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: 1534023
Sex: F
Age:
State:

Vax Date: 07/15/2021
Onset Date: 07/01/2021
Rec V Date: 08/07/2021
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: rapid heart beats; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. stated she got the shot on 15Jul2021 and she has been having rapid heartbeats. On Jul2021, The patient experienced rapid heartbeats. The patient underwent lab tests and procedures which included heart rate: rapid heartbeats on Jul2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1534024
Sex: M
Age:
State: NY

Vax Date: 03/01/2021
Onset Date: 03/10/2021
Rec V Date: 08/07/2021
Hospital: Y

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: Stomach pains in liver area.; Very tired; very painful; Hospital stated AV Block and pacemaker.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on Mar2021 at 01:00 PM (Batch/Lot Number: EN6205) (at the age of 56-year-old) as dose 1,single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. 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. Medical history included heart, asthma, and migraines. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously took nadolol and experienced allergies (reported as "known allergies: Nadalol"). The patient experienced stomach pains in liver area. Very tired and very painful. Hospital stated AV Block and pacemaker. The onset of events was on 10Mar2021 at 13:00 (01:00 PM). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. The patient was hospitalized for 8 days. Since the vaccination, the patient has been tested for COVID-19, which was a nasal swab with negative result on 20Mar2021. Therapeutic measures were taken as a result of the event which included pacemaker. The events were reported as serious - life threatening, caused/prolonged hospitalization, and disabling/incapacitating. The outcome of the events was recovering.

Other Meds: LISINOPRIL AND HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1534025
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: developed a mental delay; fatigue; weakness; shortness of breath; rapid pulse; chest pain; This is a spontaneous report from a Pfizer-sponsored program, via a contactable physician. A 28-year-old female patient received the second dose of the bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 on an unknown date at a single dose for covid-19 immunisation. On an unknown date, two weeks after the bnt162b2 vaccine, the patient developed a mental delay, fatigue, weakness, shortness of breath, rapid pulse, and chest pain. The events were further described as: patient developed fatigue, weakness, mental delay, shortness of breath, rapid pulse and chest pain (resembled pericarditis, cardiac workup negative as of now) 2 weeks after her second bnt162b2 vaccine. Per patient similar to POTS Syndrome (as reported). The patient underwent lab data and procedures which included cardiac workup: negative on an unknown date. The clinical outcome of all events was unknown. The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: The contributory role of the suspect product bnt162b2 (COMIRNATY), to reported events is possible based on temporal association and known profile of the product.

Other Meds:

Current Illness:

ID: 1534027
Sex: F
Age:
State: VA

Vax Date: 07/17/2021
Onset Date: 07/18/2021
Rec V Date: 08/07/2021
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: A-fib alerts from my fitness/health tracking device.; heart palpitations/Sleeping HR of 102-133; Left arm and chest pain.; Left arm and chest pain.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 17Jul2021 10:30 (at the age of 59-year-old) (Batch/Lot Number: GW0198) as dose 1, single for covid-19 immunisation. Medical history included gastritis. The patient was not pregnant. Concomitant medications included omeprazole magnesium (PRILOSEC) and colecalciferol (VIT D) which were her medications in two weeks. The patient previously took amoxicillin and experienced allergies. The patient had no other vaccine in 4 weeks. On 18Jul2021 at 12:00, the patient experienced heart palpitations and a-fib alerts from her fitness/health tracking device, and left arm and chest pain. On 19Jul2021, the patient experienced sleeping heart rate (HR) of 102-133. There was no treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was not covid tested post vaccination. Outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: PRILOSEC [OMEPRAZOLE MAGNESIUM]; VIT D [COLECALCIFEROL]

Current Illness:

ID: 1534028
Sex: F
Age:
State:

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 08/07/2021
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: Stated that it showed that she had sinus rhythm with arrhythmia.; stated that her chest got tight; shortness of breath; limb weakness for both arms/limb weakness for both legs; had palpitations; Tachycardia; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received bnt162b2 (Pfizer Covid 19), intramuscular in the left deltoid on 08Jul2021 (Lot Number: EW0172) dose number unknown, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The events were described as follows: she had the Pfizer vaccine on 08Jul2021 had some sort of reaction from it. Stated that 12 minutes after, her chest got tight and lasted for two days. On 08Jul2021, she had shortness of breath, limb weakness for both arms and legs, palpitations and tachycardia. The patient asked if she should get the second vaccination. Stated that she had lasting effects of shortness of breath from her chest tightness. She visited with the doctor she worked with and had an electrocardiogram (EKG) on 09Jul2021. It showed that she had sinus rhythm with arrhythmia. The doctor told her that it was due to her breathing and he thought it was completely normal. Outcome of event arrhythmia was unknown, shortness of breath recovered on 12Jul2021, limb weakness for both arms/limb weakness for both legs recovered on 09Jul2021, chest got tight, palpitations and tachycardia recovered on 10Jul2021. Events assessed by reporter as serious. The reporter assessed the events as related to vaccine.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events shortness of breath, limb weakness, palpitations, tachycardia, chest tightness, and arrhythmia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: 1534029
Sex: F
Age:
State: TX

Vax Date: 07/21/2021
Onset Date: 07/23/2021
Rec V Date: 08/07/2021
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: A little black dot in her left eye/like "broken blood vessels/ the veins are floating around"/Felt like something burst in her left eye; left eye felt like something was in it/ dot is moving around my eyeball/Every time she rolls her eye it is like something is stuck; left eye kind of felt like she had something in it, like a blood clot, there was a little dot there; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm (also reported as 'left shoulder upper arm') on 21Jul2021 13:00 (Batch/Lot number was not reported) at the age of 65 years, as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's mom had Alzheimer's, and her dad had heart attack. Concomitant medications included ongoing colecalciferol (VIT D) and ongoing regular multivitamin, both taken for an unspecified indication. The patient did not receive additional vaccines on same date of or within four weeks prior the Pfizer suspect. She does not ever get vaccines, does not get the flu shot and has never had the flu. The patient reported that she feels like something burst in her left eye. On 23Jul2021 around 07:00, she woke up because her left eye kind of felt like she had something in it, like a blood clot, there was a little dot there. She initially thought maybe she had dust or something in her eye so she rinsed her eye out with some eye drops (Lot: XD747, Expiry: Aug2023) and then went shopping but that didn't work. Every time she rolls her eye it was like something is stuck on there, looks like. She doesn't know, but like blood. When she returned home, around 11:00 am, the dot was still there, but smaller and it had kind of spread. It's now broken up like veins but at first it just started as just as little dot; that's why she thought maybe there was lint or something in her eye; but now it's like something burst, and she can see a little trail or something now. There's like "broken blood vessels/ the veins are floating around and the dot is moving around her eyeball when she reads or looks out her left eye." She called her Optometrist and is going to go in today to have her look at it, but has not had any physician's office visit, emergency room visit or hospitalization as of yet regarding this event. She called to ask if any other reports of side effects have been made like this with Pfizer-BioNTech Covid-19 Vaccine. She was on the fence about getting the Pfizer Covid vaccine and didn't want to take it, and now she was frustrated because of her left eye having problems. Outcome of the events was not recovered. The patient reported the events as non-serious. Information about lot/batch number has been requested.

Other Meds: VIT D [COLECALCIFEROL]

Current Illness:

ID: 1534030
Sex: F
Age:
State:

Vax Date: 07/17/2021
Onset Date: 07/23/2021
Rec V Date: 08/07/2021
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: Fever; Headache; Flu like symptoms; Cold; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number not provided), via an unspecified route of administration on 17Jul2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.On 23Jul2021, the patient experienced Fever, Headache, Flu like symptoms, Cold.The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1534031
Sex: F
Age:
State:

Vax Date: 07/01/2021
Onset Date:
Rec V Date: 08/07/2021
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: tiredness/exhaustion; chills; muscles feeling funny; This is a spontaneous report from a contactable consumer (patient herself). A 55-years-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 an unknown date July2021 (Wednesday) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included covid-19 from December2020. The reporter states that both she and her husband had the covid virus back in December. The patient's concomitant medications were not reported. On an unknown date, the patient experienced potential adverse event, tiredness/exhaustion, chills and muscles feeling funny. The reporter wanted to know if she could receive an antibody test to determine her immunity against the covid virus after receiving just one dose of the Pfizer BioNtech covid 19 vaccine. Also if these are normal and will they be worse after the second dose of the vaccine. The outcome of the events was unknown. There was no product quality complaint present. Information on lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100944029 Same reporter/drug/AE, different patient

Other Meds:

Current Illness:

ID: 1534032
Sex: M
Age:
State:

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

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: Vaccine breakthrough infection; has COVID; has COVID; This is a spontaneous report from a contactable consumer (patient's sister). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced vaccine breakthrough infection, and has COVID. It was reported that the consumer's brother who had the Pfizer COVID-19 vaccine and had breakthrough and has COVID and was hospitalized. The consumer did not want to do a report without the patient's permission. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1534033
Sex: M
Age:
State: NC

Vax Date: 05/03/2021
Onset Date: 06/01/2021
Rec V Date: 08/07/2021
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: he has fluid on his inner ear and crystals all stuck; There is a lot of agitation in the area and there are a lot of allergies; his heart rate was in the 40s./patient should have had an elevated heart rate and not in the forties; feeling like he was out of his own body/ Out of body experience; fatigue; Lightheadedness/dizziness; There is a lot of agitation in the area and there are a lot of allergies; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, via an unspecified route of administration, administered in Arm Left, on 03May2021, at the age of 17 years, (Batch/Lot Number: ER8736) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient received first dose of COVID vaccine (lot number: EW0150) at the age of 17 years on 14Apr2021 at single dose for COVID-19 immunization. The patient experienced some adverse events (feeling like he was out of his own body, fatigue, lightheadedness and dizziness). It was stated that his son went to his doctor this morning, was seated and inactive, but his heart rate was in the 40s. He was asking if this has been reported and if so, any information on duration. In the beginning of Jun2021, the patient began having out of body experiences along with fatigue and experienced lightheadedness, dizziness and primarily the sensation of being out of his body. The patient didn't tell anyone and this has gone on for the whole summer and thought it would go away. Yesterday, the patient confessed it's really bugging him and wants to know what was going on. The caller advised patient that maybe he has fluid on his inner ear and crystals all stuck. There was a lot of agitation and there are a lot of allergies. The patient's doctor was called and his ears were clear. MD didn't expect the patient's heart rate to be in the forties. Heart rate was noticed while patient was getting his blood pressure taken in a seated position. The patient now has referral to cardiologist and will have to monitor his heart rate through EKGs for a while to see when it happens and what it is triggered by. The patient was otherwise healthy and was an athlete. It was stated patient should have had an elevated heart rate and not in the forties. It was not a period of fatigue and then dizziness. It was stated, symptoms were all kind of at the same time and doesn't know if fatigue was just a piggyback onto the out of body experience. The patient had been feeling fatigued in the process of the out of body experiences. The patient stated he has previously had the out of body experiences. The patient had couple out of body experiences today, 23Jul2021. The caller stated both him and his son got their COVID-19 Vaccines at the same time. The caller's own out of body feelings/experiences and all of the CV symptoms he experienced were many moons ago and prior to receiving his own COVID-19 Vaccines. The patient had no dietary changes. No major or stressful life event and hasn't been sick. The patient underwent lab tests and procedures which included heart rate: decreased heart rate: in 40s. The outcome of the events heart rate was in the 40s, agitation and allergies were unknown, he has fluid on his inner ear and crystals all stuck was recovered on an unspecified date while other events were not recovered.

Other Meds:

Current Illness:

ID: 1534034
Sex: F
Age:
State: UT

Vax Date: 03/25/2021
Onset Date: 04/01/2021
Rec V Date: 08/07/2021
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: lymphocytic colitis; hives across my mid-lower back.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8733 and expiration date: not reported), via an unspecified route of administration in left arm, on 25Mar2021 (at the age of 61 years old) as dose 2, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as withheld. Medical history included osteoarthritis and gastroesophageal reflux disease (GERD) and hives which were previously developed with other antibiotics, without gastro-intestinal (GI) symptoms. The patient was allergic to erythromycin; trimethoprim, sulfamethoxazole (BACTRIM); clindamycin (CLEOCIN); rofecoxib (VIOXX); doxycycline; proparacaine; fleurescein; thiomersal (THIMERISAL) and codeine. Concomitant medications included famotidine (PEPCID AC) and melatonin (MELATONIN). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203 and expiration date: not reported), via an unspecified route of administration in left arm, on 01Mar2021 (at the age of 61 years old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Approximately one week after receiving the second vaccine, the patient developed hives across her mid-lower back and then started with GI symptoms that were ultimately diagnosed as lymphocytic colitis on 01Apr2021. The patient didn't had any prolongation of hospitalization and received treatment with budesonide following a colonoscopy with an unknown results in 2021. These events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovering at the time of report.

Other Meds: PEPCID AC; MELATONIN

Current Illness:

ID: 1534035
Sex: F
Age:
State: PA

Vax Date: 07/21/2021
Onset Date: 07/22/2021
Rec V Date: 08/07/2021
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: Hives all over body -red, itchy Would call it severe; Hives all over body -red, itchy Would call it severe; Hives all over body -red, itchy Would call it severe; This is a spontaneous report from a contactable consumer (patient). A 15-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 21Jul2021 17:00 (Lot Number: EW0196) as dose 1, single (at the age of 15 years old) for COVID-19 immunization. Medical history included Mononucleosis dx (diagnosis) from 20Jun2021 to an unknown date and known allergies: Penicillin from an unknown date. Concomitant medications included atomoxetine (ATOMOXETINE) and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]); both were taken for an unspecified indication, start and stop date were not reported. Reported that atomoxetine and excedrin were medications received by patient within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jul2021 19:00, the patient experienced hives all over body -red, itchy would call it severe. The adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of hives all over body -red, itchy would call it severe, treatment received were prednisone and ZIRTEK. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.

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

Current Illness:

ID: 1534036
Sex: M
Age:
State: MI

Vax Date: 05/19/2021
Onset Date: 05/24/2021
Rec V Date: 08/07/2021
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: Pain in limbs, arms, hands, legs knees, wrists and forearms; Pain in limbs, arms, hands, legs knees, wrists and forearms; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number and expiry date were not reported), via an unspecified route of administration, administered in right arm on 19May2021 15:00 (at the age of 67 years old) as dose 1, single for covid-19 immunization. Medical history included known allergies to "Milo gram dye" (as reported). The patient had no covid prior vaccination. The patient's concomitant medications were not reported. The patient previously took atorvastatin calcium (LIPITOR; reported as lipatour) and experienced allergy (also reported as known allergies). The patient had no other vaccine in four weeks. The most recent COVID-19 vaccine was administered in a public health clinic. On 24May2021, the patient experienced pain in limbs, arms, hands, legs knees, wrists and forearms. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events which included increased dosage of prednisone 5mg to 7mg. The patient was not tested for covid post vaccination. The events were reported as medically significant. The outcome of the events was not recovered. Information on the batch/lot has been requested.

Other Meds:

Current Illness:

ID: 1534037
Sex: F
Age:
State: IL

Vax Date: 04/09/2021
Onset Date: 04/01/2021
Rec V Date: 08/07/2021
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: Depression/ Mild depressive symptoms; mental fog; Extreme fatigue; Interfered with activity; Unable to sleep; Increased anxiety; Bad chills; Muscle pain; Arm pain, left; Light headed/Dizziness; Weird feeling in her skin; Heart palpitations/ fast heartbeat, heart racing, pounding; The initial safety information received was reporting only non-serious adverse reaction(s). Upon receipt of follow-up information on 23Jul2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735), via an unspecified route of administration in left arm on 09Apr2021 at 12:00 (around noon) (at the age of 28-years-old) at dose 1, single for COVID-19 immunization. Medical history included seasonal allergy. Concomitant medication included ongoing cetirizine hydrochloride (ZYRTEC) tablet for seasonal allergy. There were no additional vaccines administered on the same date as BNT162B2. Prior vaccinations were reported as none. The vaccine was administered at a pharmacy. The patient mentioned that she knew that Pfizer does not recommended for an individual to get the second dose of the vaccine if they experienced severe allergic reactions during their first dose. Due to the kind of reaction she had, which was palpitation/fast heartbeat, she was asking if this could be classified under a severe reaction that would recommend a consultation with a doctor. She also experienced increasing anxiety and depression, among others. She would like to know if the reactions she had fall into a category that is contraindicated for the second dose. The patient also mentioned that she experienced left arm pain on 09Apr2021 in the evening which lasted for 1 day; lightheadedness when she woke up in the morning and weird feeling in her skin on Apr2021 (24-48 hours after the vaccine) which lessened in intensity and lasted for 2-3 weeks; bad chills and muscle pain on 10Apr2021 between 2 or 3 AM which lasted for a few hours; extreme fatigue and mental fog that interfered with her activities on 11Apr2021 in the morning, the fatigue lasted 2-3 weeks and the mental fog lasted at least a week; dizziness on 11Apr2021 in the morning that was very severe for about a week and then resolved in 2-3 weeks; heart palpitations, heart racing, pounding on Apr2021 (reported as day 2 or 3 after the vaccine) which lasted 2-3 weeks, but she still get heart racing, intermittently but improved, she also went to urgent care for the event; unable to sleep which coincided with her palpitations on 11Apr2021 at nighttime which has improved; increased anxiety on 10Apr2021 which lasted for 2-3 days; and depression/mild depressive symptoms on 19Apr2021 in the morning which lasted for 3 days. She mentioned that it has been 105 days since her first vaccine. The patient underwent lab tests and procedures which included first EKG and standard set of lab on Apr2021 and second EKG on Jul2021 which were all normal, and heart beat which was fast on Apr2021. The outcome of the "mental fog" and "increased anxiety" was recovered on Apr2021; recovered on 10Apr2021 for "arm pain, left", "bad chills", and "muscle pain"; recovered on 22Apr2021 for "depression/ mild depressive symptoms"; recovering for "heart palpitations/ fast heartbeat, heart racing, pounding" and "unable to sleep"; and recovered on an unspecified date in 2021 for "light headed/dizziness", "weird feeling in her skin", "extreme fatigue" and "interfered with activity". Follow-up attempts are completed. No further information is expected.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1534038
Sex: F
Age: 54
State: IL

Vax Date: 07/30/2021
Onset Date: 08/01/2021
Rec V Date: 08/07/2021
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: Fish. Myacin

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

Symptoms: I am experiencing dizziness. Especially if I look up or down or turn my head fast or look left or right to fast.

Other Meds: Metformin, Xultophy. Metrpolo, amlodepone

Current Illness: Diabetes, high blood pressure

ID: 1534039
Sex: M
Age: 55
State: CA

Vax Date: 08/06/2021
Onset Date: 08/07/2021
Rec V Date: 08/07/2021
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: Not Applicable

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

Symptoms: Headache, body aches, muscle stiffness, tiredness

Other Meds: Methadone HCL, Baclofen, Meloxicam, Fish Oil, Vitamin D3, Gabapentin, Trilyptol, Clonadine, Clonapin, Multivitamin, Biotin, Zinc

Current Illness: None

ID: 1534040
Sex: F
Age: 31
State:

Vax Date: 07/22/2021
Onset Date: 07/23/2021
Rec V Date: 08/07/2021
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: Sulfate/ sulfites. Triptophan class migraine medication.

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

Symptoms: Nausea, extreme pain in arm, felt like hot flashes, felt like someone hit me in the arm really really really really really really really hard, made my whole body feel like sludge.

Other Meds: None. Green tea for caffeine.

Current Illness: None.

ID: 1534041
Sex: M
Age: 68
State: CO

Vax Date: 02/15/2021
Onset Date: 08/02/2021
Rec V Date: 08/07/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Severe fatigue, cough, chills for two days.

Other Meds: Ibuprofen, multi vitamin

Current Illness: Gout

ID: 1534042
Sex: F
Age:
State: NV

Vax Date: 07/12/2021
Onset Date: 07/14/2021
Rec V Date: 08/07/2021
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: rheumatoid arthritis; Nerve pain in her face from the Bells palsy and the nerve pain from Morton's Neuroma that she had in both feet activated; Nerve pain in her face from the Bells palsy and the nerve pain from Morton's Neuroma that she had in both feet activated; Skin lesions on her face; Breast swelling; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 12Jul2021 (Lot Number: EY0584) as DOSE 2, SINGLE for covid-19 immunization. Medical history included ongoing Bell's palsy, autoimmune issue and Morton's neuroma, nerve surgery in 2015 prior to vaccination, all kinds of allergies and numbness and neuralgia that happened on that right side, Numbness, nerve pain and allergic to latex and adhesive (extreme nearly life threatening reaction to latex and adhesives). The patient's concomitant medications were not reported. The patient previously took BNT162B2 on 19-JUN-2021 dose 1, lot number: EW0180, vaccine was administered on her left side for dose 1, lot number: EW0180, vaccine was administered on her left side for COVID-19 immunization and experienced barely sore. The patient previously took Z-pak for skin lesion and made her sick. The patient had a flare up of nerve pain, skin lesions and breast swelling on 14Jul2021. The flare up of what her healthcare professional suspects could be an underlying autoimmune issue but the underlying autoimmune issue ranges from what she suspects is going to be rheumatoid arthritis but she has entered into the process of getting examined by a dermatologist and rheumatologist and is on that path now. The nerve pain in her face from the Bells palsy and the nerve pain from Morton's Neuroma that she had in both feet activated as well as skin lesions on her face and all of that came out after the 2nd dose. The patient was sent in the process of investigating and knows it is underlying either severe allergies or autoimmune issue and she is on the path to get a formal diagnosis. The patient was previously treated her for things when she had skin lesions with the adhesive and latex and said it was infection but it was not and she was treated with antibiotics that made her sick and that was drawn out and gave her anti-inflammatories and by that time the issue had run it's course and there was no official diagnosis and was told it must be something she ate or came into contact with. The patient could not get into see her HCP until Wednesday 21Jul2021 and can think of nothing else and did not go to the emergency room; states she felt she needed to get the Pfizer COVID Vaccine because she works in the public and there are a lot of unmasked people that she comes in close proximity with and she can't say anything to them and does not want to be attacked by customers and pretends she does not see they wear no masks and works in retail and they want service and she does not know what they believe but they come in close contact with her and they are people that love to travel, go out to eat, and go to the gym. States the customers she has are in high risk areas and she does not know if they had the vaccine or not but she has exposure to people and wanted to protect herself and to not bring anything to her family and always worries about that. The events resulted in physician office visit. The patient had no prior vaccinations (within 4 weeks). The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Autoimmune disorder; Bell's palsy; Morton's neuroma

ID: 1534043
Sex: F
Age: 19
State: HI

Vax Date: 07/13/2021
Onset Date: 07/17/2021
Rec V Date: 08/07/2021
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: I started my menstrual period 2 weeks early, 4 days after COVID-19 Vaccine dose #1. Since it started, I have been bleeding for 3 weeks straight with drastic variations in blood volume every day. This is abnormal for me since my birth control has regulated my periods.

Other Meds: Birth control mini-pill

Current Illness:

ID: 1534044
Sex: F
Age: 51
State: AZ

Vax Date: 03/14/2021
Onset Date: 03/17/2021
Rec V Date: 08/07/2021
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: Metoclopramide - anxiety Sulfa Antibiotics

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

Symptoms: Large lump developed in my right breast.

Other Meds: Topiramate 25 mg tablet - 1 at bedtime Butalbital-acetaminophen-caffeine 50-325-40 mg - as needed for headaches adderall 15 mg - 1 daily am

Current Illness: none

ID: 1534045
Sex: M
Age:
State:

Vax Date: 07/23/2021
Onset Date: 07/01/2021
Rec V Date: 08/07/2021
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: muscle pain in his upper back between the shoulder blades/In my upper middle back, between my shoulder blades is very painful and it is like a muscle pain; It is limiting the movement of his left arm somewhat; he has sharp stabbing pain.; This is a spontaneous report from a contactable consumer (patient himself). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Jul2021 10:00 (age at vaccination: 63 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Jul2021, the patient experienced severe muscle pain in his upper back between the shoulder blades/in my upper middle back, between my shoulder blades is very painful and it is like a muscle pain, it was limiting the movement of his left arm somewhat; on an unknown date in July2021, he had sharp stabbing pain. Pain was a little more than mild. It was limiting the movement of his left arm somewhat. He states it would be an issue with putting on a t shirt for the left arm. Sometimes he has sharp stabbing pain. He denies having fever. The patient was taking Tylenol for myalgia. It was quite severe. He had taken Tylenol twice already today. There was no pain at all at the injection site. The outcome of the events was not recovered. There was no product quality complaint (PQC) present. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1534046
Sex: M
Age:
State: TX

Vax Date: 03/25/2021
Onset Date: 05/05/2021
Rec V Date: 08/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: The pain was intense enough that I thought I was possibly having a heart attack.; Myocardia; chest pain lasting for approximately seven days.; This is a spontaneous report from a contactable consumer. A 31-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm (at the age of 31-year-old) on 25Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient had no medical history. Concomitant medication included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported. On 05May2021, the patient experienced myocardia and chest pain lasting for approximately seven days. The pain was intense enough that he thought he was possibly having a heart attack. It has since subsided. No treatment was received. The outcome of the event was recovered on an unspecified date in 2021. Information on the lot/ batch number has been requested.

Other Meds: FLONASE [FLUTICASONE PROPIONATE]

Current Illness:

ID: 1534047
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: I had arm pain for 5 days I think; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself. A female patient of an unspecified age first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm pain for 5 days she thinks on an unspecified date. The outcome of the event was resolved on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1534048
Sex: M
Age:
State: TX

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/07/2021
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: Hallucinations; Feeling I was about to die; Felt my vision closing in; Paralyzed; My brain couldn't follow the tv program; Couldn't remember how to do simple tasks; An electric vibration sensation; Distinct tastes and smells; Distinct tastes and smells; Couldn't breathe; Couldn't speak or communicate; Confused; electric vibration sensation traveling up my left leg, into my arm, then the entering left side of my brain and through it to the right, then seemed to dissipate into my right shoulder.; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 09:00 (Batch/Lot Number: EN6203) as dose 2, single (at the age of 76 years) for covid-19 immunization. The patient's medical history included hypertension and chronic obstructive pulmonary disease (COPD) on an unknown date. The patient's concomitant medications were not reported. The patient received the first dose of COMIRNATY on 02Feb2021 at 09:00AM in the right arm (lot:EL9265) at the age of 76 years for Covid-19 immunisation. On 23Feb2021 18:00, the patient experienced hallucinations, feeling I was about to die, felt my vision closing in, paralyzed, my brain couldn't follow the tv program, couldn't remember how to do simple tasks, an electric vibration sensation, electric vibration sensation traveling up my left leg, into my arm, then the entering left side of my brain and through it to the right, then seemed to dissipate into my right shoulder, distinct tastes and smells, couldn't breathe, couldn't speak or communicate, and confused. The events were further reported as, around 6 pm the evening of the second dose the first event happened, followed by three more the next day. Patient's brain couldn't follow the tv program. He couldn't remember how to do simple tasks. He was having hallucinations, and couldn't distinguish between them and reality. The next day he had three or four experiences of an electric vibration sensation traveling up his left leg, into his arm, then the entering left side of his brain and through it to the right, then seemed to dissipate into his right shoulder. During that time he experienced several distinct tastes and smells all at once, and had the feeling he was about to die. He couldn't breathe, felt his vision closing in, and was completely paralyzed. He couldn't speak or communicate and was confused all day. Two weeks later, he thought it was going to happen again, and had to sit down suddenly. After this, He saw his doctor and they did scans and couldn't find anything. Patient was put on blood thinners. The patient underwent lab tests and procedures which included brain scan and sonogram in Feb2021 with unknown results. The outcome for all the events was recovered with sequelae in 2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1534049
Sex: F
Age:
State: IL

Vax Date: 07/22/2021
Onset Date: 07/23/2021
Rec V Date: 08/07/2021
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: Convulsions; Burning in nostrils; Hyperventilation; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 22Jul2021 14:00 (Lot Number: Ewo202), as single dose, for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination the patient has not been diagnosed with COVID-19. Patient was not pregnant and was not pregnant at time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced convulsions (disability, medically significant) on 23Jul2021 with outcome of not recovered, burning in nostrils (disability) on 23Jul2021 with outcome of not recovered, hyperventilation (disability) on 23Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): unknown in Jul2021 (after vaccination). No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1534050
Sex: F
Age:
State: CA

Vax Date: 05/16/2021
Onset Date: 06/01/2021
Rec V Date: 08/07/2021
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: not being able to lift my left arm higher than my shoulder.; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, via an unspecified route of administration, administered in Arm Left on 16May2021 12:00 (Batch/Lot Number: EW0185) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient stated, "I do have fibromyalgia so I don't know if this is causing part of the reaction." Concomitant medication included levonorgestrel (MIRENA) taken for an unspecified indication, start and stop date were not reported. The patient previously took tetracycline and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation and experienced vaccination site movement impairment and blood pressure decreased and morphine and experienced drug hypersensitivity. The patient stated, "About 4 weeks after the second dosage, I started having the same symptom of not being able to lift my left arm higher than my shoulder. This has continued for the last month and is still happening now" on Jun2021. The patient underwent lab tests and procedures which included blood pressure measurement: dropped on Apr2021. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: MIRENA

Current Illness:

ID: 1534051
Sex: F
Age:
State:

Vax Date: 03/10/2021
Onset Date: 03/17/2021
Rec V Date: 08/07/2021
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: Right occipital nerve inflammation; Unilateral radiating pain from base of neck to tip of ear for 3 days; This is a spontaneous report received from a contactable other healthcare professional (patient). A 40-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Batch/Lot Number: EN6199) as dose 1, single for covid-19 immunisation. Medical history included seasonal allergies and sciatica like pain last experienced during pregnancy over 5 years ago. The patient is not pregnant at the time of vaccination. 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 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included ibuprofen (ADVIL) and multivitamin [vitamins nos] (MULTIVITAMIN) both taken for an unspecified indication, start and stop date were not reported. On 17Mar2021, approximately 7 days after first dose, the patient experienced right occipital nerve inflammation and unilateral radiating pain from base of neck to tip of ear for 3 days. The patient received ibuprofen and gabapentin as treatment for the event however non-responsive to pain medications and resolved on its own. The event required physician office visit. The outcome of the events was recovered on unspecified date in 2021. Follow-up (27Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: ADVIL [IBUPROFEN]; MULTIVITAMIN [VITAMINS NOS]

Current Illness:

ID: 1534052
Sex: F
Age:
State: AZ

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/07/2021
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: Seizure; headache; chills; lethargic; diarrhea; I've had problems with sight; brain fog; I cannot spell words or recall thing; I cannot spell words or recall thing; tired; This is a spontaneous report from a non-contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 09Mar2021 10:00 (Batch/Lot Number: EN 6206) as dose 1, single; via an unspecified route of administration, administered in Arm Left on 30Mar2021 10:00 (Batch/Lot Number: EN ER9730) as dose 2, single for COVID-19 immunization. Medical history included Hashimoto, allergies to eggs and nuts. Concomitant medications included levothyroxine; ascorbic acid (VIT C); vit d [vitamin d nos] (VIT D); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced seizure (which she never had) headache, chills, lethargic, diarrhea. Since 09Mar2021, she had problems with sight, brain fog, (overnight) she cannot spell words or recall things and was constantly tired. The events occurred on 09Mar2021 18:00. No treatment given. The patient had no prior vaccination and was not tested for COVID post vaccination. Prior vaccination, the patient was not diagnosed with COVID-19. The outcome of the events recovered with sequel/ lasting effects. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: LEVOTHYROXINE; VIT C; VIT D [VITAMIN D NOS]

Current Illness:

ID: 1534053
Sex: F
Age:
State: AZ

Vax Date: 03/28/2021
Onset Date: 03/29/2021
Rec V Date: 08/07/2021
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: My face, tongue, and throat swelled; My face, tongue, and throat swelled; My face, tongue, and throat swelled; I had a high, persistent fever; My body felt numb; Couldn't stop shaking; I have had severe pulmonary and heart issues; I have had severe pulmonary and heart issues; Severe electrical-like pain in my left leg and occasionally my right; Vomited blood and bile; Vomited blood and bile; I lost 15 pounds; My iron levels are low; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN8730), via an unspecified route of administration in left arm on 28Mar2021 at 10:00 (at the age of 18-years-old) at dose 2, single for COVID-19 immunization. Medical history included asthma and allergic rhinitis. She has known allergies to egg, tree nut, sulfa, and penicillin and mentioned that she experienced anaphylaxis to all these. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Concomitant medications included montelukast, triamcinolone acetonide (NASACORT), salbutamol (ALBUTEROL), ascorbic acid (VITAMIN C), and colecalciferol (VITAMIN D). She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received sulfur and experienced allergy causing anaphylaxis. She also previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration in left arm on 07Mar2021 at 10:00 (at the age of 18-years-old) at dose 1, single for COVID-19 immunization and did not experience any severe side effects. Facility where the most recent COVID-19 vaccine was administered was reported as other. During the first dose, the patient didn't have severe side effects. She has a history of anaphylaxis, and on 29Mar2021 at 00:00 (also reported as about 12 hours after the second dose), her face, tongue, and throat swelled. She had a high, persistent fever. Her body felt numb and couldn't stop shaking. Since then, she had severe pulmonary and heart issues. Her body uncontrollably shakes and jolts. She has severe electrical-like pain in her left leg and occasionally on her right. She vomited blood and bile to the point where she lost 15 pounds. Her iron levels were low because of it. She mentioned that she was still being tested for cardiovascular problem with unknown result on an unspecified date in 2021. Therapeutic measures were taken as a result of the events. The events required doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were reported as serious causing disability. No follow-up attempts are possible. No further information is expected.

Other Meds: MONTELUKAST; NASACORT; ALBUTEROL [SALBUTAMOL]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1534054
Sex: F
Age:
State: SC

Vax Date: 02/26/2021
Onset Date: 05/13/2021
Rec V Date: 08/07/2021
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: Alkaline Phosphatase Level 269/Alkaline Phosphatase Level 444; Started feeling bad, feeling not like herself/Felt like something was inside pushing or kneading for a couple of weeks; Abnormal Mammogram; Abnormal CT Scan; Abnormal PET Scan; Doctors saying it looks like cancer; Looks like lungs are collapsing; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 26Feb2021 as dose 2, single for covid-19 immunization at a hospital. Medical history included breast cancer from an unknown date and not ongoing recovered after radiation 6 years ago. There were no concomitant medications. No additional vaccines administered on the same day. No vaccinations within four weeks prior to the first administration date, states she does not normally get vaccines. The patient previously received the first dose of BNT162B2 on 05Feb2021 for COVID-19 immunization. On an unspecified date in 2021 after the last vaccination, the patient was having a lot of tests now and the doctors saying it looks like cancer, one of her test looked like her lungs were collapsing, she started feeling bad, feeling not like herself, felt like something was inside pushing or kneading for a couple of weeks, had abnormal mammogram, abnormal CT scan, and abnormal PET scan. The patient's alkaline phosphatase level was 71 on Oct2020, 269 on 13May2021, and then 444 on 07Jul2021 and her doctor was concerned about these results. The events required physician's office visit for consultation. The patient underwent lab tests and procedures which included blood alkaline phosphatase: 71 on Oct2020, blood alkaline phosphatase: 269 on 13May2021, blood alkaline phosphatase: 444 on 07Jul2021, computerised tomogram: abnormal on 2021, test: lung were collapsing on 2021, mammogram: normal on Jan2021 nothing was wrong, mammogram: abnormal on 2021, positron emission tomogram: abnormal on 2021. The patient has a biopsy scheduled for next week on her breast and lungs. The outcome of the event feeling bad, feeling not like herself, felt like something was inside pushing or kneading for a couple of weeks was not recovered while for the rest of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1534055
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: Getting scalp on top of my head and that is like scab growing on my head; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated, I would like to speak about adverse event that I received, I had Covid Vaccine few months earlier I am getting scalp on top of my head, it is like scab that has grown. I don't know what is going on it's like "Anchil (not clarified the word) that is like scab growing on my head." Patient never had it before Covid vaccine. that is not approved and then I find a paper work, where I can do now, what am I supposed to do now. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1534056
Sex: F
Age:
State: IL

Vax Date: 04/08/2021
Onset Date: 04/28/2021
Rec V Date: 08/07/2021
Hospital: Y

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: Appendix ruptured, after second vaccine.; Pain in her side, diagnosed as infected Gall Bladder, after second vaccine.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the upper left arm on 08Apr2021 at around 11:30 AM (Batch/Lot number was not reported) (at the age of 66-year-old) as dose 2, single for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive additional vaccines on the same date of the Pfizer vaccine. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 on 12Mar2021 at around 11:30 AM (Batch/Lot number was not reported) (at the age of 66-year-old) administered in the upper left arm for COVID-19 immunization. The patient was taking the Pfizer vaccine for COVID because she did not want to get sick and wanted to be around her family. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced appendix ruptured, after second vaccine on 28Apr2021 and at about 5AM, she went to the emergency room. She was admitted to the hospital. She has heard that other people have had ruptured appendix, after the vaccine. The patient experienced pain in her side, diagnosed as infected gall bladder, after second vaccine on 05May2021 05:00 AM. The patient reported that after she was released from the hospital, 2 days later, she was with pain in her side, diagnosed with an infected gall bladder, which was not removed. The patient reported that the pain in her side diagnosed as infected gall bladder occurred early in the morning maybe 5 AM. She was hospitalized for one night. She was admitted to the same hospital, both times. The events required a visit to emergency room and to physician office (after discharge from the hospital). The patient reported that there were no relevant tests. The outcome of appendix ruptured was recovered completely on 02May2021. The outcome of pain in her side diagnosed as infected gall bladder was recovered completely on 06May2021. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1534057
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: Arm was sore; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in 2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm was sore on an unspecified date of 2021. The outcome of event was unknown. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1534058
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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 the second dose I had a fever and felt awful for a day; after the second dose I had a fever and felt awful for a day; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced after the second dose i had a fever and felt awful for a day on an unspecified date in 2021. It was reported that, patient had some issues with her second dose too. She got it when it first came out in Jan or Feb. (The caller thinks it was the Pfizer COVID-19 vaccine). After the first dose her arm was sore but then after the second dose she had a fever and felt awful for a day, then she was fine. The outcome of the event was unknown. Information on Lot/Batch information has been requested.

Other Meds:

Current Illness:

ID: 1534059
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: I have got lot of eye issues; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0176), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history and concomitant medications were none. Patient did not have prior vaccination within four weeks. The patient reported that she could not get anything online to come up about side effects from the Pfizer vaccine. Three weeks after her second shot she had got lot of eye issues. She questioned if this was the problem with the vaccine having had a lot of problem, what is going on. She stated that she just had a new prescription last year and her eyes was awesome and now they were not awesome three weeks after having her second dose of Pfizer. Not yet but apparently, she was going to have it because of the vaccine. Therapeutic measures were not taken due to the event. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1534060
Sex: U
Age:
State:

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 08/07/2021
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: Break down hives on my left wrist; I don't feel well; I am just disgusted at this point; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on Jun2021 as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution injection, Lot number/Expiration date: Unknown) for covid-19 immunization. Medical history included different allergies, allergy to plants, dust allergy, allergy to animal, food allergy as the patient was given contaminated food and water on purpose, helminthic infection as the patient have been sick for years for years with them, illness as the patient sick for years. The patient's concomitant medications were not reported. on an unspecified date of 2021, the patient experienced break down hives on left wrist, don't feel well and was just disgusted at this point. The outcome of event break down hives on left was not recovered while outcome of rest all events was unknown. Follow-up (04Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1534061
Sex: F
Age:
State: NJ

Vax Date: 07/17/2021
Onset Date: 07/01/2021
Rec V Date: 08/07/2021
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: menopause for a little over a year/menstrual like bleeding; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jul2021 at the age of 59 years old (Lot Number: EW0181; Expiration Date: Aug2021) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included hyperlipidaemia and menopause from an unknown date. Concomitant medication included rosuvastatin calcium (CRESTOR) taken for hyperlipidaemia from May2021 and ongoing. The patient had no other prior vaccination (Within four weeks). In Jul2021, the patient stated, "So, I am calling to report a potential side effects from the vaccine, So, I was vaccinated exactly one week ago on the 17Jul2021 and I am 59 years old and I have been out of menopause for a little over a year and today which is just one week after the vaccine actually started last night I had menstrual like bleeding, which is continue through today into this evening." The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: CRESTOR

Current Illness:

ID: 1534062
Sex: F
Age:
State:

Vax Date: 04/27/2021
Onset Date:
Rec V Date: 08/07/2021
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: tingling in fingers; cold numb sensation in fingers; cold numb sensation in fingers; malaise; chest discomfort; severe sciatica like pain; received first dose on 10Mar2021 and second dose on 27Apr2021; This is a spontaneous report from a contactable consumer or other health care professional (Patient). A 40-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: ER8732, Expiration date: Unknown), via an unspecified route of administration, in Left Arm on 27Apr2021 (at the age of 40-years-old) as DOSE 2, SINGLE for Covid-19 immunisation at School or Student Health Clinic. The patient medical history included seasonal allergy from an unknown date and unknown if ongoing. The patient received concomitant medications within 2 weeks included ibuprofen (ADVIL [IBUPROFEN]), ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN & MINERAL) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot/Batch: EN6199, Expiration date: Unknown), via an unspecified route of administration in Left Arm on 10Mar2021 (at the age of 40-years-old) as dose 1, single for Covid-19 immunisation. 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 no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date Approx 6-7 weeks after second vaccine: tingling in fingers, cold numb sensation in fingers, malaise, chest discomfort, followed by severe sciatica like pain for 2-3 days in right leg. I do not typically develop sciatica like pain (last experienced during pregnancy over 5 years ago), The patient received first dose on 10Mar2021 and second dose on 27Apr2021. Therapeutic measures were taken as a result of tingling in fingers, cold numb sensation in fingers, cold numb sensation in fingers, malaise, chest discomfort, severe sciatica like pain. The treatment received for the events which included Ibuprofen and gabapentin to help with pain. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events was recovered on unspecified date of 2021. Follow-up attempts are completed. No further information is expected. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: ADVIL [IBUPROFEN]; MULTI VITAMIN & MINERAL

Current Illness:

ID: 1534063
Sex: U
Age:
State:

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 08/07/2021
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: this is my eight day since I got the vaccine and I just been flat on my back, I am like, feel like crap; I have been dizzy and I had a fatigue, exhausted just flat on my back; I have been dizzy and I had a fatigue, exhausted just flat on my back; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jul2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient stated that this is eight day since patient got the vaccine and patient was just been flat on back, patient feel like crap, dizzy and had a fatigue, exhausted just flat on back. Patient feel like crap for 9 days it's been be 9 days tomorrow. Why so long it said only couple of days you know and I lost a whole week. 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: 1534064
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: lumps all over my body/breaking out all over; lumps all over my body/breaking out all over; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A patient of unspecified age and gender received bnt162b2 (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 dose number unknown, single for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that patient getting side effect from this thing, breaking out all over. It was also reported that started getting lumps all over body. When probed if consumer have some medical information about the same, patient stated, "Yes. The outcome for the event was reported as unknown at the time of this report. Information about lot/batch number has been requested. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1534065
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/07/2021
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: Vulnerable; This is a spontaneous report from a contactable consumer (patient's daughter) or other non hcp. A 73-years-old male patient (Reporter's father) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on 2021 as DOSE 2, SINGLE for covid-19 immunisation (It is about 6 months now after his second Pfizer Covid vaccination). Medical history included diabetes mellitus and heart attack (the patient has diabetes and had suffered a heart attack prior to his Covid vaccination). The patient's concomitant medications were not reported. The patient received dose 1 of bnt162b2 on an unknown date for covid-19 immunisation. The patient experienced vulnerable on an unknown date in 2021. The reporter want to enroll the patient in the Covid booster trial. Outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1534066
Sex: M
Age:
State: NJ

Vax Date: 04/18/2021
Onset Date: 06/01/2021
Rec V Date: 08/07/2021
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: bilateral leg pain from his hips all the way down; bilateral leg pain from his hips all the way down; This is a spontaneous report from a contactable pharmacist (patient's wife). A 59-years-old male patient (reporter's husband) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 18Apr2021 (Lot number and Expiry date was not reported) as dose 2, single for COVID-19 immunization. The patient's and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 26Mar2021 for COVID-19 immunization. It was reported that towards the end of Jun2021, the patient started complaining of bilateral leg pain from his hips all the way down. The patient went to an urgent care. He went to the family physician and they ordered an ultrasound to check for deep vein thrombosis and abdominal aneurysm and it was negative. The pain was not going away and it was very severe. They ordered bloodwork on an unknown date and tested lyme disease but it was negative. The pain took 2 weeks to go away. The patient had to take Tylenol and Advil around the clock spaced out for two weeks. The reporter believed that it is related to the Pfizer Covid vaccine. This was out of character for the patient. They have not been able to diagnose it. This happened after the second shot. The leg pain went away on Jul2021 (reported as 'around 10Jul2021'). The patient recovered but did not specify if completely or with lasting effects. The patient had other inflammatory markers done that came back negative. The events were reported with a seriousness of disability. The events recovered on an unknown date in Jul2021. Information about Lot/batch number has been requested; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1534067
Sex: M
Age:
State: UT

Vax Date: 06/18/2021
Onset Date: 06/19/2021
Rec V Date: 08/07/2021
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: Feel pain in my heart; I have had trouble moving or moving my left arm due to the pain; Feels like heart inflammation; This is a spontaneous report from a contactable consumer (patient). This 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Jun2021 08:30 (Lot Number: 59267-1000-02) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 19Jun2021, the patient experienced feel pain in my heart , I have had trouble moving or moving my left arm due to the pain, feels like heart inflammation. The outcome of the events was unknown. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1534068
Sex: F
Age:
State:

Vax Date: 07/22/2021
Onset Date: 07/22/2021
Rec V Date: 08/07/2021
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: short of breath; feeling extremely anxious; numbness around mouth; metal taste; This is a spontaneous report from a non-contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Rrght arm on 22Jul2021 at 10:45 (at the age of 62-years-old) as dose 1, single for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient experienced at first on 22Jul2021 at 11:54 numbness around mouth and a metal taste which lasted a couple hours. On day 3 (on 24Jul2021) started feeling extremely anxious like she could jump out of her skin and short of breath. The patient received treatment for events. It was reported that an extra Ativan was given to try to help the extreme anxiety. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. The patient did not have COVID prior vaccination and she was not COVID tested post vaccination. Numbness around mouth and metal taste were resolved, the other events were not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected

Other Meds:

Current Illness:

ID: 1534069
Sex: F
Age:
State:

Vax Date: 02/20/2021
Onset Date: 02/26/2021
Rec V Date: 08/07/2021
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: Stated that she can hardly walk on her right leg; had sciatica on the same side that she got the vaccine; stated that it affected above her buttocks; stated that she was in pain; Stated that when she goes upstairs that her right leg is a little weak; stated that it affected her thigh area; stated that it affected her knee; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient) reported herself. A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Not provided, Expiration date: Unknown), via an unspecified route on 20Feb2021, as a single dose for COVID-19 immunization. Medical history included two years ago she went to the eye doctor and had mild cataracts and when she went this year, she has to have cataract surgery, she had depression but that was 15 years ago, and she takes medication for it. She had the abnormal heartbeat before the vaccine. Stated that she takes Metoprolol for it. Stated that it was better controlled. The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), on unknown date as a single dose for covid-19 immunization. On 26Feb2021, patient went for car ride could hardly walk on her right leg and it got progressively worst. Stated that she never had back trouble. Stated that on way to Florida she stopped to use the bathroom and did not think she could make it back to the car, on unknown date in 2021, it was sciatica on same side she got vaccine, it affected above her buttocks, thigh area and knee. Stated that she could walk but she was in pain. On 12Apr2021 she could not take it anymore went to emergency and they sent her to physical therapy. She did the exercises and took a muscle relaxer ROBAXIN and was told that it could cause one to get itchy and she got itchy. They gave her opioids, but she never took it. She was taking a lot of TYLENOL and Ibuprofen and she was better now. Stated that she cannot do exercises every day because it ruins her day, and she gets pain. Stated that she does it every other day. The next day after exercises that she gets a stabbing pain in her back if she bends over, when she goes upstairs that her right leg was a little weak. She has never been like this before. The patient underwent lab test and procedure which included Computerised tomogram (CAT) scan of her back. The clinical 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: 1534071
Sex: F
Age:
State: MI

Vax Date: 05/07/2021
Onset Date: 05/07/2021
Rec V Date: 08/07/2021
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: autoimmune disorder; body pain and aches; muscular pain in my knees, hands and mouth; muscular pain in my knees, hands and mouth; 1st dose 28-APR-2021/2nd dose 07-MAY-2021; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 07May2021 15:00 (Lot Number: ew0153) as single for COVID-19 immunization. Medical history included polycystic kidneys from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: ew0170 on 28Apr2021 15:15 in the right arm for COVID-19 immunization. The patient has not been tested for COVID-19 post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Onset date of events reported as 26May2021 14:15. About a month and a half after receiving final covid shot (mid-late May of 2021), patient started to have a lot of body pain and aches. Still have muscular pain in my knees, hands and mouth. The patient had blood work done to try and understand what was happening and blood work indicated she now have some underlying autoimmune disorder. The patient never had an autoimmune disorder in her life. Events resulted in Doctor or other healthcare Professional office/clinic visit, Disability or permanent damage. No treatment given for events. Outcome of events was not recovered. It was also noted that patient experienced inappropriate schedule of vaccine administered as 1st dose was given 28Apr2021 and 2nd dose was given on 07May2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1534072
Sex: M
Age:
State: ME

Vax Date: 07/18/2021
Onset Date: 07/01/2021
Rec V Date: 08/07/2021
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: myocarditis; chest hurt; fastheart beat; blood pressure is not stable; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 18Jul2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jul2021, after a couple of days the patient felt side effects like myocarditis, chest hurt, fast heart beat and blood pressure was not stable. The outcome of the events was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1534073
Sex: F
Age:
State: NM

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 08/07/2021
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: Bone pain two days after vaccination that lasted a week/general bone pain; severe peripheral nerve pain; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), intramuscular on Jul2021 as dose 2, single for covid-19 immunisation. Medical history included known allergies: Salmonids and known allergies: juniper. The concomitant medications were not reported. The patient was not diagnosed with covid-19 prior to vaccination. The patient has not been tested for covid-19 since the vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162b2 on 22May2021 for covid-19 immunization. On Jul2021 the patient experienced bone pain two days after vaccination that lasted a week/general bone pain and severe peripheral nerve pain. The treatment received for the adverse event was Medrol pack. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of bone pain two days after vaccination that lasted a week/general bone pain and severe peripheral nerve pain. The outcome of both the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1534074
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 05/15/2021
Rec V Date: 08/07/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Triggered an auto-immune response; Triggered an auto-immune response. Had a strong fever, GI problems after the first shot; Triggered an auto-immune response. Had a strong fever, GI problems after the first shot; This is a spontaneous report from a contactable consumer. A 38-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. On 15May2021, the patient triggered an auto-immune response. He had a strong fever and GI problems after the first shot. The patient was hospitalized and received treatment of colonoscopy and prescription of anti-inflammatory. The outcome of the events was recovering. On 16Jul2021, the patient had nasal swab and showed negative result. Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951006 same patient/drug, different dose/event

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm