VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1294666
Sex: F
Age:
State: VA

Vax Date: 01/07/2021
Onset Date: 03/23/2021
Rec V Date: 05/07/2021
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: disseminated shingles; This is a spontaneous report from a contactable nurse (the patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration in the left arm on 07Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: Sjogren's syndrome, Hashimoto's thyroiditis, HBP (high blood pressure), Vit D deficiency, and Vit B deficiency. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications were reported as normal everyday medications, not specified. The patient previously took and had known allergies to hydroxychloroquine sulfate (PLAQUENIL) and BUPROPION HYDROCHLORIDE (WELLBUTRIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration in the left arm on 17Dec2020 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. On 23Mar2021, the patient was diagnosed with disseminated shingles. Treatment included valaciclovir hydrochloride (VALTREX) and steroids. The outcome of the event was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Reported event of Disseminated varicella zoster vaccine virus infection is most likely an intercurrent condition and unrelated to BNT162B2 vaccine. Case will be reassessed upon receipt of additional information. 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: 1294667
Sex: F
Age:
State:

Vax Date: 04/08/2021
Onset Date: 04/01/2021
Rec V Date: 05/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Received the first dose of the Pfizer COVID-19 vaccine and tested positive for COVID-19; Received the first dose of the Pfizer COVID-19 vaccine and tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 08Apr2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID-19 vaccine on 08Apr021 and next dose is due on 29Apr2021. In Apr2021, the patient tested positive for COVID-19 and wanted to know the timing of the second dose. The outcome of the events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Other Meds:

Current Illness:

ID: 1294668
Sex: M
Age:
State: NY

Vax Date: 04/12/2021
Onset Date: 04/13/2021
Rec V Date: 05/07/2021
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: Decreased blood platelet counts; spiked up glucose; immobility; foot joint pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 43-years-old via an unspecified route of administration, administered in arm left on 12Apr2021 11:30 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Medical history included blood cholesterol increased (other medical history: High cholesterol) from an unknown date and unknown if ongoing. The patient has no covid prior to vaccination, has not been tested post vaccination and has no known allergies. There were no concomitant medications. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 43-years-old on 03Mar2021 11:00 (lot number: EN6204) on the left arm for covid-19 immunisation. The patient reported soon after his vaccination, he was in acute foot joint pain on 13Apr2021 03:45. Immobilized depending on she'll chair (for further clarification). His blood report on an unspecified date showed decreased blood platelet counts and spiked up glucose and so many other bio markers. He was on steroid and painkiller to manage the pain but he was not getting relief. New pains coming up. He was loosing lots of employment and fun actionable opportunities due this pain and immobility. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient underwent lab tests and procedure which included platelets: decreased and glucose: spiked up on an unspecified date. Therapeutic measures were taken as a result of foot joint pain and immobile which included steroid, Tylenol 3000 mg, Diclofenac 150 mg. The patient did not recover from the events.

Other Meds:

Current Illness:

ID: 1294669
Sex: F
Age:
State: OK

Vax Date: 02/26/2021
Onset Date: 02/27/2021
Rec V Date: 05/07/2021
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: All joints are inflamed, swollen and extremely painful.; All joints are inflamed, swollen and extremely painful.; All joints are inflamed, swollen and extremely painful.; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; This is a spontaneous report from contactable consumer (patient). A non-pregnant 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 26Feb2021 at 18:30 (at the age of 73 years old) (Lot Number: EN6202, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included lupus and known allergies to penicillin and cephalosphorins. Concomitant medications included prednisone; and boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN). The patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, unknown expiration) on 03Feb2021 at 20:30 in right arm for COVID-19 immunisation at the age of 73 years old. The patient experienced all joints are inflamed, swollen and extremely painful; and muscles, ligaments, tendons etc are also inflamed and painful on 27Feb2021 at 05:00. The patient not been able to exit her house. The events resulted in physician office visit. The patient received treatment for the events. The patient did not receive other vaccines in four weeks. The patient had not yet recovered from the events. The events were assessed as serious (disability). No follow-up attempts are possible. No further information is expected.

Other Meds: PREDNISONE; ESTROVEN

Current Illness:

ID: 1294670
Sex: F
Age:
State: CO

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 05/07/2021
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: she received the first dose of the Pfizer covid 19 vaccine on 07Apr2021 and was told it was ineffective because of the way it was stored.; she received the first dose of the Pfizer covid 19 vaccine on 07Apr2021 and was told it was ineffective because of the way it was stored.; she received the first dose of the Pfizer covid 19 vaccine on 07Apr2021 and was told it was ineffective because of the way it was stored.; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 14:00 (Lot number: UNKNOWN) at the age of 18 years, as a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she received the first dose of the Pfizer COVID-19 vaccine on 07Apr2021 and was told it was ineffective because of the way it was stored. She received notification that Covid-19 vaccine was stored incorrectly and that the vaccine was ineffective. The patient stated they informed her she needed to be revaccinated but did not tell her when. The patient wanted to know what Pfizer says about that. She wanted to see if Pfizer would recommended that she restart the Covid-19 vaccine series and get both doses of the Covid-19 vaccine. The patient reported that she was not getting much help on what she should do next. The clinical outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1294671
Sex: M
Age:
State:

Vax Date: 01/30/2021
Onset Date:
Rec V Date: 05/07/2021
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: getting infected with covid after the 1st dose; getting infected with covid after the 1st dose.; This is a spontaneous report from a contactable Pharmacist. A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 30Jan2021 (Lot number: UNKNOWN) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The pharmacist inquired that since it has been more than 6 weeks, whether the patient needs to restart the covid vaccine series after getting infected with covid after the 1st dose. The pharmacist would like to know whether the patient should get the 2nd dose of the covid vaccine or if his history of covid infection is considered the 2nd dose. The 1st dose was received on 30Jan2021 and he contracted covid between both doses so 2nd dose was postponed. The patient had lab tests which included sars-cov-2 test: infected on unspecified date. He has had several negatives since then. The clinical outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.

Other Meds:

Current Illness:

ID: 1294672
Sex: M
Age:
State: NY

Vax Date: 02/14/2021
Onset Date: 02/01/2021
Rec V Date: 05/07/2021
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: hearing loss; bad tinnitus in his left ear; This is a spontaneous report from a contactable consumer. A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on 14Feb2021 11:30 (Batch/Lot Number: EL9266; Expiration Date: 31May2021) as SINGLE DOSE (at the age of 39-year-old years) for covid-19 immunisation. The Patient received second dose in left arm on 07Mar2021 11:45 lot number: EN6201, expiration date: Jun2021. Medical history included ongoing asthma which was diagnosed when he was 9 years old. He states the he is also susceptible to chest infections. There were no concomitant medications. The patient experienced hearing loss (medically significant) on Feb2021 with outcome of not recovered and bad tinnitus in his left ear on Feb2021 with outcome of not recovered. The patient underwent lab tests and procedures which included acoustic stimulation tests: this morning it's in his right ear on 21Apr2021 and acoustic stimulation tests: hearing loss on 2021 the hearing loss was initially only in his left ear; magnetic resonance imaging: negative on unspecified date. He is an audio engineer and sound editor and that is how he makes his money. He states that today (21Apr2021) will make the 5th hearing test in total and his hearing hasn't gotten any better. Three weeks ago it was only the left ear and as of today the right (21Apr2021) ear is also being affected. Symptoms started in Left ear and are now in the right ear as well. An MRI was done and that was negative. He thinks it is related to the vaccine. The patient went to the physician office for treatment. The patient did not have additional vaccines administered on same date of the Pfizer Suspect. The patient had no prior vaccination within 4 weeks. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Asthma (was diagnosed when he was 9 years old. He states the he is also susceptible to chest infections.)

ID: 1294673
Sex: F
Age:
State: NY

Vax Date: 01/13/2021
Onset Date: 03/01/2021
Rec V Date: 05/07/2021
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: she will bruise in the drop of a hat; This is a spontaneous report from a contactable registered nurse (the patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3249), via an unspecified route of administration in the left deltoid on 13Jan2021 13:00 (at the age of 53-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: Von Willebrand's disease: diagnosed from when she was 8-years-old- when she was baby she went in for cleft palate repair and they gave her aspirin and she almost didn't survive, when she went for tooth removal the dentist suggested she get tested; mitral valve prolapse: diagnosed from when she was 13 or 15-years-old; Treacher-Collins' syndrome: diagnosed at birth. The patient had no family history. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730), via an unspecified route of administration in the right deltoid on 22Dec2020 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. No other vaccine was administered on the same date as the Pfizer vaccine. The patient had a history of Von Willebrand disease, but since getting her second vaccine dose on 13Jan2021, she has noticed that she has been bruising more easily, since Mar2021. This has continued for over a month now. It had never been an issue before. She didn't bruise easily, but since she got the vaccine, she noticed she will bruise in the drop of a hat (Mar2021). In the last couple of months, she has had bruises that she didn't have any idea where they came from. She noticed more bruising a month or a month half ago on the inside of the right forearm. Then probably two or three weeks ago, she noticed bruises on both her right and left thighs. Then yesterday, she went to give blood from the right anti cube, and she got a bruise from that. The bruises on her thighs were still there. She had her physical yesterday with her primary healthcare professional who stated he had seen a couple of people with this side effect. She asked whether she should get a booster third dose when it becomes available. The patient considered the event bruise in the drop of a hat to be medically significant. The outcome of the event was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bruise cannot be excluded. The medical history of Von Willebrand's disease may provide a plausible alternative explanation for the event. 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: 1294674
Sex: M
Age:
State: TX

Vax Date: 04/03/2021
Onset Date: 04/08/2021
Rec V Date: 05/07/2021
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: Pneumonia; Itchy, dry, non-productive cough; Itchy, dry, non-productive cough; Itchy, dry, non-productive cough; This is a spontaneous report from a contactable consumer (reporting for self). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),dose 1 via an unspecified route of administration, administered in Left Arm on 03Apr2021 (Batch/Lot Number: ER8732) as SINGLE DOSE (at the age of 63 years) for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (diagnosed for a decade), ongoing hypertension (diagnosed for a decade), ongoing type 2 diabetes mellitus (5-6 years ago diagnosed, very well maintained type 2 diabetes), ongoing pneumonia (He has been hospitalized 4 different times for pneumonia. In Dec2020 when he had pneumonia, they did not hospitalize him. He has had pneumonia 5 time since 1982. Concomitant medication included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. "He gets the flu shot every, and he has had the shingles shot. He also gets the pneumonia vaccine every 2 years." The patient experienced pneumonia (hospitalization) on an unspecified date with outcome of not recovered, itchy, on 08Apr2021 with outcome of unknown, dry cough on 08Apr2021 with outcome of not recovered and non-productive cough on 08Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results on Oct2020. On 13Apr2021 He reported it to the doctor and he told the patient to skip a dose of Lisinopril that sometimes it can have those symptoms of a deep nonproductive cough. He skipped the medication, and it hasn't gotten better. He thinks it is from the COVID vaccine. At the peak of his cough, he probably had 6 days where he coughed uncontrollably for 24 hours in a day. He still has a cough. Therapeutic measures were taken as a result of pneumonia. The doctor didn't do a chest X-ray or COVID test.

Other Meds: LISINOPRIL

Current Illness: Blood pressure high (been diagnosed for a decade); COPD (been diagnosed for a decade); Pneumonia (He has been hospitalized 4 different times for pneumonia. In Dec 2020 when he had pneumonia they did not hospitalize him. He has had pneumonia 5 time since 1982.); Type 2 diabetes mellitus (5-6 years ago diagnosed, very well maintained type 2 diabetes.)

ID: 1294675
Sex: F
Age:
State: TX

Vax Date: 04/04/2021
Onset Date: 04/01/2021
Rec V Date: 05/07/2021
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: blood clot; anemia; knee down felt tingly/like her legs were falling asleep; knee down felt tingly/like her legs were falling asleep; could not sleep; She was feeling uncomfortable constantly/she did not feel well; Shortness of breath; Her arm started hurting/was just at the injection site; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533) at the age of 36-years, via an unspecified route of administration in left arm on 04Apr2021 12:15 at single dose for COVID-19 immunisation. Medical history included had a pregnancy (a while ago, not ongoing). No other products. The patient stated that she experienced shortness of breath on 08Apr2021 (4 days after receiving the first dose), it got so severe on day 7 that she went to the ER on 11Apr2021. She started getting progressively more shortness of breath. Twice, she called the nurse line for her doctor and was advised to go to the emergency room. Added she could not catch her breath, and it was worse at night, could not sleep, so she went to the emergency room, she was in emergency room for 2 and a half hours and then went home. She wanted to know if the second dose could cause issues or if she should get it, added that the paperwork said that people should not get the vaccine if they received an adverse reaction to the first dose or any vaccination. She did not know if this was normal for it to get progressively worse and 2 to 14 days later. Patient wanted to know if the shortness of breath was something that can get worse, if this was a reaction to the vaccine even though it happened so many days later. Patient added it was the only thing she could think of and that her heart rate, oxygen levels, and everything was good minus she felt like she could not catch her breath. The doctor in the ER gave her anti-anxiety medicine, something with an L, but the doctor gave her that and it really seemed to help. It was kind of like, she did not know, it made her feel calm enough to fall asleep. Caller added that she has that and an salbutamol (ALBUTEROL) inhaler. She was not sure whether progressively worsening shortness of breath had gotten any better or was still going on, added that yesterday was the day she did not need either treatment medication. The day before, she took just the anxiety medicine and not the albuterol. Yesterday, she took none. During the day on 11Apr2021 (Sunday), she had called because she was feeling uncomfortable constantly. She has two children and all day she did not feel well. She told her husband she did not feel well at all. Sunday when she went to lay down, she could not sleep. Patient reported that as her shortness of breath subsided, her arm started hurting again, thought this began on 19Apr2021 and was not sure, it went away completely and was just at the injection site, probably lasting half a day or so and then it went away, clarified as left arm, same as injection. Caller added that 15Apr2021 was after the ER visit, was that she was standing up doing things and from her knee down felt tingly. Stated that knee down felt tingly on 15Apr2021, which was after her ER visit occurred, she was standing up and doing things. She had not been doing things for long periods but her knee down felt tingly. Added not like numb, but like her legs were falling asleep. She was preparing dinner and moving around and felt tingling in both legs. This probably lasted about three hours. She just kind of took it easy and it started to subside and then it was gone. While mentioned investigations, patient stated the ER did an EKG, where they put stickers and monitor her heart. They did a chest x-ray, and they took blood. She believed they checked for blood clot tests and anemia. Patient did not know any results but stated the doctor came into the room and told her everything was clear and nothing came back with anything on it. She stated the date was either the night of 11Apr2021 or the morning of 12Apr2021 for the tests. Outcome of the events shortness of breath and arm hurting was recovered/resolved in Apr2021; of the event knee down felt tingly/like her legs were falling asleep was recovered/resolved on 15Apr2021; while of remain was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1294676
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/07/2021
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: Most arrhythmias and heart beat subsided; Most arrhythmias and heart beat subsided; Pain in arm kept her awake that night; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced arrhythmia, heart rate abnormal and pain in arm. The events were described as "some side effects she had the first 5 minutes after the injection most arrhythmias and heart beat subsided within first 5 minutes of having the shot, they asked me to wait 15 minutes. The pain in arm kept her awake that night". The patient recovered from arrhythmia and heart rate abnormal on an unspecified date, while clinical outcome of pain in arm was unknown at time of this report. No follow-up attempts are possible, information about lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1294677
Sex: F
Age:
State: PA

Vax Date: 02/25/2021
Onset Date: 02/27/2021
Rec V Date: 05/07/2021
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: ear is still blocked; ear aches; ear aches and is numb; no hearing in my left ear; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown), via an unspecified route of administration in the left arm on 25Feb2021 at 17:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history was none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 27Feb2021 at 07:00, the patient woke up with no hearing in the left ear. Some hearing had come back but the ear was still blocked as of an unspecified date. The ear ached and was numb as of an unspecified date. The patient visited the ear nose and throat (ENT) doctor and was treated with steroids, twice, for the events. The patient was scheduled for an MRI. The patient reported that she was perfectly fine with no problems prior to the vaccine. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of "no hearing in my left ear", "ear is still blocked", "ear aches and is numb" was not resolved. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1294678
Sex: F
Age:
State:

Vax Date: 04/16/2021
Onset Date: 04/01/2021
Rec V Date: 05/07/2021
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: shortness of breath; My heart rate was up; Feels like I'm having an allergic reaction; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history included she had severe allergies. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunization and didn't have anything. Patient stated she took her 2nd dose last Friday (16Apr2021) and 2 hours after her heart rate was up and had shortness of breath. It was not consistent it went away and came back. It started with her heart rate going up then the shortness of breath, then she had to do breathing exercise to calm down and it went away. She didn't have anything after the 1st dose. Patient added she had severe allergies, she carried an EpiPen, this felt like she was having an allergic reaction. She wished she never took this vaccine. Patient said she would be seeing her doctor today. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1294679
Sex: F
Age:
State: VA

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 05/07/2021
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: anaphylactic shock; I started to pass out; tingle in her lip/her tongue was tingling; her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat is starting to close up; trouble swallowing; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 17Apr2021 at 14:45 (Batch/Lot Number: EW0162), at the age of 57 year, as single dose for COVID-19 immunization. Medical history included anaphylactic reaction to spider bites, pruritus, ongoing hypersensitivity, ongoing allergy to arthropod sting. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Lortab [hydrocodone bitartrate;paracetamol] and experienced drug hypersensitivity, singulair and experienced drug hypersensitivity. Concomitant medication included neocell super collagen, 6g collagen six per day as supplement. On 17Apr2021 the patient experienced anaphylactic shock, reported as medically significant. The patient reported "I started to pass out. She had tingle in her lip/her tongue was tingling. Her BP was 150 something over 90 she thinks she heard 159 before they gave her; her throat was starting to close up, she had trouble swallowing. She went to the hospital straight from the clinic where she received the vaccine. The patient reported the following: she went for shot at 14:30 and they didn't take her in until like 14:45. Patient stated after the shot, she sat down and knew she had to wait for at least 30 minutes because 10 years ago she had a couple events of anaphylactic shock due to spider bites. So patient stated she knew she should wait. Patient stated she started reading her book and had trouble swallowing at 5 minutes later, but she decided to keep reading book. Patient stated that 10 minutes she started to feel a tingle in her lip and then she started paying attention. Patient stated she then went over to the staff and found someone who was not busy and explained to them what was happening. Patient stated that staff member walked her over to the nurses station and at that time her tongue was tingling and this is not even 15 minutes later. The patient stated they gave her 10 ml of Benadryl and at about 15:05 at about 15:20 they had to give her the epinephrine because her throat was starting to close up and they called 911. The patient stated unfortunately the epi didn't; it may have slowed it down but she started to pass out. She don't know what her oxygen level was at that point. The patient recalled that her BP was 150 something over 90, she thinks she heard 159 before they gave her the Benadryl or at the same time. The patient stated once the EMT's showed up they gave her an IV and gave her steroids and that stopped her throat from closing and they gave her oxygen and that made her feel so much better. The patient stated it's like reliving the story here and her throat is starting to close up, patient clarified she is just choking up thinking about it and denied that her throat is actually closing up during call. The patient stated they did a lot of testing after did not show any signs of clotting which was good. Patient stated she did have trouble breathing, and they checked heart and her heart was fine. Patient states her throat, that is the part she needs to talk with her doctor about. Her throat didn't start to completely relax. Patient stated it was still tight on Sunday and Monday and that was a little concerning for her, but as far as lab work, no. Patient stated she was not admitted to the hospital, she spent 5 hours in the emergency room (ER) for observation and got sent home with an epi pen which she is not going to get and steroids which she finished yesterday. Patient stated she is not going to get the EpiPen because she does not foresee any need for it due to the amount of money it costs. Patient stated it costs $232 dollars and that is just too much, not to mention the amount of money she will have to give to hospital for the bill due to this event. Patient stated she is pretty clear that she won't or shouldn't get the next shot. The clinical outcome of Anaphylactic shock was recovered on 20Apr2021. The clinical outcome of her throat is starting to close up was not recovered. The clinical outcome of the remaining events was unknown.

Other Meds:

Current Illness: Allergic reaction; Allergy to arthropod sting

ID: 1294681
Sex: M
Age:
State: MN

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 05/07/2021
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: typical reported symptoms that mimic COVID; I went into a-fib; itchy inner arm; This is a spontaneous report from a contactable other HCP (healthcare professional/patient). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. It was reported that the patient had no known diseases or conditions. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications ("other medications in two weeks") were reported as no. It was reported that the patient was not on any medications prior to the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EL9266) via an unspecified route of administration in the right arm on 03Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation and experienced sore arm. On 25Mar2021 at 08:45 the patient experienced I went into a-fib and itchy inner arm and on an unspecified date the patient experienced typical reported symptoms that mimic COVID. The clinical course was reported as follows "I had just sore arm after shot 1, but after shot 2 I went into a-fib. I also had the typical reported symptoms that mimic COVID and itchy inner arm." The adverse events I went into a-fib and itchy inner arm resulted in a physician office visit and the event I went into a-fib required treatment with blood thinner and calcium blocker. The patient was tested for COVID-19 post vaccination on 07Apr2021 with a nasal swab which was negative. The clinical outcomes of the events I went into a-fib and itchy inner arm were not recovered/not resolved and the clinical outcome of typical reported symptoms that mimic COVID were unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Atrial fibrillation cannot be excluded. The case will be reassessed if 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.

Other Meds:

Current Illness:

ID: 1294682
Sex: F
Age:
State: WA

Vax Date: 03/03/2021
Onset Date: 03/08/2021
Rec V Date: 05/07/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: I had DVTs in my right calf that landed me in the ER a week after my first shot.; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 at 10:45 AM (Lot number: UNKNONW), at the age of 33 years, as a single dose for COVID-19 immunization. Medical history included protein C deficiency, drug hypersensitivity to Sulfa. 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. There were no concomitant medications. The patient reported "I had DVT's in my right calf that landed me in the emergency room (ER) a week after my first shot on 08Mar2021. Therapeutic measures were taken as a result of "I had DVTs in my right calf that landed me in the emergency room (ER) and included blood thinning medication. The clinical outcome of DVT was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1294683
Sex: M
Age:
State: NJ

Vax Date: 03/18/2021
Onset Date: 04/18/2021
Rec V Date: 05/07/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: ptosis of right eye; leg pain (both legs); This is a spontaneous report from a consumer. A 64 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 18Mar2021 (Lot Number: EN6208) as SINGLE DOSE (at age of 64 years old) for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing , anxiety from an unknown date and unknown if ongoing, restless legs syndrome from an unknown date and unknown if ongoing, sleep disorder from an unknown date and unknown if ongoing, Neurological Disease from an unknown date and unknown if ongoing, spinal fusion from an unknown date and unknown if ongoing (had 2 spinal fusions. One spinal fusion was of the cervical spine with hardware, and the other spinal fusion was of the lumbar spine with hardware). Concomitant medications included amlodipine besilate, atorvastatin calcium (CADUET) strength 5mg/20mg taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; carvedilol taken for an unspecified indication, start and stop date were not reported; tadalafil 5 mg taken for enlarged prostate, start and stop date were not reported; alprazolam (XANAX) 0.5 mg taken for anxiety, start and stop date were not reported; ropinirole (ROPINIROLE) taken for restless leg syndrome, start and stop date were not reported; clonazepam taken for sleep disorder, start and stop date were not reported; carbidopa, levodopa 50mg/200mg taken for an unspecified indication, start and stop date were not reported. Historical vaccine information included BNT162B2, dose 1 on 28Feb2021 (Lot Number: EN6205) dose 1, for covid-19 immunization at age of 63 years old. He received second dose on 18Mar2021; 30 days later 18Apr2021 woke up at 5 A.M., noticed ptosis of right eye on 18Apr2021. Concerned she took him to the hospital where he was assessed for stroke, TIA, all tests were negative. Consumer states, "my fiance was hospitalized over the weekend, we do feel it was exactly 30 days after second dose of Pfizer dose, from what I read in medical articles. I see that there were some cases of Palsy experienced by people in clinical trial. He is currently at home. He was in the hospital (emergency room)from 7am on 18Apr2021 and left at 3:50pm that same day against medical advise due to they did not have a neurologist. They wanted to admit him and transfer him to another facility because they didn't have a neurologist available. She clarified her fiance's adverse event as ptosis of his right eye. She said her fiance had diagnostics and blood work performed while at the Emergency Room. She said she wasn't positive if the blood work performed was a CBC and basic blood chemistry, but the blood work results were normal. She said the hospital she brought her fiance to did not have a neurologist on staff. She said the hospital wanted to admit and transfer her fiance to a specialized hospital with a neurologist on the premises. She said her fiance's condition did not worsen while at the Emergency Room, but she felt her fiance was not being monitored closely, and was not getting any care. She said since her fiance was not receiving anything at the Emergency Room, and the Emergency Room didn't have the bandwidth to address his issues, and nothing was done to transport him to another hospital, her fiance left the Emergency Room against medical advice (AMA). She said her fiance went to a neurologist on Monday (19Apr2021). Emergency Room Visit Treatment: Stated her fiance was given Oxycodone while at the Emergency Room. She said she did not know the Oxycodone dose, NDC, Lot, and Expiration Date. She said the Oxycodone was administered for leg pain (both legs) caused by a pre-existing condition her fiance had. She said her fiance normally took Ropinirole for his leg pain. Consumer reported her fiance had follow-up testing done at the neurologist on Monday (19Apr2021), and was waiting for the test results to come back. She clarified the neurologist was doing the follow-up testing to confirm or rule-out a diagnosis of Myasthenia Gravis. Consumer reported when she took her fiance to the Emergency room she thought he was going to be assessed for a possible TIA or stroke, but when it was mentioned her fiance may have Myasthenia Gravis, it was equally concerning. Neurologist Visit Treatment: She stated the neurologist prescribed Pyridostigmine 60mg on Monday (19Apr2021) for her fiance to start taking while the doctor waited for the blood work and repetitive nerve conduction study results to come back. She said the doctor's logic was to take the Pyridostigmine 60mg, and see if the ptosis resolved, and if the ptosis resolved the doctor would know the cause of the ptosis. She said her fiance's right eye ptosis had not improved, changed, or resolved since he started taking the Pyridostigmine 60mg. She said she did not have the Pyridostigmine 60mg NDC, Lot, and Expiration Date. The patient underwent lab tests and procedures which included blood gases (ABG): unknown on 18Apr2021, Vital capacity: normal on 18Apr2021, Blood test: unknown on 18Apr2021, COVID-19: negative on 18Apr2021; vital signs measurement: normal on 18Apr2021 . Therapeutic measures were taken as a result of ptosis of right eye. Outcome of the event ptosis of right eye was not recovered. Outcome of the event leg pain (both legs) was unknown.

Other Meds: CADUET; LISINOPRIL; CARVEDILOL; TADALAFIL; XANAX; ROPINIROLE; CLONAZEPAM; CARBIDOPA/LEVODOPA

Current Illness:

ID: 1294685
Sex: F
Age:
State:

Vax Date: 04/06/2021
Onset Date: 04/07/2021
Rec V Date: 05/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: vomiting; a severe migraine headache for 5-7 days; chills; fever; vertigo; slept all day long; she also had a full leg charlie horse; Nausea; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The next day on 07Apr2021, the patient vomited at least 30 times, had a severe migraine headache for 5-7 days as well as chills, fever, vertigo and slept all day long. She also had a full leg charlie horse. When she spoke to her HCP about the vaccine, they suggested getting the second dose and enduring the side effects is better than dying of covid and wrote prescriptions for migraines and nausea. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1294686
Sex: M
Age:
State: CA

Vax Date: 04/03/2021
Onset Date: 04/11/2021
Rec V Date: 05/07/2021
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: Bell's Palsy; This is a spontaneous report from a contactable Other healthcare professional (HCP). A 57-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 03Apr2021 (Lot number was not reported) as SINGLE DOSE (at age of 57 years old) for covid-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing , covid from an unknown date and unknown if ongoing. Patient did no have any known allergies. Concomitant medication(s) included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; glipizide taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The vaccination was given in a hospital. The patient experienced bell's palsy on 11Apr2021. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of bell's palsy which included Prednisone, Valacyclovir. Outcome of the event was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between event Bell's Palsy and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) 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: ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; LISINOPRIL; GLIPIZIDE; METFORMIN

Current Illness:

ID: 1294688
Sex: F
Age:
State: VA

Vax Date: 03/18/2021
Onset Date: 03/01/2021
Rec V Date: 05/07/2021
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: tiredness; A little bit of chills; A sense of not feeling well/She just does not feel good/her body not feeling okay; Her neck and head felt so heavy. Her neck and head felt so heavy that she could not hold it up; She felt like her body was so sick, she had no strength; she has pain in her back, neck and spinal cord; Body pain/body aches; Neck pain/neck felt so heavy; She felt like her body was so sick/Her body felt really really sick; Severe back pain/pain in her back; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) at right arm on 18Mar2021 09:00 AM at single dose for COVID-19 immunization (She believes in vaccines. She thinks its better to be vaccinated than to not be vaccinated). Medical history included COVID-19 from 01Feb2021 and three heart ablations. Concomitant medications were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) was None. Family Medical History Relevant to AE was None. She is calling about the Pfizer covid vaccine. She received her first dose of the covid vaccine on 18Mar2021. She got body aches (Mar2021) after. On 02Apr2021, she had to go to the emergency room. She had severe neck and body pain. She went to the emergency room because she could not take it anymore. Her body felt really really sick. Now she has pain in her back, neck and spinal cord (Mar2021). She has a weird feeling in her body. She just does not feel good. At the emergency room, they did blood tests on her. She did not have covid or the flu. Her hemoglobin came back normal, and so did all of the other things. She has this tiredness (Apr2021), pain in her back and a sense of not feeling well. She is calling to see what Pfizer suggests. She is asking if she can take anything, if so what can she take. She is asking how long will this last. She is asking if this is related to the vaccine. After first dose, Body aches began about five days after receiving the covid vaccine. She had body aches, a sense of not feeling well, and a little bit of chills. A little bit of chills began about five days after receiving the covid vaccine and resolved completely now. Clarifies that on 18Mar2021, she received the first dose of the covid vaccine. On that same day (18Mar2021), is whenever she had chills and a sense of her body not feeling okay. 48 hours after that, she had no more chills. Two or three days after, she started having back and neck pain. Her neck and head felt so heavy. Her neck and head felt so heavy that she could not hold it up. She was in pure desperation. She had to go to the emergency room. She never goes to the emergency room, unless she absolutely has too. She felt like her body was so sick, she had no strength. Then she received her second dose on 08Apr2021 (Lot number: ER8732). It has been 12 or 13 days since and her body aches have continued. She still feels like she is very sick. She just wants to lay down, but she can not because she has to work. She does not feel like herself. She feels like something is off in her body. Pain in her back, neck and spinal cord began two to three days after receiving the first dose of the covid vaccine. Body aches was reported as worsened. Pain in her back, neck and spinal cord was reported as worsened. No Investigation Assessment. She was not admitted to the hospital. Physician Office was No. outcome of Body pain, neck pian, Severe back pain, she has pain in her back, neck and spinal cord and She felt like her body was so sick was not recovered, outcome of chills is recovered in Mar2021, outcome of other events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1294689
Sex: M
Age:
State: TX

Vax Date: 04/19/2021
Onset Date: 04/19/2021
Rec V Date: 05/07/2021
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:

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

Symptoms: heart rate jumped from a normal 70 bpm to 90 then 110; face, tounge, lips and arm went extremely tingly; face, tounge, lips and arm went extremely tingly; face, tounge, lips and arm went extremely tingly; It was hard to swallow; taking a breath felt empty; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 19Apr2021 12:30 (39-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included psoriasis and asthma as a kid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received ustekinumab (STELARA) 90mg on 24Jan2021; previously received sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergies. At the 13 minute mark of the safety wait time, his face, tongue, lips and arm went extremely tingly. It was hard to swallow, taking a breath felt empty and his heart rate jumped from a normal 70 bpm to 90 then 110 while sitting within a few seconds of the tingling starting. He sat for 10 more minutes then left the pharmacy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1294690
Sex: F
Age:
State: NJ

Vax Date: 04/19/2021
Onset Date: 04/20/2021
Rec V Date: 05/07/2021
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: stroking; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW01B1/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 (at the age of 67 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included ongoing hypertension (HTN) and COVID-19 on an unspecified date. The patient had known allergies to ciprofloxacin (CIPRO), latex and iodine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Apr2021 at 12:00AM, the patient reported that after having her first vaccine on 19Apr2021, the next morning her blood pressure went up to 210/110 and HR 130 with a pounding headache and reported "thought I was stroking". The patient received treatment for these events which included extra medicine: an extra dose of losartan, clonopin and two acetaminophen (TYLENOL) and slept 24 hours. The outcome of the events blood pressure went up, heart rate increased, headache and "thought I was stroking" was recovering. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) 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: LOSARTAN

Current Illness: Hypertension

ID: 1294691
Sex: M
Age:
State: TX

Vax Date: 04/20/2021
Onset Date: 04/21/2021
Rec V Date: 05/07/2021
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: fainted; aches; headache; fever; nauseous; excessively sweating; heartrate was elevated to about 90 bpm vs resting heartrate of 60 and remained elevated for the next 12 hours; This is a spontaneous report from a contactable consumer reporting for himself. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number ER8735/expiration date: not provided), via an unspecified route of administration, on 20Apr2021 at 08:30 (at the age of 29 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on 04Jan2021 at 12:00 (at the age of 29 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included was not provided. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included melatonin, fish oil, calcium. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Apr2021 at 02:00, the patient fainted, experienced aches, headache, fever, nauseous, excessively sweating, and heartrate was elevated to about 90 bpm vs resting heartrate of 60 and remained elevated for the next 12 hours. The patient went to the emergency room due to the events and received treatment for these events which included fluids. The clinical course was as follows: after experiencing expected side effects (aches, headache, fever), the patient got up to use the restroom in the middle of the night. About 1-2 minutes after getting up, he fainted. The patient awoke shortly after on the floor and felt nauseous and was excessively sweating. His heartrate was elevated to about 90 bpm vs resting heartrate of 60 and remained elevated for the next 12 hours. The outcome of the events was recovering. Since the vaccination, the patient had been tested for COVID-19 (saliva test) on 20Apr2021, and the result was negative.

Other Meds: MELATONIN; FISH OIL; CALCIUM

Current Illness:

ID: 1294692
Sex: F
Age:
State: PA

Vax Date: 03/17/2021
Onset Date: 04/21/2021
Rec V Date: 05/07/2021
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: Tested positive for COVID-19 21Apr2021; Tested positive for COVID-19 21Apr2021; This is a spontaneous report from a contactable consumer. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 17Mar2021 15:00 (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation . Medical history included prior cancer (nonspecific) from an unknown date and unknown if ongoing. Patient was not pregnant. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 at 03:00PM on 24Feb2021, Lot EL3247 for covid-19 immunization. Concomitant medication(s) included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) taken for an unspecified indication, start and stop date were not reported. The patient received Dose 2 on 17Mar2021 then had fever 16Apr that resolved in 2 days. Three days later she experienced loss of smell. Patient was tested positive for COVID-19 21Apr2021. Outcome for events vaccination failurewas unknown , 21apr2021. Outcome for tested positive for covid-19, fever , loss of smell was recovering. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): positive on 21Apr2021.

Other Meds: VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]

Current Illness:

ID: 1294693
Sex: U
Age:
State: NC

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/07/2021
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: Back cramps could not lift arms past neck; Back cramps could not lift arms past neck; Complete numbness in both arms and hands/finger tips in right hand still numb; Complete numbness in both arms and hands/finger tips in right hand still numb; Complete numbness in both arms and hands/finger tips in right hand still numb; This is a spontaneous report from a contactable consumer (Patient) . A 51-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 09:00 (Batch/Lot Number: Er8734) as SINGLE DOSE for covid-19 immunisation . Medical history was none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, Lot number En6205, Administration date on 25Mar2021 at 10:30 AM on left arm for covid-19 immunisation. Patient did not have COVID-19 prior to vaccination. There were no concomitant medications. The patient experienced back cramps that patient could not lift arms past neck, complete numbness in both arms and hands on 15Apr2021 20:00 with outcome of recovering , complete numbness in both arms and hands(hypoaesthesia) (disability) on 15Apr2021 20:00 with outcome of recovering. The patient added that a week later finger tips in right hand were still numb (outcome recovering). The events resulted in doctor's office/clinic visit with seriousness of disability or permanent damage. The patient was not tested positive post vaccination.

Other Meds:

Current Illness:

ID: 1294694
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/07/2021
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: I received the first dose and have tested positive for Covid; I received the first dose and have tested positive for Covid; chills; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 1 via an unspecified route of administration in 2021 for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose and tested positive for covid and had chills in 2021. The patient was scheduled to be tested again on 28Apr2021 and to get the second dose of the vaccine on 30Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021. The outcome of tested positive for covid and chills was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1294695
Sex: M
Age:
State: OH

Vax Date: 04/07/2021
Onset Date: 04/09/2021
Rec V Date: 05/07/2021
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: Hearing loss and tinnitus in ears - primarily right ear; Hearing loss and tinnitus in ears - primarily right ear; This is a spontaneous report from a contactable consumer (patient). This 50- year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EP7533), via an unspecified route of administration, on 7Apr2021 at 11:00 am (at the age of 50-years-old) as a single dose for COVID-19 vaccination, in left arm, at a Pharmacy or Drug Store. Historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP6955, expiration date: unknown) via unspecified route of administration in on 17Mar2021 at 12:00 pm as a single dose for COVID-19 immunization. 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. The patient has no known allergies. Medical history included: Rheumatoid arthritis, hypothyroidism. Concomitant medications included: Thyroid medication. The patient reported hearing loss and tinnitus in ears - primarily right ear on 09Apr2021. No treatment was received. The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1294696
Sex: F
Age:
State: NJ

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

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: paralysis in both legs; extreme difficulty walking; horrible body aches; This is a spontaneous report from a contactable consumer (the patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0151), via an unspecified route of administration on 05Apr2021 at 10:30 as a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6208) on 15Mar2021 at 09:30. There were no concomitant medications. Twelve hours after the vaccination the patient began to experience "symptoms;" she had horrible body aches. By 08Apr2021 she had extreme difficulty walking and went to a hospital. She experienced paralysis in both legs on 08Apr2021 with outcome of not recovered, extreme difficulty walking on 08Apr2021 with outcome of not recovered. The patient was hospitalized for paralysis of both legs and extreme difficulty walking. The patient also experienced horrible body aches on 05Apr2021 with outcome of recovered. The events required an Emergency Room visit and a Physician office visit. The patient was hospitalized for extreme difficulty walking from 08Apr2021 to 10Apr2021 and she was again hospitalized on 12Apr2021 to 15Apr2021. The patient underwent lab tests and procedures which included lumbar puncture on 14Apr2021 which revealed that she does not have Guillain-Barre.

Other Meds:

Current Illness:

ID: 1294697
Sex: M
Age:
State: FL

Vax Date: 01/30/2021
Onset Date:
Rec V Date: 05/07/2021
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: received the 1st dose of the vaccine on 30Jan2021 and between that period and the 2nd dose the patient contracted covid and has not had the 2nd dose of the vaccine yet; 1st dose of the vaccine on 30Jan2021 and between that period and the 2nd dose the patient contracted covid; This is a spontaneous report from a contactable consumer (a pharmacy intern). This consumer reported on behalf of a 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 30Jan2021 as single dose for COVID-19 immunization. Medical history included chronic kidney disease (CKD) requiring weekly dialysis. The patient's concomitant medications were not reported. The patient was not enrolled in the clinical trial. The consumer reported that the patient received the 1st dose of the vaccine on 30Jan2021 and between that period and the 2nd dose the patient contracted COVID and has not had the 2nd dose of the vaccine yet. The consumer also stated the patient has had several COVID tests recently that were negative. The patient was tested negative on COVID tests on unspecified dates. The consumer was calling to find out if the 2nd dose is ok to give now or if the patient can go without the 2nd dose or if they need to restart the series. The clinical outcome of the patient "received the 1st dose of the vaccine on 30Jan2021 and between that period and the 2nd dose the patient contracted COVID and has not had the 2nd dose of the vaccine yet" was not reported at the time of reporting on 21Apr2021. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1294698
Sex: F
Age:
State: TX

Vax Date: 03/23/2021
Onset Date: 03/01/2021
Rec V Date: 05/07/2021
Hospital: Y

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: vomiting; chest pain; stomach pain; nausea; chills; body ache; stomach pain more intense; acute pancreatitis; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER2613, second dose) solution for injection intramuscular in the left arm on 23Mar2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included ARMD (age-related macular degeneration), high blood pressure, and anxiety. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and AREDS vitamins. The patient had no known allergies. Historical vaccine included BNT162B2 (first dose, lot EN6202) for COVID-19 vaccination on 02Mar2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021 at 07:00, the patient experienced stomach pain, nausea, chills, and body ache. On 26Mar2021, the patient experienced vomiting and chest pain. In Mar2021, the patient experienced acute pancreatitis and stomach pain more intense. The events resulted in emergency room/department or urgent care visit and hospitalization for 10 days in 2021. Lab test in Mar2021 included CT scan: revealed acute pancreatitis. Treatment for the events included antibiotics, fluids, and oxygen. The outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: BABY ASPIRIN

Current Illness:

ID: 1294699
Sex: F
Age:
State:

Vax Date: 02/27/2021
Onset Date: 02/27/2021
Rec V Date: 05/07/2021
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: Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head; new and sudden onset of popping joints; Temporary paralysis and numbness upon waking up in the morning; Temporary paralysis and numbness upon waking up in the morning; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands; Heart rate spike to 180; dizziness; sweating; sudden aching and weakness in both hands, progressed upwards through legs, hips, arms, back, neck and head; sudden aching and weakness in both hands; Severe head and facial pain; Severe head and facial pain; Pain, tingling, burning, and weakness in extremities and limbs; Pain, tingling, burning, and weakness in extremities and limbs; Vibrations/tremor-like sensation in upper back; Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EN6200, first dose) solution for injection intramuscular in the left arm on 27Feb2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. Medical history included SVT (supraventricular tachycardia). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Feb2021, the patient experienced heart rate spike to 180 within first 2-3 minutes of vaccine with dizziness, sweating and sudden aching and weakness in both hands; severe head and facial pain, pain, tingling, burning, and weakness in extremities and limbs; vibrations/tremor-like sensation in upper back; tingling tongue; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands, sent to ER for monitoring. Continued heart rate spikes for approx. 7 days afterwards. Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head over 1 week period. On 09Mar2021, 10 days after vaccination; two more ER visits. Severe head and facial pain. Pain, tingling, burning, and weakness in extremities and limbs. Vibrations/tremor-like sensation in upper back. Tingling tongue, new and sudden onset of popping joints, temporary paralysis, and numbness upon waking up in the morning. Multiple lab work orders, X-rays, MRIs - all ruled out other causes/conditions in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, with disability or permanent damage due severity of symptoms required 4 weeks of medical leave from work. Treatment for the events included medication and physical therapy. The outcome of the events was not recovered. Post vaccination, a Nasal Swab, Covid test result was negative in Mar2021.

Other Meds:

Current Illness:

ID: 1294700
Sex: M
Age:
State: NV

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 05/07/2021
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: Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with Cold; Night Sweats, states it is like he took a shower; Diarrhea, states when he goes to the bathroom, it is water; Lost 14 Pounds; felt really bad; This is a spontaneous report from a contactable consumer reported for himself. A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at 55 years old on 06Apr2021 08:45 (Lot Number: ER8733; Expiration Date: 31Jul2021) at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, diagnosed 20 years prior to the report. The patient's concomitant medications were none. There were no other vaccines Administered on Same Date of the Pfizer Suspect or within 4 weeks. The patient experienced coughing, headache, fever, body shakes a lot with cold, night sweats, states it is like he took a shower; diarrhea, stated when he went to the bathroom, it was water, coughing blood, trouble breathing, lungs damaged, lost 14 pounds, all on 06Apr2021. Patient stated he was calling because his doctor told him to call. Stated he got his first injection on 06Apr2021. Told to sit for 15 minutes, and he felt fine and went to work and felt really bad after 1 hour; 09:45-10:00. Since then he had been super sick and at the hospital 3 times, later confirmed ER, not hospitalized. Patient stated the doctor also told him his lungs are damaged and they were sending him to see a specialist. Patient was asking what was going on with his body, is this a normal reaction? Stated his doctor said to call because it had been too long, stated usually it lasted 2-3 days and with Tylenol, it was gone, then it should be clear, but it had been almost 16 days for him. Stated one hour after his injection, he started feeling really bad. Stated he was coughing up blood from coughing so much. Stated he was 154 pounds, but he has lost 14 pounds. Patient stated his first injection was on 06Apr2021. Stated his second vaccine is supposed to be on 28Apr2021 but he was not going because he was afraid to go back in case it got worse. Treatment received for the events included 3 Different Antibiotics; Tylenol and Drinking Hot Tea. Patient clarified that he has had 3 Emergency Room Visits (10Apr2021, 19Apr2021, and 20Apr2021), Physician Office on 21Apr2021, but he was never admitted to hospital. Patient stated one time they kept him in the ER for 20 hours. Patient stated once he went to Hospital and then yesterday and the other day, he went to Hospital because he was having trouble breathing. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Blood pressure high (Verbatim: High Blood Pressure, diagnosed 20 years prior to the report)

ID: 1294701
Sex: F
Age:
State: ND

Vax Date: 04/10/2021
Onset Date: 04/10/2021
Rec V Date: 05/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: She had an arrhythmia; got really hot all the way down her body; hands were sweaty and clammy; hands were sweaty and clammy; fast heart beat; Dry mouth; She didn't feel good at all; arm soreness; felt like she had a big hot flash; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 10Apr2021 at 13:50 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. No other vaccines were given within 4 weeks. The patient medical history was not reported. There were no concomitant medications. The patient previously took sucrose and experienced drug hypersensitivity, flu vaccine for influenza immunization (never had a reaction after having a flu vaccine/'I am not allergic to eggs), tetanus vaccine for immunization (The last one she had was 10 or more years ago) and experienced soreness. On 10Apr2021, The patient experienced arrhythmia, got really hot all the way down her body, hands were sweaty and clammy, fast heart beat, dry mouth, she didn't feel good at all, arm soreness, felt like she had a big hot flash. The patient underwent lab tests and procedures which included heart rate: fast on 10Apr2021. The clinical course is as follows. Within the first 5 minutes of receiving the vaccine she got really hot all the way down her body. Her hands were hands sweaty and clammy. arm soreness. She had an arrhythmia, her heart was pounding fast. She belly breathed and kept calm. She didn't feel good at all. This all lasted for about 5 minutes. She has a pretty good immune system. She was not nervous about getting the vaccine. She had childhood vaccinations and had no problems. She was not nauseated. She just felt like she had a big hot flash through her body. Her mouth was dry. The adverse events did not require a visit to the physician office or emergency room. The clinical outcome of the events got really hot all the way down her body, hand were sweaty and clammy, fast heart beat, didn't feel good at all, Dry mouth was recovered on 10Apr2021 while arm soreness was recovered on 13Apr2021 and while arrhythmia, felt like a big hot flush was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1294702
Sex: M
Age:
State: FL

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 05/07/2021
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: Joint pain in shoulder; It felt like bursitis when he had it before on another part of his shoulder; his arm was paralyzed and was hurting a lot/arm was painful; It is a sharp, burning, stabbing pain; Arm was paralyzed; Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle; Injection was too low/Injection point was a little lower than expected; he had shoulder pain; This is a spontaneous report from a contactable consumer. A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE (at age of 42 year old )for covid-19 immunisation. Medical history included he's had bursitis previously and that the symptoms lasted 6 weeks to 6 months (reported both lengths of time, unsure which is correct duration). The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced he had shoulder pain and the injection was too low/Injection point was a little lower than expected. On 17Apr2021, the patient experienced muscle pain at the deltoid/intense muscle pain in the deltoid muscle. On 20Apr2021, the patient experienced arm was paralyzed , Joint pain in shoulder, It felt like bursitis when he had it before on another part of his shoulder, his arm was paralyzed and was hurting a lot/arm was painful, It is a sharp, burning, stabbing pain.Outcome of the events Muscle pain at the deltoid/intense muscle pain" in the deltoid muscle, Joint pain in shoulder, his arm was paralyzed and was hurting a lot/arm was painful, he had shoulder pain was not recovered. Outcome of Arm was paralyzed, Injection was too low/Injection point was a little lower than expected, It felt like bursitis when he had it before on another part of his shoulder, It is a sharp, burning, stabbing pain was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1294703
Sex: F
Age:
State: NY

Vax Date: 04/19/2021
Onset Date:
Rec V Date: 05/07/2021
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: lost consciousness; fever; chills; cold / hot sweat; cold / hot sweat; body aches; diarrhea; vomiting; vertigo; fell on the bathroom floor; had a little pain in the arm; This is a spontaneous report from a contactable consumer reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 at 08:15 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Mar2021 (at the age of 52 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced fever, chills, body aches, left arm pain, and diarrhea. Relevant medical history included COVID-19 infection on an unspecified date, lyme disease, seasonal allergies and penicillin allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm. The events resulted in an emergency room visit, however, the patient did not receive any treatment for these events. The outcome of the events lost consciousness a few times, and fell on the bathroom floor, fever, chills, cold / hot sweat, body aches, diarrhea, vomiting, vertigo and had a little pain in the arm was unknown. Since the vaccination, the patient had not been tested for COVID-19. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : same patient/reporter, different AE/first dose.

Other Meds:

Current Illness:

ID: 1294704
Sex: M
Age:
State: CA

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 05/07/2021
Hospital: Y

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: Myocarditis; Troponins greater than 11,000; Mild Fever; Chills; Malaise; Chest pain; Body Aches; Cough; Headache; Nausea; This is a spontaneous report from a contactable nurse. This nurse reported for a 18-year-old male patient that: This is a spontaneous report from a contactable other hcp. A 18-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation . Medical history included ongoing attention deficit hyperactivity disorder (ADD) , ongoing autism. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose1 received on 10Mar2021, LOT: Unknown for COVID-19 Immunization. Concomitant medication(s) included risperidone (RISPERDAL) taken for attention deficit hyperactivity disorder from an unspecified start date and ongoing; methylphenidate (METHYLPHENIDATE) taken for attention deficit hyperactivity disorder from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication from an unspecified start date and ongoing. The patient presented to the ER two days after receiving his second dose of the vaccine. The patient experienced myocarditis (hospitalization 01Apr2021 to 03Apr2021, medically significant) on 01Apr2021 with outcome of unknown, patient was post ICU admission, chest pain (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , body aches (hospitalization) on 30Mar2021 with outcome of unknown , cough (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , headache (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , nausea (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , troponins greater than 11,000 (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , mild fever (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , chills (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , malaise (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included echocardiogram: unknown result on unknown date, electrocardiogram: no acute changes on 01Apr2021, electrocardiogram: abnormal with ST elevation on 19Apr2021 and patient needed to consult with Cardiology, COVID-19 antigen test: negative on unknown date. The patient was treated in the ICU, exact treatment unknown at this time. Information about Lot/batch number is requested.; Sender's Comments: The contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) to reported events is probable.

Other Meds: RISPERDAL; METHYLPHENIDATE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness: ADD (Verbatim: ADD); Autism (Verbatim: Autism)

ID: 1294705
Sex: F
Age:
State: PA

Vax Date: 04/02/2021
Onset Date:
Rec V Date: 05/07/2021
Hospital: Y

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: got Covid after she got the vaccine; got Covid after she got the vaccine; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 1 via an unspecified route of administration on 02Apr2021 for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient got COVID after she got the vaccine on an unspecified date and was hospitalized for the event for 6 days. Laboratory tests and procedures included sars-cov-2 test: positive on an unknown date. The outcome of COVID after she got the vaccine was unknown.

Other Meds:

Current Illness:

ID: 1294706
Sex: F
Age:
State:

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 05/07/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: contracted the Covid 19 virus; contracted the Covid 19 virus; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number and expiration date unknown), via an unspecified route of administration, on 18Mar2021 at age of 71-year) as a single dose for COVID-19 vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. He had his first Covid 19 vaccine on 18Mar2021. He came down with the Covid 19 virus after receiving the vaccine and was in the hospital and was treated with plasma and antivirals. He doesn't know how he got the Covid 19 virus he wore his mask everywhere. Pt was hospitalized for the event. The clinical outcome of the event was unknown. Information about the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1294707
Sex: F
Age:
State: NH

Vax Date: 04/16/2021
Onset Date: 04/17/2021
Rec V Date: 05/07/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Lightheaded and dizzy; Nauseous; Dehydrated; Lightheaded and dizzy; Atrial fibrillation with rapid ventricular response; Not feeling well; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 at the age of 79 years old, (Batch/Lot Number: EW0164) as SINGLE DOSE for covid-19 immunisation, and dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 Batch/Lot number was E or F, N6205;) as a single dose, for covid-19 immunisation. Medical history included diabetes from 2009, coronary artery disease from Jan2020, and atrial fibrillation and Shingrix Vaccine/NDC, Lot Number, Expiration Date not known by caller.Vaccination Date: Jul2018. Concomitant medications were not reported. On 17Apr2021, the patient reported not feeling well. 18Apr2021 she woke up in the morning and was lightheaded and dizzy. She was also nauseous.States she called an ambulance. She was found to be in Atrial Fibrillation. she also found out when she got to the Emergency Room that she was dehydrated. States she does not know if that ties in with the vaccine or not. She states someone told her she should be drinking a lot of water since she had the vaccines; asks if this is true. She was admitted to the hospital on Sunday 18Apr2021 and was released yesterday afternoon 20Apr2021.On 19Apr2021, she was lightheaded and dizzy, nauseous. She also experienced atrial fibrillation with rapid ventricular response and was dehydrated. The patient was admitted to the hospital on 18Apr2021 and released on 20Apr2021. The outcome of the events of not feeling well, lightheaded and dizzy, nauseous were recovered on 20Apr2021, the remaining events was unknown. .

Other Meds:

Current Illness: Atrial fibrillation (Verbatim: Atrial Fibrillation); Coronary artery disease (Verbatim: Coronary artery disease); Diabetes (Verbatim: Diabetes)

ID: 1294708
Sex: F
Age:
State: AL

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 05/07/2021
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: Body is full of bumps was reported as worsened / bumps are on body from stomach to inner thighs/ It is spreading all over arms; The bumps are spreading. It is painful. She is off work. She cannot even work. She got the steroid pills; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 16Apr2021 09:00 (Lot Number: EP7534) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot number: EP6455) at 9 am on 26Mar2021, administered in arm right for COVID-19 immunization. Clinical course: After vaccination, her body was full of bumps (also reported as body is full of bumps was worsened). She had to go the emergency room, and they gave her steroid pills. It was not clearing up from the steroid pills. She had to leave work today. She went to the clinic today, and they gave her a steroid shot. The bumps were on her body from her stomach to her inner thighs. This all started on 16Apr2021 after the second vaccine. It was spreading all over her arms. The bumps were spreading. It was painful. She was off work. She could not even work. She got the steroid pills, Methylprednisolone on 18Apr2021. She started with 6 tablets and decrease by one tablet per day for 6 days. The events required to visit emergency room and physician office. No prior vaccinations received within 4 weeks. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer. The event seriousness was provided as unspecified by reporter. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1294710
Sex: F
Age:
State: IL

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 05/07/2021
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: Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stem

Other Meds:

Current Illness:

ID: 1294711
Sex: U
Age:
State: TX

Vax Date: 03/10/2021
Onset Date:
Rec V Date: 05/07/2021
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: experiencing higher glucose than usual. Type 2 diabetic. Running 20 to 40 points higher than usual.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 dose 1 on an unspecified date for COVID-19 immunisation. It was reported that after 2nd covid vaccine on March 10, the patient was experiencing higher glucose than usual. Type 2 diabetic. Running 20 to 40 points higher than usual. It started about week after 2nd shot and continues to present. The patient mentioned that there was nothing different in his/her eating or activity or meds. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1294712
Sex: F
Age:
State:

Vax Date: 06/29/2018
Onset Date: 04/13/2021
Rec V Date: 05/07/2021
Hospital: Y

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: COVID vaccine causing her arm, hand and face to go numb; COVID vaccine causing her arm, hand and face to go numb; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer (manufacturer control number: UNT-2021-006890). A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included ongoing pulmonary arterial hypertension. Co-suspect medication was treprostinil sodium (TYVASO) via inhalation route at 60-120 ug (10-20 breaths), four times a day for pulmonary arterial hypertension from 29Jun2018, Concomitant medications bosentan (TRACLEER) and tadalafil (ADCIRCA). The patient was admitted to the hospital (in Apr2021) with possible adverse event from COVID vaccine causing her arm, hand and face to go numb on 13Apr2021. The action taken with treprostinil was unknown. The clinical outcomes of the "COVID vaccine causing her arm, hand and face to go numb" were unknown. Case Description: This case is a spontaneous report received on 14Apr2021, from a consumer via (pharmacy name). This 40-year-old, 125-lb, female patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 29Jun2018 for primary pulmonary arterial hypertension. The current dose was reported as 60-120 ug (10-20 breaths), four times a day (QID) (off label use), via inhalation (IH) route. On 13Apr2021, the patient experienced the event term of COVID vaccine causing her arm, hand and face to go numb (hypoaesthesia, hospitalized). Co-suspect included coronavirus disease (COVID-19) vaccine. Concomitant medications included Tracleer (bosentan) and Adcirca (tadalafil). Relevant medical history included primary pulmonary arterial hypertension. On 13Apr2021, 2 years, 9 months, and 16 days after initiating IH Tyvaso, the patient was admitted to the hospital with possible adverse event from COVID vaccine causing her arm, hand and face to go numb. Action taken with IH Tyvaso was not reported for the event of hypoaesthesia. Action taken with Covid-19 vaccine was not applicable for the event of hypoaesthesia. At the time of reporting, the outcome of hypoaesthesia and off label use was unknown. The reporter did not provide causality for the event of hypoaesthesia. Case Comment: The company has assessed the serious adverse event of hypoaesthesia as not related to IH treprostinil and TD-300/A device. The event was likely post vaccination with COVID vaccine. Pfizer is a marketing authorization holder of BNT162b2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162b2 has submitted the same report to the regulatory authorities. No follow-up attempts are possible. Information about BNT162b2 vaccine lot/batch number cannot be obtained.

Other Meds: TRACLEER [BOSENTAN]; ADCIRCA

Current Illness: Pulmonary arterial hypertension (Ongoing, Current Condition, Pulmonary arterial hypertension)

ID: 1294713
Sex: F
Age:
State: FL

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 05/07/2021
Hospital: Y

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: 24 hours later my neck started swelling up, my left lymph node; abnormal mass in my neck which was my lymph node; I developed a headache over the whole left side of my head; I could hardly move my neck; All of a sudden I kind of broke out in the sweat; Left side of my head just went totally numb; Started feeling tingling in my left hand; I went to eat some yoghurt and I could not swallow at all; Airway is being compromised by the swelling in my neck; I cannot walk my left leg is dragging, so I am lurking around having to hold on; My voice was like had to whisper; Right side of my body started shaking; Later that evening the numbness subsided. I could speak better my left lymph node was still sore; blood pressure went up; white blood cells count was really, really extremely high; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 13Apr2021 (Lot Number: EW0153), at the age of 52 years, as single dose for COVID-19 immunization. Medical history included covid-19 in Sep2020. Concomitant medication was not reported. The patient experienced 24 hours later, after vaccination, her neck started swelling up, her left lymph node; abnormal mass in her neck which was her lymph node, which required hospitalization. The patient she developed a headache over the whole left side of her head. She could hardly move her neck. All of a sudden she kind of broke out in the sweat, left side of her head just went totally numb. Started feeling tingling in her left hand. She went to eat some yoghurt and she could not swallow at all, airway was being compromised by the swelling in her neck. She cannot walk her left leg was dragging, so she was lurking around having to hold on. Her voice was like had to whisper. Right side of her body started shaking, Later that evening the numbness subsided. She could speak better, her left lymph node was still sore. Blood pressure went up, white blood cells count was really, really extremely high. The patient was hospitalized from 14Apr2021 to 16Apr2021. The clinical course was reported by the patient as follows: When probed for the reason of hospitalization, consumer stated, "The symptoms I had was, I got the vaccination in my left arm, 24 hours after getting the COVID vaccination shot on 13Apr2021, almost exactly 24 hours later my neck started swelling up, my left lymph node, which I was expecting to have that problem. And I could hardly move my neck and then I developed a headache over the whole left side of my head and behind my eye and it was hurting and then it hurt my ear. So, I was having ear ache too. So, that went on for about an hour and a half and then all of a sudden I kind of broke out in the sweat and the left side of my head just went totally numb and then I started feeling tingling in my left hand and so I went to the bathroom to see if my face was numb, to see if I had any paralysis of my face which I did not have any at all, it was just numb. So, then I am concerned, so I decide I am going to take an Aspirin and so before I took the Aspirin I wanted to eat something because I had not had anything to eat that day. I went to eat some yoghurt and I could not swallow at all, I couldn't swallow the yoghurt. So, then I am concerned my airway is being compromised by the swelling in my neck. So, I got to call # and then I cannot walk my left leg is dragging, so I am lurking around having to hold on and then when I called # my voice was like had to whisper and it was hard to get an information where I was at. Finally they arrived and I was taken into the ambulance and when I was in the ambulance my blood pressure went up and also the right side of my body started shaking, they took me to the hospital. I was in the hospital. I had MRI, a CT scan and all of those things and it was negative for a blood clot or anything, heart problems or brain bleed. So, they ruled all of that out, my white blood cells count was really, really extremely high that is what the doctor said and anyway so I was admitted in the hospital and now I can talk better and the numbness is going away on the 14th a day later which went on for the symptom. So, later that evening the numbness subsided. I could speak better my left lymph node was still sore and everything and of course they did noticed that in the scan, MRI stuff about the abnormal mass in my neck which was my lymph node.". The patient stated, "I was hospitalized on 14Apr2021 and I was released the evening of 16Apr2021. Treatment: the patient stated they did not treat her for anything except for the high blood pressure when out there and that is it. The clinical outcome of Lymph node pain was not recovered. The clinical outcome of the remaining events was unknown.

Other Meds:

Current Illness:

ID: 1294714
Sex: M
Age:
State: TN

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

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: Cerebral venous sinus thrombosis; This is a spontaneous report from a contactable consumer, the patient. This 69-year-old male patient the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318; Expiration Date: 31May2021), via an unspecified route of administration in the left arm on an unspecified date as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On 08Mar2021, the patient experienced cerebral venous sinus thrombosis and treated with PRADAXA. The patient underwent multiple "over 100" unspecified lab tests in the hospital with unknown results. The patient was hospitalized for cerebral venous sinus thrombosis from 26Mar2021 to 28Mar2021. The clinical outcome of cerebral venous sinus thrombosis was improved/resolving.

Other Meds:

Current Illness:

ID: 1294715
Sex: M
Age:
State: OK

Vax Date: 03/27/2021
Onset Date:
Rec V Date: 05/07/2021
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: cardiac amyloidosis; Dilated cardiomyopathy (I42.0); left ventricular hypertrophy (LVH); has increased on fatigue; cannot take breath well occasionally on exertion; abdominal swelling; weight gain/ weight had increased from 217 lbs to 227 lbs; dry cough since Covid shot; This is a spontaneous report received from a contactable physician. A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for Covid-19 immunization on an unspecified date. He reported that on 27Mar2021 he got the 2nd COVID Pfizer shot and has increased on fatigue now and cannot take breath well occasionally on exertion, also reported some abdominal swelling, none in legs. He reported weight gain but can la flat and no issues on resting conditions. He also reported dry cough since COVID shot but did not have any of such issues after the 1st dose. No fever, no dizziness or passing out. Diagnosis: Dilated cardiomyopathy (I42.0) -Left ventricular ejection fraction (LVEF) 25-30. Left ventricular hypertrophy (LVH) was diagnosed with cardiac amyloidosis. His weight had increased from 217 lbs to 227 lbs - reported shob but no edema, they discussed increasing furosemide (LASIX) to 40/d from 20 daily for a week and reassess. Also suspect COVID vaccine related immune phenomenon. Treatment received for the events (Dilated cardiomyopathy, Left ventricular hypertrophy, cardiac amyloidosis and weight gain). Events (has increased on fatigue, cannot take breath well occasionally on exertion, abdominal swelling, weight gain and dry cough since COVID shot) onset date was on unspecified date in 2021. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported cardiac amyloidosis, Dilated cardiomyopathy, and the administration of the COVID19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. More information on the patient's medical history, underlying medical conditions would be helpful for the Company to make a more meaningful causality assessment. 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 RA, IEC, as appropriate.

Other Meds:

Current Illness:

ID: 1294716
Sex: F
Age:
State: FL

Vax Date: 04/02/2021
Onset Date:
Rec V Date: 05/07/2021
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: pneumonia; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient's husband) reported for a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter was asking for his wife who is scheduled to get a second dose tomorrow 22Apr2021. However, he wants to reschedule the appointment because the doctor informed them not to take the second dose yet because his wife (patient) has pneumonia. They might miss the second dose appointment. Outcome of the event was unknown. Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021454451 same drug and patient, different event and drug dose

Other Meds:

Current Illness:

ID: 1294717
Sex: F
Age:
State:

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 05/07/2021
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: patient stated recent eye exam showed corneal ulcer; This is a spontaneous report from a contactable other health professional. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. On an unspecified date, the patient stated recent eye exam showed corneal ulcer. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product information, the causal relationship between the reported ulcerative keratitis and use of BNT162B2 cannot be fully excluded. However, the medical history of rheumatoid arthritis may confound the reported drug event pair. The limited information precludes a more meaningful assessment. The case will be assessed further upon receipt of additional information. 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 Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1294718
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/07/2021
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: he tested positive after receiving the first covid vaccine.; he tested positive after receiving the first covid vaccine.; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if he should receive his second COVID vaccine since he tested positive after receiving the first COVID vaccine on unspecified date. The patient also experienced unspecified side effects on unspecified dates. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1294719
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: contracted Covid; contracted Covid; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know how to reschedule her second dose. The patient stated that after she got her first dose, she and her husband contracted Covid on an unknown date. The outcome of the events was unknown. Information about batch/Lot number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm