VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1080173
Sex: F
Age:
State: KS

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 03/08/2021
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: headache; 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2/fever; chills; muscle aches; nausea; This is a spontaneous report from a contactable Other Health Professional reported for herself (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302; expiration date not provided), intramuscular (left arm) on 02Feb2021 13:30 at SINGLE DOSE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. Patient is not pregnant. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140; expiration date not provided), intramuscular (left arm) on 13Jan2021 for COVID-19 immunisation. The patient experienced headache, '9.5hrs after the 2nd vaccine dose a fever set in', chills, muscle aches, and nausea all on 02Feb2021 at 23:00. Patient's clinical course is as follows: 9.5hrs after 2nd vaccine dose a fever set in and climbed to 101.2. To accompany the fever were chills, muscle aches, nausea, and a headache. After taking a fever reducer, the nausea stayed and the fever returned approximately 8hrs as did the chills, muscle aches, and headache. It was reported that patient took a fever reducer again and now waiting to see if that helps again. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included body temperature with result of '101.2 (9.5hrs after 2nd vaccine dose a fever set in, and climbed to 101.2)' on 02Feb2021. The patient has not received treatment for headache, chills, muscle aches, and nausea. Facility where the most recent COVID-19 vaccine was administered was reported as 'Workplace clinic'. Outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1080174
Sex: F
Age:
State: MI

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 03/08/2021
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: muscle pain in arm and back; Soreness/Tenderness in arm as expected; Headache; fever; chills; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3248), via an unspecified route of administration on the left arm, on 02Feb2021 08:15 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 20:00, the patient experienced soreness/tenderness in arm as expected. At around 8pm (12 hours after injection), patient started feeling muscle pain in arm and back. About an hour later, patient started to run a fever and had chills. Headache came on after and lasted through the night and into the next morning. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on an unspecified date. Case was reported as non-serious.

Other Meds:

Current Illness:

ID: 1080175
Sex: F
Age:
State: MI

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 03/08/2021
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: Body aches; Muscle pain; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 21Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced body aches on an unspecified date, muscle pain on an unspecified date. Patient took one 650mg extra strength tylenol 12 hours later due to body aches and muscle pain. The outcome was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1080176
Sex: F
Age:
State: MI

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 03/08/2021
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: felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Similar to a migraine; tired; slept for a long time; light and sound was very painful; light and sound was very painful; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration from 28Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included chronic sinus infections. Patient was not pregnant at the time of vaccination and the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone, xylometazoline hydrochloride (SUDAFED), cetirizine hydrochloride (ZYRTEC), and fluticasone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took clarithromycin (BIAXIN) and experienced allergies (reported as know allergies). About an hour after the injection, on 28Jan2021 11:00 AM, patient felt lightheaded, had a low grade fever, chills and sweating, light and sound was very painful - similar to a migraine even though patient have never had one previously, and patient was very tired and slept for a long time. These lasted for 5 days. The events required doctor or other healthcare professional office/clinic visit in response to the events. Patient received treatment for the adverse events and was reported as unknown. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events reported was recovering. Information on the lot/batch number has been requested.

Other Meds: TRAZODONE; SUDAFED; ZYRTEC; FLUTICASONE

Current Illness:

ID: 1080177
Sex: M
Age:
State: AZ

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 03/08/2021
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: Fever; Muscle aches; Low back and hip pain; Low back and hip pain; Severe headache; This is a spontaneous report from a contactable consumer reported for himself. A 69-year-old male patient received the first dose of BNT162B2 (lot number: EL 9264), via an unspecified route of administration in the left arm on 02Feb2021 07:00 (at the age of 69-years-old) at single dose for COVID-19 immunization. Medical history included COVID-19 on 23Nov2020, heart bypass, high cholesterol and triglyceride. Concomitant medication included clopidogrel bisulfate (PLAVIX), lisinopril, metoprolol, fenofibrate and atorvastatin calcium (ATORVAST). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 03Feb2021 at 12:00 AM, the patient experienced fever, muscle aches, low back and hip pain and severe headache. He stated that its like he has COVID all over again. The outcome of the events was not recovered. It was unknown if the patient received treatment for the events.

Other Meds: PLAVIX; LISINOPRIL; METOPROLOL; FENOFIBRATE; ATORVAST

Current Illness:

ID: 1080178
Sex: F
Age:
State: GA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 03/08/2021
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: Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given), the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1080179
Sex: F
Age:
State: NY

Vax Date: 01/13/2021
Onset Date: 01/30/2021
Rec V Date: 03/08/2021
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: My skin started to become itch with red spots; My skin started to become itch with red spots; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number and expiry date unknown), via an unspecified route of administration at the left arm on 13Jan2021 09:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient reported that her skin started to become itch with red spots on 30Jan2021 14:00. No treatment was received for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 27Jan2021. The outcome of the events were recovering. Events were reported as non-serious. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1080180
Sex: F
Age:
State: CO

Vax Date: 01/27/2021
Onset Date: 02/02/2021
Rec V Date: 03/08/2021
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: abdominal pain- feels like pulled muscles/like I got kicked in the stomach; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) solution for injection at the age of 35-years-old, via an unspecified route of administration on 27Jan2021 at 1:15 PM at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications were reported as none. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. She did not receive any other vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was unknown. The patient experienced abdominal pain which felt like she pulled a muscle, like she got kicked in the stomach on 02Feb2021 at 3:00 PM. The patient did not receive any treatment in response to the event. The outcome of the event was not recovered. The event was assessed as non-serious. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1080181
Sex: M
Age:
State: WV

Vax Date: 01/21/2021
Onset Date: 01/28/2021
Rec V Date: 03/08/2021
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: Severe chills; entire body muscle aches; mild nausea; extreme fatigue; mild cough; severe headache; Slight fever; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 13:00, at single dose, for COVID-19 immunization, at a public health department. Medical history included dermatomyositis (autoimmune disorder). The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: unknown) received at 53 years of age, via an unspecified route of administration on the left arm, on 29Dec2020 09:00, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 28Jan2021 at 10:00, the patient experienced severe chills, entire body muscle aches, mild nausea, extreme fatigue, mild cough, severe headache, all lasting several days; and slight fever which lasted for 1 day. The adverse events resulted to physician office visit. The patient underwent lab tests and procedures which included rapid test (nasal swab) on 31Jan2021 with negative result and nasal swab on 01Feb2021 with unknown result (pending). The patient recovered from slight fever on 29Jan2021a at 10:00; and was recovering from severe chills, entire body muscle aches, mild nausea, extreme fatigue, mild cough and severe headache.

Other Meds: MYCOPHENOLATE

Current Illness:

ID: 1080182
Sex: F
Age:
State: LA

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 03/08/2021
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: Nervous Anxiety; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported PFIZER BIONTECH COVID-19 VACCINE; lot number: EL9265; expiration date: unknown) at vaccination age of 77-year-old via an unspecified route of administration in the left arm on 27Jan2021 13:30 at a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. The patient previously took naproxen (ALEVE) but had allergies to Aleve. The patient reported that she had nervous anxiety for second day (28Jan2021). The event did not receive treatment. The patient has not been tested for COVID-19 since vaccination. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1080183
Sex: F
Age:
State: CA

Vax Date: 01/29/2021
Onset Date: 01/31/2021
Rec V Date: 03/08/2021
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: Quivering muscle pain when attempting to stand and to sit; Thigh muscles still feel quivering and tight/tight and unstudy; This is a spontaneous report from a contactable consumer (patient). A 79 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number:EL9262), via an unspecified route of administration (on left arm) on 29Jan2021 (at the age of 79 -years-old), single dose for COVID-19 immunization. Medical history included Mech. Valve/ Arthritis from an unknown date. Concomitant medication included warfarin, bempedoic acid, hydrochlorothiazide, losartan potassium. The patient previously took ciprofloxacin and experienced drug allergy. The patient experienced quivering muscle pain when attempting to stand and to sit. Occurring upper thighs in front and under buttocks in rear. Similar feeling across groin area when sitting. Began the 2nd day after vaccine shot on a Sunday. Now, on Wednesday still occurring . however, not as pronounce. I still push myself up from sitting as well as sitting down as thigh muscles still feel quivering and tight and unstudy. No treatment for the adverse events. The outcome of the events was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were assessed as non-serious.

Other Meds: WARFARIN; BEMPEDOIC ACID; LOSARTAN/HYDROCHLOORTHIAZIDE

Current Illness:

ID: 1080184
Sex: F
Age:
State: MA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 03/08/2021
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: chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1080185
Sex: F
Age:
State: CA

Vax Date: 12/29/2020
Onset Date: 12/30/2020
Rec V Date: 03/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe back muscle spasm 1 day after injection; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL1284), via an unspecified route of administration on left arm on 29Dec2020 at 11:30 (at the age of 35years) at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergies: Sulfa. The patient's concomitant medications were not reported. The patient experienced severe back muscle spasm 1 day after injection (30Dec2020). Severe right leg (thigh knee and calf) pain 7 days after vaccine (05Jan2021). There were no treatment given for the events. The events were considered non-serious by the patient as did not results in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The adverse events result in doctor or other healthcare professional office/clinic visit. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The COVID-19 test (nasal swab) on 12Jan2021 was negative. The outcome of the events was recovered for pain in extremity and arthralgia in 2021 and for muscle spasms on an unspecified date.

Other Meds:

Current Illness:

ID: 1080186
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/08/2021
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: she got a cold; This is a spontaneous report from a non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (BNT162B2, also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient informed that she had an appointment to receive her second dose of the vaccine tomorrow, but her HCP advised to wait since she got a cold. The outcome of event was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1080187
Sex: M
Age:
State: NY

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 03/08/2021
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: diarrhea; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The consumer's father received the first dose of Pfizer's vaccine yesterday (02Feb2021). He had diarrhea since last night (02Feb2021). The consumer asked if it was due to the vaccine and how long it will last. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1080188
Sex: F
Age:
State: CA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 03/08/2021
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: Nausea; sore arm; fever; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3246), via an unspecified route of administration on the right arm on 02Feb2021 08:15 at single dose for COVID-19 immunisation. Medical history allergies: pcn, latex, wheat/gluten, dairy, soy, corn. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (lot number: EL 3246) on 11Jan2021 06:30 PM on the right arm for covid-19 immunisation; epinephrine and experienced allergies. At 6:00 PM on 02Feb2021, patient developed fever 99.4 and steadily rose to 101.5 by 9:30 PM; sore arm all day and night, following day much less sore and easier to move. Fever stayed overnight, down to 100.5 morning on 03Feb2021. Nausea accompanied fever and still have slight nausea. The patient received no treatment. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1080189
Sex: F
Age:
State: VA

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

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

Lab Data:

Allergies:

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

Symptoms: only sore arm; feeling tired; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (reporting for herself). A 76-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration (at the age of 76) single dose on 02Feb2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced only sore arm and feeling tired both on an unspecified date. She has had to take a nap everyday since. The outcome was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1080190
Sex: M
Age:
State:

Vax Date: 02/03/2021
Onset Date: 02/01/2021
Rec V Date: 03/08/2021
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: light headedness to the point of feeling like passing out; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (Age: 71; Unit: Unknown; as reported) received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced: light headedness to the point of feeling like passing out (non-serious) in Feb2021. The clinical course was reported as follows: The patient reported that during the 15 minutes after receiving the injection, he was fine. Thirty minutes post vaccination, while driving home, the patient experienced light headedness to the point of feeling like passing out. The patient had to pull over on the highway. The feeling lasted about an hour before subsiding. The patient stated that after an hour and a half after receiving the injection, the light headedness was mostly gone. The clinical outcome of the event was recovering. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1080191
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 03/08/2021
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: ear pain; allergic sinusitis; This is a spontaneous report from a Pfizer Sponsored Program . A non-contactable consumer reported that a 34-year-old female patient received her second dose of bnt162b2 (BNT162B2 also reported as Pfizer-Biontech covid-19 vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 02Feb2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced ear pain and allergic sinusitis on an unspecified date. She already took Tylenol as treatment. The outcome of event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1080192
Sex: M
Age:
State: MO

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 03/08/2021
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: Fever worsened; arm soreness/achy legs; minor aches and pains; Chills; slight/mild headache; fever of 100 Fahrenheit then 101.6 Fahrenheit; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration on 02Feb2021 at 09:45 at 68-years-old at a single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for type 2 diabetes mellitus from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: arm soreness/achy legs (non-serious) on 02Feb2021 with outcome of recovering, minor aches and pains (non-serious) on 02Feb2021 with outcome of recovering, chills (non-serious) on 02Feb2021 with outcome of recovered on 03Feb2021, slight/mild headache (non-serious) on 02Feb2021 with outcome of recovered on an unspecified date, fever of 100 Fahrenheit then 101.6 Fahrenheit (non-serious) on 02Feb2021 (as reported) with outcome of not recovered, fever worsened (non-serious) on an unspecified date with outcome of unknown. The clinical course was reported as follows: The patient reported having aches, pains, chills, a slight headache, and a fever of 100 Fahrenheit in the afternoon and evening on 02Feb2021 (as reported). On the morning of 03Feb2021, the patient reported having a fever of 101.6 Fahrenheit (as reported). The patient also reported a fever of 99.1-99.4 Fahrenheit (the night before the report); then, the next morning had a fever at 100 Fahrenheit and then 101.6 (as reported).The patient further reported that he had arm soreness, upon which the patient put a cold towel on it, and it was a lot better on 03Feb2021. The patient also had a mild headache and took paracetamol (TYLENOL). The patient was concerned about the fever. The patient read to drink liquids and dress lightly; and had been drinking plenty of liquids. The patient reported that his weight was 190-200 lbs. The had minor aches and pains, and he was a little achy in his legs which started on 02Feb2021 as well. At the time of the report, it was about the same. It was worse in the morning but was better now. Then the patient had a small chill the day before and at the time of the report. The patient he turned up the heat, and it went away. The was scheduled for his second dose on 23Feb2021. The doctor recommended the patient to get the vaccine because of his age and having type 2 diabetes. The patient had his diabetes under control with metformin. The patient underwent lab tests and procedures which included body temperature: 99.1 Fahrenheit on 02Feb2021, body temperature: 99.4 Fahrenheit on 02Feb2021, body temperature: 100 Fahrenheit on 02Feb2021, body temperature: 101.6 Fahrenheit on 03Feb2021. Therapeutic measures were taken as a result of arm soreness/achy legs and slight/mild headache.

Other Meds: METFORMIN

Current Illness:

ID: 1080193
Sex: F
Age:
State: MI

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 03/08/2021
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: Fever; aches and pains; headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration (right arm) on 02Feb2021 08:30 at a single dose for COVID-19 immunization at a workplace clinic. Medical history included allergies to macadamia nuts. There were no concomitant medications. No other medications the patient received within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (brand=Pfizer) on 14Jan2021 07:30 AM (vaccine location= left arm). The 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. The patient experienced fever, aches and pains, headache on 03Feb2021 05:00 AM. No treatment received for the events. The events were reported as non-serious (did not result to death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, and not congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1080194
Sex: F
Age:
State: NM

Vax Date: 01/02/2021
Onset Date: 01/01/2021
Rec V Date: 03/08/2021
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: white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia; body ache; sore throat; chills; I've haven't had this shift before in lymphocyte; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunisation. Medical history included MS and saw neurologist in Nov2020, prior to getting the vaccine and at that time did not have the typical blood work drawn which would have been a CBC and CMP and white blood cell could usually runs in the 3.5-3.7. Concomitant medication included dimethyl fumarate (TECFIDERA). The patient previously took TYSABRI and had to be taken off of that in 2010 due to evidence by CBC of bone marrow suppression. The patient had IVIG and experienced myelosuppression. Patient participated in clinical trials with rituximab and took VIOXX before it was removed from the market. The patient really loved VIOXX and used to prescribe it to her patients; first dose of BNT162B2 on 17Dec2020 for COVID-19 immunisation. A week after the patient got the vaccine, she had a sore throat, chills and body aches. The patient just went to bed early and was fine. The patient reported those symptoms through the CDC VAERS site. The patient had blood work drawn on 29Jan2021 and was shocked that the white blood cell count was down to 2.3 and absolute neutrophils were low. The patient was referred to follow up with a hematologist for the neutropenia. The patient thinks this is not related to the Covid vaccine. The patient haven't had this shift before in lymphocyte and neutrophil count. On 29Jan2021, CBC and CMP and that is comprehensive metabolic panel, complete blood count and lipid panel. The patient received no treatment. The outcome of white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia was not recovered and other events was unknown.; Sender's Comments: Based on the information available a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: TECFIDERA

Current Illness:

ID: 1080196
Sex: F
Age:
State: TX

Vax Date: 01/24/2021
Onset Date: 01/28/2021
Rec V Date: 03/08/2021
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: a little cough; sore throat; runny nose; a bit of pressure in chest; fever; her heart was beating fast; Granddaughter had covid virus and passed to caller/she tested positive for COVID 19/she was diagnosed with COVID; she was feeling bad; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date: 30Apr2021), via an unspecified route of administration at the right arm on 24Jan2021 07:15 at a single dose for COVID-19 immunization. The patient's medical history included diabetic. The patient's concomitant medications were not reported. It was reported that the patient's granddaughter had COVID virus and passed to the patient. The 2nd dose appointment scheduled for 14Feb2021. Patient stated she had the first dose of the Pfizer COVID 19 vaccine on 24Jan2021 at 0715AM in the right arm. After that, she found out she got infected with COVID 19. On 01Feb2021, she tested positive for COVID 19. On 28Jan2021 (also reported as on 28Jan20201 or 29Jan2021), she was feeling bad. Her little granddaughter had COVID virus (was infected at the school) and passed it on to her. Now she has been going to different places checking it out and she went to urgent care because her heart was beating fast on 02Feb2021. She had an electrocardiogram and her lungs were okay on an unspecified date. They told her was eligible to get an infusion but she doesn't know what it is. The urgent care clinic told her she could get the infusion but then she can't get the second dose of the Pfizer COVID 19 vaccine. She wants to ask if this is true. She was being offered a monoclonal antibody infusion. When ask if this is the first time to call, she stated she called once before right after she found out that she had the COVID 19 infection to ask if she could still get the second shot. She did report at that time that she had gotten the first dose and then tested positive for COVID 19 and she previously provided product information including the lot number from her vaccine card. She added that her heart has been going very fast and has been having fever on 02Feb2021 for two or three days. It is not as high today as it was before. She does want to get the second dose. The first dose helped her so much. On 04Feb2021 (reported as yesterday), she was checked at urgent care because of heart concern and a bit of pressure in chest. Patient stated she only had a little cough, sore throat and runny nose, but she hasn't experienced any other symptoms on an unspecified date. The patient's weight was 54.43 kg on 01Feb2021. The outcome of the events "fever" and "her heart was beating fast" was recovering, while the outcome of the other events was unknown. Patient was scheduled to receive her second dose on 14Feb2021.

Other Meds:

Current Illness:

ID: 1080197
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/08/2021
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: weakness; Headache; metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, metallic taste in her mouth, weakness after 2nd dose of vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1080198
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 03/08/2021
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: Caller had symptoms like vertigo and nausea after the 1st dose; Caller had symptoms like vertigo and nausea after the 1st dose; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose, COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced symptoms like vertigo and nausea after the 1st dose. She wanted to know what to take or to do. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1080199
Sex: F
Age:
State: SC

Vax Date: 02/02/2021
Onset Date: 02/01/2021
Rec V Date: 03/08/2021
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: Arm sore; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (Pfizer CoVid-19 Vaccine), via an unspecified route of administration on 02Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had arm sore on Feb2021 after receiving first dose yesterday (02Feb2021). She was asking if she can take Tylenol. The outcome of the event was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1080200
Sex: F
Age:
State:

Vax Date: 01/26/2021
Onset Date: 02/02/2021
Rec V Date: 03/08/2021
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: Tested positive for Covid; Really bad headache; Shooting pain; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sales representative. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# not provided), via an unspecified route of administration on 26Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had really bad headache with shooting pain exactly one week after COVID vaccine (noted on 02Feb2021). The patient also tested positive for COVID one week later on 03Feb2021. 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: 1080201
Sex: M
Age:
State: MI

Vax Date: 01/15/2021
Onset Date: 01/25/2021
Rec V Date: 03/08/2021
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: They both had COVID after the 15th, after the first shot; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program. This consumer (wife) reported similar events for herself and her husband. This is 2nd of 2 reports. A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure measurement. Concomitant medications were not reported. The wife reported that on 25Jan2021, she and her husband both had COVID after the 15th, after the first shot. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 25Jan2021. She reported that they were done with quarantine that day, 03Feb2021. Therapeutic measure was taken as a result of the event that included Zepac. And then, her husband took an additional like a steroid. She did not know what he took. But they both took Zepac and their doctor prescribed Zepac, and then her husband took a steroid too. Clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111355 same reporter/product, events, different patients.

Other Meds:

Current Illness:

ID: 1080202
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/08/2021
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: my left leg started killing me, I cannot put it in the floor anymore; I can hardly walk; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second shot bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date (reported as 21st) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date) at unknown vaccination age via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization and was ok. The patient reported that "I had got this injection on the 21st and I never had any problems but yesterday, my left leg started killing me, I cannot put it in the floor anymore Is this a thing from the injection?" The patient had this vaccination on 21st, the first shot ok and nothing happed to the patient but yesterday the patient's left leg is bothering the patient and the patient can hardly walk. The patient inquired that can this be because of the vaccination. The patient added that "That's all I want to know. It is really killing me." The outcome of the events was unknown. The information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1080203
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/08/2021
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: I got the Corona; That's a shock, I got the Corona; I got the Corona; That's a shock, I got the Corona; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID -19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first shot of COVID 19 vaccine and had to leave the country. Patient stated, "I got the Corona. That's a shock, I got the Corona and I am not going to be able to get out from here maybe for another 2 weeks because I have to be in currently in here. So, now what's going on with my first shot and what's going on my second, I have to make an appointment for my second shot or what else?" Patient added, "tomorrow I have the second shot, but I am not there, and I have the corona anyhow." Outcome of the event was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1080204
Sex: M
Age:
State:

Vax Date: 01/30/2021
Onset Date: 02/01/2021
Rec V Date: 03/08/2021
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: he passed blood in urine; hematoma formation; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as "Age:79, Unit: Unknown") received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Jan2021 at single dose COVID-19 immunization; and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication. Medical history included blood in urine in 2020 (about a year ago). The patient's concomitant medications were not reported. The patient was on Eliquis. He received the COVID vaccine on 30Jan2021. On the 06Feb2021 and 09Feb2021, he passed blood in urine. He reported a similar experience about a year ago for the 1st time after which he saw a urologist who told him it was okay. He is also scheduled to see his urologist on the 25th for a 1-year follow-up. The patient would like to know what the connection is between the COVID vaccine and being on a blood thinner. On unspecified date in Feb2021, the patient had hematoma formation. The action taken in response to the events for suspect drug apixaban was unknown. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds: ELIQUIS

Current Illness:

ID: 1080205
Sex: F
Age:
State: NV

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 03/08/2021
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: tongue swelled; shaking like Parkinson's- she was cold; shaking like Parkinson's- she was cold; Headache; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) (at 74 years of age), via an unspecified route of administration in the arm on 01Feb2021 at a single dose for protection against COVID-19. She will be 75 in September, date of birth unknown. Medical history included cancer in which she doesn't know when was diagnosed but was supposed to be cancer free and hypertension. The patient's concomitant medications were not reported. The patient got to the ER last night (01Feb2021), she went to the health department to get the shot, then the ER. It was reported that last night, the patient was shaking like Parkinson's- she was cold, her tongue swelled, and she had a headache. The patient was not admitted. Shaking like Parkinson's, cold outcome: the patient felt better, she was a little quivery, but was given a steroid and IV last night, and her tongue was not swollen now. Headache: is still ongoing, but improving, she still has it. The outcome of tongue swelled was recovered on an unknown date; shaking like Parkinson's- she was cold and headache was recovering. Therapeutic measures were taken as a result of the events.

Other Meds:

Current Illness:

ID: 1080206
Sex: M
Age:
State: IL

Vax Date: 02/02/2021
Onset Date: 02/11/2021
Rec V Date: 03/08/2021
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: No problem at first 9 days after injection I woke up with a very sore spot of the injection/his arm is hurting, the same arm he received the injection in; his arm is hurting, states it is his left shoulder and arm, the same arm he received the injection in; his arm is hurting, states it is his left shoulder and arm, the same arm he received the injection in/could be a sign of an infection; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: El3247; expiration date: unknown) at vaccination age of 76-year-old via an unspecified route of administration in the left arm on 02Feb2021 12:00 at a single dose for covid-19 immunization. The patient's medical history concomitant medications were none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the COVID-19 vaccine in a public health clinic/veterans administration facility. The patient reported that there was no problem at first 9 days after injection. He woke up with a very sore spot on the injection on 11Feb2021. The event did not received treatment for the adverse event. The patient considered the event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The patient further stated that got the Pfizer Covid vaccination on 02Feb2021, but he had no reaction and everything was fine. He mentioned that this morning (11Feb2021) which was 9 days later, his arm was hurting. He stated that it was his left shoulder and arm, the same arm he received the injection in which was given the injection by the employer. The patient wanted to know if it is normal to experience this type of reaction 9 days later. He was wondering if it could be a sign of an infection. The patient was encouraged to reach out to his healthcare provider. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1080207
Sex: F
Age:
State: CT

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 03/08/2021
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: lightheadedness, not sure of her footing and not walking as forcefully as usual; When she turned around she felt like she didn't have control.; lightheadedness, not sure of her footing and not walking as forcefully as usual; When she turned around she felt like she didn't have control.; lightheadedness, not sure of her footing and not walking as forcefully as usual; When she turned around she felt like she didn't have control.; arm hurt a little; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9263), on the right arm, via an unspecified route of administration on 25Jan2021 at 13:45 at single dose for COVID-19 immunisation. Medical history was reported as none. No family medical history. Concomitant medication included denosumab (PROLIA) given on 06Jan2021. No additional vaccine administered at the same date as BNT162B2 and no prior vaccinations within 4 weeks. No tests were done. On 26Jan2021, it was reported that her arm hurt a little but not much. A day or so later on 27Jan2021, the patient started to experience a lightheadedness, not sure of her footing and not walking as forcefully as usual. When she turned around she felt like she didn't have control. Adds she felt like she walking through a field of marshmallows. She is scheduled to receive the next dose of the vaccine on 15Feb2021 at 14:00. The events did not require physician office or emergency room visit. The vaccine was administered in a school. The outcome of the event arm hurt a little was recovered on 27Jan2021 while for the rest of the events was recovering.

Other Meds: PROLIA

Current Illness:

ID: 1080208
Sex: M
Age:
State: MI

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 03/08/2021
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: Left lower portion of my leg ached; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received first dose of BNT162B2 (lot number: EL3248), via an unspecified route of administration on the left arm on 28Jan2021 at 08:15 at a single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient had no known allergies. No other vaccine was given in four weeks. No other medications was given in two weeks. No covid prior vaccination. No covid test was done post vaccination. The patient experienced Left lower portion of leg ached. It felt like similar to growing pains experienced as a child. Lasted only one night, the same day as when I received the shot. No treatment was received in response to the adverse event. The next day (29Jan2021) the pain was gone. The patient was not allowed to contact hcp. The patient recovered from the event on 29Jan2021.

Other Meds:

Current Illness:

ID: 1080209
Sex: M
Age:
State: NM

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 03/08/2021
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: feeling in tongue had changed; skin turned rosy on face; lip swollen; digestive issues; gas; Itchy skin; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 26Jan2021 at 11:00 at 73-years-old at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, the patient experienced events and outcomes: feeling in tongue had changed (non-serious) with outcome of recovering, skin turned rosy on face (non-serious) with outcome of recovering, lip swollen (non-serious) with outcome of not recovered, digestive issues (non-serious) with outcome of not recovered, gas (non-serious) with outcome of not recovered, itchy skin (non-serious) with outcome of not recovered; all of which required an emergency room (ER) visit. The patient stated that immediately after the vaccination, he came down with a mild reaction. The patient stated the feeling in his tongue felt off, skin turned rosy, lower lip was swollen, and he has had some gas and digestive issues. The patient stated that he spent an hour and a half in the emergency room (ER), and everything calmed down there, and he was able to go home. The patient stated that he may not take the second dose.

Other Meds:

Current Illness:

ID: 1080210
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 01/30/2021
Rec V Date: 03/08/2021
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: Headaches; no taste or smell; no taste or smell; This is a spontaneous report from a non-contactable consumer. A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on an unspecified date for covid-19 immunisation. Medical history included barretts esophagus. The patient's concomitant medications were not reported. The patient experienced headaches on 30Jan2021, no taste or smell on 30Jan2021. No treatment received. The events outcome was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1080211
Sex: F
Age:
State: MS

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 03/08/2021
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: Swelling to the upper lip; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received BNT162B2 (Pfizer COVID 19 vaccine), lot no. EL0142 with expiry date Mar2021, via an unspecified route of administration (left arm) on 03Feb2021 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no concomitant medications. The patient got the COVID vaccine today (03Feb2021). She had an adverse reaction. She didn't have it within 15 minutes. She had it several couple of hours later. She had swelling to the upper lip on 03Feb2021. She took a Tylenol and Benadryl. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1080212
Sex: F
Age:
State: CA

Vax Date: 02/02/2021
Onset Date: 02/01/2021
Rec V Date: 03/08/2021
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: Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms; Headache; Diarrhea; Chills; Tenderness where the shot area is; Joint pain; Really bad flu; A little bit of a rash from it because my skin is all red from itching; A little bit of a rash from it because my skin is all red from itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN5318), via an unspecified route of administration on 02Feb2021 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol and eye disorder. Concomitant medication included atorvastatin, ubidecarenone (COQ-10), colecalciferol (VITAMIN D3), cyanocobalamin (VITAMIN B12), monascus purpureus (RED YEAST RICE) and unspecified OCUVITE for the eyes. On 02Feb2021 at 14:30, within 15 minutes of the vaccination, the patient was itching really bad (itchy in the ears, scalp, neck, chest, arms). The patient was kept in observation after the vaccination for an hour and was treated with diphenhydramine (BENADRYL) which did not seem to help. The patient drover home and went to bed. Her physician suggested that she see an allergist. The allergist was not sure what was in the vaccine and requested the patient ask her doctor for another referral. On 02Feb2021, the patient also experienced headache; diarrhea; chills; tenderness where the shot area was. On 03Feb2021, the patient woke up with cold sweats, like cold wet perspirations and chills again. On an unspecified date in Feb2021, the patient experienced joint pain and felt like she had a really bad flu, developed a little bit of a rash because the skin was all red from the itching, which she couldn't stop. The patient reported that she was treated for the events with diphenhydramine and paracetamol (TYLENOL). She questioned whether there were other reports of itchiness. The clinical outcome of "within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms", headache, diarrhea, chills, cold sweat was not resolved; while "tenderness where the shot area is", joint pain, really bad flu, "a little bit of a rash from it because my skin is all red from itching" was unknown.

Other Meds: ATORVASTATIN; COQ-10; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]; RED YEAST RICE

Current Illness:

ID: 1080213
Sex: F
Age:
State: FL

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 03/08/2021
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: Exhausted; Chills; Aches; Fever 100.8; Nausea; This is a spontaneous report from a contactable nurse (patient). This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318) via an unspecified route of administration in the left arm on 26Jan2021 at 14:00 (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included hypertension and Hashimoto's disease; the patient was allergic to sulfa and penicillin. Concomitant medications included enalapril, sertraline, lansoprazole (PREVACID) and rosuvastatin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140) on 05Jan2021 at 12:15 in the left arm. On 26Jan2021 at 15:00, the patient experienced exhausted, chills, aches, fever 100.8 and nausea. All the events were considered as non-serious. Corrective treatments taken as a result of the events included paracetamol (TYLENOL) and she went to bed-slept for 14 hours straight. The patient recovered from the events on an unspecified date. The patient had not COVID-19 prior to vaccination and she was not tested for COVID-19 post vaccination.

Other Meds: ENALAPRIL; SERTRALINE; PREVACID; ROSUVASTATIN

Current Illness:

ID: 1080214
Sex: F
Age:
State: OH

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 03/08/2021
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: Moderate head/headache; jaw clenching; chills; feeling unwell; This is a spontaneous report from a contactable consumer who reported for herself. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 15Feb2021 at 15:15 (at the age of 36-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included sub clinical hyperthyroidism and obesity, both from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (received within two weeks of vaccination) included celecoxib (CELEXA), bupropion hydrochloride (WELLBUTRIN), vitamin D NOS (VITAMIN D) and levothyroxine, all for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received penicillin and amoxicillin and experienced allergy. On 16Feb2021 at 14:00 the patient experienced moderate head/headache, jaw clenching, chills and feeling unwell. The clinical course was reported as follows: "Moderate head began 23 hours later. Then chills, feeling unwell, and my jaw clenched shut. I slept all day and night and finally took Tylenol and a prescribed Ativan for the headache and jaw clenching. It did not help. I put a heating pad on my shoulders, neck, and head for the past two hours and that helped. I would not have been able to finish work if I had to work today. It was terrible." The events were reported as non-serious and did not result in hospitalization. It was reported that treatment was not received for the events. The clinical outcomes of the events moderate head/headache, jaw clenching, chills and feeling unwell were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: CELEXA [CELECOXIB]; WELLBUTRIN; VITAMIN D [VITAMIN D NOS]; LEVOTHYROXINE

Current Illness:

ID: 1080215
Sex: F
Age:
State: CT

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 03/08/2021
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: Arm soreness at vaccination site; This is a spontaneous report received from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201, expiry date unknown), via an unspecified route of administration, on 19Feb2021 09:15, at single dose, for COVID-19 immunization. Medical history included asthma and penicillin allergy. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 19Feb2021 at 11:00, the patient experienced arm soreness at vaccination site. Treatment included Aspirin. The outcome of the event was unknown. The reporter assessed the event as non-serious. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1080216
Sex: F
Age:
State: CA

Vax Date: 02/18/2021
Onset Date: 02/20/2021
Rec V Date: 03/08/2021
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: Redness at injection site on day 2; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN2600) on left arm, via an unspecified route of administration on 18Feb2021 15:00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced redness at injection site on day 2 on 20Feb2021 13:30. There was no treatment received for the adverse event. The 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. Since the vaccination, the patient has not been tested for COVID-19. The event was reported as non-serious. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1080217
Sex: M
Age:
State: SC

Vax Date: 02/13/2021
Onset Date: 02/01/2021
Rec V Date: 03/08/2021
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: covid test result was Positive/sore throat and headache; aches; Still sick; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of bnt162b2 (lot number EL9262), via an unspecified route of administration in right arm on 13Feb2021 13:00 at single dose for covid-19 immunization. Medical history included Diabetes. The patient received unspecified medications within 2 weeks of vaccination. Since the vaccination, patient had been tested for COVID-19. The Nasal Swab (Aegis) was tested on 13Feb2021. The covid test result was Positive. In Feb2021, the patient had aches, sore throat and headache. Came down with full blown Covid moderate to severe. Still sick. Patient was reluctant to get his second shot and was sure it serves no purpose. No treatment received for events. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1080218
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 02/14/2021
Rec V Date: 03/08/2021
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: Severe explosive diarrhea; This is a spontaneous report from a contactable female other health professional reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on an unspecified date at 15:45 (Lot number: EL9269) via an unspecified route of administration in the left arm at single dose for COVID-19 Immunization in the Public Health Clinic. The patients medical history included She had sulfa and latex allergy. The patients concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested after vaccination. On 14Feb2021 04:30 the patient had severe explosive diarrhoea within 12 hours of injection. Diarrhoea, several times per day, accompanied by loud rumbling, bowel sounds. Bowel movements would be watery and worsen with the ingestion of any form of solid foods. No bloating or cramps. The event assessed as serious (medically significant). The patient didn't receive treatment. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the strong temporal relation, the association between the event diarrhea and the administration of the vaccine cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1080220
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 03/08/2021
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: Flu-like symptoms; joint pain; This is a spontaneous report from a contactable other-HCP. A 64-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on an unspecified date, lot number unknown, at single dose for COVID-19 immunisation. The patient medical history included breast cancer. The patient concomitant mediations included palbociclib (IBRANCE, strength: 125mg) by mouth at 125mg once daily at cycle: 21 days on, 7 days off from 2019 and ongoing for breast cancer. The patient previously received the first dose of bnt162b2 on an unspecified date, lot number unknown, at single dose for COVID-19 immunisation. The patient experienced flu like symptoms and joint pain after the injection but had now resolved (on unknown date). It was unknown if MD is aware but the patient was advised to notify MD of any symptoms. Information about lot/batch number has been requested.

Other Meds: IBRANCE

Current Illness:

ID: 1080221
Sex: M
Age:
State:

Vax Date: 02/04/2021
Onset Date: 02/01/2021
Rec V Date: 03/08/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Patient was hospitalized for covid pneumonia (positive for covid infection); This is a spontaneous report from a contactable physician. A 77-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at single dose for COVID-19 immunization. Medical history included patient's wife had contracted covid infection the week prior the patient received his first dose, in Jan2021, and patient did not have symptoms of covid infection at time of 1st dose vaccine. Concomitant medications were not reported. Patient experienced covid pneumonia in Feb2021 (positive for covid infection in Feb2021) and was hospitalized on 08Feb2021. Patient received treatments as follows: 12L O2, steroid, remdesivir and convalescent plasma. Patient was fully recovered from the event in Feb2021. Information on the lot/batch number has been requested.; Sender's Comments: Covid 19 pneumonia is assess as an intercurrent medical condition based on patients exposure to a patient who is positive for Covid 19 prior to vaccination. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1080222
Sex: M
Age:
State: NM

Vax Date: 02/10/2021
Onset Date: 02/18/2021
Rec V Date: 03/08/2021
Hospital: Y

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: Pulmonary embolism; Multiple clots in his lungs; Shortness of breath; This is a spontaneous report from a contactable consumer (patient wife). A 72-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown and expiration date not reported), via an unspecified route of administration on 10Feb2021 at a single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine. The patient previously took first dose of bnt162b2 (EL8982) on 19Jan2021. The reporter (wife) stated that she and her husband both took the Covid vaccine. The patient (husband) is the one who have the adverse reactions. On 19Jan2021, she and her husband had the first shot, the Pfizer Covid shot. On 10Feb2021, they had the second shot. Just today she picked her husband from the hospital, they dismissed him for today because on 18Feb2021, she had to take him to emergency room because he had pulmonary embolism. He has multiple clots in his lungs. This is nothing that they dealt before with him. The reporter is afraid that it might be related to have taken the vaccine. Reporter stated that when she took him to the emergency room, it was 18Feb2021. Now he had a little shortness of breath for few days before the 18th but they didn't realize that he was having a big problem. He fully developed this on 18Feb2021. The reason for hospitalization was pulmonary embolism and blood clots in his lungs. He is little bit slow like the reporter said she got him to the hospital where he stayed 3 days she guess with pulmonary embolism, from 18Feb2021 to 21Feb2021. He had lot a of lab work while he was in hospital on these days the wife described. He had blood work, Echocardiogram, CAT scan, Ultrasounds, Chest X-ray, Covid rapid test, they haven't got back the result yet. Outcome of the events was unknown.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1080223
Sex: M
Age:
State: MT

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 03/08/2021
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: muscle stiffness and soreness - legs,arms, shoulders, etc.- for the past 14days or so - since injection.; muscle stiffness and soreness - legs,arms, shoulders, etc.- for the past 14days or so - since injection.; Movement, sleeping, bending, etc.,almost impossible; Movement, sleeping, bending, etc.,almost impossible; This is a spontaneous report from a contactable consumer reported for himself. A 78-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=em9801), via an unspecified route of administration at the age of 78 years old on 12Feb2021 at single dose on arm left for covid-19 immunisation. Medical history was none. No Allergies to medications, food, or other products. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received no other medications within 2 weeks of vaccination. The patient's concomitant medications were none. The patient experienced muscle stiffness and soreness - legs, arms, shoulders, etc.- for the past 14 days or so - since injection. Movement, sleeping, bending, etc., almost impossible. 4- 200mg-ibuprofen helps for about 4 hrs. The onset date for the adverse events was reported as 13Feb2021. The events outcome was not recovered. The seriousness of the events was reported as no.

Other Meds:

Current Illness:

ID: 1080255
Sex: F
Age: 75
State: UT

Vax Date: 02/25/2021
Onset Date: 03/01/2021
Rec V Date: 03/08/2021
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: 0

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

Symptoms: Developed a large, itchy rash approximately 1and1/2 inch below the injection site 4 days after injection. Applied 1% cortisone ointment to site for 2 days. Symptoms subsided.

Other Meds: Lorsartan Escadaloprim

Current Illness: 0

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm