VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1530679
Sex: F
Age:
State: CO

Vax Date: 03/10/2021
Onset Date: 03/11/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: severe tachycardia; severe muscle tremor; fatigue; what seems to be a skip in my heart beat.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in arm left on 10Mar2021 09:30 AM (at the age of 66-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in arm left on 17Feb2021 09:30 AM (at the age of 66-year-old) as dose 1, single for COVID-19 immunization. On 11Mar2021, the patient experienced severe tachycardia, severe muscle tremor, fatigue, what seems to be a skip in my heartbeat. Adverse event: 16 hours post 2nd injection experienced severe tachycardia and severe muscle tremor on and off for several hours during the night. There is no history of this occurring. I am experiencing fatigue and what seems to be a skip in my heartbeat. The patient did not receive treatment for the events. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1530680
Sex: F
Age:
State: NM

Vax Date: 03/17/2021
Onset Date: 03/01/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: experienced fast heart beat; little lightheadedness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 17Mar2021 11:30 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Mar2021, the patient experienced fast heartbeat started around 12:50 after the vaccine and stated that she is feeling better now just a little lightheadedness on unspecified date in Mar2021 but other than that she is good and wanted to know what she should do. The patient underwent lab tests and procedures which included heartbeat resulted as experienced fast on 17Mar2021. The clinical outcome of the events was resolving. No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1530681
Sex: F
Age:
State: NJ

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 08/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Experienced fast heart beat within 40 mins after receiving first shot.; This is a spontaneous report from Non-contactable other HCP. A 44-year-old non-pregnant female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ep7534), via an unspecified route of administration on arm left on 15Mar2021 10:30 AM (Age at Vaccination: 44 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included pre-diabetic and had no known allergies. If other vaccine in four weeks and other medications in two weeks was reported as no. If covid prior vaccination and If covid tested post vaccination was reported as no. The patient Concomitant medications were not reported. On 15Mar2021 11:00 AM, the patient experienced fast heart beat within 40 mins after receiving first shot. The treatment received as a result of events was reported as no. The outcome of the event was recovered on an unknown date in Mar2021

Other Meds:

Current Illness:

ID: 1530682
Sex: F
Age:
State: AZ

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: fast heartbeat; Dizziness; Weakness; heart started palpitating; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER2613, Expiration date: Unknown) via an unspecified route of administration, administered in left arm on 16Mar2021 13:30 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No prior vaccinations were given within 4 weeks. Medical history included schizophrenia, blood cholesterol increased, gastrooesophageal reflux disease, calcium deficiency, breast cancer, bone loss, osteopenia, mastectomy. Family medical history was none. Concomitant medications included paliperidone (INVEGA [PALIPERIDONE]) taken for schizophrenia, from unknown start date to 05Mar201; atorvastatin taken for blood cholesterol increased from an unspecified start date and ongoing; famotidine taken for an unspecified indication from 05Mar2021 and ongoing; calcium taken for calcium deficiency from an unspecified start date and ongoing; anastrozole (ARIMIDEX) taken for bone loss, osteopenia, calcium deficiency, start and stop date were not reported. On 16Mar2021 at 15:30, the patient experienced fast heartbeat, dizziness, weakness and heart started palpitating. Patient stated right after the shot her heart started palpitating, fast heartbeat, happened all 16Mar2021 at 15:30 lasted till 5 am of 17Mar2021. Patient stated the fast heartbeat started the same time as heart palpitation, dizziness, and weakness and lasted all the way until about 5 am of 17Mar2021. The events did not result in emergency room or physician office. The patient stated the side effects are almost all gone. The patient underwent lab tests and procedures which included heart rate: fast on 16Mar2021. No treatment was given for the events. The outcome of the events was recovered on 17Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds: INVEGA [PALIPERIDONE]; ATORVASTATIN; FAMOTIDINE; CALCIUM; ARIMIDEX

Current Illness:

ID: 1530683
Sex: M
Age:
State:

Vax Date: 03/07/2021
Onset Date:
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: fast heartbeat; Boredom; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 83-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unspecified route of administration on 07Mar2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Mar2021, the patient experienced following symptoms fast heartbeat, boredom and fatigue. The patient underwent lab tests and procedures which included heart rate: fast on an unknown date. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1530684
Sex: F
Age:
State: KS

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: my heart felt like I had a couple cups of coffee/or taken a huge dose of prednisone/my heart beating like a jackhammer/Heart beating really hard and fast; my heart felt like I had a couple cups of coffee/or taken a huge dose of prednisone/my heart beating like a jackhammer/Heart beating really hard and fast; flushed face (hot and red); flushed face (hot and red); flushed face (hot and red); Anxious/Worried; I'm nervous; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (Patient) reported that a 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EP7534), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 11:00 (Age at vaccination 70 years) as dose 1, single for covid-19 immunisation. Medical history included Covid-19, slight cold and antibodies. The patient's concomitant medications were not reported. The patient previously took prednisone and experienced heart rate increased, prednisone and experienced erythema, prednisone and experienced hot flush. On 17Mar2021, the patient experienced my heart felt like i had a couple cups of coffee/or taken a huge dose of prednisone/my heart beating like a jackhammer/heart beating really hard and fast; flushed face (hot and red) and anxious/worried. The patient underwent lab tests and procedures which included heart rate: really hard and fast on 17Mar2021. Case was not serious. It was reported that Caller (female, age 70 will be 71 next month) stated "I received my first injection Pfizer vaccine. I didn't have a reaction right away. As I was driving home, my heart felt like I had a couple cups of coffee.. or taken a huge dose of prednisone, my heart beating like a jackhammer, flushed face (hot and red). I didn't have nausea and headache. Now it's a little tiny bit, I'm nervous didn't know what to do and will I have another one in 3 weeks. I was worried about my health last night; that's what I'm concerned about. I did have covid in November. I'm surprised I had side effects. It's been 3 and 1/2 months. When I had covid I felt like I had a slight cold. Did that affect it. I'm tired of not having information. I have the antibodies; I wish I hadn't done it (received the vaccine) because nobody knows. It's a very confusing thing. One doctor told me to get it. My other doctor said not to get it. A pharmacist said don't worry about it until later. I was really worried because I didn't know what's happening after, since it was later in the afternoon I had it done at 11 in the morning. If that was normal, if I should have the second vaccine, if I should have gone to the emergency room. Facility name where the vaccine was administered at sport complex. Consumer stated, "I am anxious because of what happened yesterday because when I read what the difference side effects can be nothing like what I experienced was listed and I read the form that they handed me and it said that you have raising heart rate and all that type of thing then that's a severe allergic reaction. So I am concerned as to what was happening and should I, what will happen with my second shot and should I have seen gone to a doctor for assurance something after I have those sever reaction. And that did not happen later in the afternoon but it lastly till after midnight. When confirmed that the heart is racing, consumer stated, "Have you ever taken Prednisone. I am just asking you personally if you ever experienced taking Prednisone because it was I have the same reaction yesterday as I have when I have ever in the past have to take prednisone. Your face gets really hot and red and your heart beats really hard and fast and that's what I had and it did not happen within the 15 minutes that I waited after the shot, it happen later on and it continued till after midnight. The clinical outcome of event anxious/worried and nervous ness was unknown; while other events outcome were recovered on unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1530685
Sex: F
Age:
State:

Vax Date: 03/18/2021
Onset Date: 03/01/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: fast heart rate/Pulse rate increased; headache; muscle aches; chills; joint pain; slight fever; ached all over; This is a spontaneous report from a contactable Nurse (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on 18Mar2021 08:00 as DOE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Patient stated that she received her 2nd dose on 18Mar2021, morning at 8 and didn't develop symptoms until after 5 pm. She had a fast heart rate, headache, muscle aches, chills, joint pain, and a slight fever. When she woke up twice during the night, she ached all over. She was in the 90s for her pulse rate and had a fever too. She drank something, went to bed and woke up again and was bounding. And today her pulse rate was 100-112. It did come down to the 80s. Patient also stated with Moderna's COVID vaccine, they're seeing up to weeks with a rapid pulse and was wondering if Pfizer's COVID vaccine was the same. The patient underwent lab tests and procedures which included heart rate: 90 on Mar2021 (I was in the 90s for my pulse rate), heart rate: 80 on Mar2021(It did come down to the 80s), heart rate: fast on Mar2021, heart rate: 100-112 on 18Mar2021 (today my pulse rate is 100-112). The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021307523 same reporter, different patient/drug/event

Other Meds:

Current Illness:

ID: 1530686
Sex: F
Age:
State: FL

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Fast breathing; lightheaded, dizzy; Disorientation.; Pains in upper and lower torso; Unable to work; This is a spontaneous report from a contactable consumer. This 72-year-old female consumer reported that: A 72-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6207 and Expiry date was not reported), dose 2 via an unspecified route of administration arm left on 19Mar2021 11:45 AM (age at vaccination was 72-year-old) as DOSE 2, single dose for covid-19 immunisation. Medical history included diabetes mellitus and known allergies like red fire ants, caterpillars from an unknown date and unknown if ongoing. The patient received other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient received other vaccine in four weeks was BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6198 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm left on 26Feb2021 as DOSE 1, single dose for covid-19 immunisation. After administration of second dose, on 19Mar2021 12:15 PM patient experienced fast breathing, dizzy, lightheaded, disorientation, Pains in upper and lower torso and she was in 2day of pains, unable to work. No treatment received for the events. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1530687
Sex: F
Age:
State: IA

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Chills; Muscle ache; Headache; achy all over; Fever; lightheaded; Fast heart rate; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204; Expiration Date: Jun2021), via an unspecified route of administration on 17Mar2021 (at the age of 66-year-old), as dose 2, single in left arm for COVID-19 immunization. The patient's medical history included heart racing; last fall was in 2020, after exertion, was checked out and everything came back normal. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On 17Mar2021, after the second dose of vaccine, the patient experienced fast heart race, chills, muscle ache, headache, achy all over, fever and lightheaded. The patient underwent lab tests and procedures which included body temperature: 99-100 degrees on 17Mar2021, heart rate: fast, during night it was 90 on 17Mar2021 and heart rate: 112, morning it was still high, running around 112 on 18Mar2021. The clinical outcome of all the events was reported as not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1530688
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 08/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: brought down to normal people level; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for 4 patients. This report is for 4th of 4 patients. This consumer reported for a female patient (sister). A female patient of an unspecified age received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown single dose for covid-19 immunization. It was reported that While reporting on herself she was mentioned details about her sister when speaking about fatigue. She mentioned with the COVID 19 Vaccine with her and her sister it brought them down to normal people level on an unspecified date. Stated they were way up there anyways. The outcome for the even was reported as unknown at the time of this report. No follow-up attempts are possible. Lot/Batch number cannot be requested. No further information is expected.

Other Meds:

Current Illness:

ID: 1530689
Sex: F
Age:
State:

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: severe heart palpitations; Break out in sweats; Freezing cold; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 at 15:00 (3:00 PM) (at the age of 67-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 12Mar2021 at 04:00 AM, the patient experienced severe heart palpitations, break out in sweats, freezing cold. 67-year-old female patient received Pfizer's COVID vaccine on 11Mar2021 at 3 pm. Patient stated, from 3 to midnight, I had no effects whatsoever, but from 12 am - 4 am, I was not well with heart palpitations. One minute I would break out in sweats and 5 minutes later I would be freezing cold. Since then, I've had no effects. My other shot is 01Apr2021. Patient is asking if it is safe for her to have the second dose. Patient also asking if there are any records of worse reactions after the second dose. The patient is calling about the covid vaccine. The patient had the first vaccine on 11Mar2021 and she had it at 3:00pm and was fine until midnight and then she started having severe heart palpitations, breaking out in sweats then to freezing and it lasted about 4 hours. This happened between midnight at 4:00 am. Since then she has been fine. The patient is scheduled for her second dose on 01Apr2021. Is it safe for her to get her second dose. Is this a reaction from the vaccine. Outcome of the events was recovered on an unspecified date in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1530690
Sex: F
Age:
State: GA

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: wheezing when breathed.; Gestation 26 weeks; This is a spontaneous report from a contactable consumer (patient). A 43-year-old pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot num-ber: EK(orR)8130 7/21), via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 43-year-old) as a dose 1, single for COVID-19 immunisation. Maternal exposure during pregnancy second trimester (26 weeks). The medical history of the patient included renal tubular acidosis, hypertension, gestational diabetes. The patient was allergic to doxycycline, KEFLEX, OM-NICEF, amoxicillin, pollen, mold and animal danders. The patient last menstrual date was reported on 21Sep2020 and delivery date to be 26Jun2021. The concomitant medication of the patient included po-tassium chloride (KLOR-CON), cetirizine (ZYRTEC) and levothyroxine (MANUFACTURER UNKNOWN), labetalol (MANUFACTURER UNKNOWN) and insulin (MANUFACTURER UNKNOWN), all are taken on an unknown date. The patient experienced wheezing an hour and a half after the vaccine on 23Mar2021 at 11:30. Therapeutic measures were taken as a result of wheezing and included treatment with BEN-ADRYL and one puff of inhaler. The patient thinks symptoms were gone by about 20 minutes. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of wheezing was recovering at the time of this report. Follow-up attempts completed. No further information expected.

Other Meds: LABETALOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; INSULIN; LEVOTHYROXINE; KLOR CON

Current Illness:

ID: 1530691
Sex: F
Age:
State: NJ

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Mole surgery for possible skin cancer in the face.; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient) A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that she will be having a procedure (mole surgery) tomorrow (on 19Mar2021) for possible skin cancer in the face. She wanted to know if that is okay or wait after taking her second dose. The first dose was given on 02Mar2021. She was scheduled to have her second dose on 23Mar2021.The outcome of the event was unknown No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1530692
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: red blood cells were low; This is a spontaneous report from a contactable other healthcare professional. This other HCP reported for a female patient (friend). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Caller stated her friend received the second dose of the vaccine and a couple days later her red blood cells were low. The patient underwent lab tests and procedures which included red blood cell count: low on unspecified date. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1530693
Sex: F
Age:
State: CA

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Gas trapped causung tightness in chest.; Gas trapped causung tightness in chest.; Maternal Exposure During Pregnancy, third trimester; This is a spontaneous report from a contactable consumer, the patient. This is a maternal report. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7535), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 13:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took escitalopram (LEXAPRO) 25 mg, on unknown date for unspecified indication and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 13:30, the patient was exposed to vaccine during pregnancy (gestation period of 33 weeks) and last menstrual date was reported as 26Jul2020. On 20Mar2021 at 12:00, the patient experienced trapped gas causing tightness in chest. Therapeutic measures were taken as a result of chest tightness and included treatment with two antacids. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event chest tightness was recovering and of the maternal exposure during pregnancy was unknown at the time of pregnancy. Follow-up (30Jun2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1530694
Sex: M
Age:
State: WI

Vax Date: 03/16/2021
Onset Date: 03/17/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: diarrhea; did not eat for a day other than little bit of Gatorade, patient lost 4.5 pounds; tired and fatigued; felt like 1000 monkeys with baseball bats was beating him; chills; Patient appetite is starting to pick up; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 81-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: ER2613) via an unspecified route of administration, administered in arm right on 16Mar2021 at 12:00 (at the age of 81-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included reaction to penicillin (when he was a baby, he had a reaction to penicillin) and he had flu shots for immunization with no problems. There were no concomitant medications reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EN6200) via an unspecified route of administration, administered in arm right on 23Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines on the same day of vaccination. On 17Mar2021, the consumer stated that, a day and half afterwards he felt like 1000 monkeys with baseball bats were beating him. It started at the base of his neck, on his back to his shoulders and his elbows his back and hips and knees. He also had chills, diarrhea on 18Mar2021 and he didn't eat for a day other than a little bit of Gatorade. He lost about 4.5 pounds on 17Mar2021. He reported that he went to bed on the evening of 16Mar2021 and he was woken at around 1:20 AM, so about 13 hours after he received the vaccine. He tired and kind of fatigued today on 17Mar2021. He reported his appetite was starting to pick up on an unspecified date in 2021. He has had flu shots with no problems. Adverse events following prior vaccinations on the vaccine supplemental form, his mother told him when he was a baby, he had a reaction to penicillin. The adverse events did not require emergency room visit and physician office visit. The patient underwent lab tests and procedures which included weight lost: 4.5 lbs on 17Mar2021. The outcome of the events felt like 1000 monkeys with baseball bats was beating him, chills was recovered on 18Mar2021, diarrhea, tired and fatigued was not recovered, did not eat for a day other than little bit of Gatorade, patient lost 4.5 pounds, patient appetite is starting to pick up was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1530695
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/06/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: heart was racing and pounding and her breathing was labored; She decided to go to bed as she wasn't feeling well; but was unable to sleep well that night as she kept waking up every 2 hours; heavy breathing; got "achy"; This is a spontaneous report from a contactable consumer (patient) received from a initiative; CEP 159558. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Enquired, caller received the first Pfizer covid vaccination in the morning and that night about 8 PM experienced side effects, after first dose her heart was racing and pounding and her breathing was labored. She decided to go to bed as she wasn't feeling well but was unable to sleep well that night and got achy as she kept waking up every 2 hours. These symptoms subsided on their own, without intervention. The caller was scheduled to receive her second dose tomorrow but was worried about these side effects happening again and being more pronounced as this will be the second dose. The caller wanted to know whether the side effects would be worse in the second shot. Stated that, she heard that people have worse side effects after the second dose. The caller stated that, her physician had the Moderna COVID vaccine (she was fairly sure as this was the only one her family physician's office was offering) and couldn't sleep the night after he received it. She wanted guidance from Pfizer as to whether she should receive the second dose and when she needed to seek medical attention if the side effects occur again. Any unaddressed medical questions referred or forwarded to Medical Information was reported as yes. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1530696
Sex: M
Age:
State: MS

Vax Date: 03/19/2021
Onset Date: 03/01/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Costal chrondritis; Atelectasis; Dyspnea; Her husband has partially collapsed lungs.; This is a spontaneous report from contactable consumer (patient) reported for himself. A 43-year-old male patient received second dose of bnt162b2 (Pfizer/BioNTech Covid-19 vaccine, Solution for injection, Lot/ Batch number: en6204), via an unspecified route in the left arm on 19Mar2021 (age at vaccination: 43-year-old) at 12:15, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer/BioNTech Covid-19 vaccine, Solution for injection, Lot/ Batch number: el9267) via an unspecified route in the left arm on 26Feb2021 at 12:15, as a single dose for covid-19 immunization. There were no reported allergies to medications, food, or other products. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not receive any other medications within two weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 20Mar2021 at 12:00, after getting the 2nd dose, patient experienced costal chrondritis, atelectasis and dyspnea. Adverse events resulted in doctor or other healthcare professional office/clinic visit. On an unknown date in Mar2021, patient had partially collapsed lungs. It was unknown if patient received any treatment for adverse events. The clinical outcome of partially collapsed lungs was unknown and costal chrondritis, atelectasis and dyspnea was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1530697
Sex: F
Age:
State: CO

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Sore arm; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable consumer (Patient). This consumer or other non hcp reported information for both mother and fetus/baby. This is a {enter maternal or fetus/baby} report. A 35-years-old female Pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number EN6208), via an unspecified route of administration on 22Mar2021 at 14:30 (at the age of 35-years-old) into left arm as a single dose for COVID-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing Gestation period: 18 weeks. The patient's concomitant medications were not reported. The patient previously took morphine and experienced allergies. 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 has not been tested for COVID-19. The patient had allergies to food, or other products. On 22Mar2021 at 14:30, The patient was Pregnant at the time of vaccination. On 22Mar2021 at 15:30, the patient experienced sore arm. The mother was 18 Weeks pregnant at the onset of the event. The mother was due to deliver on 23Aug2021. No treatment medication was given for sore arm. The outcome of the event was recovering for sore arm and unknown for another event.

Other Meds:

Current Illness:

ID: 1530698
Sex: F
Age:
State: GA

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rapid heartbeat; dizziness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient herself). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 19Mar2021 09:00 (at the age 35-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included ongoing Allergy to Amoxicillin from an unknown date in Jan 2015- She had not officially been diagnosed, but she was prescribed it at that time and had been taking it for several days. She broke out in a rash all over her body and had dryness or tightness in her throat. Her doctor said it sounded like she was having an allergic reaction and to stop taking it. No NDC/lot/expiry was reported for Amoxicillin. She was also breastfeeding. The patient concomitant medications were not reported. Family Medical History Relevant to AE(s) included as her mother also got the vaccine on Wednesday and she had the same reaction of rapid heart and dizziness on Wed 24 2021. The patient Prior Vaccinations within 4 weeks was reported as none and no AE(s) following prior vaccinations. No previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines administered on Same Date of the Pfizer Suspect. It was reported that Patient received her 1st dose of the Pfizer COVID19 Vaccine on 19Mar2021 and experienced a couple side effects. After vaccination on 19Mar2021, during 15 minutes observation window, she experienced rapid heart-beat and dizziness and these symptoms seemed to have faded by time the 15 minute observation window was up. AE did not cause to visit Emergency Room or Physician Office. No Investigation Assessment was reported. She was looking back on the sheet and those symptoms are listed as a severe allergic reaction according to the fact sheet that was given before getting the injection and asked to confirm if it was safe for her to get the second dose. Relevant tests were none. Seriousness was reported as No. The outcome of both events was recovered on 19Mar2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021336494 Same reporter/drug/event, different patient.;US-PFIZER INC-2021351470 same drug/reporter, different patient.

Other Meds:

Current Illness: Drug allergy (hives, dryness in the throat, and slight difficulty of breathing about into a week of her regimen.)

ID: 1530699
Sex: F
Age:
State: NJ

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: experienced heart palpitation and red rash after her 1st dose; experienced heart palpitation and red rash after her 1st dose; This is a spontaneous report from a Pfizer Sponsored Program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown, Expiration date: unknown), via unspecified route of administration, on 05Mar2021, as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Mar2021, the patient experienced heart palpitation and red rash. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1530700
Sex: F
Age:
State: CA

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: tachycardia; chest felt heavy; This is a spontaneous report from a contactable Physician via Medical Information Team. A 51-years-old female physician (patient) reported for herself and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6204, Expiry date and NDC number were unknown) via intramuscular route in right arm on 11Mar2021 at 18:15 (at the age of 51-years-old) as dose 1, single for Covid-19 immunisation. The patient medical history included sinus tachycardia From Unspecified date to ongoing, had for years and she had COVID-19 on unknown date in Jul2021. The patient concomitant drugs included ongoing Bisoprolol (MANUFACTURER UNKNOWN, has taken for years, strength 5mg tablets), she takes 2.5 mg daily for Sinus tachycardia and immune support vitamins (MANUFACTURER UNKNOWN) from unspecified date for unknown indication. The patient did not have history of any previous allergies to specific products or any conditions indicative of an allergy. The patient called about the COVID 19 vaccine. She received her first dose of the COVID-19 vaccine on 11Mar2021 at a local (pharmacy name), She didn't realize she had had an allergic reaction classified as severe until the (pharmacy name) sent her a questionnaire regarding her upcoming second COVID-19 vaccine. About 24 hours after she received the COVID-19 vaccine she experienced tachycardia at 145bpm on 12Mar2021 at 18:00, she has a Fitbit watch, so she was able to see her heartrate, while probing for specific event details she reports her Fitbit watch was vibrating with her heartrate and her chest felt heavy (on 12Mar2021). She doubled the dose of her medication and while she was sleeping her heartrate was around 105-109 beats per minute. She kept her Fitbit watch on at night and monitored her heartrate throughout the night. With rest her heartrate returned to a normal range, she doubled her dose of her regular medication to override that extreme heart rate, she wanted to know what was being recommended on getting the second COVID-19 vaccine. She was on the fence about getting that second COVID-19 vaccine, but she knows the benefits of getting it, she doesn't know what other side effects getting the second COVID-19 vaccine may cause. The tachycardia started around 6:00PM on 12Mar2021, around dinner time. Her heartrate went up quickly, like she was just sitting, and her heartrate ramped up instantly. She immediately took her medication and her heartrate started coming down. She has a portable EKG machine at her house, and it showed sinus tachycardia, nothing else going on, she also has a blood pressure cuff to check her blood pressure and heart rhythm, she states if you label yourself as having a severe reaction you will be unable to get the second COVID-19 vaccine. The tachycardia was listed under severe reactions. The patient did not visit emergency room, physician office, intensive care unit, did not require medical intervention, was not hospitalized. The patient did not receive Vaccine at Military Facility, had no history of all previous immunization with the Pfizer vaccine considered as suspect. Laboratory details included heart rate at 145 bpm and went up quickly on 12Mar2021. The patient did not take Prior Vaccinations (within 4 weeks) or had AE(s) following prior vaccinations, did not receive any recent vaccines for any other conditions prior to the event being reported. The outcome of the events was resolved on 13Mar2021. Relatedness of drug to reaction(s)/event(s): Reaction assessed: tachycardia, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection. Drug result: Related. Relatedness of drug to reaction(s)/event(s): Reaction assessed: chest felt heavy, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related. Verbatim event relatedness: COVID-19 Vaccine: tachycardia-Related, COVID-19 Vaccine: chest felt heavy-Related.

Other Meds: BISOPROLOL

Current Illness: Sinus tachycardia (Verbatim: sinus tachycardia, Had for years)

ID: 1530701
Sex: F
Age:
State: CT

Vax Date: 03/25/2021
Onset Date: 03/27/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Woke up 3/27 left ear feels clogged hard to hear; Woke up 3/27 left ear feels clogged hard to hear; Woke up 3am heart racing; This is a spontaneous report from a contactable Nurse (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: En6199) via unknown route of administration on 25Mar2021 01:15 PM (age at vaccination 52-year-old) as dose 2 single in left arm for COVID-19 immunization at Other. Medical history included migraine and COVID-19. Allergies to medications, food, or other products included Sulfa allergy. Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included ascorbic acid (VIT C), ergocalciferol (VIT D) and montelukast sodium (SINGULAIR). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient woke up 3am heart racing on 27Mar2021 03:00 AM and Woke up 3/27 left ear feels clogged hard to hear on 27Mar2021 04:30. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown whether patient received treatment received for the adverse events. The outcome of event heart racing was recovered in 2021, while for others was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: VIT C; VIT D; SINGULAIR

Current Illness:

ID: 1530702
Sex: M
Age:
State: CA

Vax Date: 03/02/2021
Onset Date: 03/03/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: low red blood cells; Bleeding from his nose; This is a spontaneous report from a contactable (patient's daughter). An 86-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration, administered in left arm on 02Mar2021 at 13:00 (at the age of 86-year-old) as a single for COVID-19 immunisation. Medical history included diabetes mellitus from 2012 and ongoing Verbatim: Diabetes, ongoing hypertension Verbatim: Blood pressure high, hypersensitivity from an unknown date and unknown if ongoing Verbatim: Allergy, atrial fibrillation from 2009 to an unknown date Verbatim: Atrial fibrillation, blood cholesterol increased from an unknown date and unknown if ongoing Verbatim: High cholesterol, prophylaxis from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing. Concomitant medications included rivaroxaban (RIVAROXABAN) taken for prophylaxis, start and stop date were not reported; metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; lovastatin (LOVASTATIN) taken for hypertension, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for seasonal allergy, start and stop date were not reported. Historical vaccine given to patient previously bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration, administered in left arm on 09Feb2021 at 14:00 (at the age of 86-year-old) as a single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No vaccine administered at military facility. No additional vaccines administered on same date of the pfizer suspect. On 03Mar2021, the patient experienced bleeding from his nose, On 05Mar2021, low red blood cells. It was reported that consumer stated her dad was fine with his first vaccine but after his second vaccine, her dad started having nose bleeds. Consumer stated her dad received his first Pfizer vaccine on 09Feb2021 and his second Pfizer vaccine on 02Mar2021. While obtaining patient details caller stated she is not sure of her dad's weight. Consumer stated on day 2, clarified as 03Mar2021, after her dad received his second vaccine, he started bleeding from his nose a lot, on the left side of his nose. There were consecutive days where her father was bleeding a lot, the blood was all over his clothing. The nose bleeds were heavy and strong from 03Mar2021 to 05Mar2021. Those three days the bleeding was horrible. On 05Mar2021, the nosebleed was so strong and heavy, she took her dad to the emergency room. Caller stated her dad was in the emergency room for 8 to 9 hours and then discharged home. Caller checked with dad's doctor, (name withheld) who instructed him to stop his blood thinner for 3 days, the medication to prevent strokes. The bleeding has not stopped. She clarifies her dad does still have nose bleeds but not as much or as heavy. Consumer says it's been 3-4 weeks and she was wondering and had concerns about his bleeding. Consumer asked if anyone else has reported nose bleeds. Concomitant products: When probed for the name of the blood thinner, she mentions her father is not given the brand Xarelto, it was the generic, Rivaroxaban. Consumer states before it was Coumadin and then the name was changed. Caller confirms her father takes a cholesterol medication, but she does not know which one because they keep changing the medication. Her father has seasonal allergies and takes an allergy medication. She clarifies her father takes Zyrtec sometimes, but sometimes they change the name. Sometimes, it's like a spray in his nose. Recently, when her father went to the doctor, he was prescribed an allergy medication that was a pill, but she can't remember the name of it. Her father told her the medication made him drowsy/sleepy so after 3 days he stopped it. Caller confirms he is not using the nasal spray because of the bleeding from his nose. Consumer was probed for Lot/expiry dates for the concomitant products listed, but this information was not known by the caller. Treatment: He was instructed by his primary physician, PRIVACY to use Vaseline for his nose to help stop the bleeding. Also, cold water or ice on his head has helped a lot. Investigations: Consumer stated dad had a blood test and an MRI of the brain while in the emergency room. Caller stated the MRI of the brain was normal. Caller stated the blood test showed no anaemia but low red blood cells, she stated probably for the nose bleeds. Adverse event required a visit to Emergency Room. Consumer stated her dad was in the emergency room for 8-9 hours and then discharged home. Adverse event required a visit to physician office. Therapeutic measures were taken as a result of bleeding from his nose (epistaxis). The patient underwent lab tests and procedures which included blood test: red blood count was low on Red blood count was low, magnetic resonance imaging head: normal on Normal. The outcome of the event bleeding from his nose was resolving and outcome of the other event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: RIVAROXABAN; METFORMIN; LOVASTATIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness: Blood pressure high (Verbatim: Blood pressure high); Diabetes (Verbatim: Diabetes)

ID: 1530703
Sex: F
Age:
State: KS

Vax Date: 03/08/2021
Onset Date: 03/01/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: heart rate wasn't normal; At night feels like she is baking in an oven /Back of neck becomes hot /body overheating; skin flushing in heat /Face became flushed and hot; transient tachycardia; This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 19:00 (Batch/Lot Number: EN6206) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included general health and wellness, like a vitamin supplement from an unknown date and unknown if ongoing. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) (She started it about 2 months ago. She stopped taking it a day or two after she got the vaccine) taken for general health and wellness, like a vitamin supplement, start and stop date were not reported; vitamin d [vitamin d NOS] (VITAMIN D [VITAMIN D NOS]) (She started it about 2 months ago. She stopped taking it a day or two after she got the vaccine) taken for general health, start and stop date were not reported; curcuma longa (TURMERIC [CURCUMA LONGA]) (She started it about 2 months ago. It is a proprietary complex and says 727 mg. She stopped taking it a day or two after she got the vaccine), taken for general health and wellness, like a vitamin supplement start and stop date were not reported. On 08Mar2021 19:30 caller stated she got the vaccine 3 weeks ago today on 08Mar2021. Since then, she has been having transient tachycardia and skin flushing in heat, at night especially. She stated her skin is hot but not to the touch, she just feels hot. She wanted on some information on if she should proceed with the second vaccine. She is supposed to get the second one today. She asked if she waited and got it at 4 weeks if that would be okay. She stated the person administering it said you can get it within 4 days of the 3 weeks. She asked if that was true. Caller received the first dose of the covid vaccine on 08Mar2021, and there have been some strange things since then. 30 minutes after the vaccine her face became flushed and hot. Since then, at night, she feels like she is baking in an oven. The back of her neck becomes hot. When she is under the covers she can't cool off. She has also experienced transient tachycardia. She is supposed to receive the second dose today. She saw a physician and a cardiologist. She is looking for guidance on if she should get the second dose of the vaccine. She asks if anyone else has reported these symptoms. She overheats in the night and gets really hot. It is improving. It goes from her neck, head, and face, and goes to her whole body when she is under the covers. She got to a point the week after the vaccine where she felt like she was in an oven. She never had a fever. She was seen for tachycardia at the doctor on Tuesday the 23rd. She isn't sure when it started, the week of the 14th, about a week before that. Her biggest complaint was the heat thing. She occasionally has it, but it has improved. It was pretty bad last Monday when she saw the physician. Adverse Events Face flushed, body overheating, transient tachycardia. Time of Onset the face flushing started about 30 minutes after she got the vaccine, about 7:30. The body overheating started about 10 pm, it started that evening of the 8th. She couldn't be sure when she noticed the transient tachycardia re-turn, it was that week or the week after. It happened after her vaccine on the 8th, then resolved, then became transient. The adverse event result in doctor or other healthcare professional office/clinic vis-it. She was seen at the physician last week after all the symptoms started. They did blood work and an EKG and nothing was abnormal, just her heart rate wasn't normal. They prescribed corag, but she hasn't taken it. Her physician prescribed it then she saw the cardiologist and they said she didn't need it. There isn't much information out there. Her cardiologist said he had seen people who had the same symptoms, but he's the only one who has said that. On an unspecified dare patient underwent lab tests and procedures which included blood test: nothing was abnormal; electrocardiogram: nothing was abnormal; heart rate: wasn't normal. The outcome of the event heart rate wasn't normal was un-known and outcome for other events was recovering. No follow up attempts are possible. No further information is expected.

Other Meds: VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; TURMERIC [CURCUMA LONGA]

Current Illness:

ID: 1530704
Sex: F
Age:
State: WI

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: racing and irregular heart rate/irregular heartbeat; dizziness; vomiting; locked jaw and internal ear pain also sensitive to touch; locked jaw and internal ear pain also sensitive to touch; locked jaw and internal ear pain also sensitive to touch; painful pressure in head (sensitive to touch)/severe pressure in her head/Feels like her head will explode; very severe headache/pain at the top of the head; wakes her up in the night; This is a spontaneous report from a non-contactable consumer or other non hcp. A 49-year-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL1283) via an unspecified route of administration in Arm Right on 05Feb2021 16:30 (age at vaccination was 49-year-old) as dose 1, single for COVID-19 immunization (at doctor's office). Patient was not pregnant at the time of vaccination. Patient didn't receive other vaccines within 4weeks prior to vaccination, patient received other medications rizatriptan within 2weeks prior to vaccination. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medications included rizatriptan (RIZATRIPTAN) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies, patient was not diagnosed with covid prior to vaccination, patient was not tested for covid to post vaccination. On 05Feb2021 16:30 the patient experienced racing and irregular heart rate/irregular heartbeat, dizziness, vomiting, locked jaw and internal ear pain also sensitive to touch, locked jaw and internal ear pain also sensitive to touch, locked jaw and internal ear pain also sensitive to touch, racing and irregular heart rate, painful pressure in head /severe pressure in her head/feels like her head will explode, very severe headache/pain at the top of the head, wakes her up in the night. Patient had physician office visits for the events. No therapeutic measures were taken for the events but labs ordered a heart monitor and used a heart monitor. The events were non-serious (not resulted in death, not life threatening, no hospitalization required or prolonged, no Disabling/Incapacitating and no Congenital anomaly/birth defect was reported). The outcome of the events heart rate irregular, dizziness, vomiting, trismus, ear pain, hyperaesthesia, heart rate increased, sensitive to touch, head discomfort, headache, middle insomnia was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: RIZATRIPTAN

Current Illness:

ID: 1530705
Sex: F
Age:
State: NC

Vax Date: 03/22/2021
Onset Date: 03/01/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Fast heart rate; This is a spontaneous report received from a contactable consumer (Patient) via Pfizer sponsored program COVAX US support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 22Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date in Mar2021, the patient experienced fast heart rate. She got her 1st dose of the vaccine on 22Mar2021. She called about the side effects of the vaccine. She said she experienced a fast heart rate after getting the 1st dose of the vaccine. The outcome of event was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1530706
Sex: M
Age:
State: LA

Vax Date: 03/20/2021
Onset Date: 03/01/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: When I go to sleep I can feel my fast heartbeat; Dizzy; Sore mouth; I have been feeling that my scalp is on flame and it too hot; heart palpitations/palpitations of heart/When I go to sleep I can feel my fast heartbeat; pain and soreness in his left armpit/arm/Soreness in the right arm/Pain under my left arm and my left side; Aches and pain to the right arm and all over his whole body; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 64-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot: ER8727), via an unspecified route of administration, administered in arm right on 20Mar2021 11:00 as dose 1, single for COVID-19 immunization. Medical history included allergies to sulfa (highly allergic to bactrim- causes blisters) and penicilin (rashes) and palpitations from an unknown date and unknown if ongoing. Concomitant medications included azithromycin (AZITHROMYCIN) taken for bacterial infection from 18Mar2021 to 24Mar2021, dosage: 250mg tablet, 2 tablets on day 1, then 1 tablet by mouth once a day after that for total of 6 days taken for had cuts in arm and not healing kind of red around cut doctor prescribed. The patient previously took flu for antiviral prophylaxis, bactrim and experienced allergies, bactrim and experienced blister, penicilline and experienced rash. On 20Mar2021, the patient experienced heart palpitations/palpitations of heart/when i go to sleep i can feel my fast heartbeat, pain and soreness in his left armpit/arm/soreness in the right arm/pain under my left arm and my left side. On an unspecified date, experienced when i go to sleep i can feel my fast heartbeat (heart rate increased), dizzy, sore mouth, i have been feeling that my scalp is on flame and it too hot. On an unknown date in Mar2021, experienced aches and pain to the right arm and all over his whole body. Caller was a 64y/o male who received his first dose of Pfizer-Biontech Covid19 vaccine 20Mar2021. He has since experienced heart palpitations (starting the day after vaccination), pain and soreness in his left armpit/arm, even though he was given the vaccine in his "right shoulder". He wants to know if these symptoms have been reported, before, and how long they might last? Should he get his second dose? Patient reported that he originally developed palpitations following a vein procedure in his right leg that was performed 9 months ago. The palpitations continued for 6 months, and he had not had them for 3 months, they are now recurring after receiving his first Covid19 vaccine. He also reports a pain in his heel after the vein procedure. Just filed a report about the Pfizer Biontech Covid19 vaccine- The day after experienced soreness in the right arm- next morning had heart palpitations. Soreness in my left armpit- have not gotten no better or worse. pain and palpitations, worse at night time. Had palpitation before and everything surgery on my veins in my right leg. The day of the surgery it caused the palpitations to happen. Finally went away about the 3 months. (palpitations lasted for like 6 months before it went away). No symptoms from the flu shot. Ingredients-anything like sulfa-highly allergic to bactrim and penicillin- rashes. Bactrim-blisters. Patient was asking that should I take the second dose? He has a history of being highly allergic to sulfa drugs, specifically stating that "bactrim gives me blisters. He has an allergy to penicillin, stating his reaction as a rash. He wanted to know if there were bad batches of the vaccine, since he was asked for the lot number during his report. Patient stated that he was calling about the COVID 19 vaccine and had got his first shot and experienced the usual deal of feeling dizzy and soreness in right arm. He stated later that night and earlier next morning when he woke up early that next morning after getting the vaccine he experienced palpitations of the heart which he had a long time ago maybe 2 or 3 months ago and that had started back all over again. He also had soreness under his left arm and upper left side by his upper left arm and is still experiencing this pain and soreness in his left armpit and upper left side by his upper left arm. Dizzy: He stated right after he received the vaccine as he was just a little dizzy. He stated this started a few hours after receiving the vaccine but then clarified event stopped an hour or two after the shot same date, recovered completely; but it was just a little dizziness not bad. Soreness in right arm: He stated he had soreness in his right arm right after the shot since he got the vaccine in his right arm. He stated this stopped the day after the injection. He stated as far as the shot soreness he has recovered completely but has other aches and pain to the right arm and all over his whole body. Palpitations of heart: He stated this started after the vaccine that night of 20Mar2021 into the next morning 21Mar2021 while sleeping early early morning woke up with palpitations of his heart. He stated this is still going on every time he goes to sleep and wakes up early in the morning he experiences this. He stated this has stayed about the same. Soreness under left arm and upper left side by his left arm: He stated this started that next morning when he woke after getting the vaccine and is still ongoing. He stated it is the same as when he first noticed it. Aches and pain to the right arm and all over his whole body: He stated this was not because of shot since he had body aches previously before the vaccine. He stated after the vaccine it has intensified it a little bit and is more sore. He stated he had back troubles and everything before the shot but the vaccine made it increased a little bit and he feels like his back hurts a little bit more than it used to be he guesses after the shot which has made it intensified the pain that he had before. He stated this started 2 or 3 days after the shot, so onset around 22Mar2021 or 23Mar2021 and is ongoing as he feels like it is more painful than usual but the pain is not unbearable pain but it is just more intensified than he usually has. Caller stated this is about the same as when it started around 22Mar2021 or 23Mar2021. He stated just kind of soreness and palpitation as he has had palpitations long time ago which went away and the last time he had the palpitations before was about 3 months ago when they finally went away. He stated he guesses the palpitations occurred again since he had got rid of them and the palpitations came back again. He stated the soreness of the arm he has never had that before and is having that now. Concomitant Products: Caller reported not really, he told the other agent that when he went to get the first dose of the COVID 19 vaccine he told the person giving him the shot that he was on antibiotic Azithromycin tablet and had started taking this medication 2 days before the injection and that is was a 6 day supply where he took 2 tablets the first day and then 1 tablet daily until he finished the medication. He stated he asked the person administering the vaccine if it was ok and the person administering the vaccine told the caller yes it was alright and gave him the information to make sure. He stated the only other vaccine he has had was the flu shot back in December and had no adverse events at all, not even soreness. Medical information request:Caller stated he wanted the telephone number to see if it was ok to get the second shot and to see about the conditions since he did not get an email? He stated, I got the Pfizer first vaccine COVID-19 on 20Mar2021 and I tried calling you guys but never could. I had lot of reactions to this vaccine. The first one when I got the vaccine was you know I felt little dizzy and my mouth was sore, but that night when I woke up the next morning, I had palpitations in the heart and I am still having the palpitations. I am having like soreness and pain under my left arm and my left side since first night after the shot. I was like what do I get to solve this. The next morning, I have been feeling that my s

Other Meds: AZITHROMYCIN

Current Illness:

ID: 1530707
Sex: M
Age:
State: NY

Vax Date: 03/24/2021
Onset Date: 03/26/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: He explained he then gets "dizzy when [he] gets up and when [he] moves too fast."/ Dizziness; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration on 24Mar2021(age at vaccination 35-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that Pfizer vaccine that he got 24Mar, he confirms the COVID 19 vaccine. He stated that on 26Mar2021 (2 days after) he got the shot, he got dizzy whenever he gets up or sits down and Dizziness was reported as worsened. caller wanted to know if there was anything, he should do about it because it has been 8 days already. He wanted to speak with someone in medical information because he was supposed to get the other shot and he does not know what to do about that. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1530708
Sex: F
Age:
State: VA

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Heart pounding; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8732), via an unspecified route of administration in left arm on 25Mar2021 at 16:30 (at the age of 54-year-old) as dose 1, single for covid-19 immunisation in clinic. Medical history included left bundle branch block from 2017 and ongoing (She was diagnosed in either 2017 or 2018. She clarifies that she was diagnosed in 2017), acid reflux from an unknown date and unknown if ongoing, heart Condition from 2018 to an unknown date. Concomitant medications included omeprazole taken for acid reflux taking for about three and a half years and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that she was called about the first dose of the Pfizer COVID vaccine. She has been tried to call this number. She has also been trying to call the place that she received the first dose of the COVID vaccine and has not gotten a return phone call. She has been on hold for forever. She received her first dose of the covid vaccine on 25Mar2021. That same night, her heart was racing for four hours, and pumping very hard. She does not know if she should get the second dose of the covid vaccine. She was supposed to get it on 15Apr2021. She was worried that her heart may do this again because it was pretty severe. She was asking if she does not get the second dose of the COVID vaccine on 15Apr2021, because she needs to wait, how was that going to effect her. She was asked does it cancel it out or will she have to start over. She does not have a primary care physician. She states she should have gone to the doctor. Her heart was racing for four hours and pumping very hard. She received the first dose of the covid vaccine about 4:30PM. Her heart started pumping about 10:00PM. Her heart started pumping really hard about 10:30PM, it was beating really hard. She guesses that it was a little after 2:00AM that her heart started to go back to normal. She was terrified if it was part of that or what it could be. "She was diagnosed with a heart condition in 2018. She only has to take a medication for acid reflux. She does not have to take anything else; she was healthy. The outcome of the event was resolved on 26Mar2021. No follow-up attempts are possible. No further information is expected. Follow-up (02Apr2021): This follow-up contains no new medically significant information.

Other Meds: OMEPRAZOLE

Current Illness: Left bundle branch block (She was diagnosed in either 2017 or 2018. She clarifies that she was diagnosed in 2017)

ID: 1530709
Sex: F
Age:
State: CA

Vax Date: 03/10/2021
Onset Date: 03/01/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: fast heart rate/it has been high every day; fast heart rate/it has been high every day; heart palpitations; This is a spontaneous report from a contactable consumer other non-health professional (Patient). A female patient unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number, Expiry date: Unknown), via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunisation. The patients medical history was high blood pressure since Jan2021 and got a machine to keep track of it and noticed in Feb2021 it was up 5-6 times. Fast heartbeat since Feb2021, prior to vaccine. The concomitant medications were not reported. On unspecified date in Mar2021, patient experienced fast heart rate/it has been high every day, heart palpitations. The patient stated that she was about to go for her second shot today at 9AM and she was leaving in half an hour, that she was reading about the side effects that could happen with the Pfizer vaccine, stated she has a fast heartbeat, up to 94 to 100s, stated that she was trying to deal with it with her doctor, she has had a fast heart beat since Feb2021, prior to vaccine, she had it a few times like 5-6 times in Feb, states she got the first shot on 10Mar2021 form 15Mar2021-23Mar2021 it was high about 4 times, and since 24Mar2021 it has been high every day 86, 106, 94, today it was 88. Stated one or two times it palpitated so much that it was hard to sleep, felt like it was going to beat out of her pajamas. Patient was wondering if it was connected to the vaccine. Patient wanted to know if she should get the vaccine and needs an answer within 20 minutes. Patient declined report, states she does not have time because she has to get to the appointment for her second dose and has to level low in 20 minutes. The report was not related to a study or programme. The outcome of the events was Unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Heart rate high (States she has had a fast heart beat since Feb2021, prior to vaccine)

ID: 1530710
Sex: F
Age:
State: TX

Vax Date: 03/06/2021
Onset Date: 03/09/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: flu symptoms; fever for 7 days; tingling and pins & needles in my hands; dull crushing feeling in arms; hot burning sensation in hands up to shoulders; nervous system reaction; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 06Mar2021 as dose 1, single for COVID-19 immunisation. The medical history included asthma and minor heart arrhythmia. The concomitant medications of the patient were not reported. On 09Mar2021, the patient experienced tingling and pins & needles in my hands, dull crushing feeling in arms, hot burning sensation in hands up to shoulders, nervous system reaction 3 days after the vaccination and the patient experienced flu symptoms after 7 days, fever for 7 days on an unspecified date. The patient reported she had vaccine dose 1 on 06Mar and had a bad reaction to it. In addition to having flu symptoms (for much longer than she heard others experience them, ie, fever for 7 days she had to take antibiotics for she also had nervous system reaction primarily in her hands and arms. That was still going on. It began 3 days after her shot, with tingling and pins & needles in her hands, dull crushing feeling in arms and hot burning sensation in hands up to shoulders both arms. She stated could she get the second dose and wanted to know more information about the adverse event that she experienced. She said she had seen reports about a similar experience to what she had. Their doctors had recommended to not take the second dose of the vaccine. She also has spoken with someone in the FDA and they had advised her to not take the second dose of the vaccine since the adverse events after the second dose are generally worse. She also said that according to VAERS, there are 30,000 cases of her experience with the Pfizer and Moderna COVID-19 vaccine. Her arms just felt like they were being simultaneously crushed, burned, and stabbed. It was so strange, and persistent. After a few weeks it subsided so she would only have a flare up every day, or maybe a couple times a day. she made a VAERS report. She also called the FDA and talked to a virologist she advised her not to take second dose as she said her nervous system reaction would be stronger the second time. Could they weigh in with their opinion. What was the max efficacy she looking at with only one dose. No other important information available. The health authority was notified. The enquiry did not involve a report of exposure during pregnancy. Therapeutic measures were taken as a result of fever for 7 days she took the antibiotics. The outcome of the events nervous system reaction, hot burning sensation in hands up to shoulders, dull crushing feeling in arms, tingling and pins & needles in my hands was reported as not resolved ands the patient recovered from fever for 7 days, flu symptoms on an unspecified date. Follow up (03Apr2021): This is a follow up spontaneous report based on information received by Pfizer from LP-BioNTech (report number 35-6969). This consumer reported for herself that includes: New information received. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1530711
Sex: F
Age:
State: OH

Vax Date: 03/23/2021
Onset Date: 03/01/2021
Rec V Date: 08/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: dizziness; Bad headache; blood pressure was rising; mouth started tingling/tongue started tingling; tingling in her chest; chest got some tightness/ her chest was getting tight; tingling in her lips; This is a spontaneous report from a contactable consumer (Patient). A 55-Year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, dose 2 intramuscular, administered in Arm Right on 23Mar2021 17:00 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) (at the age of 55-years-old) as DOSE 2, SINGLE for covid-19 immunisation . The patient medical history included blood pressure, heart flutter and COVID in Nov2021.The concomitant medications included LOSARTAN from 2020 and ongoing taken for Blood pressure and VERAPAMIL for Heart flutter. The patient had received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6201), via an unspecified route of administration on 02Mar2021 at 16:00(at the age of 55-years-old) into left arm as a single dose for COVID-19 immunization at hospital. In Mar2021, the patient experienced tingling in her lips. On 23Mar2021, the patient mouth tongue started tingling, mouth started tingling, tingling in her chest, chest got some tightness/ her chest was getting tight, blood pressure was rising. On 24Mar2021, the patient experienced bad headache. On 26Mar2021, the patient experienced dizziness. she had the second COVID shot on 23 MAR 2021 and after she received the second COVID shot, her tongue started tingling, her mouth started tingling, and five minutes after, she had tingling in her chest. Her chest got some tightness and this was after she received it. she went to a nurse that was nearby and she had given her some water and told her to take some deep breaths. she did and it started going away but since then from 23 MAR 2021 and up until 26 MAR 2021, her blood pressure was rising and her blood pressure on Friday, she had caller her doctor, because it was 167/90, and just kept rising in the morning. Then in the afternoon it was 162/103 in her right arm, and then the other arm was 167/105 and then later at 420PM, she called the doctor back, it was 170/103, and her chest was getting tight with that. Caller states her pulse was 106 and they told her to go straight to the emergency room. Caller states when she got to the emergency room, her blood pressure was 182/102 and then when she went straight back to the room, they checked her again and her vitals were 168/112. They did blood work, a chest x-ray, and an EKG. Caller states everything was normal on her except her blood pressure and that the blood pressure is a result of this COVID Vaccine and that's what they are telling her. Caller states she had to up her blood pressure medicine until this relieves, even the next day her blood pressure was up. Caller states it wasn't as high as it was in the emergency room, but she has to take an extra 1/2 tablet for a few days of her blood pressure medicine because of this. Caller states her worry is that they couldn't give her any medicine in the emergency room because they were thinking that the blood pressure would go back down and she would probably plummet. Caller states they didn't keep her in the emergency room, they told her to go home and take her blood pressure medicine and go to the doctor on Monday. Caller states she did and now they are telling her it's all a result of the COVID vaccine. Caller states is there anyway she can get help paying for the emergency room payment, Caller states it is over $1200 and she doesn't want the same thing to happen to other people like it did her. Caller verifies the shot she is speaking of is the Pfizer COVID shot, the second one. Caller states she had tingling in her mouth, lips, in her chest. Caller states the nurse told her to take some deep breaks and drink some water. Second Dose: Tingling in her chest, chest got some tightness: Caller states the tightness in her chest, when her blood pressure was high, like on 26 MAR 2021, when her blood pressure was high, she had gotten some tightness in her chest when she went to the emergency room. Caller states she had it on Friday and she had a little on Monday, the chest tightness. Caller states it could have some lasting effects because her blood pressure Monday night was 154/100, this past Monday, she noticed because she's been keeping track of it. Caller states well right now it was low this morning. Caller states it tends to be a little bit higher at night, but not like it was. Caller states it's going towards it's normal, it's going down. Caller states 30 MAR 2021, it was 128/88, it was going down from the other hundred, then like the next night, the 31 MAR 2021, it was 127/84, so it was going down. Caller states she think's its starting to get better, it's ongoing, but it's improved. Second Dose: Tingling in her chest, chest got some tightness: Caller states she had some tightness in her chest on Monday, when her blood pressure was 163/100 that night, that Monday, 29 MAR 2021.she also had some dizziness and light headedness when her blood pressure was high. she has been doing better with it. Caller states when her blood pressure rises that high, that's when it came about, but she is doing. Caller states now the first one, her symptoms were she had a bad headache, has a bad headache with this one too, it made her really tired, then her arm was sore, but she had a headache for like five days with the first one, but didn't have the other problems. Caller states on 02 MAR 2021, she had a headache when she got home, took some Tylenol and had to lay down. Caller states went on for a couple of days; Outcome/To date of first dose: bad headache, but the headache lingered for about five days. Outcomes/To dates: Caller states her arm soreness and the tiredness got better after a couple of days. Tylenol: Caller states it's the (unlisted brand), Acetaminophen, Extra Strength. EXP: 5/22, LOT: P120336, Barcode: 078742092065. Caller states total number of tablet is 400, they are 500mg a piece. Caller states she only takes two at a time, only every 6 hours if that. Her doctor told her to, she was kind of hesitant to get it to be honest because she had COVID in November and when the first round at came, she was still within that 60 day or 30 day of having it so she waited and then her doctor told her, she told her with COVID on the rise and the different, new strands, that the caller should probably get this vaccine and the caller said okay so she went ahead and done it. Caller states there is no dose, just stickers. Caller states all that's here is Pfizer, Lot number, Expiration, date they gave it to you, and the Place. she takes medicine for blood pressure, cause of a heart flutter. she had borderline high blood pressure. Caller states blood pressures have been fine. Caller states her blood pressure went back up when she had COVID, back in November. Her blood pressure is just borderline, but it's been a while. she takes Verapamil, 120 mg once at night, by mouth. Caller states she also takes a low dose of Losartan in the morning, 20mg, by mouth, it has been about a year on the Losartan. Caller verified started sometime in 2020. Caller states has been on Verapamil for years because of her heart flutter, she has a heart flutter. Losartan: Caller states they told her to take 1/2 tab more when her blood pressure as high at night. Caller states they told her to do that after going to the emergency room. They told her to go straight to the emergency room before on that Friday. Verifies her Losartan and Verapamil are in brown bottles from a grocery store; therefore, no information is provided in NDC, LOT, Expiry date for either medication. She takes a low dose in the morning when her blood pressure was high, she takes another 1/2 tablet at night of the Losartan, but that was Monday, on the 29 MAR 2021. Caller states that Dr. that told her to do that after she went to the emergency room on 26 MAR 2021.Test Results details everything was normal except her blood pressure still being skyrocketed. Time the Vaccination was Given For first and second d

Other Meds: VERAPAMIL; LOSARTAN

Current Illness:

ID: 1530712
Sex: F
Age:
State: TN

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: trouble breathing; fuzzy feeling; Itching eyes; feeling like bugs under skin; her allergic reaction began about 4 hours later/ allergic reaction for binders is getting worse; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6207, expiry date: unknown), via an unspecified route of administration on arm left on 26Mar2021 10:00 (age at vaccination: 64 years) as dose 1, single for COVID-19 immunization. The patient medical history included allergic reaction (she is allergic to some medication binders, and is allergic to the ethanol glycol that is in the Pfizer COVID-19 vaccine), thyroid surgery, Open heart surgery. The patient reported that that she has a thyroid medication that she has been taking for over 20 years, after they took half of her thyroid out. She says that they found out about her binder medication allergy when she had open heart surgery for a birth defect when she was 55. She says she had an allergic reaction in the hospital to those meds, which they said was to the binders, but they didn't know which ones because she was on more than one medication at the time, so she avoids medications period. She says she doesn't know which medications those were, there were seven and they removed them all at one since she was having a severe reaction at that point, and they had been giving them IV. She says they removed all 7 and said to just watch. She says that she is allergic to one binder, ethanol glycol, which is one used for this vaccine, but she may be allergic to other ones also, she just knows she is allergic to that one. The patient stated that she did not had any other recent vaccinations or started any new medications. The patient Concomitant medications reported as yes. On 26Mar2021, the patient experienced Fuzzy feeling, Itching eyes, feeling like bugs under skin, trouble breathing. It was reported that she received the first dose of the Pfizer-BioNTech COVID-19 Vaccine, and reported to have had an allergy to the "binders" used. Caller stated that this is only "suspected but did not know for sure" she clarified that it wasn't an anaphylactic reaction. It started right away, but "was very very light" and ended 9 hours later. During the last half-hour, she stated that she had trouble breathing. The patient asked, "if I take Benadryl, will that have an effect on the vaccine?" she reported that her first dose of the vaccine was injected around 10:00 AM, and her allergic reaction began about 4 hours later. She says when it became known that was what was happening, she was having a fuzzy feeling before that but nothing definite, she knew it was an allergic reaction 4 hours later when she had itching eyes and feeling of bugs under her skin, which is her normal allergic reaction to binders. She says the allergic reaction for binders is getting worse when she has them, and that time her reaction went on for another 5 hours, then after that it then went away when the binder went out of her system. She clarifies the allergic reaction gets worse every time she takes meds with binders in them, though some meds aren't available without binders, like vaccines. She says in the past for treatment she took Benadryl, one of them, which the product calls for two, but she took one. She clarifies she didn't take anything with the COVID-19 vaccine because she didn't know if it would make anything worse and she wasn't having trouble breathing except for a half hour. She says if her trouble breathing had continued she would have taken something, but it went away so she didn't take anything this time because she was afraid it would interact and it didn't get bad enough to where she couldn't breathe. She says she would like to know if she has trouble with the second dose, when should she take Benadryl? It was reported there was product complaint. Description of complaint was reported as Allergic to ingredient/binder in Pfizer COVID-19 vaccine: Caller says that they found out about her binder medication allergy when she had open heart surgery for a birth defect when she was 55. She says she had an allergic reaction in the hospital to those meds, which they said was to the binders, but they didn't know which ones because she was on more than one medication at the time, so she avoids medications period. She says she doesn't know which medications those were, there were seven and they removed them all at one since she was having a severe reaction at that point, and they had been giving them IV. She says they removed all 7 and said to just watch. She says that she is allergic to one binder, ethanol glycol, which is one used for this vaccine, but she may be allergic to other ones also, she just knows she is allergic to that one. She says the allergic reaction gets worse every time she takes meds with binders in them, though some meds aren't available without binders, like vaccines. Treatment received as a result of trouble breathing was reported as no. The outcome of trouble breathing, allergy aggravated was recovered on an unknown date in 2021. The outcome of her allergic reaction began about 4 hours later was resolving, while outcome of other events was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1530713
Sex: F
Age:
State: SC

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: After vaccine #2, my fever got up to 105; a hemiplegic migraine was triggered; subsequent "falling asleep" of my face, arm, spine; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 16:30 (Batch/Lot number was not reported) (at the age of 33-years-old) as dose 2, single for COVID-19 immunisation. Medical history included mitral valve prolapse and ongoing hemiplegic migraine. Concomitant medications included sumatriptan succinate (IMITREX) and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]). The patient previously took REGLAN [metoclopramide hydrochloride] and experienced drug hypersensitivity. Historical vaccine included BNT162B2 (unknown lot number) in the left arm as dose 1, single on 11Mar2021 18:30 (at the age of 33-years old) for COVID-19 immunisation and experienced fatigue. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 since the vaccination with negative result. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was a life-long hemiplegic migraine patient. Prior to taking vaccine number two, she was fine. The patient had no reaction other than fatigue. After vaccine number two, on 02Apr2021 at 01:00 her fever got up to 105 (unspecified units) and a hemiplegic migraine was triggered. The patient had to go to the emergency room three days after the vaccine was given to have them help her break the hemiplegic migraine and subsequent "falling asleep" of her face, arm, spine on an unknown date in Apr2021. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events which also included treatment with medications to relieve the hemiplegic migraine. On 04Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event fever got up to 105 and a hemiplegic migraine was triggered, and subsequent "falling asleep" of face, arm, spine was resolving at the time of this report. Information on the lot/batch number has been requested.

Other Meds: IMITREX; EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]

Current Illness: Hemiplegic migraine

ID: 1530714
Sex: F
Age:
State: FL

Vax Date: 01/26/2021
Onset Date: 04/03/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: covid_test_result=Positive/flu like symptoms; covid_test_result=Positive/flu like symptoms; This is a spontaneous report from a contactable physician. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 26Jan2021 at 11:00 (at the age of 68-year-old) and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 05Jan2021 at 11:00 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and had multiple allergies to medications. Patient did not have any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 10:00, the patient experienced flu like symptoms. On 06Apr2021, the patient underwent covid test (nasal swab test) and the result was positive. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the events was recovering at the time of this report. Information on lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event vaccination failure and covid-19 cannot be ruled out.

Other Meds:

Current Illness:

ID: 1530715
Sex: M
Age:
State: CA

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Relapse of Fibromyalgia; Bad balance lasted 3 days; muscles in my legs are tense and tight; A lot of pain walking and standing; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received BNT162B2 (solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 10:45 (Batch/Lot Number: Er2613) as dose 2, single for covid-19 immunisation. Medical history included fibromyalgia once in 1980, once in 2000. Concomitant medication included diazepam (VALIUM); ibuprofen (MOTRIN [IBUPROFEN]); alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 for covid-19 immunisation on 12Feb2021 at the age of 73-year-old, neurontin and experienced Allergy, quinine sulfate and experienced Allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had severe Fibromyalgia conditions twice before, once in 1980, once in 2000 and now after 2nd Pfizer Vaccine. Patient have short relapses for a few days every so often, but symptoms do go away. His bad side effects had him grabbing on to walls and furniture to walk. Bad balance lasted 3 days. The muscles in his legs are tense and tight. A lot of pain walking and standing. It was going on to 3 weeks since my 2nd Vaccine and was still hurting. He was taking the only medications that have a beneficial effect on his body. The patient did not receive treatment for the adverse events. Outcome for the events was not recovered.

Other Meds: VALIUM; MOTRIN [IBUPROFEN]; XANAX

Current Illness:

ID: 1530716
Sex: F
Age:
State: CA

Vax Date: 03/19/2021
Onset Date: 03/20/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Contracted Shingles 2 days after vaccine in left armpit; Experienced whole body aches 1 day after vaccine; pain in back felt like a charlie horse; had back pain in between left shoulder blade and spin/ Pain in back got worse; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution (COVAES ). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 19Mar2021 at 15:45 (lot number: EN6208; expiry date: unknown) as dose 1, single, for COVID-19 immunization. The patient had no relevant medical history. The patient had no allergies to medications, food, or other products.The patient was not diagnosed with COVID prior vaccination. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The vaccine was administered in the hospital. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient did not receive other medications within two weeks of vaccination. On 20Mar2021 (1 day after vaccine), at 12:00, the patient experienced whole body aches, back pain in between left shoulder blade and spine, pain in back got worse; whole body aches subsided. Pain in back felt like a Charlie horse for 5 days. She couldn't get out of bed; she was in extreme pain. On 21Mar2021, 2 days after vaccine, the patient contracted shingles in left armpit. Dr. stated that pain in back was connected to shingles. Patient was put on steroids and nerve blockers then pain subsided. Patient took antivirals (Valtrex) for shingles. Shingles rash subsiding. The events resulted to doctor or other healthcare professional office/clinic visit as well as Emergency room/department or urgent care. The events were considered serious, medically significant. Outcome of the event shingles was recovering, while for the other events was recovered on unspecified date in 2021. The patient has not been tested for COVID-19 since vaccination.

Other Meds:

Current Illness:

ID: 1530717
Sex: F
Age:
State: TN

Vax Date: 03/08/2021
Onset Date: 03/01/2021
Rec V Date: 08/06/2021
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: thought about suicide; Severe Depression after both doses; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old [non-pregnant] adult female received COVID-19 immunization with the first dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as single dose in the left arm on 08Mar2021 at 08:00 (at 44-years-old); and the second dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as single dose in the right arm on 07Apr2021 at 10:45 (at 44-years-old). Relevant medical history included high blood pressure and penicillin allergy. Concomitant medications sans indication, posology and therapy dates included amlodipine; benazepril; and nebivolol hydrochloride (BYSTOLIC). The patient was not pregnant at the time of vaccination. The patient denied receiving any other vaccine within four weeks prior to this vaccine. The patient reported that she experienced severe depression after both doses. The patient explained that on an unspecified date in Mar2021, reported as about three days after the first dose of the vaccine, the patient experienced severe depression. The patient reported that on 07Apr2021, around eight hours after the second dose of the vaccine, the patient experienced severe depression. The patient reported that she thought about suicide as well. There was no treatment received. The outcome of the events severe depression and thought about suicide was not recovered. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds: AMLODIPINE; BENAZEPRIL; BYSTOLIC

Current Illness:

ID: 1530718
Sex: F
Age:
State: VA

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 08/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: Got dizzy; Pain in right arm and shoulder; Pain in right arm and shoulder; Low grade fever; Chills; Migraine; Aches; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to tree nuts and COVID-19 from unknown dates. Concomitant medications included buspirone (MANUFACTURER UNKNOWN) and multivitamins (unspecified) for unknown indications from unknown dates and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:45, immediately after the vaccination, the patient got dizzy and had pain in her right arm and shoulder. That night and continuing into the following day, the patient had a low-grade fever, chills, aches and migraine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events got dizzy, pain in right arm and shoulder, low grade fever, chills, aches, migraine were resolving at the time of the report. No follow-up attempts are needed. No further information is expected.

Other Meds: BUSPIRONE

Current Illness:

ID: 1530719
Sex: F
Age:
State: MA

Vax Date: 03/11/2021
Onset Date: 03/14/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Inflammation and throbbing in hands; Inflammation and throbbing in hands; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm on 11Mar2021 at 05:15 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. Medical history included thyroid disease - Hashimoto and thyroid (thyroid disorder NOS). The patient had a history of allergy to penicillin. Concomitant medications included levothyroxine sodium (LEVOXYL) from an unknown date for thyroid (thyroid disorder NOS). The patient previously received sulfur on an unknown date and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021, the patient experienced inflammation and throbbing in hands. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included the process of X-ray of right hand and blood work. On an unknown date in 2021, the patient underwent lab tests and procedures which included X-ray of right hand, blood work and the results were unknown. The clinical outcome of the events inflammation and throbbing in hands was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: LEVOXYL

Current Illness:

ID: 1530720
Sex: F
Age:
State: LA

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 08/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Fever in excess of 102; Body aches; Swelling at injection site; Bruising at injection site; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and cholesterol. The patient was allergic to to mycin drugs. The patient had received unspecified concomitant medications within 2 weeks of vaccination. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021 at 00:00, reportedly experienced fever in excess of 102 for over two days, body aches, swelling and bruising at injection site. Caused me to miss work both times I had the immunization. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 16Mar2021 at 00:00, the patient underwent body temperature and the result was 102. The clinical outcome of the event of fever was recovered on 18Mar2021, with the duration of two days. The clinical outcome of the events of body aches swelling at vaccination site and bruising at vaccination site was recovered on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1530721
Sex: F
Age:
State: KY

Vax Date: 04/05/2021
Onset Date: 04/06/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: heart palpitation; Just a little tired; This is a spontaneous report received from a contactable consumer (patient herself). An unspecified aged female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 05Apr2021 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Mar2021 for COVID-19 immunization and experienced with fever, achy, allergic reaction, face swelling and hives. Lad data includes patient went to her family doctor and had an EKG, which didn't show any palpitations on an unspecified date. She received her second dose on 05Apr2021. She felt great on Monday and yesterday, just a little tired. However, last night (06Apr2021) at about 10:30 she started getting heart palpitations. She felt like her heart is dancing in her chest. She called the Health Department this morning. Stated they have heard of that as a Pfizer side effect. She stated that they heard the palpitation. She was put on a 3 day Holter monitor and the doctor never heard of this as a COVID vaccine side effect. She has not had heart issues before. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1530722
Sex: F
Age:
State: DE

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Very itchy/Throughout the night they spread throughout my body; Broke out in warm hives on both my arms/it was down my legs too; Still itch especially at night when I am trying to sleep; Broke out in warm hives on both my arms/it was down my legs too; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old [non-pregnant] adult female received the first dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as single dose in the right arm on 31Mar2021 at 14:00 (at 58-years-old) for COVID-19 immunization. Relevant medical history included Diabetes, Asthma, High blood pressure, and cholesterol. Concomitant medications sans indication, posology and therapy dates included losartan; dulaglutide (TRULICITY); metformin; levothyroxine sodium (SYNTHROID); and losartan potassium (COZARIL). Prior to the vaccination the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination and denied receiving any other vaccine within four weeks prior to this vaccination. The patient denied being tested for COVID-19 since receiving the vaccine. The patient also denied any allergies to medications, food or other products. The patient reported that on 01Apr2021 at about 12:00 noon, reported as the next day about mid-day, the patient broke out in warm hives on both my arms. On that same date at about 20:00 it was down her legs too and was very itchy. The patient reported that she called her doctor who told her to take something like diphenhydramine hydrochloride (BENADRYL) and use an anti-itch lotion which helped but not the best. The patient explained that throughout the night they spread throughout her body and by 02Apr2021 (Friday) in the morning (AM) it was everywhere except the face, neck, palms of hands and bottom of the feet. The patient explained that it became intense over the next twenty-four hours or so and by 04Apr2021 (Sunday) the patient had to go to the local medical care facility to see a doctor, whom administered a shot and gave prednisone for four days. The patient stated the hives are not as visible though they still itch especially at night when I am trying to sleep. The outcome of the events broke out in warm hives on both my arms, down her legs too and was very itchy, spread throughout her body and itch especially at night when I am trying to sleep was not recovered. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds: LOSARTAN; TRULICITY; METFORMIN; SYNTHROID; COZARIL

Current Illness:

ID: 1530723
Sex: F
Age:
State: FL

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 08/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: A couple minutes after the vaccine, it felt like left side of chest felt tight; Heart rate was high; Oxygen showed that the patient was hyperventilating; Felt hot; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8733) via an unspecified route of administration in the left arm on 02Apr2021 at 18:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, anxiety, acid reflux and allergy to sulfa. Concomitant medications included escitalopram oxalate (LEXAPRO), gliclazide (CLARITIN), ibuprofen (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all from unknown dates and for unknown indications. The patient previously the received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6208) via an unspecified route of administration in the left arm on 12Mar2021 at 18:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 18:00, a couple minutes after the vaccination, the patient experienced tightness in left side of her chest, then it was like she could felt the vaccine going through her veins and then immediately after that felt like she was hypoglycemic times 1000. It was like it affected her glucose levels. The pharmacist tried to tell her it was anxiety. The patient knew that it was 100% not anxiety. The paramedics came and also said it was anxiety and they stated oxygen showed that the patient was hyperventilating. The patient felt like her heart rate was high and she was hot and again felt hypoglycemic. But it was not the hypoglycemia that she had felt before, she did not feel like she needed to eat to take it away. They told her since the patient was not wheezing or had any sort of rash that she could leave. The patient actually sat in the car for a half hour and therapeutic measures were taken as a result of anxiety which included treatment with ATIVAN 0.5 (unspecified units) just in case and to help herself calm down. If this was anxiety, the ATIVAN would have completely taken away the symptoms. But it did not and the patient still felt "off" two hours later. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events a couple minutes after the vaccine, it felt like left side of chest felt tight, heart rate was high, oxygen showed that the patient was hyperventilating, felt hot and anxiety were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: LEXAPRO; Claritin; IBUPROFEN; OMEPRAZOLE

Current Illness:

ID: 1530724
Sex: F
Age:
State: KY

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: extremely severe fatigue; feeling terrible; arm pain; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 23Mar2021 09:30 (at the age of 31 years) (Batch/Lot Number: ER2613) as a single dose for COVID-19 immunization. Medical history included blood thyroid stimulating hormone high, NSAID allergies, and Hashimoto's. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Concomitant medications (other medications in two weeks) included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL). On 24Mar2021, the next morning, the patient could not get out of bed. She had extremely severe fatigue and missed class that whole week. The fatigue has not gone away or gotten much better and she was very concerned about getting dose 2. This is concerning because she was feeling fine and had tons of energy before the vaccine. The patient that this caused an autoimmune response as she felt like she did when her TSH was high years ago. The patient stated that it was not normal to be in bed for weeks feeling terrible after a vaccine. She went to a clinic to get an IV with vitamins on Friday, 26Mar2021 (cocktail and zinc) and felt mildly better but still not close to being better. Patient also had the normal arm pain but that resolved in 48 hours. Treatment received included: IV vitamins and saline. Outcome of the event arm pain was recovered on 26Mar2021 and of the other events was not recovered.

Other Meds: SYNTHROID; CYTOMEL

Current Illness:

ID: 1530725
Sex: F
Age:
State: KY

Vax Date: 04/06/2021
Onset Date: 04/07/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: aggressively heave; full body sweating; Intense nausea; pain and soreness in the arm that received the vaccination; Incapacitated with violent vomiting continued to aggressively heave and would vomit yellow bile; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 06Apr2021 at 16:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression on unknown dates. The patient was allergic to avocado (fruit allergy) and cinnamon (spice allergy). Concomitant medications included paracetamol (ACETAMINOPHEN), bupropion (BUPROPION XL), ethinylestradiol, norgestrel (CRYSELLE) and chlorcyclizine hydrochloride, pseudoephedrine hydrochloride (STAHIST AD) all taken from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 13:00 the patient experienced intense nausea to the point of being incapacitated with violent vomiting, after vomiting everything in the stomach, the patient continued to aggressively heave and vomited yellow bile, movement of any sort would trigger intense nausea and eventually vomiting, any solid, bland food was unable to stay down for longer than 5 minutes, vomiting was coupled with full body sweating despite having no fever and other negative effects included pain and soreness in the arm that received the vaccination. Severe symptoms lasted at least 12 hours, and less severe nausea continues. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events Intense nausea (nausea) to the point of being incapacitated with violent vomiting (vomiting). After vomiting everything in her stomach, she continued to aggressively heave (retching) and would vomit yellow bile (vomiting). Vomiting was coupled with full body sweating(hyperhidrosis) despite having no fever. Severe symptoms lasted at least 12 hours, and less severe nausea continues. Other negative effects included pain and soreness in the arm (pain in extremity) that received the vaccination were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: ACETAMINOPHEN; BUPROPION; CRYSELLE; STAHIST AD

Current Illness:

ID: 1530726
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 08/06/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: spread of disease; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient had experienced spread of disease. The adverse event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the event. The clinical outcome of the event spread of disease was unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1530727
Sex: F
Age:
State: IL

Vax Date: 04/05/2021
Onset Date: 04/06/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dizziness; Body aches; Severe diarrhea; Vomiting; Headache; Joint pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and LOGESTERON taken for unknown indications from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021 at 21:00, the patient experienced severe diarrhoea and vomiting, headache, body aches, joint pain, dizziness and fatigue, all for over 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe diarrhea, vomiting, headache, body aches, joint pain, dizziness and fatigue were not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: IBUPROFEN

Current Illness:

ID: 1530728
Sex: F
Age:
State: NC

Vax Date: 04/06/2021
Onset Date: 04/07/2021
Rec V Date: 08/06/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: left armpit swollen, lump is sensitive soft and warm to touch; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 06Apr2021 at 10:45 (at the age of 60-year-old) as a single dose for COVID-19immunisation. Medical history included cholesterol high and sulfonamide allergy. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) , GUMMY VI for unknown indication on an unknown date, magnesium (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), all for unknown indication, from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 12:00 the patient experienced left armpit swollen, lump is sensitive soft and warm to touch. It was unknown whether therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event left armpit swollen, lump is sensitive soft and warm to touch was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: ATORVASTATIN; CALCIUM

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm