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

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1000632
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 01/12/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Tested positive for Covid a week later; Tested positive for Covid a week later; This is a spontaneous report from a contactable other hcp (patient). A 30-year-old non-pregnant female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 04Jan2021 08:45, and 1st dose on an unspecified date via an unspecified route of administration; both at single doses for COVID-19 immunization. There were no medical history and concomitant medications. The patient has no known allergies. On 12Jan2021, the patient tested positive for COVID a week later from 2nd dose. Outcome of the events was reported as recovering. No treatment was given for the events. The patient underwent lab tests and procedures which included Nasal Swab: positive on 13Jan2021. The patient was not diagnosed with COVID prior vaccination. Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "tested positive for Covid a week later".

Other Meds:

Current Illness:

ID: 1000633
Sex: F
Age:
State: MI

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: pain at the site of injection; redness radiating from the injection site; chills; fatigue; difficulty driving; This is a spontaneous report from a contactable consumer, the patient, via a Pfizer sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown) solution for injection intramuscular (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (Pfizer) for COVID-19 vaccination, first dose on an unknown date. The patient recently received both doses of the Pfizer vaccine for Covid. On an unknown date, the patient experienced many side effects with the second dose such as pain at the site of injection, redness radiating from the injection site by about 6 inches, chills, fatigue, and difficulty driving. The outcome of the events pain at the site of injection, redness radiating from the injection site, chills, fatigue, and difficulty driving was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1000634
Sex: F
Age:
State: TX

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

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

Symptoms: Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day jan 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day 15Jan 2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; Next day15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; over all not feeling well; Burning feeling around sternum area; Next day 15Jan2021.wake up with flu like symptoms: Aches. Pain .nausea. Tire. Little Stomach cramps needle like feeling. .Headache. Little dizziness.over all not feeling well.; 2 hrs after vaccine. Felt like multiples needles like shooting to both side of sternum.; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 51-years-old non-pregnant female patient (nurse) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm from 14Jan2021 16:45 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital. The patient medical history was not reported. There were no concomitant medications. The patient had no allergies to medications, food or other products. Historical data includes patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), on 23Dec2020 at 16:00 in left arm for Covid-19 Immunisation. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 14Jan2021 (2 hrs after vaccine) the patient experienced felt like multiples needles like shooting to both side of sternum. No others symtoms. On the next day 15Jan2021 the patient woke up with flu like symptoms: aches. pain .nausea. tired. little stomach cramps needle like feeling, headache. little dizziness. over all not feeling well. Burning feeling around sternum area. No treatment was given for the events.. However, it was also stated 'Took 2 tylenol symptoms. Remains. I slept off most of the time.'. Clinical outcome of the events Felt like mutiples needles like shooting to both side of sternum, flu like symptoms: Aches. Pain .nausea. Tired. Little Stomach cramps needle like feeling.. Headache. Little dizziness. Over all not feeling well. Burning feeling around sternum area was reported as unknown

Other Meds:

Current Illness:

ID: 1000635
Sex: U
Age:
State: FL

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Diagnosed with COVID after first vaccine; Diagnosed with COVID after first vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with COVID after first vaccine and wanted to know if the patient could take the second dose afterwards. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional 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:

Current Illness:

ID: 1000636
Sex: F
Age:
State: FL

Vax Date: 01/13/2021
Onset Date: 01/15/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: sporadic itching mostly on chest and some on legs and arms; slight sore at the Injection site.; itchy eyes; slight redness in the corner of her eyeballs.; This is a spontaneous report from a contactable consumer or other non hcp. A 73-year-old female patient started to receive BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: Unknown), via an unspecified route of administration on 13Jan2021 at 10:00 (at the age of 73-years-old) as a single dose for Covid-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 15Jan2021, the patient experienced itchy eyes, slight redness in the corner of her eyeballs, sporadic itching mostly on chest and some on legs and arms and slightly sore at the injection site. The clinical outcome of the events itchy eyes, slight redness in the corner of her eyeballs, sporadic itching mostly on chest and some on legs and arms and slightly sore at the injection site was resolved on 17Jan2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1000637
Sex: M
Age:
State: IL

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Right Leg tingling; Strange Feeling; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 via an unspecified route of administration on 20Jan2021 10:00 AM at a single dose as COVID vaccine. There were no medical history and no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). The patient had no known allergies. The patient experienced right leg tingling and strange feeling on unspecified dates. Treatment was not received for the events. He had no COVID prior to vaccination. He did not have COVID tested post vaccination. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000638
Sex: M
Age:
State: WV

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: got the first dose of COVID vaccine and afterwards he tested positive for COVID; got the first dose of COVID vaccine and afterwards he tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored Program, Pfizer First Connect, received from a contactable nurse. A male patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient received first dose of COVID vaccine and afterwards he tested positive for COVID. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. 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: 1000639
Sex: F
Age:
State: FL

Vax Date: 01/16/2021
Onset Date: 01/17/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Massive headache; Severe chills; Couldn't get warm all day even with multiple layers of clothing; Dizziness/lightheaded; Feverish; Going from freezing cold to sweating profusely; Right arm is really itchy; Place on right arm started out as a red blotch the size of a nickel, but today is as big around as a grapefruit; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 16Jan2021 (17:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 30Dec2020 (when the patient was 55 years old) on the left arm for COVID-19 immunization. The patient had no issues with the first dose of vaccination. On 17Jan2021, the morning after the second dose of vaccination, the patient woke up with a massive headache; developed severe chills; could not get warm all day long even with multiple layers of clothing; was dizzy and lightheaded; feverish; was freezing cold one minute, and then sweating profusely the next; right arm was really itchy; and had red blotch that was as big as a nickel, then as big around as a grapefruit at the time of reporting. The outcome of the events was recovered on 19Jan2021 for 'massive headache', 'could not get warm all day long even with multiple layers of clothing' and 'dizziness/lightheaded'; was recovering for 'severe chills', 'feverish' and 'freezing cold one minute, and then sweating profusely the next'; was not recovered for 'right arm was really itchy' and 'red blotch that was as big as a nickel, then as big around as a grapefruit'.

Other Meds:

Current Illness:

ID: 1000640
Sex: U
Age:
State: TN

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Route:
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Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: all got the first dose, and they all came down with COVID in a week; all got the first dose, and they all came down with COVID in a week; This is Spontaneous report from a contactable Physician. This physician reported similar events for four patients. This is the fourth of four reports. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient came down with COVID in a week of vaccination. The outcome of the event came down with COVID in a week was unknown. The reporting physician stated that he doesn't think that them getting the vaccine and having COVID is related, he thinks it is a coincidence. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.,Linked Report(s) : US-PFIZER INC-2021064977 same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 1000641
Sex: F
Age:
State: MD

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: all of her joints that had been previously hurt in the past started killing her; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received at a clinic the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left upper arm on 14Jan2021 08:15 (quarter of 8 in the morning) at a single dose for COVID-19 immunization. The patient's second dose was scheduled on 04Feb2021. Medical history hurtful joints, 2 bad knees she has had surgery, pain in her elbow that she had injured in the past, and unspecified reactions to a number of medications like penicillin she can't take, and severe arthritis. There were no concomitant medications. The patient previously took swine flu vaccine in 1976), and stated to have a terrible reaction, she has not had another vaccine since 1976, however she did have the flu shot last 2021 and she had no reaction to that, but in 1976 to the swine flu vaccine she ran a super high fever for a week, she did not get Guillain barre from it. Patient also previously took aspirin and ibuprofen (MOTRIN) and reported that she can't those. The patient stated that all of her joints that had been previously hurt in the past started killing her, she turned over and woke up with the pain on 14Jan2021 about 23:00 or 24:00. Patient further described that she started having pain in her elbow that she had injured in the past and also her wrists and it hurt so bad. The patient reported to take paracetamol (TYLENOL) as the remedy that took about 4-5 days for it to go away. The patient recovered from the event (reported as fine now) on 19Jan2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness: Arthritis (she has severe arthritis)

ID: 1000642
Sex: F
Age:
State: NC

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaking really hard; feeling unwell; still cold; Just like when one catches the flu, all the symptoms came at one time; It was so stiff one time; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EK01231), via intramuscular route on the left arm on 19Jan2021 12:11 as a single dose for COVID-19 immunization. Medical history included stomach issues, two stents, pacemaker, asthma that turned into bronchitis. Historical vaccine data included the pneumococcal 13-valent conjugate vaccine (PREVNAR 13) first dose in "September" and the second Pneumonia shot on 11Jan2021, second dose, on the right arm within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing prasugrel for blood thinner. On 20Jan2021 03:00, the patient experienced really heavy chills, she was shaking really hard, she had muscle pain like the flu, joint pain, fever that started at 100.6 degrees Fahrenheit and worsened to 101.6 degrees Fahrenheit, nauseated, feeling unwell. The caller clarifies that all of the symptoms came on at once, around 3am. Just like when one catches the flu, all the symptoms came at one time. The patient reported that it felt like she had the virus (not specified) all over again. The chills had calmed down, but she was still cold. Where the injection was given it was real sore. She had been doing arm circles and such to keep her muscles loosened up. It was so stiff at one time last night (20Jan2021) that she thought, she could not move it. The clinical outcome of events chills was recovering; muscle pain, fever, nauseated, still cold was not recovered; joint pain, shaking really hard, feeling unwell, vaccination site pain, stiff, flu like symptoms was unknown.

Other Meds: PRASUGREL

Current Illness:

ID: 1000643
Sex: F
Age:
State: SC

Vax Date: 01/15/2021
Onset Date: 01/17/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: cough; started to feel chills; Fever; Upper respiratory infection; This is a spontaneous report. A contactable physician reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 15Jan2021 at SINGLE DOSE for covid-19 immunization. Patient does not have other relevant medical history. There were no concomitant medications. On 17Jan2021 21:00, the patient experienced upper respiratory infection. She experienced fever and started to feel chills on 18Jan2021. Then on an unspecified date, paient experienced cough. The outcome of events upper respiratory infection and fever was recovering whereas events cough and started to feel chills was unknown. Follow-up attempts are completed. The following information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 1000644
Sex: F
Age:
State: OK

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Stress on body; Little over weight- usually about 150 sometimes 162 around this time she was 162; Stage 3 kidney failure; High/Increased blood pressure; Outbreak of genital herpes; Hip pain bilateral; Extreme fatigue; on and off headaches/Intermittent headache; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history ongoing included sickle cell trait (diagnosed as a child, sickly as a child, found out in 2016. It was reported that patient has the sickle cell that mimics the disease), ongoing high blood pressure, and ongoing genital herpes, and pre-diabetes, all diagnosed prior to vaccination, and 'blood pressure'. Concomitant medication included chlorthalidone from 2018 and ongoing for 'blood pressure'. It was reported that patient got her first dose of Covid vaccine on 04Jan2021. Patient stated that she has been experiencing some effects, started maybe 2 days after, she began experiencing fatigue (06Jan2021). Patient also stated that she has genital herpes diagnosed before the vaccine, and stated that she usually doesn't have an outbreak unless there is extreme stress on body. On 08Jan2021, patient clarified she experienced a genital herpes outbreak and thought that it may associated. Patient stated that she treated it with valaciclovir (VALTREX) and some cream and it went away. States that she had another outbreak after, treated it again, and it went away and now she is struggling with another outbreak of genital herpes. Patient also reported that she has on and off headaches (also reported as intermittent headaches) on 04Jan2021, states this could be due to her high/increased blood pressure which she first experienced on 14Jan2021 (as reported). Patient mentioned that her blood pressure has been higher than it ever has been after the vaccine. Patient also stated that she noticed that after the vaccine it was out of control, that she got a blood pressure cuff and it was 149/103, she contacted her nephrologist, stated she is treating it with her usual diuretic and the doctor just prescribed her amlodipine (NORVASC). Patient further stated that she is still struggling to get the diastolic blood pressure in the 90s, stated this is abnormal for her. Also is experiencing severe hip pain bilateral on 08Jan2021 after the vaccine. Patient further reported that she was a little over weight - usually about 150 sometimes 162 around this time she was 162. Patient clarified that her current weight is 159.2 and stated that she was diagnosed with sickle cell trait and stated that she has the kind that mimics the disease and will have a lot of side effects of sickle cell disease. Patient further added that she also has stage 3 kidney failure on 18Jan2021 due to either her high blood pressure or sickle cell trait and is also pre-diabetic. Patient also thought that the outbreak was associated with stress on body. Patient wanted to know if she refuses the second vaccine, if the first vaccine will do anything. Outcome of the events 'Stage 3 kidney failure', 'High/Increased blood pressure', 'Outbreak of genital herpes', and 'on and off headaches/Intermittent headache' was not recovered, outcome of the event 'extreme fatigue' was recovered on 06Jan2021, outcome of the event 'hip pain bilateral' was recovering, outcome of the remaining events was unknown.; Sender's Comments: The reported stage 3 kidney failure was due to either the pre-existing high blood pressure or sickle cell trait or prediabetic condition, and was unrelated to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).

Other Meds: CHLORTHALIDONE

Current Illness: Blood pressure high; Genital herpes; Sickle cell trait

ID: 1000645
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: a "significant discomfort" on her lower back also described as being "pretty painful"; a "significant discomfort" on her lower back also described as being "pretty painful"; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no previous back injuries. On an unspecified date in Jan2021, the patient experienced a significant discomfort to her lower back also described as being "pretty painful" during the first two days post vaccination. The clinical outcome of a "significant discomfort" on her lower back also described as being "pretty painful" was resolving, reported as "much better today" and "almost" gone. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1000646
Sex: M
Age:
State: AL

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Oxygen saturation low/ checked his oxygen level and it was 78 and then after a few minutes it was 86 and 88; Fever of 102 F for 4 days; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (Unknown if given intramuscularly) on 15Jan2021 09:30 at a single dose on left arm below shoulder for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient experienced fever of 102 for 4 days on 16Jan2021 14:00 and oxygen saturation low on 20Jan2021 12:00 (reported as "12:00 - 12:30"). He received first dose 15Jan2021. He has not had a cough, but had 102 degree Fahrenheit fever for 4 days, so he had to stay home from work. He had to get a COVID test and it was negative today (unspecified date). While he was there, they checked his oxygen level and it was 78 and then after a few minutes it was 86 and 88. There was no prescriber. He received it at a healthcare facility. He is supposed to go back to get second dose on 05Feb2021. It is unknown if it was given intramuscularly. The outcome of the events was not recovered. NO ER or physician's office required. He is to follow up with his general practitioner, but he has not gone yet. No prior vaccinations (within 4 weeks) and no adverse event following prior vaccinations. No additional vaccines administered on same date of the Pfizer Suspect. Vaccination facility type was Hospital. Family medical history includes, Father is Diabetic and mother has colon cancer.

Other Meds:

Current Illness:

ID: 1000647
Sex: F
Age:
State: DE

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Hot flashes; Chills; Body aches; Migraine; Neck pain; Fatigue; This is a spontaneous report from a non-contactable Nurse. A non-pregnant 22-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3246), intramuscular in the right arm on 11Jan2021 at 11:30 AM (at the age of 22-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), intramuscular, right arm on 21Dec2020 for COVID-19 immunization. On 11Jan2021 at 23:30 PM, the patient experienced hot flashes, chills, body aches, migraine, neck pain, and fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events hot flashes, chills, body aches, migraine, neck pain, and fatigue was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1000648
Sex: F
Age:
State:

Vax Date: 01/19/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: a little arm soreness; This is a spontaneous report from a contactable consumer (patient). This female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: unknown), via unknown route of administration, on 19Jan2021 as a single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On Jan2021, the patient reported that she took the 1st vaccine yesterday. She did not have any problems other than a little arm soreness. The outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1000649
Sex: F
Age:
State: WI

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: her arm was sore and hurting; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284 /expiration date: not provided), via intramuscular route of administration, on 29Dec2020 10:15 AM (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was none. Concomitant medication was not provided. On an unknown date, the patient experienced her arm was sore and hurting. The outcome of the event her arm was sore and hurting was unknown.

Other Meds:

Current Illness:

ID: 1000650
Sex: F
Age:
State:

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1000651
Sex: F
Age:
State: WI

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Site:

Lab Data:

Allergies:

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

Symptoms: chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm is killing her; pain was in her body/whole body was killing her; not able to walk; whole body joint pain; feeling cold and warm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), intramuscular on the left arm on 19Jan2021 10:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiry date not reported), intramuscular on the left arm on 29Dec2020 10:15 for COVID-19 immunization and experienced arm was sore and hurting. The patient reported that she just got the second dose of the vaccine yesterday (19Jan2021). She had a really bad side effects. With the first dose only her arm was sore and hurting, states it was nothing, she did not have side effects. With the second dose her left arm is killing her on 19Jan2021. She clarifies the side effects that she is experiencing are whole body joint pain and muscle pain on 19Jan2021, chills on an unspecified date, nausea on 20Jan2021, headache on an unspecified date, and she is very, very tired on 19Jan2021. She received the second dose of the vaccine around 10:15 am yesterday and she went to work and she was ok. About 12 hours later on 19Jan2021 she started feeling bad, by 10-10:30pm her whole body was killing her and she was not able to walk. Around 11:15pm she had to talk to her supervisor since she was not able to work. She was experiencing the whole body pain and muscle pain. She did not have nausea or dizziness last night. She could not sleep last night, she was not comfortable in bed since she was in pain, her pain was in her body. She started feeling dizzy and nauseous this morning (20Jan2021) when she was getting out bed. States she could not even drive, she wish she had someone that could have picked her up from work since it was horrible. She reported all night she was feeling cold and warm, yesterday she felt warm and she thought she had a fever and when she checked her temperature she did not have a fever. Her temperature this morning was 97.5. Right now she feels freezing, the chills. The patient underwent lab tests and procedures which included body temperature: 97.5 on 20Jan2021. The patient did not recover from her left arm is killing her, whole body joint pain, feeling cold and warm, muscle pain, nausea, very tired, and dizziness while the outcome of the rest of the events was unknown.

Other Meds:

Current Illness:

ID: 1000652
Sex: F
Age:
State:

Vax Date: 01/16/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

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

Symptoms: Caller had the second shot 16Jan2021 and was tested today 20Jan2021 and now she is back positive.; Caller had the second shot 16Jan2021 and was tested today 20Jan2021 and now she is back positive.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 26Dec2020 (first dose; Batch/lot number: EL5738) at single dose into right arm and on 16Jan2021 (second dose LOT EL3248) at single dose into left arm. Medical history was none. Concomitant medication included gummy bear vitamins, no further details provided. Patient did her first COVID test on 16Dec2020, prior to getting the vaccination, and was negative. Patient got the first dose of the vaccine on 26Dec2020 and on 30Dec2020 tested positive (via COVID-19 PCR test) for Covid. She was tested negative on 03Jan2021 and 04Jan2021 (both COVID-19 PCR tests). Patient had the second shot on 16Jan2021 and COVID-19 PCR test on 20Jan2021 was back positive. Patient clarified she got the injection twice, and each time she has gotten it and gotten tested after, each test was showing positive. She clarified that she went to a nursing home and was tested every 14 days when she went to see her mom and all times prior to getting the vaccine doses she was negative. She said her first dose of the vaccine was on 26Dec2020, then four days after that it was time to go get tested to go see her mom and the test was positive within no time it lights up. She said as a medical worker (she was a patient registration clerk at the emergency room- ER) she can wait 5 days after that for it to come up after being positive and after that if it was showing up negative she had to wait 24 hours to confirm negative test and repeated the test within 24 hours, which was negative too. She got the second dose on 16Jan2021 and then she went to go get tested to go back to the nursing home and again it came back positive. Outcome of the event was unknown. Patient wanted to know if this was a herd immunity vaccine and if the vaccine had covid in it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051224 same patient, different dose

Other Meds:

Current Illness:

ID: 1000653
Sex: M
Age:
State: MN

Vax Date: 01/21/2021
Onset Date: 01/25/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
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Allergies:

Symptom List: Unevaluable event

Symptoms: Dramatic unexplained drop in INR from 2.9 on January 11, 2021 to 1.3 on January 25, 2021; This is a spontaneous report from a contactable consumer (patient). This 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231) via an unspecified route of administration in the right arm on 21Jan2021 at 09:45 at single dose for COVID-19 immunisation. Vaccination facility type: urgent care center. The patient did not receive other vaccines in four weeks. Relevant medical history included recent stroke, cardiac failure congestive, chronic obstructive pulmonary disease, chronic renal failure, diabetes, high cholesterol, SP aortic valve replacement, atherosclerotic cardiovascular disease and COVID-19 (the patient had COVID-19 prior to vaccination). Concomitant medications included hydralazine, carvedilol, warfarin and isosorbide. On 25Jan2021 at 09:00, the patient experienced dramatic unexplained drop in INR from 2.9 on 11Jan2021 to 1.3 on 25Jan2021. The event resulted in life-threatening illness (immediate risk of death from the event). Corrective treatment taken as a result of the event included subcutaneous enoxaparin sodium (LOVENOX) twice daily. The patient was not tested for COVID-19 after the vaccination. At the time of the report, the outcome of the event was unknown.

Other Meds: HYDRALAZINE; CARVEDILOL; WARFARIN; ISOSORBIDE

Current Illness:

ID: 1000654
Sex: F
Age:
State: TN

Vax Date: 01/11/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Vax Site:

Lab Data:

Allergies:

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

Symptoms: white mucous stools with blood; abdominal pain; tenesmus; white mucous stools with blood; fatigue; chills; headache; temp 99.5; This is a spontaneous report from a contactable nurse. This 58-year-old female Nurse (Patient) reported that A 36-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19 pfizer, Lot#: EL3246), via an unspecified route of administration on 11Jan2021 01:00 PM on Right arm at single dose for COVID-19 immunisation. She is not pregnant. Medical history was none. Known allergies: NKA. Facility type vaccine was other. No other vaccine in four weeks. Concomitant medications included thyroid (ARMOUR THYROID), estrogens conjugated/medroxyprogesterone acetate (PREMPRO), Regular vitamin. 4:00 am on 20Jan2021 woke with abdominal pain, tenesmus, white mucous stools with blood, fatigue, chills, headache, Temp 99.5 called physician told it sounds like reaction. Took Tylenol 500 mg for symptoms. 21Jan2021 feel better but still mucous blood stools dr wants to see me monday 25Jan2021 if still having blood. AE resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with lasting effects. Treatment received. No COVID prior vaccination. No COVID tested post vaccination.; Sender's Comments: Based on the information currently available and in absence of strong confounding factors, a possible contributory role of the suspect BNT162B2 in triggering the onset of blood stool cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: ARMOUR THYROID; PREMPRO

Current Illness:

ID: 1000655
Sex: F
Age:
State: MN

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: tired; head feels fuzzy; throat and neck pain; throat and neck pain; hurts to swallow; Low grade fever/low grade temp of 99.4; Headache; body aches; This is a spontaneous report from a contactable Nurse (patient). A 26-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left deltoid on 20Jan2021 11:00 at 0.3 mL, single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient received her first dose yesterday at 11:00am. She was talking to someone and all of a sudden she got throat to neck pain that was intense that lasted two minutes on 21Jan2021. It has been about 10-15minutes since and if she hold her neck straight she is fine, but if she looks up it hurts. She can breathe fine. It hurts to swallow all of a sudden on 21Jan2021. Asking if it is normal to experience this. She had a low grade fever/low grade temp of 99.4, body aches, and a headache that started today 21Jan2021. She received Tylenol as treatment. States she is a nurse and she is tired. Her head feels fuzzy, she has not taken her temperature recently and it still hurts to swallow. The events did not require a visit to emergency room or physician office. Relatedness of drug to events from reporter for throat and neck pain, hurts to swallow, low grade fever, headache, body aches was reported as related. Reporter seriousness for throat and neck pain and hurts to swallow was medically significant. Event outcome of throat and neck pain was recovered, of hurts to swallow was not recovered, of others was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The reported events were likely causally related to the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. However, it is worth noting that the reporter/user of the vaccine was nurse, and her tiredness from job could have confounded with the events. 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: 1000656
Sex: F
Age:
State: TN

Vax Date: 01/19/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: fever of 100.6; chills; fatigue that lasted 36 hours.; This is a spontaneous report from a contactable consumer. This 34-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: Unknown), second dose, via an unspecified route of administration on 19Jan2021 at 10:30 (at the age of 34-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication was reported as none and no other medications were received within 2 weeks of the vaccination. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK9231), dose #1, via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 vaccination. On 20Jan2021, the patient received her second dose and experienced fever of 100.6 degrees Fahrenheit, chills and fatigue that lasted 36 hours. No therapeutic measures were taken as a result of the events. The clinical outcomes of the fever of 100.6 degrees Fahrenheit, chills and fatigue were resolved on unspecified dates in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1000657
Sex: F
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

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

Symptoms: Had heartburn like she was going to have a heart attack; Intense GERD; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose BNT162B2 via an unspecified route of administration on 21Jan2021 12:50 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had first COVID shot today (21Jan2021) at 12:50. Was doing fine, arm wasn't even sore. While eating dinner started having intense GERD on 21Jan2021. Had heartburn like she was going to have a heart attack. Took a Famotidine, but it didn't do anything. Took one of a Pepto Bismol Ultra at about 5:30PM. Starting to get some relief, but just didn't know whether she is going to be relieved throughout the night. Wants to know whether she should go to an urgent care facility to give her something to quiet it down. Events outcome was recovering. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1000658
Sex: M
Age:
State: TN

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Stroke; leukemia; This is a spontaneous report from a contactable consumer. This consumer reported for a 68-year-old male (consumer's husband) received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EL0140, Expiry Date: Mar2021), via an unspecified route of administration on 31Dec2020 13:30 at single dose on right upper shoulder for COVID-19 prophylaxis. Medical history included smoker for 50 years, and blockage in his carotid artery. His grandma died of a stroke and his folks, his dad died of lung cancer and his mom died of uterine cancer. Both his parents had high blood pressure. His dad had a heart attack and his mom had Parkinson's because her hands would shak. There were no concomitant medications. On the 08Jan2021 at about 8PM he had a massive stroke and they had to life flight him to hospital from 08Jan2021 to 19Jan2021. He did have a blockage in his carotid artery but they have been told. She says her husband just had his second vaccine with lot is EL1283 and exp is Apr2021 and all of this could be a coincidence but he told her to call so that was why she was calling. Also he was diagnosed with, it is 4 words and then leukemia and he had an appointment with doctor to get his blood drawn every 2 weeks. The neurosurgeon that did surgery on him on 09Jan2021 at 4 am said that his carotid artery in his neck was plugged and he went in and cleaned it out and put in a stent and he said that his carotid artery was plugged all the way to his temple and he tried to get that out and couldn't. He had his stroke at 8PM on the 08Jan2021. They had dinner at 5 pm and at 6pm they were sitting on the couch and all of sudden he started slurring his words and he said his mouth felt like someone give him Novocain and then he had his arm around her and all of sudden it felt like he was choking her so she grabbed his hand and his fingers started rolling up, started closing up tight so she started playing with his fingers and then he went out in the kitchen and then he hit the floor and she called # and the paramedics came up there. When they got there he could squeeze both hands and lift both feet by that time it was 7:30, they had just brought in a chair, by time they got done bringing in the chair they realized his left side was becoming paralyzed and so they had to go back and get the stretcher so they were there for about 30 minutes, maybe 15 minutes then they headed up the hill toward the hospital at about 8pm and they came in and gave anti-blood clotting medicine and took him for a scan with dye, they found he still had a blockage on his brain so at 2AM on the 9th they came in with a medical helicopter and flew him to (institution name withheld) in (place name withheld) and they did an MRI on and seen his carotid blockage there so he had emergency surgery at from # that morning of the 09Jan2021 at (institution name withheld) and he was in ICU from Saturday until a week ago at 3 oclock 13Jan2021 he was placed in a regular room and on the 19Jan2021 at 7:30PM he was moved (hospital name) in (place name withheld) for 14 days having 15 hours per day of therapy for a week and then he will go to (place name withheld) (rehab name withheld) and he could be there 2-3 weeks. Wednesday right before they moved him he needed a therapist in the back and one in the front and a 6 inch belt to help him stand up. He started out 08Jan2021 and was put in (institution name withheld) on the 09Jan2021 and then he was discharged to rehab on the 19Jan2021 7:30 pm She has been told it may take up to year for recovery as much as he can. The week of his stroke they were adding on to his home and he was doing the electrical upstairs so it is not like he just sat around and ate bon bons, he was very active. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1000659
Sex: F
Age:
State: CO

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Numbness and tingling in both feet and lower extremities; Numbness and tingling in both feet and lower extremities; This is a spontaneous report from a contactable Registered nurse reporting for herself. A 26-years-old female patient received the first dose BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL3302, via an unspecified route of administration in right arm on 19Jan2021 at 17:30, at 26 years of age, at single dose for COVID-19 immunization as she was a front line worker. The vaccine was administered at the facility where the patient works. The patient had no relevant medical history and no concomitant medications. On 19Jan2021, about 20 minutes after receiving the vaccine dose (also reported at 18:00) she started having nonstop numbness and tingling in both feet and lower extremities, which has been going on for 46 hours straight. The events were assessed as medically significant, although a visit to emergency room or physician office was not required. The nurse reported that a doctor mentioned Guillain-Barre Syndrome which can lead to progressive muscle weakness and damaged nerves and she is severely concerned, although she has no health history. At the time of the report the reported events had not recovered yet. The reporter assessed the event related to BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Method of assessment: Global Introspection).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1000660
Sex: F
Age:
State: MI

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Tested positive for having the Covid Virus; Tested positive for having the Covid Virus; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer reported that a 20-year-old female patient (reporter's daughter) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received the first dose on 04Jan2021 or 05Jan2021 and was tested positive for having the COVID-19 virus. They want to know when and if she can get the second dose. She returned to school and she took the spit swab that the university was requiring for all students. She took it on Saturday or Sunday (unspecified dates in Jan2021) and she got the result yesterday morning and it was positive. It was reported that she was currently isolated, she went home, she was fine and everything. It was also stated that she is asymptomatic and she really has no signs. Outcome of the events was unknown. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1000661
Sex: M
Age:
State: FL

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Cardiac Arrest; Ventricular Fibrillation; This is a spontaneous report from a contactable physician reporting for a patient. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) in two weeks. It was unknown if the patient received Other vaccine in four weeks, if patient had Covid prior vaccination, if Covid was tested post vaccination. Patient went for Running after returning home suffered Cardiac Arrest, Ventricular Fibrillation on 28Jan2021, CPR (Cardiopulmonary resuscitation) by Wife, Intubated by EMS (Emergency Medical Service) brought to the Hospital. The adverse events resulted in visiting Emergency room/department or urgent care and Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of cardiac arrest and ventricular fibrillation which included CPR and Intubated. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac arrest and ventricular fibrillation 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: ASPIRIN [ACETYLSALICYLIC ACID]; LISINOPRIL HCTZ

Current Illness:

ID: 1000662
Sex: F
Age:
State: OH

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Headache; Horrible calf pain bilaterally; I could barely walk; Horrible calf pain bilaterally; I could barely walk; Major injection site soreness; my arm started getting super sore; Major injection site soreness; my arm started getting super sore; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) at left deltoid on 18Jan2021 12:45 PM at single dose for COVID-19 immunisation in Hospital. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), just the Vitamins and supplements. Patient was just calling to report the side effects to the Covid 19 vaccine, major injection site soreness, she was having headache today (19Jan2021) and horrible calf pain bilaterally. the first dose was 18Jan2021 and due date of second dose was 08Feb2021. As of causality, nurse practitioner stated Yes, yesterday (18Jan2021) her arm started getting super sore and it kept getting worse and then she woke up this morning and she could barely walk because her calf pain is so bad, in both of her legs. Treatment include she have taken Advil, she took 600 mg today and she took 400 mg last night. As Results of Lab work, she stated she don't have it. She asked if anyone had the calf pain with it. Patient was not recovered from the events. Event relatedness for Covid 19 vaccine with Major injection site soreness; my arm started getting super sore and Horrible calf pain bilaterally; I could barely walk were Related. Relatedness of drug to Major injection site soreness; my arm started getting super sore, Headache, Horrible calf pain bilaterally; I could barely walk per Source of assessment: Source of assessment. Method of assessment: Global Introspection. Drug result: Related.

Other Meds: VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]

Current Illness:

ID: 1000663
Sex: F
Age:
State: FL

Vax Date: 01/10/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

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

Symptoms: Got tested and came positive after receiving first vaccine; Got tested and came positive after receiving first vaccine; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; Had reaction; bad arm swelling and pain; worst I couldn't even lift or move my arm; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported similar events in two patients. This is the first of two reports. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not reported), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included vitamins nos. It was reported that both the patient and her husband received the Pfizer Vaccine on 10Jan2021; and they had reaction to it. They both both had bad arm swelling and pain. Her was worst she couldn't even lift or move her arm. At first, they just thought it was a reaction as they read reactions could be and then she started to get small cough but by Friday, her husband went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday, they both went and got tested, they did the rapid and they did what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. So, she thought they need to know that they got sick and it was after the vaccine. The patient needed to ask a question as they were supposed to go for their second vaccine on 31Jan2021 and do they do it even though they got sick. They knew they were claiming that they can't get sick because of the vaccine but it's very ironic that they did get this. They had been following CBC guidelines, both her husband and the patient because they are older and they wear mask all the time and they did everything they needed to and they could not understand how they got this. The patient underwent lab tests and procedures which included Rapid and PCR: positive in Jan2021. Therapeutic measures were taken as a result of "bad arm swelling and pain; worst she couldn't even lift or move her arm" which included treatment with Tylenol. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092094 same reporter and drug, similar events in a different patient

Other Meds: VITAMINS NOS

Current Illness:

ID: 1000664
Sex: M
Age:
State: FL

Vax Date: 01/10/2021
Onset Date:
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

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

Symptoms: Tested positive after receiving the vaccine; Tested positive after receiving the vaccine; bad arm swelling and pain; bad arm swelling and pain/leg pain; not feeling well having severe back pain; not feeling well; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events in two patients. This is the second of two reports. A 67-year-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included vitamins nos. It was reported that the patient as well as the reporter had bad arm swelling and pain. By Wednesday the patient was not feeling well he was having severe back pain and leg pain and what not. At first they just thought it was a reaction as they read reactions could be and then the reporter started to get small cough but by Friday the patient went and got tested and on Wednesday he was tested positive and this is after the vaccine and then he got the results and it said he was positive. So, Saturday they both went and got tested, they did the rapid and what they call the PCR, and they both came positive for both of them and this was after they receive the first vaccine. The patient underwent lab tests and procedures which included Rapid and PCR: positive on Jan2021. Therapeutic measures were taken as a result of bad arm swelling and pain, not feeling well having severe back pain and leg pain which included treatment with Tylenol. The outcome of the events was unknown. Information on Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092066 same reporter and drug, similar events in a different patient

Other Meds: VITAMINS NOS

Current Illness:

Date Died: 01/20/2021

ID: 1000665
Sex: M
Age:
State: FL

Vax Date: 01/18/2021
Onset Date: 01/20/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Death 2 days later; This is a spontaneous report from a contactable Other HCP. A 97-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular in the left arm on 18Jan2021 12:00 PM at single dose for covid-19 immunisation. Medical history included prostate cancer, macular degeneration, type 2 diabetes, atrial fibrillation. No known allergies. Concomitant medications included glipizide, warfarin and metformin in two weeks. The patient had no other vaccine in four weeks. The patient experienced death on 20Jan2021 at 09:00 PM. Death cause was undetermined. No autopsy was performed. No treatment was received for AE. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the event was fatal.; Sender's Comments: Event unknown cause of death is assessed as Related until sufficient information is available to confirm an unrelated cause of death or if there is sufficient information to allow an unrelated causality assessment. Case will be reassessed when follow-up information is received. 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.; Reported Cause(s) of Death: Death 2 days later

Other Meds: GLIPIZIDE; WARFARIN; METFORMIN

Current Illness:

ID: 1000666
Sex: U
Age:
State:

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

Vax Type:
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Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: confirmed about a blood clot/check me for a blood clot, I didn't have one but it was kind of like a thrombosis kind of thing; Both of my legs, lower part of my legs were swollen that night when I went to bed and they got really red, almost purply red; Both of my legs, lower part of my legs were swollen that night when I went to bed and they got really red, almost purply red; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer stated that after the first vaccine and it might be coincidental, the patient was not sure because the patient didn't know what to expect. Both of the patient's legs, lower part of the patient's legs was swollen that night (unspecified date) when the patient went to bed and they got really red, almost purply red and the patient stayed that way for a couple of days. The patient went to see the doctor two days later and doctor confirmed about a blood clot, so they did check the patient for a blood clot; the patient didn't have one, but it was kind of like a thrombosis kind of thing. So, the doctor put the patient on antibiotics for that. The patient asked if it is related to the shot, the patient didn't know it happened the same day the patient got the shot; so, the patient didn't know about that. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1000667
Sex: F
Age:
State: OK

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

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

Symptoms: Breakout in fever blisters all over my mouth; usually happens when my body is under stress like that; local tenderness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot EL3249), via an unspecified route of administration, on 12Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunization.The facility where COVID-19 vaccine was administered was at a hospital. Medical history included pain and anxiety depression from an unknown date and unknown if ongoing. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; PARACETAMOL]) for pain and desvenlafaxine succinate (PRISTIQ) for anxiety and depression. On Jan2021, the patient experienced local tenderness and on 18Jan2021, the patient experienced breakout in fever blisters all over her mouth, stating this usually happens when her body is under stress like that. Therapeutic measures were taken as a result of local tenderness and breakout in fever blisters all over my mouth (anti-fever blister type medicine). The clinical outcome of the events fever blisters all over her mouth and local tenderness were unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]; PRISTIQ

Current Illness:

ID: 1000668
Sex: F
Age:
State: TN

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

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

Symptoms: Super tired/exhausted; This is a spontaneous report from a contactable consumer (patient). This 90-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and expiry date unknown), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included blood cholesterol abnormal and thyroid disorder. Concomitant medications included levothyroxine for thyroid, atorvastatin for cholesterol, and unspecified vitamins. When she got the first dose of the vaccine, she felt fine when she got it in the morning and then she felt super tired later in the evening. She went to bed about an hour early as she was just exhausted. She stated that at her age, she was always tired in the evening but she was just exhausted that evening. She got "no temperature". The patient felt fine/normal the next day. She felt as good as she usually did. She did not receive treatment for the event. Due date for the second dose was reported as 28Jan2021. Outcome of the event was recovered on 07Jan2021.

Other Meds: LEVOTHYROXINE; ATORVASTATIN

Current Illness:

Date Died: 01/26/2021

ID: 1000670
Sex: F
Age:
State: AL

Vax Date: 01/19/2021
Onset Date: 01/01/2021
Rec V Date: 02/04/2021
Hospital: Y

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: she was hurting at her chest/ Chest pain; on her left arm hurt real bad that's what the clot on her left arm; on her left arm hurt real bad that's what the clot on her left arm; She passed away; heart attack; This is a spontaneous report from a contactable consumer. An 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus, for which she was taking a pill like an hour before she would take her meal. On Monday (Jan2021) the patient experienced was hurting at her chest/ chest pain, her left arm hurt real bad as she had a blockage in her left arm/clot on her left arm, and they wanted to put in a stent and after the surgery it went well and she all go home in two days. The patient was hospitalized in Jan2021 due to the events. She had a heart attack and that the chamber between the dividers had a hole in it and her heart tissue was too thin so much thin she couldn't repair it. The patient passed away on 26Jan2021. The patient was tested negative for COVID-19 on unknown date. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: She passed away

Other Meds:

Current Illness:

ID: 1000671
Sex: F
Age:
State: IL

Vax Date: 01/09/2021
Onset Date: 01/11/2021
Rec V Date: 02/04/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

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

Symptoms: re-dislocated right shoulder; This is a spontaneous report from two contactable physicians. A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration on 09Jan2021 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Vaccine was not administered at a military facility. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (at the age of 54-year-old) lot number: EK5730, intramuscularly at the left arm on 19Dec2020 at a single dose for COVID-19 immunization and experienced fractured and dislocated rt shoulder while doing exercise on 20Dec2020 0930 and torn labrum on 24Dec2020. The patient had no history of previous immunization. The patient is not deceased. Patient had no other prior vaccinations within four weeks. The patient experienced re-dislocated right shoulder on 11Jan2021 15:50 but did not require hospital admission. Therapeutic measure was taken as a result of the event which included wearing brace and surgery tentative. Outcome of the event was not recovered. It was reported that there was a reasonable possibility that the event is related to suspect product.; Sender's Comments: Based on the available information the event "re-dislocated right shoulder" is attributed to an underlying medical condition and assessed unrelated to BNT162B2 vaccine. 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: 1000672
Sex: U
Age:
State: NY

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

Vax Type:
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Lab Data:

Allergies:

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

Symptoms: tested positive after receiving the first shot of the Covid-19 vaccine; tested positive after receiving the first shot of the Covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse. This nurse reported similar events for three patients. This is the second of three reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0140; Expiration date: Mar2021), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive after receiving the first shot of the covid-19 vaccine. The patient underwent lab tests and procedures which included a positive Covid-19 test on an unspecified date. The outcome of tested positive after receiving the first shot of the covid-19 vaccine was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive based on the known safety profile. However the short duration of 3 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.,Linked Report(s) : US-PFIZER INC-2021050427 Same reporter, drug and event; different patient;US-PFIZER INC-2021104537 Same reporter, drug and event; different patient

Other Meds:

Current Illness:

ID: 1000673
Sex: M
Age:
State: CA

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

Vax Type:
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Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Neurological concerns with parsons turner syndrome; sharp pain down middle of shoulder blade; difficulty snapping fingers; pain; Initial information received on 21-Jan-2021 regarding an unsolicited valid non-serious case from a other health professional. This case involves male patient (age unknown) who experienced neurological concerns with parsons turner syndrome (neuralgic amyotrophy), sharp pain down middle of shoulder blade (arthralgia),difficulty snapping fingers (musculoskeletal stiffness) and pain, after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (clarifying with patient prefilled syringes or MDV- Multidose vial), lot number and expiration not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious neurological concerns with parsons turner syndrome (neuralgic amyotrophy), sharp pain down middle of shoulder blade (arthralgia), difficulty snapping fingers (musculoskeletal stiffness) and pain, few weeks after receiving INFLUENZA QUADRIVAL A-B VACCINE. No laboratory data reported. Patient had to start steroids. At the time of reporting, the outcome was unknown for all the events. Reporter was investigating more on vaccine to see what strains it covers, had no way of knowing if cause or effect from vaccine. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1000677
Sex: F
Age: 23
State: MA

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

Vax Type:
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Lab Data:

Allergies: N/A

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

Symptoms: Vasovagal syncope intermittent for 45 minutes, still present but remaining in a laying position

Other Meds: Sertraline 50mg QD, probiotic, iron supplement

Current Illness: N/A

ID: 1000678
Sex: M
Age: 58
State: CA

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

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

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

Symptoms: This patient was given a second dose of the Moderna Covid vaccine on 4/3/21 with the vaccine administrator unknowingly unaware that the first dose had already been administered the day before on 4/2/21. The patient did not have any significant immediate side effect but the patient will be checked by the yard physician today 4/4/21 to reevaluate the patient.

Other Meds:

Current Illness:

ID: 1000679
Sex: F
Age: 58
State: PA

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

Vax Type:
Manufacturer:
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Lot:
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Lab Data:

Allergies:

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

Symptoms: 12 hours post-injection recipient developed a low-grade fever, body aches, and headache that lasted about 24 hours.

Other Meds:

Current Illness:

ID: 1000680
Sex: M
Age: 78
State: IN

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

Vax Type:
Manufacturer:
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Lab Data:

Allergies: cipro et al

Symptom List: Vomiting

Symptoms: Intermittent sharp pain in top of skull began yesterday and has moved to intermittent sharp pain in right ear. No treatment. Just waiting to see if it subsides

Other Meds: prednisone, irbesarten, lasix, fenesteride, flomax, baclofen, temazepam, requip, vit d, potassium, cranberry

Current Illness:

ID: 1000681
Sex: F
Age: 73
State: FL

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies: Steroids, opiates, codeine, sulphur, dilaudid, highly sensitive to epi Foods allergies are peanuts and shell fish

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Red, warm, swollen, hard lump at injection site

Other Meds: Lecothyroxin, Xarelto, timolol, metropolol

Current Illness:

ID: 1000682
Sex: F
Age: 67
State: MD

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
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Lab Data:

Allergies: none

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

Symptoms: left arm very sore several hours after vaccine and even more sore the next day

Other Meds: none

Current Illness: none

ID: 1000683
Sex: F
Age: 61
State: NY

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: tetracycline preservative to flu shots some metals

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Redness numbness and tingling in both hands Increases when hands are pointed down improves when lifted above the heart Is lessening but is clearly not listed as a side effect It is improving however is concerning more information and direction needs to be addressed several other coworkers have experienced or went to the ED with the same adverse effect. It is clearly not life threatening but I hope it will not increase with the second dose or continue in the future

Other Meds: synthroid botox biotin Multivitamin cortisone injections, latisse protonix

Current Illness: autoimmune hypothyroid, psoriasis, gerd.

ID: 1000684
Sex: F
Age: 70
State: CO

Vax Date: 02/01/2021
Onset Date: 02/03/2021
Rec V Date: 02/04/2021
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Allergies: MRI Dye - Anaphylactic Antibiotics - Approximately 5 different antibiotics

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

Symptoms: Noticed aching in left hip/leg. Was out shopping and the pain progressively got worse by the time I got home was having trouble even walking. The pain seemed to be in whole leg and seemed to be muscular and also a lot of pain in hip joint area. Also was feeling a burning and numbness sensation down my leg. By 7pm was in bed because it was too painful to walk. Took 600 mg of Ibuprofen. This morning the hip pain is better and I am walking ok. I still have burning and numbness mostly in the calf area of left leg. I am also feeling burning and numbness on the left area of my lip. This is an area of my lip where I have had cold sore in past but don't see a cold sore.

Other Meds: Synthroid 100mcg Cytomel 2.5 mcg Magnesium 400mg.

Current Illness: I was tested for covid about a week before the vaccine. Had served on a Jury a week prior and about a week later had symptoms of sore throat, headache and fatigue. Test was negative for covid

ID: 1000685
Sex: F
Age: 58
State:

Vax Date: 12/24/2020
Onset Date: 12/25/2020
Rec V Date: 02/04/2021
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Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Headache Tongue sore; site tenderness; throat congestion Narrative: 12/25 tenderness at injection site Mild headache Tongue sore 12/26 tenderness at injection site Tongue white Visible sores under tongue...difficult to eat....very sore Throat congestion Mod headache.....took ibuprofen 3-4 times 12/27 Tongue very sore ...sores under tongue and on top and sides of tongue. Difficult to eat and talk Migraine headache.... Light sensitive...took Ibuprofen In bed majority of day Throat congestion 12/28 Exact same.....but tongue no longer white 12/29 Migraine Sores on top of tongue are gone. Sores remain under tongue and on sides of tongue Throat congestion gone 12/30 mild headache upon awakening.....back to work today 2 sores under tongue...all others are gone

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am