VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
PLEASE CHECK BACK SOON
Download the files above while you wait.






Manufacturers

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

Incidents per State

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

ID: 1349689
Sex: F
Age:
State:

Vax Date: 05/12/2021
Onset Date: 05/01/2021
Rec V Date: 05/26/2021
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: This is a spontaneous report from a contactable other HCP (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 12May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included she had an issue with red dye in the past and states her 'throat started closing up' from it. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient stated she had her second Pfizer Covid vaccine dose on Wednesday 12May2021. On Sunday 16May2021 she developed hives and a rash that has gotten progressively worse. She was taking prednisone and Benadryl to help treat it. She wanted to know if this has been reported before and how long it could potentially last. The outcome of event was unknown. Information about Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1349690
Sex: M
Age:
State: PA

Vax Date: 05/06/2021
Onset Date: 05/14/2021
Rec V Date: 05/26/2021
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: Headache; dizziness; foggy; heavy feeling in chest; heavy feeling in shoulders, and arm; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 54 years old, in left arm on 06May2021 15:30 at single dose for covid-19 immunisation. The patient medical history was reported as none. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks and any other medications within 2 weeks prior to vaccination. The patient experienced headache, dizziness, foggy, heavy feeling in chest, shoulders, and arm on 14May2021 05:00. The patient had not been tested for covid-19 since the vaccination. No treatment was received. The outcome of events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1349691
Sex: F
Age:
State: CO

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 05/26/2021
Hospital: Y

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: patient is not in great health; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported that a 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported) in Jan 2021 via an unspecified route of administration as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient was not in great health and was just admitted to nursing home and the nursing home doctor called. She said it was 21 to 42 day out for the second dose and asks for confirmation on that window and asked whether it needs to be started. She says that she asked her to at least do a test for antibodies but she is not sure It was reported that it has now been 3 months out and asked whether the patient can take the second dose and whether it would still be effective. The outcome of event was unknown. Information on the lot/batch number has been requested. Additional information has been requested; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event asthenia and the administration of the vaccine cannot be excluded.

Other Meds:

Current Illness:

ID: 1349692
Sex: F
Age:
State: VA

Vax Date: 04/14/2021
Onset Date: 04/16/2021
Rec V Date: 05/26/2021
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: R arm, then L (1st) at inject area ache/pain that remains 5/20 & gets worse; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: ER8729), at the age of 79 years old, in right arm on 14Apr2021 14:00 at single dose for covid-19 immunisation. Medical history included low thyroid and high blood pressure. Both were medicated. The patient's allergies were unknown. The patient was not pregnant at time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. Concomitant medications included lisinopril at 20 mg and levothyroxine sodium (SYNTHROID) at 112 ug the patient received within 2 weeks of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to vaccination. On 16Apr2021, the patient experienced R arm, then L (1st) at inject area ache or pain, that remains 20May2021 and got worse. The patient had not been tested for covid-19 since the vaccination. No treatment was received. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: LISINOPRIL; SYNTHROID

Current Illness:

ID: 1349693
Sex: F
Age:
State: CO

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 05/26/2021
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: I felt like my throat was swelling and closing up followed by swelling of the lip; I felt like my throat was swelling and closing up followed by swelling of the lip; I felt like my throat was swelling and closing up followed by swelling of the lip; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ew0182), via an unspecified route of administration at Left arm on 20May2021 12:00 (at the age of 33-year-old) as single for COVID-19 immunisation. Medical history included migraine, asthma and peanut allergy. Concomitant medications included rizatriptan and amitriptyline. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20May2021 at 12:15, patient experienced i felt like my throat was swelling and closing up followed by swelling of the lip. Patient received Benadryl and Ventolin as treatment for event to reduced symptoms. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received. Therapeutic measures were taken as a result of i felt like my throat was swelling and closing up followed by swelling of the lip. The outcome of the events was recovering.

Other Meds: AMITRIPTYLINE; RIZATRIPTAN

Current Illness:

ID: 1349694
Sex: F
Age:
State: TN

Vax Date: 05/19/2021
Onset Date: 05/20/2021
Rec V Date: 05/26/2021
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: This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown and expiration date was not reported), via an unspecified route of administration in left arm, on 19May2021 at 10:00 (at the age of 43 years old) as second dose, single for COVID-19 immunization in pharmacy/drug store. Medical history included grave's disease. The patient had sulfa drug allergy. Concomitant medications included levothyroxine and montelukast sodium (SINGULAIR). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown and expiration date was not reported), via an unspecified route of administration in left arm, on 26Apr2021 at 11:30 (at the age of 43 years old) as first dose, single for COVID-19 immunization. The patient was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient experienced chills and headache on 20May2021. No treatment was received by the patient due to these events. The outcome of these events was recovering at the time of report. Information on the lot/batch number has been requested.

Other Meds: LEVOTHYROXINE; SINGULAIR

Current Illness:

ID: 1349695
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
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: allergy; Initial information received on 30-Apr-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional. This case involves adult female patient who experienced allergy (hypersensitivity) when received vaccine TETANUS TOXOID. The patient's past medical treatment, vaccination, concomitant medication and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious (pertussis) allergy (hypersensitivity) (unknown latency) following the administration of TETANUS TOXOID. It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the event (allergy). The event outcome was unknown for allergy. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1349696
Sex: M
Age: 1
State: IL

Vax Date: 05/05/2021
Onset Date: 05/05/2021
Rec V Date: 05/26/2021
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: A patient was given an expired ACT-HIB, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00589040) and transmitted to Sanofi on 05-May-2021. This case involves a 15 month old male patient who received 0.5 ml dose of expired suspect HIB (PRP/T) VACCINE [ACT-HIB] vaccine (lot number: UJ178AAB; expiry date: 04-May-2021) via unknown route in the right thigh for prophylactic vaccination on 05-May-2021 (expired product administered). Medical history, medical treatment(s), past vaccination(s), and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (lot number and expiry date: not reported) for prophylactic vaccination and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) (lot number and expiry date: not reported) for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). The reporter wanted to know if they should revaccinate the patient. 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 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; DTAP VACCINE

Current Illness:

ID: 1349697
Sex: F
Age: 1
State: PA

Vax Date: 05/07/2021
Onset Date: 05/07/2021
Rec V Date: 05/26/2021
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: An expired Pentacel was given to a 15 month old as a 4th dose, no AE; Initial information was received on 07-May-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional. This case involves a 15-month-old female patient who was administered 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot: DTAP/ IPV: U6395AA, ActHIB: UJ160AA, expiry date: 24-Apr-2021) via intramuscular route in thigh for prophylactic vaccination on 07-May-2021. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA) for prophylactic vaccination. It was a case of an actual medication error due to Expired product administered (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.

Other Meds: PREVNAR 13; PNEUMOVAX; MMR; VARICELLA VACCINE

Current Illness:

ID: 1349698
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
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: patient got Menactra when they were supposed to get meningococcal B, no AE; Initial information received on 12-May-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (inquiry reference number 00598144). This case involves a patient of unknown age and gender patient who got MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6521AB and expiration date not reported) when was supposed to get MENINGOCOCCAL VACCINE B not produced by Sanofi Pasteur (lot number U6521AB and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date (wrong product administered). The patient's past medical history, medical treatment(s), vaccination(s), concomitant mediation(s) and family history were not provided. It was an actual medication error due to wrong vaccine administered (same day latency). It was reported that registered pharmacist was calling to see if a Lot number provided matches the Menactra vaccine that had been given inappropriately. Checked her stock and the lot number did not match. This was given a few months back and the lots have changed. Caller said she was calling from overseas. She was asking to confirm if a certain lot (given here) was Menactra. Caller also stated that a physician noticed in a patient chart recently that this patient got Menactra when they were supposed to get meningococcal B. Caller also said that they were not sure if maybe the nurse who documented this typed in Menactra instead of meningococcal B by mistake. Caller said the lot number documented was U6521AB. Caller does not have any details on patient. She said this happened months ago. They are not even sure if this was an error. If Sanofi can confirm that the lot is not Menactra then it was probably typed wrong by nurse. No AE (adverse event) template done as caller does not have any details. 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: 1349699
Sex: F
Age: 0
State: NJ

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 05/26/2021
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: Patient was administered ActHib vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00598281) and transmitted to Sanofi on 12-May-2021. This case involves a 7 months old female patient who was administered with a expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ178AAB and expiry date: 04-May-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 11-May-2021. The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for Immunisation. It was an actual medication error case due to expired vaccine used (latency: same day). The reporter wanted to know what to do. At the time of reporting, the patient experienced 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: HEPATITIS B VACCINE; DTAP VACCINE

Current Illness:

ID: 1349700
Sex: U
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
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: Vaccines were kept at elevated temperature excursions, no AE; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-healthcare professional via Medical Information (Reference number- 00599790) and transmitted to Sanofi on 13-May-2021. This case involves a patient (unknown demographics) who received IPV (VERO) [IPOL] (lot number and expiry date not reported) and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] ((lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination which were kept at temperature excursions for unknown periods of time on an unknown date (product storage error). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The reason for the elevated temperature excursions of unknown duration was that the person who was trained to properly use the data loggers stopped showing up to work so that the people who took over did not know that the data loggers had to be periodically cleared, but in addition to that, something is wrong with the data loggers so that they will not download the historical data for the temperature excursions. Practice manager asked for any extended stability information, and information on whether and when to revaccinate. The practice manager reports their data logger was not cleared so it was showing high temps for unknown periods of time. On April 22 it read 9.2 degree Celsius, through the end of the month and then 11.2 degree Celsius and then on May 7 12.6 degree Celsius. This was a case of actual medication error case due to incorrect product storage (latency 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. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1349701
Sex: F
Age: 0
State: MI

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 05/26/2021
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: A patient received only liquid DTaP-IPV portion without mixing the powder HIB portion, no AE; Initial information regarding an unsolicited valid non-serious case was received from nurse via Medical Information (Reference number- 00599798) and transmitted to Sanofi on 13-May-2021. This case involves a three-month-old female patient who received 0.5 mL 2nd dose which was only liquid dtap-ipv portion without mixing the powder hib portion of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ389AB and expiry date: 09-Oct-2021) via an unknown route in the left thigh for prophylactic vaccination on 13-May-2021 (product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for prophylactic vaccination. The caller would like to know if this will be considered a full vaccine for polio or not. This was a case of actual medication error case due to inappropriate reconstitution technique (latency 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: ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE 13V

Current Illness:

ID: 1349702
Sex: U
Age:
State: CA

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 05/26/2021
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: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Medical Information (Reference number- 00599921) and transmitted to Sanofi on 13-May-2021. This case involves a patient (unknown demographics, adult) who received an expired 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported and expiry date: 08-May-2021) via an intramuscular route in an unknown administration site for prophylactic vaccination on 10-May-2021 (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. This was a case of actual medication error case due to expired vaccine used (latency 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. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1349703
Sex: M
Age:
State: NJ

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 05/26/2021
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: A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00600408) and transmitted to Sanofi on 13-May-2021. This case involves a male patient (age not reported) who received 0.5 mL dose of an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U658BA and expiry date: 20-Apr-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 13-May-2021 (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The medical assistant (MA) was calling to get more information in regards to expired MENACTRA had been administered. This was a case of actual medication error case due to expired vaccine used (latency 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: 1349704
Sex: U
Age:
State: TN

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 05/26/2021
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: administered an expired vaccine to a patient, no AE; Initial information received on 13-May-2021 regarding an unsolicited valid non-serious case from a nurse practitioner via Media Information (inquiry reference number 00600500). This case involves a patient in his 50s was administered with 0.5 ml expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot c5578aa and expiration date :28-Jan-2021) via unknown route in the deltoid (but not sure which one) for prophylactic vaccination on 13-May-2021 (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant or no other vaccines were given to the patient. It was a case of actual medication error due to expired vaccine used (same day latency). It was reported that a medical assistant (MA) gave a dose of Tenivac yesterday which had expired. Caller mentioned that she sent an email to Pharmacovigilance about this last night and missed return phone call. The nurse practitioner who was reporting the event is currently at home and does not have the patient initials or dob (date of birth) with her. Reported that the caller did not have this with her today, but stated that it was in her previous web inquiry. The lot information documented here was pulled from that web inquiry-GMI -00600500). And was with the question that what are the effects of an expired vaccine. 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: 1349705
Sex: F
Age: 0
State: NY

Vax Date: 05/15/2021
Onset Date: 05/15/2021
Rec V Date: 05/26/2021
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: a patient received a dose of Pentacel vaccine that had been at a temperature of greater than 77 F for 12 hours/ No AE; Initial information received on 17-May-2021 regarding an unsolicited valid non-serious case received from a Nurse educator via physician via Medical Information (Reference number- 00603828). This case involves a five months old female patient who received a 0.5 ml third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] that had been at a temperature of greater than 77 f for 12 hours lot UJ416AA, expiry date: 22-MAR-2022, frequency: once, strength: standard via intramuscular route in the left thigh (left quadriceps) on 15-May-2021for prophylactic vaccination (product storage error). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) via oral route for prophylactic vaccination respectively. It was an actual medication error due to incorrect product storage (latency same day). Potential Product Technique Complain: No. At the time of report no adverse event was reported. No causality not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: PREVNAR; ROTATEQ

Current Illness:

ID: 1349707
Sex: F
Age: 26
State: TX

Vax Date: 05/20/2021
Onset Date: 05/21/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies: Sun allergy Oranges Grass Citrus acid Lactose

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Rash began to occur around the vaccine site by the morning after given. Then by Saturday Morning it had spread across my upper back and shoulders. On Sunday , it was on my right arm and face. I used Benadryl and Calamine lotion to stop itching and spread.

Other Meds: My medications are Minocycline, Blackburn mixture, tacrolumis ointment ,clindamycin phosphate, and sodium sulfacetamide and Sulfur.

Current Illness: None

ID: 1349708
Sex: F
Age: 59
State: NE

Vax Date: 03/17/2021
Onset Date: 03/01/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies: Possible egg allergy; almonds; gluten intolerance; cane sugar

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: 1. 3/21 leading up to 3/31 I had a low grade fever that would not go away. 2. 3/31 at 2am, hit with bout of intense nausea which continued through 4/-3. The most intense was 3/31-4/1. 3. 4/3-4/4 my right side under rib cage was screaming in pain Treatment -- went to doctor's office on 4/2 to make sure not covid (tested negative), given a perscription for nausea. Called Dr.'s office and advised to go to Primary Care Physician. Also, advised hot water bottle on organs that hurt. The hot water bottle soothed the intense pain. Had soup when could tolerate it. 4. Went to doctor's office on 4/5 regarding the intense pain on right side. An abdominal Ultrasound was ordered. April 25, 4am, my eye sight went to seeing 1/2 of objects and words, then went to tunnel vision. 1. I saw Primary Physician who referred me to an opthamalogist. 2. Opthamalogist saw nothing wrong with eye -- suggested taking baby asprin and that there had been a TIA, referred me back to Primary Physician for a referral to Cardiologist / Vascular physician

Other Meds: Cymbalta, neurontin, Armour Thyroid, Vit C, D, NAC, Omega-3,

Current Illness: none known

ID: 1349709
Sex: F
Age: 21
State: VA

Vax Date: 05/16/2021
Onset Date: 05/17/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies: NKDA, no known food, or other allergies.

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

Symptoms: 21yo Active Duty female Navy Sailor currently deployed to UAE reports to Fujairah Detachment medical clinic with c/o bottom lip swelling x 96hrs, which began about 24 hours post receiving the J&J vaccine on 16May21 in Jebel Ali, UAE. Pt denies any pain, tingling, or numbness but does report a throbbing sensation in the lip. Pt denies any dyspnea, SOB, dysphagia, or difficulty eating/drinking. Pt states there is also a blister like red spot on the middle of the lip. Pt denies any fever, body aches, fatigue, n/v, or other skin lesions. Pt denies any history of cold sores/herpes labialis. Pt denies having anything like this from a vaccine in the past. No history of medication, food, or environmental allergies. Pt also reported HA, stomach ache, and feeling weak for 24 hours after vaccination then resolved, but lip then swelling began and persisted prompting medical evaluation. Provider prescribed 25mg Benadryl which significantly decreased the lip swelling over the following 6-8 hours.

Other Meds: The patient takes no daily medications, supplements, or herbals.

Current Illness: N/A

ID: 1349710
Sex: F
Age: 37
State: PA

Vax Date: 05/24/2021
Onset Date: 05/24/2021
Rec V Date: 05/26/2021
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: Unk

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Injection site reaction presenting possibly due to injection higher in the arm than it should be. Bright red and hot to touch. Improved by anti inflammatory oral Medications, unresolved by them entirely. Worsening at day 3 post injection.

Other Meds: Vitamin D, multi vitamin, antioxidant OPC-3,

Current Illness: None

ID: 1349735
Sex: M
Age:
State: KS

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 05/26/2021
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: Haematochezia; This case was received via FDA VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of HAEMATOCHEZIA (Haematochezia) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced HAEMATOCHEZIA (Haematochezia) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (Haematochezia) had 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. Treatment information was not provided. Concomitant product use was not provided by the reporter. Patient reported to the nurse at his second COVID vaccine appointment that he had bloody stools for 2 days, and then the bloody stools stopped. 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1349736
Sex: F
Age:
State: NE

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 05/26/2021
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: Loss of consciousness; Malaise; Pyrexia; This case was received via FDA VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoarthritis, Osteoporosis, GERD, Hypercholesterolemia, Irritable bowel syndrome, Hypothyroidism, Hypertension, Diabetes mellitus and Coronary atherosclerosis. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, UBIDECARENONE (COQ10 [UBIDECARENONE]), DOCUSATE SODIUM, BIFIDOBACTERIUM LACTIS, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS (FLORAJEN3), GLIPIZIDE, LEVOTHYROXINE, OMEPRAZOLE, INSULIN DEGLUDEC (TRESIBA), VALSARTAN, VITAMIN D3 and ZOLEDRONIC acid for an unknown indication. On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (Pyrexia). On 26-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and MALAISE (Malaise). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), MALAISE (Malaise) and PYREXIA (Pyrexia) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood glucose: 142 mg/dl (abnormal) 142 mg/dl. On 26-Feb-2021, Blood pressure measurement: 117/60 (normal) normal, Earlier it was noted to be in the 90s systolic. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. On night of 25-Feb-2021. The patient reported running a fever. On 26-Feb-2021, the patient woke up with not feeling well. The patient's blood sugar was checked which was 142 mg/dl and shortly after she passed out. The patient's blood sugar was noted to be in the 90's systolic as taken by her daughter, who was a nurse. On re-checking the patient's blood pressure, it got improved to 117/60. The patient was scheduled to be seen with her primary care provider on 26-Feb-2021 to verify that the patient was stable. Company Comment: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; COQ10 [UBIDECARENONE]; DOCUSATE SODIUM; FLORAJEN3; GLIPIZIDE; LEVOTHYROXINE; OMEPRAZOLE; TRESIBA; VALSARTAN; VITAMIN D3; ZOLEDRONIC acid

Current Illness: Coronary atherosclerosis; Diabetes mellitus; GERD; Hypercholesterolemia; Hypertension; Hypothyroidism; Irritable bowel syndrome; Osteoarthritis; Osteoporosis

ID: 1349737
Sex: F
Age:
State: SC

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 05/26/2021
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: Anaphylactoid reaction; Dyspnoea; Swollen tongue; Throat tightness; This case was received via FDA VAERS (Reference number: 1072186) on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ANAPHYLACTOID REACTION (Anaphylactoid reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Egg allergy and Allergy to vaccine (flu vaccine). On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ANAPHYLACTOID REACTION (Anaphylactoid reaction) (seriousness criterion medically significant), DYSPNOEA (Dyspnoea), SWOLLEN TONGUE (Swollen tongue) and THROAT TIGHTNESS (Throat tightness). At the time of the report, ANAPHYLACTOID REACTION (Anaphylactoid reaction), DYSPNOEA (Dyspnoea), SWOLLEN TONGUE (Swollen tongue) and THROAT TIGHTNESS (Throat tightness) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. Waiting on the EMS to arrive the patient started having rebound anaphylaxis so was given shot of another EpiPen. Patient was then put into EMS and left for the hospital. 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Allergy to vaccine (flu vaccine); Egg allergy

ID: 1349739
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
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 vaccination failure; believe I have suffered VZV Opthm / had a more severe outbreak of herpes zoster which included infection of my. Eye; have chronic herpes zoster in my trigeminal nerve; believe I have suffered VZV Opthm / believe I had Vz; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included immunodeficiency. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), herpes zoster infection neurological (serious criteria GSK medically significant) and varicella zoster. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, herpes zoster infection neurological and varicella zoster were unknown. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster infection neurological and varicella zoster to be related to Shingrix. Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient was being treated for an immune deficiency. The patient also asked should he/she get shingles vaccine if he/she has an immune problem. The patient stated that after receiving the Shingrix vaccine, he/she had a more severe outbreak of herpes zoster which included infection of his/her eye. The patient also had chronic herpes zoster in his/her trigeminal nerve and any amount of stress causes an outbreak of varicella zoster virus. The patient believe he/she had suffered from ophthalmic herpes zoster. The patient also believe he/she had varicella zoster. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for Herpes zoster and time to onset were unknown.

Other Meds:

Current Illness: Immunodeficiency

ID: 1349740
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
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: Got The Vaccine And 2 Weeks Later Got The Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles vaccine and got the shingles.

Other Meds:

Current Illness:

ID: 1349741
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
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: Several of my friends got shingles from the shot/Suspected Vaccination failure; Several of my friends got shingles from the shot; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 GSK medically significant) and shingles. The patient was treated with vitamin e and lysine. On an unknown date, the outcome of the vaccination failure and shingles were unknown. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The patients were reporter's friend. The age at vaccination was not applicable to this report. The reporter stated that several of his/her friends (patients) got shingles from the shot and Lysine and Vitamin E stop and prevent it. The reporter stated that you did not need to shoot up poison unless you want to get sick. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1349742
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
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: I HAD A FRIEND WHO HAD THE SHOT AND GOT IT ANYWAY/ Suspect vaccination failure; HAD THE SHOT AND GOT IT ANYWAY; This case was reported by a consumer via 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 GSK medically significant) and shingles. 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 reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient received Shingles vaccine and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1349746
Sex: M
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
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: Patient was administered with Menveo using another diluent; Patient was administered with Menveo using another diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient was administered with Menveo using another diluent than the one supplied by Glaxo SmithKline, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The information regarding the patient was not reported.

Other Meds:

Current Illness:

ID: 1349747
Sex: U
Age:
State: MN

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 05/26/2021
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: nurse/tech diluted the powder vial with sterile water; nurse/tech diluted the powder vial with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On 14th May 2021, the patient received Menveo. On 14th May 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Menveo which was diluted the powder vial with sterile water which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter was asked if patient need to vaccinated. The reporter does not have detail of patient or vaccine. The reporter consented to follow up. This case had been linked with case US2021111552, as reported by the same reporter; Sender's Comments: US-GLAXOSMITHKLINE-US2021111552:Same reporter

Other Meds:

Current Illness:

ID: 1349748
Sex: F
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: ACUTE KIDNEY INJURY; UNCONTROLLED HYPERTENSION; ELEVATED SEDIMENTATION RATE; ELEVATED C REACTIVE PROTEIN; ELEVATED LIVER FUNCTION TESTS; DAILY PERSISTENT HEADACHE; This spontaneous report received from a pharmacist concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was reported that, the patient received care at the clinic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) 1 total, dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient had acute kidney injury, uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, elevated liver function tests, and daily persistent headache. The patient visited doctor/healthcare professional office for the events. The patient's laboratory data included blood pressure (not reported), C-reactive protein elevated, erythrocyte sedimentation rate elevated, and Liver function tests elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uncontrolled hypertension, elevated sedimentation rate, elevated c reactive protein, daily persistent headache, elevated liver function tests, and acute kidney injury. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210537406-COVID-19 VACCINE AD26.COV2.S-Acute Kidney Injury. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1349749
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BLOOD CLOTS; HEADACHES; This spontaneous report received from a consumer who reported by seeing a news report 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) 1 total, 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. It was reported that, on an unspecified date, the patient had blood clots, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches and blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210540314, 20210539987 and 20210547453.; Sender's Comments: V0- 20210540327- Covid-19 vaccine ad26.cov2.s-This case concerns with female of unspecified age.-Blood clot. This event is considered unassessable. The event has an unknown temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1349750
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
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: GOT A BLOOD CLOT IN LEG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height and weight were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient got a blood clot in their leg and our vaccine is not good to compare to mRNA Vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got a blood clot in leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210541027-COVID-19 VACCINE AD26.COV2.S-Got a Blood Clot in Leg. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

Date Died:

ID: 1349751
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: DIED; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total dose administered for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers .No concomitant medications were reported. It was reported that on an unspecified date, the patient died from covid-19 vaccine ad26.cov2.s. The cause of death was unknown. it was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death); Sender's Comments: V0: 20210546018-covid-19 vaccine ad26.cov2. s Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1349752
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 05/20/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 20 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: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0.20210546789-covid-19 vaccine ad26.cov2.s -confirmed immunological vaccine failure . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1349753
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

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

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician 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 not reported and expiry: Unknown) dose not reported, 1 total, 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 18-May-2021, the doctor called in for efficacy of the vaccine given to one of his patient (confirmed immunological vaccine failure) experienced on an unspecified date, and measured the spike protein about a month apart. On 19-APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) undetected antibody. On 17-MAY-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) undetected antibody. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210546864-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1349754
Sex: U
Age:
State: MT

Vax Date:
Onset Date:
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: VACCINE DOSE GIVEN AFTER 2 HOUR OF ROOM TEMPERATURE/GIVEN OUTSIDE OF TEMPERATURE RECOMMENDATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 vaccine dose given after 2 hour of room temperature/given outside of temperature recommendation. The action taken with covid-19 vaccine was not applicable. The outcome of vaccine dose given after 2 hour of room temperature/given outside of temperature recommendation was not reported. This report was non-serious

Other Meds:

Current Illness:

ID: 1349755
Sex: F
Age:
State: KS

Vax Date:
Onset Date: 04/07/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: SEQUENTIAL USE WITH MRNA VACCINE; This spontaneous report received from a health care professional concerned a 20 year old female. The patient's height, and weight were not reported. The patient had no known drug allergies. The patient was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced sequential use with mrna vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sequential use with mrna vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1349756
Sex: F
Age: 38
State: TN

Vax Date: 04/09/2021
Onset Date: 04/10/2021
Rec V Date: 05/26/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Cytokines Storm; Thickening of the blood; Polycythemia; Extremely Short Of Breath; Elevated Heart Rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CYTOKINE STORM (Cytokines Storm), HYPERCOAGULATION (Thickening of the blood), POLYCYTHAEMIA (Polycythemia), DYSPNOEA (Extremely Short Of Breath) and HEART RATE INCREASED (Elevated Heart Rate) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. No medical reported history provided by the reporter. On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced CYTOKINE STORM (Cytokines Storm) (seriousness criteria hospitalization and medically significant), HYPERCOAGULATION (Thickening of the blood) (seriousness criterion hospitalization), POLYCYTHAEMIA (Polycythemia) (seriousness criterion hospitalization), DYSPNOEA (Extremely Short Of Breath) (seriousness criteria hospitalization and intervention required) and HEART RATE INCREASED (Elevated Heart Rate) (seriousness criterion hospitalization). At the time of the report, CYTOKINE STORM (Cytokines Storm), HYPERCOAGULATION (Thickening of the blood), POLYCYTHAEMIA (Polycythemia), DYSPNOEA (Extremely Short Of Breath) and HEART RATE INCREASED (Elevated Heart Rate) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: elevated (High) Elevated. No treatment related information has been reported. Since receiving the second vaccine patient visited the ER a total of 4 times. Patient had no medical history of heart disease or Short Breath. 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: 1349757
Sex: F
Age: 68
State: CA

Vax Date: 01/29/2021
Onset Date: 02/27/2021
Rec V Date: 05/26/2021
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: Sore Throat in Neck Area; Diagnosed with ITP; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M2EA and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat in Neck Area). On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) and OROPHARYNGEAL PAIN (Sore Throat in Neck Area) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 10,000 (Low) Platelets had dropped to 10,000 and 47,000 (Low) Decreased. Concomitant medications were not reported. Patient went to urgent care and blood work revealed that her platelets had dropped to 10,000 and she was directed to the emergency room and was treated with steroids and gamma globulin. She was diagnosed with ITP and treated with 4 infusions of Rituxan and her platelets are still low at 47,000. Treatment information were included gamma globulin, steroids, 4 infusions of Rituxan at hospital. Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1349759
Sex: F
Age: 41
State: MD

Vax Date: 03/09/2021
Onset Date: 04/24/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies: Bees Percocet

Symptom List: Pain in extremity

Symptoms: Developed extreme anxiety symptoms after the vaccination, thought it was normal until the onset of extreme chest pains on or around 4/24/2021. Was diagnosed with Pericarditis on 4/29/2021.

Other Meds: Sertraline Multivitamin B-12 Vitamin D Calcium

Current Illness: Fibromyalgia Inverse T Waves Asthma

ID: 1349760
Sex: F
Age: 22
State: ME

Vax Date: 05/25/2021
Onset Date: 05/26/2021
Rec V Date: 05/26/2021
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: I was vaccinated yesterday and woke up in horrible pain and nausea. I vomited and had to go back up so bed since I was so dizzy.

Other Meds:

Current Illness:

ID: 1349761
Sex: M
Age: 77
State: MD

Vax Date: 04/09/2021
Onset Date: 04/10/2021
Rec V Date: 05/26/2021
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: None

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

Symptoms: The morning after his second vaccine, he had the expected body aches, but he also began having diarrhea, which has fluctuated between diarrhea and constipation......back and forth.......ever since. Today is May 26, 2021.

Other Meds: Rivaroxaban 20 mg Tamsulosin HCL 0.4 mg

Current Illness:

ID: 1349762
Sex: F
Age: 43
State: MO

Vax Date: 05/21/2021
Onset Date: 05/21/2021
Rec V Date: 05/26/2021
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: Tetanus shot, Zithromax antibiotics

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

Symptoms: After the first 15 minutes started to feel very dizzy, 30 minutes after the shot depression and darkness came over me and lasted for about 90 minutes, still dizzy and felt like I was drunk plus my shoulder felt tight and heavy. Depression left after 1,5 hours , started to feel manic episode for 5 hours with racing thoughts, restlessness, irritation, anger, and not calm. Still dizzy, had chills. The next day and the day after that felt fatigued and not well, the place of a shot hurt.

Other Meds: Levothyroxine

Current Illness:

ID: 1349763
Sex: M
Age: 30
State: PA

Vax Date: 05/24/2021
Onset Date: 05/25/2021
Rec V Date: 05/26/2021
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: none

Symptom List: Vomiting

Symptoms: Swollen, painful lymph nodes in right armpit

Other Meds: zyrtec

Current Illness: none

ID: 1349764
Sex: F
Age: 47
State: NY

Vax Date: 04/17/2021
Onset Date: 05/05/2021
Rec V Date: 05/26/2021
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: sulfa drugs, mangos

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: beginning about 2.5 weeks after injection site became itchy and a hard amber colored "plug" came out of the site. It was definitely not a scab. The same symptom occurred a second time about a week later.

Other Meds: synthroid, remicade

Current Illness:

ID: 1349765
Sex: F
Age: 59
State: NM

Vax Date: 05/24/2021
Onset Date: 05/26/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies: Penicillin

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

Symptoms: Big red hot itchy tender painful rash on arm spot of injection. A bad headache, nausea and vomiting, chills, aches and pains all over. Feels like flu coming on.

Other Meds: On daily methadone, as needed I take phenergan for nausea, and as needed albuterol inhaler for asthma, Fosomax once a week, Calcium & vitamin D

Current Illness: Just mild seasonal allergies

ID: 1349766
Sex: M
Age: 31
State: TN

Vax Date: 05/25/2021
Onset Date: 05/25/2021
Rec V Date: 05/26/2021
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: Upon receiving the second dose of the COVID-19 vaccine, I immediately felt tingling or chills in the arm where the shot was administered. This developed into muscle soreness as I sat through the waiting period before leaving the facility. (For this reason, I had taken acetaminophen at about 8:30 that morning.) I experienced both of these symptoms after my first shot of this COVID-19 vaccine, so these did not concern me. After taking a nap back at my house, I woke up about 3:30 p.m. experiencing some partial numbness in my left arm, which received the injection. It was not inhibitive, but I can somewhat relate it to the neuropathy my mother experienced before being diagnosed with diabetes in 2005. It was a bit like the tingling I first experienced after the injection, but throughout the injected arm. As I continued through that afternoon and evening, my arm kept getting stiffer and stiffer. This prompted me to take my temperature at about 8 p.m. and then again at 10 p.m. Both of these tests resulted in a normal temperature of 98.3 or 98.4 degrees. By the time I was about to climb into bed at midnight, the stiffness had spread to my shoulder joint -- such that almost any movement of that arm elicited some mild discomfort, especially if I leaned against the wall with that shoulder or raised my arm above my head. I took a third dose of acetaminophen. My normal prone sleeping position was not comfortable with this stiffness, so I did my best to sleep on my back. Next, I woke up too hot about 3:30 a.m. (Wednesday, May 26) and could not get back to sleep. Full-body chills set in soon after, prompting me to turn off my ceiling fan. I faced some mild nausea as I attempted to get comfortable in bed again. I suspected I was feverish by at least 4 a.m., but I did not get up to check my temperature until 5 a.m. The thermometer gave a reading of 100.3 degrees, so I took another dose of acetaminophen (my fourth in 24 hours) and tried to go back to sleep.

Other Meds: acetaminophen

Current Illness:

ID: 1349768
Sex: F
Age: 57
State: MD

Vax Date: 04/03/2021
Onset Date: 04/04/2021
Rec V Date: 05/26/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: I was sick with nausea, vomiting, headache, muscle aches, extreme exhaustion, and feeling extreme hormonal changes like extreme night sweats. Worse than anything I ever had during menopause. I was in bed for 1 week, and feeling sick for 2 weeks. I am still suffering with extreme night sweats almost 2 months later.

Other Meds: None

Current Illness: None

ID: 1349769
Sex: F
Age: 54
State: OH

Vax Date: 01/12/2021
Onset Date: 01/17/2021
Rec V Date: 05/26/2021
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: SHRIMP

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

Symptoms: Vibration (feeling of cell phone vibrating) throughout my entire body, my right jaw has locked and painful, I have a constant headache, eyesight worse (blurry even with glasses), all over constant body throbbing, stomach issues (sharp pains and cramping), constant numbness (the feeling of when you rub your skin when the novocaine is starting to wear off after a dental procedure) from my feet up to my waist and the feeling of pins and needles (like when you hand is asleep) from my feet up to my pelvic area. This all started with just a small vibration in my right hip and has increasing gotten worse over the last several months.

Other Meds: LEVOTHYROXINE GOLI GUMMIES TYLENOL PM

Current Illness: FIBROMYALGIA IBS

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm