunately your medicine caused a stroke to my brain; Drug dose omission; Headache (hasn't gone away); Vomiting; Running nose; Diarrhea; Ache; Running temperature; Chills; Developed fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Lasted for two weeks.) from 28-Mar-2021 to April 2021. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced RHINORRHOEA (Running nose), DIARRHOEA (Diarrhea), PAIN (Ache), PYREXIA (Running temperature), CHILLS (Chills), FATIGUE (Developed fatigue) and VOMITING (Vomiting). On 29-Apr-2021, the patient experienced HEADACHE (Headache (hasn't gone away)). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Drug dose omission). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) outcome was unknown, RHINORRHOEA (Running nose), DIARRHOEA (Diarrhea), PAIN (Ache), PYREXIA (Running temperature), CHILLS (Chills), FATIGUE (Developed fatigue), VOMITING (Vomiting) and PRODUCT DOSE OMISSION ISSUE (Drug dose omission) had resolved and HEADACHE (Headache (hasn't gone away)) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. In April 2021, SARS-CoV-2 test: negative (Negative) Negative. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. 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. Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow up received contains no new information. On 18-Jul-2021: Follow up received, new event cerebrovascular accident 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: 1490032
Sex: M
Age: 61
State: NY

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 07/21/2021
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: NKDA

Symptom List: Injection site pain

Symptoms: Developed weakness in legs, needed help with walking, legs got weak like rubber, couldn't hold self up. ambulance to hospital, next day, could walk again. Was sent home after 3 days with home PT, had return of weakness, slid off bed, couldn't stand up. Was sent to Rehab- 2 weeks, 75% back to baseline and is extremely tired, sleeping easily

Other Meds: Taking Lantus Solostar Pen 100 units/mL solution 26 units b.i.d Taking metformin 500 mg tablet 1 tab(s) orally bid Taking pantoprazole 40 mg delayed release tablet 1 tab(s) orally once a day Taking atorvastatin 40 mg tablet 1 tab(s

Current Illness:

ID: 1490033
Sex: M
Age: 57
State: MD

Vax Date: 07/19/2021
Onset Date: 07/20/2021
Rec V Date: 07/21/2021
Hospital:

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

Lab Data:

Allergies: codeine

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

Symptoms: Muscle aches, headache, chills lasting from the morning of 7/20/2021 to morning of 7/21/2021. I took Tylenol for pain, which seemed to help. Slept at least 10 hours on the night of 7/20-7/21. Feeling a little better the morning of 7/21.

Other Meds: furosemide, spironolactone, protonix, carvedilol, lactulose, tamsulosin, ferrous sulfate, folic acid, D2, B12, acetaminofen

Current Illness: None

ID: 1490034
Sex: F
Age: 33
State: VT

Vax Date: 04/19/2021
Onset Date: 06/06/2021
Rec V Date: 07/21/2021
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: Sick for the two days; Had period the following week and was extremely emotional and had a heavy period; Felt awful the rest of the day; Extremely emotional; Seizure; Not feeling well; Twitching my hands.; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038c21a and 019b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sulfonamide allergy. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (VIENVA) from 15-Mar-2021 to an unknown date for Birth control, MINERALS NOS, VITAMINS NOS (ONE A DAY [MINERALS NOS;VITAMINS NOS]) from 01-May-2015 to an unknown date and COLLAGEN from 15-Mar-2021 to an unknown date for an unknown indication. On 19-Apr-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced MALAISE (Not feeling well) and MUSCLE TWITCHING (Twitching my hands.). On 06-Jun-2021 at 2:30 PM, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (Sick for the two days), HEAVY MENSTRUAL BLEEDING (Had period the following week and was extremely emotional and had a heavy period), FEELING ABNORMAL (Felt awful the rest of the day) and EMOTIONAL DISORDER (Extremely emotional). At the time of the report, SEIZURE (Seizure), ILLNESS (Sick for the two days), HEAVY MENSTRUAL BLEEDING (Had period the following week and was extremely emotional and had a heavy period), MALAISE (Not feeling well), MUSCLE TWITCHING (Twitching my hands.), FEELING ABNORMAL (Felt awful the rest of the day) and EMOTIONAL DISORDER (Extremely emotional) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: negative (Negative) Negative. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding the event has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow Up document was received and had significant information. Added Lab data. On 18-Jul-2021: Follow-up document was received and had significant information. Added vaccine facility, patient demographics, medical history, concomitant medications, event start date. Added new events like sick, heavy period, not feeling well, hand twitching, emotional.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding the event has been provided at this time.

Other Meds: VIENVA; ONE A DAY [MINERALS NOS;VITAMINS NOS]; COLLAGEN

Current Illness: Sulfonamide allergy

ID: 1490035
Sex: F
Age: 80
State: PA

Vax Date: 03/15/2021
Onset Date: 06/14/2021
Rec V Date: 07/21/2021
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: No Known Allergies

Symptom List: Tremor

Symptoms: Cough, congestion, head cold, fever methylprednisolone Monitor home O2 level

Other Meds: ascorbic acid, vitamin C, (VITAMIN C) 500 mg tablet atorvastat

Current Illness: None

ID: 1490036
Sex: M
Age: 0
State: LA

Vax Date: 10/19/1960
Onset Date: 04/06/2021
Rec V Date: 07/21/2021
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: none

Symptom List: Erythema, Pruritus

Symptoms: Burning sensation all over my body

Other Meds: none

Current Illness: none

ID: 1490037
Sex: F
Age: 76
State: PA

Vax Date: 03/27/2021
Onset Date: 07/12/2021
Rec V Date: 07/21/2021
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: AtorvastatinMyalgia / Muscle Pain IbuprofenHallucinations LisinoprilHives / Urticaria PravastatinMyalgia / Muscle Pain AmlodipineNausea Only EzetimibeDizziness / Lightheaded NiacinDizziness / Lightheaded

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

Symptoms: Fever or Chills Fatigue Muscle or body aches Headache Congestion or running nose

Other Meds: ascorbic acid/collagen hydr (COLLAGEN PLUS VITAMIN C ORAL) aspirin 81 mg tablet ibuprofen (MOTRIN) 600 mg tablet multiple vitamins (MULTI-DELYN) liquid VIT C/VIT E AC/LUT/COPPER/ZINC (PRESERVISION LUTEIN ORAL)

Current Illness: None

ID: 1490038
Sex: M
Age: 61
State: IN

Vax Date: 07/19/2021
Onset Date: 07/20/2021
Rec V Date: 07/21/2021
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: Compazine

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

Symptoms: Slight nausea and severe malaise.

Other Meds: Vit C, 82mg aspirin, Latanoprost, multivitamin

Current Illness: None

ID: 1490039
Sex: F
Age: 85
State: PA

Vax Date: 04/24/2021
Onset Date: 07/08/2021
Rec V Date: 07/21/2021
Hospital: Y

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

Lab Data:

Allergies: Hydrocodone-acetaminophenIndigestion / GI upset Iodinated Contrast MediaOther (document details in comments), Anaphylaxis IodineOther (document details in comments) Iodine Containing MultivitaminAnaphylaxis LisinoprilCoughing MeperidineNausea and Vomiting, Other (document details in comments) MorphineIndigestion / GI upset PenicillinsItching Propoxyphene N-acetaminophenNausea and Vomiting Sulfa (Sulfonamide Antibiotics)Itching PropoxypheneNausea And Vomiting Tramadol HydromorphoneOther (document details in comments)

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Acute respiratory failure with hypoxia wet cough Shortness of breath

Other Meds: acetaminophen (TYLENOL EXTRA STRENGTH) 500 mg tablet albuterol 2.5 mg /3 mL (0.083 %) nebulizer solution albuterol HFA (PROAIR HFA) 90 mcg/actuation inhaler allopurinoL (ZYLOPRIM) 100 mg tablet amLODIPine (NORVASC) 10 mg tablet aspirin 81 m

Current Illness: suspected liver cirrhosis.

ID: 1490040
Sex: F
Age: 22
State: PA

Vax Date: 07/20/2021
Onset Date: 07/20/2021
Rec V Date: 07/21/2021
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: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: temporary loss of vision-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: pt was given vaccine and approximately 5minutes or less later patient fell out of chair and onto floor. patient was pale,unresponsive for less than 30 seconds and clammy to touch. her lips were blue. 911 was called. came to almost immediately and did not remember what happened. vision went black but came back after a few minutes. tested her blood sugar is was 114. pulse was rapid. anbulance arrived pt walked out on her own power. refused treatment from emts and refused to go to er.

Other Meds:

Current Illness:

ID: 1490041
Sex: M
Age: 31
State: MI

Vax Date: 07/20/2021
Onset Date: 07/20/2021
Rec V Date: 07/21/2021
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: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild

Other Meds:

Current Illness:

ID: 1490042
Sex: F
Age: 40
State: RI

Vax Date: 07/19/2021
Onset Date: 07/19/2021
Rec V Date: 07/21/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: Pt felt a burning sensation right away and stated that their heart was racing. I checked BP several times and the range was between 130-158 / 70-90. Pt went to urgent care & MD monitored until BP & HR was normal. They are unsure if this was vaccine related or nerves. Pt was instructed to rest at home today & is feeling better but noted that she felt itchy when she first woke up this AM but it has since passed.

Other Meds:

Current Illness:

ID: 1490043
Sex: F
Age: 59
State: CA

Vax Date: 07/20/2021
Onset Date: 07/20/2021
Rec V Date: 07/21/2021
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: Site: Swelling at Injection Site-Mild, Systemic: Hematoma immediately formed at injection site-Mild, Additional Details: Small amount of bleeding at injection site, but immediate hematoma formation. Correct landmarks were used and vaccine was administered into left deltoid in correct location. Pt denies any use of blood thinners or any bleeding disorders.

Other Meds:

Current Illness:

ID: 1490044
Sex: F
Age:
State: CA

Vax Date: 03/05/2021
Onset Date: 03/06/2021
Rec V Date: 07/21/2021
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: (Patch) nine days later started itching; (Patch) developed a bump; Large, red patch that was very sore; Headache; Slightly Achy/ was very sore/ Ached like I have never ached in my life/ Excruciating Pain; Nauseated; Running a fever of 100.6 degrees; Rigor Chills; Cytokine Reaction; Interstitial Cystitis; UTI; Sick to her stomach; Couldn't eat; Dizzy; Couldn't keep anything down; Inflammation Storm; Very unsteady; This spontaneous case was reported by a consumer and describes the occurrence of CYTOKINE STORM (Cytokine Reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced CYTOKINE STORM (Cytokine Reaction) (seriousness criterion medically significant), CYSTITIS INTERSTITIAL (Interstitial Cystitis), URINARY TRACT INFECTION (UTI), ABDOMINAL DISCOMFORT (Sick to her stomach), EATING DISORDER (Couldn't eat), DIZZINESS (Dizzy), MOBILITY DECREASED (Couldn't keep anything down), INFLAMMATION (Inflammation Storm), MALAISE (Very unsteady), HEADACHE (Headache), MYALGIA (Slightly Achy/ was very sore/ Ached like I have never ached in my life/ Excruciating Pain), NAUSEA (Nauseated), PYREXIA (Running a fever of 100.6 degrees) and CHILLS (Rigor Chills). On an unknown date, the patient experienced VACCINATION SITE PRURITUS ((Patch) nine days later started itching), VACCINATION SITE SWELLING ((Patch) developed a bump) and VACCINATION SITE ERYTHEMA (Large, red patch that was very sore). At the time of the report, CYTOKINE STORM (Cytokine Reaction), CYSTITIS INTERSTITIAL (Interstitial Cystitis), URINARY TRACT INFECTION (UTI), ABDOMINAL DISCOMFORT (Sick to her stomach), EATING DISORDER (Couldn't eat), DIZZINESS (Dizzy), MOBILITY DECREASED (Couldn't keep anything down), INFLAMMATION (Inflammation Storm), MALAISE (Very unsteady), VACCINATION SITE PRURITUS ((Patch) nine days later started itching), HEADACHE (Headache), MYALGIA (Slightly Achy/ was very sore/ Ached like I have never ached in my life/ Excruciating Pain), NAUSEA (Nauseated), PYREXIA (Running a fever of 100.6 degrees), CHILLS (Rigor Chills), VACCINATION SITE SWELLING ((Patch) developed a bump) and VACCINATION SITE ERYTHEMA (Large, red patch that was very sore) outcome was unknown. Concomitant product was not provided by the reporter Patient reported that after receiving vaccine she experienced rash then it large, red patch that was very sore and bump developed. After 9 days it began to itch. After second dose she experienced cytokine reaction and inflammation storm in her system. and other events from next day. Treatment information was not provided. 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: 1490045
Sex: F
Age: 68
State: AZ

Vax Date: 12/09/2019
Onset Date: 03/01/2021
Rec V Date: 07/21/2021
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: Total of 3 falls; a little off balance/lost her balance; inflammation; Cold (congestion); Broke sacrum and pelvic; broke her pelvis; Broke sacrum and pelvic; pain in right femur; This spontaneous case was reported by a consumer and describes the occurrence of PELVIC FRACTURE (Broke sacrum and pelvic; broke her pelvis) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMANTADINE HYDROCHLORIDE (GOCOVRI) capsule for Dyskinesia. The patient's past medical history included Breast cancer in 2002, Fall (A number of falls but none in the 3-6 months prior to the start of Gocovri; had fallen at work, hit her head and lost consciousness), Concussion (Fell at work and hit her head and lost consciousness), Loss of consciousness (Fell at work and hit her head and lost consciousness; had a concussion), Stereotypy, Corrective lens user and Hip replacement. Concurrent medical conditions included Drug allergy (Patient was allergic to erythromycin), Drug allergy (Patient was allergic to hydrocodone), Drug allergy (Patient was allergic to meperidine and related), Drug allergy (Patient was allergic to morphine and related), Drug allergy (Patient was allergic to naloxone), Drug allergy (Patient was allergic to prochlorperazine edisylate), Drug allergy (Patient was allergic to propoxyphene), Drug allergy (Patient was allergic to methadone), Dyskinesia and Parkinson's disease. Concomitant products included CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) for Parkinson's disease, MAGNESIUM and CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D) for Supplementation therapy, RASAGILINE for an unknown indication. On 09-Dec-2019, the patient started AMANTADINE HYDROCHLORIDE (GOCOVRI) (Oral) 274 milligram once. On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced FRACTURED SACRUM (Broke sacrum and pelvic). In April 2021, the patient experienced PELVIC FRACTURE (Broke sacrum and pelvic; broke her pelvis) (seriousness criterion medically significant). In 2021, the patient experienced BONE PAIN (pain in right femur). On an unknown date, the patient experienced FALL (Total of 3 falls), BALANCE DISORDER (a little off balance/lost her balance), INFLAMMATION (inflammation) and NASOPHARYNGITIS (Cold (congestion)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PELVIC FRACTURE (Broke sacrum and pelvic; broke her pelvis), FALL (Total of 3 falls), BALANCE DISORDER (a little off balance/lost her balance), FRACTURED SACRUM (Broke sacrum and pelvic), INFLAMMATION (inflammation), NASOPHARYNGITIS (Cold (congestion)) and BONE PAIN (pain in right femur) outcome was unknown. Not Provided 04/02/2021 Computerized tomogram. --/--/2021 Magnetic resonance imaging. 04/02/2021 X-ray , Not conclusive On an unspecified date, during the last week in MAR-2021, the patient broke her sacrum. The patient fell while she was helping her husband cut down a tree and was pulling a rope so the branches would not go into the neighbor's yard. The rope gave away and she fell backwards on rocks on her sacrum. She was seen in the ER (emergency room) and was given a shot to reduce the inflammation. Company Comment: Based on reporter's causality and patient?s concomitant condition (Parkinson?s disease and dyskinesia) the events Fall, balance disorder, Pelvic fracture, Fractured sacrum, Inflammation and Bone pain are assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product, and the start date of the event nasopharyngitis, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-Significant follow up; Sender's Comments: Based on reporter's causality and patient?s concomitant condition (Parkinson?s disease and dyskinesia) the events Fall, balance disorder, Pelvic fracture, Fractured sacrum, Inflammation and Bone pain are assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product, and the start date of the event nasopharyngitis, a causal relationship cannot be excluded.

Other Meds: RASAGILINE; MAGNESIUM; CALCIUM AND VITAMIN D; CARBIDOPA/LEVODOPA

Current Illness: Drug allergy (Patient was allergic to propoxyphene); Drug allergy (Patient was allergic to prochlorperazine edisylate); Drug allergy (Patient was allergic to naloxone); Drug allergy (Patient was allergic to morphine and related); Drug allergy (Patient was allergic to methadone); Drug allergy (Patient was allergic to meperidine and related); Drug allergy (Patient was allergic to hydrocodone); Drug allergy (Patient was allergic to erythromycin); Dyskinesia; Parkinson's disease

ID: 1490046
Sex: F
Age: 64
State: CA

Vax Date: 03/30/2021
Onset Date: 05/11/2021
Rec V Date: 07/21/2021
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: CRPS (Complex Regional Pain syndrome); Right middle finger and then all of her right fingers felt like she had a million ants in them and in her entire hand; Right hand felt very tight,was about to explode; Right hand was swollen; This spontaneous case was reported by a consumer and describes the occurrence of COMPLEX REGIONAL PAIN SYNDROME (CRPS (Complex Regional Pain syndrome)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PARAESTHESIA (Right middle finger and then all of her right fingers felt like she had a million ants in them and in her entire hand), LIMB DISCOMFORT (Right hand felt very tight,was about to explode) and PERIPHERAL SWELLING (Right hand was swollen). On an unknown date, the patient experienced COMPLEX REGIONAL PAIN SYNDROME (CRPS (Complex Regional Pain syndrome)) (seriousness criterion medically significant). The patient was treated with RISPERIDONE (NERVE) at an unspecified dose and frequency. At the time of the report, COMPLEX REGIONAL PAIN SYNDROME (CRPS (Complex Regional Pain syndrome)), PARAESTHESIA (Right middle finger and then all of her right fingers felt like she had a million ants in them and in her entire hand), LIMB DISCOMFORT (Right hand felt very tight,was about to explode) and PERIPHERAL SWELLING (Right hand was swollen) outcome was unknown. On 11-MAY-2021, the patient experienced her right middle finger and then all of her right fingers felt like she had a million ants in them and in her entire hand. Her right hand felt very tight like it was about to explode and was also swollen. She saw three doctors and had no blood clots. Patient was diagnosed with CRPS (Complex Regional Pain syndrome). Treatment information Antidepressant medicine was provided by the reporter. 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-2021-258023 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1490047
Sex: F
Age: 73
State: GA

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 07/21/2021
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: Burning sensation on both of her legs; Statis dermatitis; Agitated; Infection leg; arm soreness; Excruciating pain on both legs; Arm soreness at the injection site; Extreme edema in both legs; Triggered Manic episodes; Lupus flare up; Arthritis flare up; Swelling of both legs; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Psoriasis, Cellulitis and Intra-cerebral aneurysm clipping since an unknown date. Concurrent medical conditions included Drug allergy (Allergy to Methothrexate.), Drug allergy (Allergy to Prednisone.), Drug allergy (Allergy to Peroxide (topical).), Hepatitis B carrier and Bipolar disorder. On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) (seriousness criterion medically significant), ARTHRITIS (Arthritis flare up), PERIPHERAL SWELLING (Swelling of both legs), OEDEMA PERIPHERAL (Extreme edema in both legs), MANIA (Triggered Manic episodes), PAIN IN EXTREMITY (Excruciating pain on both legs) and VACCINATION SITE PAIN (Arm soreness at the injection site). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation on both of her legs), STASIS DERMATITIS (Statis dermatitis), AGITATION (Agitated), LOCALISED INFECTION (Infection leg) and PAIN IN EXTREMITY (arm soreness). The patient was treated with AMOXICILLIN at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. On 09-Jul-2021, VACCINATION SITE PAIN (Arm soreness at the injection site) had resolved. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up), ARTHRITIS (Arthritis flare up), PERIPHERAL SWELLING (Swelling of both legs), BURNING SENSATION (Burning sensation on both of her legs), OEDEMA PERIPHERAL (Extreme edema in both legs), AGITATION (Agitated), LOCALISED INFECTION (Infection leg), PAIN IN EXTREMITY (Excruciating pain on both legs) and PAIN IN EXTREMITY (arm soreness) outcome was unknown and MANIA (Triggered Manic episodes) and STASIS DERMATITIS (Statis dermatitis) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. 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: Bipolar disorder; Drug allergy (Allergy to Prednisone.); Drug allergy (Allergy to Peroxide (topical).); Drug allergy (Allergy to Methothrexate.); Hepatitis B carrier; Intra-cerebral aneurysm clipping

ID: 1490048
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: Myocarditis/ swelling around my heart on my heart; Pericarditis; Swelling around left lung; My ribs and collar bones feel bruised; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis/ swelling around my heart on my heart) and PERICARDITIS (Pericarditis) 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. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis/ swelling around my heart on my heart) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), PNEUMONITIS (Swelling around left lung) and CONTUSION (My ribs and collar bones feel bruised). At the time of the report, MYOCARDITIS (Myocarditis/ swelling around my heart on my heart), PERICARDITIS (Pericarditis), PNEUMONITIS (Swelling around left lung) and CONTUSION (My ribs and collar bones feel bruised) outcome was unknown. Not Provided The concomitant medications were not reported. The treatment information was not provided. Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1490049
Sex: F
Age:
State: CT

Vax Date: 03/16/2021
Onset Date: 04/12/2021
Rec V Date: 07/21/2021
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: Cant not write; Cannot walk up the stairs, she used to walk "4 miles a day in winter time (30,000 steps) but now zero; Cannot get out of bed feels like she is 100 years old; Arms, knees, elbows and ankles feel like being crippled; Anxiety went through the roof; Joint pain continued to intensify; Rheumatoid arthritis; Arthritis flared up when she got the vaccine; She was so cold, could not get warm; Teeth were chattering; fever of 104.5F; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis), DYSGRAPHIA (Cant not write), GAIT INABILITY (Cannot walk up the stairs, she used to walk "4 miles a day in winter time (30,000 steps) but now zero), MOVEMENT DISORDER (Cannot get out of bed feels like she is 100 years old) and HYPOKINESIA (Arms, knees, elbows and ankles feel like being crippled) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma, Arthritis, Drug allergy (Aspirin Allergy) and Drug allergy (Advil Allergy). On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced FEELING COLD (She was so cold, could not get warm), CHILLS (Teeth were chattering) and PYREXIA (fever of 104.5F). On 16-Jul-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Arthritis flared up when she got the vaccine). On an unknown date, the patient experienced DYSGRAPHIA (Cant not write) (seriousness criterion disability), GAIT INABILITY (Cannot walk up the stairs, she used to walk "4 miles a day in winter time (30,000 steps) but now zero) (seriousness criterion disability), MOVEMENT DISORDER (Cannot get out of bed feels like she is 100 years old) (seriousness criterion disability), HYPOKINESIA (Arms, knees, elbows and ankles feel like being crippled) (seriousness criterion disability) and ANXIETY (Anxiety went through the roof). an unknown date, the patient experienced ARTHRALGIA (Joint pain continued to intensify). On 16-Apr-2021, PYREXIA (fever of 104.5F) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and ARTHRALGIA (Joint pain continued to intensify) had not resolved and DYSGRAPHIA (Cant not write), GAIT INABILITY (Cannot walk up the stairs, she used to walk "4 miles a day in winter time (30,000 steps) but now zero), MOVEMENT DISORDER (Cannot get out of bed feels like she is 100 years old), HYPOKINESIA (Arms, knees, elbows and ankles feel like being crippled), ANXIETY (Anxiety went through the roof), CONDITION AGGRAVATED (Arthritis flared up when she got the vaccine), FEELING COLD (She was so cold, could not get warm) and CHILLS (Teeth were chattering) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 104.5 ?F (High) 104.5?F. On an unknown date, Blood test: has autoimmune disorder (abnormal) Blood works revealed that she now has an autoimmune disorder. Concomitant medications were not provided by the reporter. Treatment information was 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. Concomitant medical conditions (arthritis) could be potentially confounders/co-suspects for the events.; 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. Concomitant medical conditions (arthritis) could be potentially confounders/co-suspects for the events.

Other Meds:

Current Illness: Arthritis; Asthma; Drug allergy (Aspirin Allergy); Drug allergy (Advil Allergy)

ID: 1490050
Sex: F
Age: 42
State: NY

Vax Date: 01/23/2021
Onset Date:
Rec V Date: 07/21/2021
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: Autoimmune disorder; Serum sickness; Vertigo; Short term memory loss; This spontaneous case was reported by a physician and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune disorder) in a 43-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 23-Jan-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune disorder) (seriousness criterion medically significant), SERUM SICKNESS (Serum sickness), VERTIGO (Vertigo) and AMNESIA (Short term memory loss). At the time of the report, AUTOIMMUNE DISORDER (Autoimmune disorder), SERUM SICKNESS (Serum sickness), VERTIGO (Vertigo) and AMNESIA (Short term memory loss) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details was reported. No treatment medication details was reported. Patient was also tested by Neurology. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up information received on 20-JUL-2021 contains significant information - Outcome of the events changed from unknown to recovering/resolving.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested

Other Meds:

Current Illness:

ID: 1490051
Sex: M
Age: 54
State: IL

Vax Date: 04/26/2021
Onset Date: 04/27/2021
Rec V Date: 07/21/2021
Hospital: Y

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: Car accident; miss second dose; chills; "little" fever; "little" headache; This spontaneous case was reported by a consumer and describes the occurrence of ROAD TRAFFIC ACCIDENT (Car accident) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included METFORMIN, INSULIN and ENALAPRIL for an unknown indication. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced CHILLS (chills), PYREXIA ("little" fever) and HEADACHE ("little" headache). On 15-May-2021, the patient experienced ROAD TRAFFIC ACCIDENT (Car accident) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (miss second dose). At the time of the report, ROAD TRAFFIC ACCIDENT (Car accident), CHILLS (chills), PYREXIA ("little" fever), HEADACHE ("little" headache) and PRODUCT DOSE OMISSION ISSUE (miss second dose) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. The patient miss the second shot because on 15 May 2021 his had a car accident and his was hospitalized. His was crashed by another car. Concomitant medication included blood pressure pill. 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 (Chills, Pyrexia, Headache), 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 (Chills, Pyrexia, Headache), a causal relationship cannot be excluded.

Other Meds: METFORMIN; INSULIN; ENALAPRIL

Current Illness: Blood pressure abnormal

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm