VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1409664
Sex: F
Age:
State: NY

Vax Date: 06/02/2021
Onset Date: 06/02/2021
Rec V Date: 06/18/2021
Hospital: Y

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: anaphylactic reaction; This is a spontaneous report from a contactable pharmacist. This Pharmacist reported for two patients. This is the second of two reports regards to a female patient. A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Deltoid Left on 02Jun2021 (Batch/Lot Number: EW0178; Expiration Date: Aug2021) at the age of 29-year-old, as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications was reported as taking other medication (unspecified). The patient experienced anaphylactic reaction on 02Jun2021. They took her to the hospital. It was reported the vaccine shot was between 11:30 and 12:00 in the morning. The patient experienced anaphylactic reaction literally like may be within 5 minutes after taking the shot. So its again 11:30 or 12:00. The outcome of event was unknown. Information on Lot/Batch number is available; Further information has been requested.; Sender's Comments: Based on the plausible temporal relationship and known drug safety profile, a possible causal relationship between the event Anaphylactic reaction and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021641495 same reporter, product, different patient and similar events.

Other Meds:

Current Illness:

ID: 1409665
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 06/18/2021
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: eyes were so swollen, they were almost swollen shut; voice is really rough and raspy; throat swollen; headache; blood pressure was high; had a panic attack/anxiety; Low blood sugar; It was like it made her seizure medicines stop working like it halted the seizure medicines; non-stop seizures; It was like it made her seizure medicines stop working like it halted the seizure medicines; Allergic to the vaccination; made her nose run; made her cough like she was in the middle of a grass field; couldn't think straight; not in her right mind before she had her seizures, it affected her brain; has sore calves; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 01Jun2021 (Lot Number: EN0178) at the age of 54-year-old as single dose for covid-19 immunisation(reported as wanted to be able to hold her grandbaby). Time of the vaccination was given at 20:15 - 20:30. Co-suspect drugs included clonazepam, orally taken for seizure at 2.5 mg a day, takes it 5 times a day, they break it up, anxiety from an unspecified start date and ongoing; lamotrigine (LAMICTAL) taken for seizure from an unspecified start date and ongoing at 600 mg a day, 6 pills a day; gabapentin (NEURONTIN) taken for seizure from an unspecified start date and ongoing at 600 mg a day per day. There were no vaccines administered on same date with the Pfizer vaccine considered as suspect. Prior vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as none. Medical history included seizures, ongoing anxiety, brain tumor (discovered when she was 21 years old), brain surgery in 1994 (brain surgery was on the left side, her surgery was done when she was 27 years old, she had been pregnant), blood pressure usually low, really low, allergic to blue dye, allergic to a lot of antibiotics, ongoing thyroid being gone, allergic to grass. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid being gone from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC) taken for allergy from an unspecified start date and ongoing. The patient previously took lorazepam for seizure. The patient experienced non-stop seizures on 01Jun2021 with outcome of recovered on 01Jun2021, headache on 01Jun2021 20:45 with outcome of recovered on 02Jun2021, blood pressure was high on 01Jun2021 with outcome of unknown, eyes were so swollen, they were almost swollen shut on 02Jun2021 with outcome of not recovered, voice is really rough and raspy on 02Jun2021 with outcome of recovering, throat swollen on 02Jun2021 with outcome of not recovered, made her nose run on Jun2021 with outcome of unknown, made her cough like she was in the middle of a grass field on Jun2021 with outcome of unknown, couldn't think straight on Jun2021 with outcome of unknown, not in her right mind before she had her seizures, it affected her brain on Jun2021 with outcome of unknown, has sore calves on Jun2021 with outcome of unknown, had a panic attack on 01Jun2021 with outcome of recovering, allergic to the vaccination on Jun2021 with outcome of unknown, low blood sugar on 01Jun2021 with outcome of unknown, "It was like it made her seizure medicines stop working like it halted the seizure medicines" on 01Jun2021 with outcome of recovered on 01Jun2021. The patient was calling to report this vaccination, which had caused her a lot of trouble. She had an ambulance come within the hour after receiving it. The police department, ambulance and the EMT they charged for that and then she had non-stop seizures they wouldn't stop and she took medication and they finally did stop. She did have seizures, they found out she had low blood sugar, but that's from a brain tumour and brain surgery she had. She had to be careful of her sugar content, she's not diabetic, she's opposite of diabetic. Her blood sugar was 92. Her blood pressure was high, it's usually low, really low. It was 138/72 or something and it's usually 92/56. She's not heavy, she's light, about 110 pounds. She's healthy, well in a healthy condition. She didn't have a thyroid, but she took medication. She guessed she's not the healthiest person. She finally made it to bed last night and she was up this morning and her eyes were so swollen they were almost swollen closed. She was putting tea bags under eyes. They were so swollen one of them was almost swollen shut and now she could hear her voice was really rough and raspy. She was pretty positive she's allergic to the vaccination. She didn't know what to do. She could not hold her grandbaby unless she had the vaccination that's the only reason she got one and now she's stuck and her eyes look terrible. She thought people with seizures with epilepsy she thought there should be a warning that it could cause seizures and to double up on medication. She was allergic to blue dye, that would do the same to her she didn't know if it had blue dye in it but she's allergic to that. She's also allergic to a lot of antibiotics. She got the vaccination late at (facility name withheld) about 20:15 last night on 01Jun2021 and within half an hour these symptoms started 20:45-21:00. Her throat was swollen. She didn't normally sound raspy, she sounded normal and had a little nicer voice usually. She still had the headache with seizures. The seizure ended because of the medication, she still wouldn't have ended her seizures if she hadn't take the medication, they would have ended later. The seizures were gone because she's on her medicine. Now it was her eye and her voice. The headache started within a half hour its a precursor an aura to the seizure. It started at 20:45. It was like it made her seizure medicines stop working like it halted the seizure medicines. She couldn't think straight she called people and talked to people. She was not in her right mind before she had the seizures it was weird. It affected her brain. She also had sore claves. Her calves were very strong and muscled she worked out a lot. She had anxiety but its better since her divorce and one of the pills for the seizures was an anxiety pill too it did both they figured out. What happened after she got the shot was she got anxiety, she thought what the heck. She had a panic attack, she thought that was so weird that was on the road. When she got home she was okay. Her voice was feeling better this was her talking normally, it's getting better. Also this shot made her nose run and made her cough like she was in the middle of a grass field, which she's allergic to grass. She just felt like that was weird. She's just allergic to that blue dye and allergic to a lot of medicine. Events did not resulted in emergency room or physician office visit. Patient declined to go to emergency room when asked by ambulance. The ambulance offered to take her she said no thank you. Treatment received included lorazepam: she took something called lorazepam to stop the seizures. That's the drug they gave her at the hospital and she had some for non-stop seizures which she's had in the past she's had these pills just in case because she lived alone. She put it by her bed just in case she had to take it again. The Lorazepam was 0.5 mg tablets she took one. She only took it if it's a non-stop seizure. She's taken it 3 times maybe in the last 3.5 years. The action taken in response to the events for clonazepam, lamotrigine and gabapentin was unknown.

Other Meds: Neurontin; LAMICTAL; CLONAZEPAM; SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness: Anxiety (Verbatim: anxiety); Thyroid disorder (thyroid being gone)

ID: 1409666
Sex: F
Age:
State: NC

Vax Date: 05/22/2021
Onset Date: 05/31/2021
Rec V Date: 06/18/2021
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: Unable to fully move left arm due to severe pain.; Supraclavicular lymphadenopathy; This is a spontaneous report from a non-contactable consumer (patient). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22May2021 17:00 (at the age of 16-year-old) as unknown, single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. There is no known allergies, no other medical history. The patient experienced unable to fully move left arm due to severe pain and supraclavicular lymphadenopathy on 31May2021 09:00. There is no other vaccine in four weeks, no other medications in two weeks. There is no covid prior vaccination. The patient did not test covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. AE resulted in emergency room/department or urgent care. The patient received treatment (Pain reliever) for the adverse event. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1409668
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 06/18/2021
Hospital: Y

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: Throwing up, defecating, violently ill; Throwing up, defecating, violently ill; Throwing up, defecating, violently ill; Not totally conscious; Seizures; Has left side paralysis does not have movement in left arm and; nausea; Sweating/Cold sweats; hard time breathing; his legs were getting weaker and weaker as well/Whole left side of his body is extremely week, right side is weak; his legs would go numb/arms are numb; Not feeling so good; Sweating/Cold sweats; shaking; Dizzy; Pain is through his whole body; Not feeling good; Palms of his hands were pins and needles and pain after and the pain was so bad; huge pain in his groin; This is spontaneous report from contactable consumer (reporting for himself). A 51 year-old male consumer received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified route of administration in arm right on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history included chronic back pain (diagnosed for years) and type I diabetes mellitus, both ongoing. Concomitant medications were not reported. Historical vaccine includes first dose of BNT162b2 (got violently ill, weak, sweat, very dizzy, nausea, sick). After the second shot of vaccine, the patient started profusely sweating and nausea, had hard time breathing, only lasted a day, the next day he was fine. Stated within that week, he started noticing when he was kneeling in the garden he could not get back up, knew that it was not due to the chronic back pain from years ago and type one diabetic but otherwise he was fine and knew how to handle himself. The patient stated his legs were getting weaker and weaker as well, if he sat down with his nephew or with the neighbor's kids, the minute he sat down or tried to sit Indian style his legs would go numb. He reported this to his doctor, they did 2 conferences with him and they didn't know, all his labs were good, could be neuropathy from diabetes. Second week after second shot (middle of May2021 or end of May2021, as reported) he had to go to the ER at some point during the day he had a huge pain in his groin that felt like a pulled muscle but it progressed all day, by the end of the day if felt like there was a block in there or a clot in his artery going down his leg. went to the ER, did a full CT scan of whole body, no clots no hernias. Gave him morphine and sent him home. For another week he went home and went back to the ER because his legs were so numb it was not just when he was sitting down but all the time, getting worse when sitting down. They just had pins and needles all the time. his legs were getting weaker. On 23May2021, he was not feeling so good, called the doctors, arms are numb, he is just getting weaker, slept all day into the next day, palms of his hands were pins and needles and pain after and the pain was so bad that putting pressure on the hands would help with the pain. On 24May2021 he had cold sweats, not feeling good, dizzy, somethings messed up, pain through his whole body, whole left side of his body was extremely week, right side was weak. Throwing up and defecating just violently sick for 3 hours straight, not totally conscious because he did not remember so much of it. Shaking and profusely sweating, 8am he was able to slide arm and hit the emergency button, left a message they called him back, they sent 911 and they got him. Took him to ED and he had three seizures back to back and they treated the seizures with Ativan. They did another CT scan and they saw he has not fallen, no issues in his head. Sent him to a different hospital. That first night at that hospital he had three more back to back seizures. Woke up and had one more seizure. When he woke up he had electrodes on his head and were measuring his brain activity. He was cleared by neurology at this time, they did not find any issues with his brain. His full body MRI was negative. Rheumatology was now testing him for Lymes, MS, lupus, everything has been negative. He has still gotten worse, has left side paralysis did not have movement in left arm and leg. Can use right arm, but the pins and needles and dead arm comes and goes in right side. Throwing up, defecating, violently ill were serious due to hospitalization, required Emergency Room Visit and were not resolved. Outcome for other events was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness: Chronic back pain (Verbatim: Chronic back pain); Type I diabetes mellitus (Verbatim: Type I diabetes mellitus)

ID: 1409670
Sex: F
Age:
State: AZ

Vax Date: 03/30/2021
Onset Date: 06/01/2021
Rec V Date: 06/18/2021
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: This is a spontaneous report from a non-contactable consumer (patient). This 36-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 30Mar2021 10:00 (Batch/Lot number was not reported) as single dose at age of 35 years old for COVID-19 immunization. There was no concomitant medication. The patient did not receive other vaccine in four weeks, no other medications in two weeks. Medical history included asthma and migraine, from an unknown date and unknown if ongoing. The patient had known allergies but unspecified. The patient's concomitant medications were not reported. The patient experienced irregular menstrual cycle (12 days late), extremely heavy flow and blood clots on 01Jun2021. No treatment received for the events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1409671
Sex: F
Age:
State: MD

Vax Date: 04/21/2021
Onset Date: 04/28/2021
Rec V Date: 06/18/2021
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: post menopausal vaginal bleeding; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 21Apr2021 16:45 (Lot Number: EW0161) at the age of 56-year-old as single dose for covid-19 immunisation. The patient was not pregnant. Medical history included hypertension, anxiety, depression, COVID-19 (Prior to vaccination, the patient was the patient diagnosed with COVID-19). The patient had no known allergies.The patient previously received first dose of bnt162b2(lot number: ER8732) at arm left on 31Mar2021 04:30PM at the age of 56-year-old for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included venlafaxine hcl; metoprolol tartrate; multivitamin; hydrochlorothiazide (HCTZ); all taken for an unspecified indication, start and stop date were not reported. One week after the second dose (28Apr2021), the patient began to have post menopausal vaginal bleeding. It lasted for 8 days and ended on 08May2021. The bleeding was similar to a menstrual cycle. Her last menstrual cycle was in Sep2017. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Covid test post vaccination covid test type post vaccination(Nasal Swab) on 03May2021 was negative. No treatment received for the event. The event was recovered on 08May2021.; Sender's Comments: Based on the information currently available, the reported event post menopausal vaginal bleeding one week after the second dose more likely represented intercurrent illness, but not related to bnt162b2. 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: VENLAFAXINE HCL; METOPROLOL TARTRATE; HCTZ

Current Illness:

ID: 1409672
Sex: F
Age:
State: NJ

Vax Date: 05/19/2021
Onset Date: 05/23/2021
Rec V Date: 06/18/2021
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: Pyrexia, White blood cell count decreased

Symptoms: Myocarditis; chest pain; shortness of breath; This is a spontaneous report from a contactable physician. A 20-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient had not known allergies. Medical history included, abdominal pain ongoing, the patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, On 23May2021, The patient experienced myocarditis, chest pain , shortness of breath with outcome of recovering. The patient was hospitalized for myocarditis for 5 days. The patient was hospitalized for chest pain for 5 days. The patient was hospitalized for shortness of breath for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23May2021. Therapeutic measures were taken as a result of myocarditis (myocarditis), chest pain (chest pain), shortness of breath. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of myocarditis,chest pain,dyspnoea. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1409673
Sex: F
Age:
State: TX

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 06/18/2021
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: Received third dose of Covid 19 vaccine; the patient had an appointment for the hepatitis B vaccine. By mistake, the pharmacist had administered the Pfizer COVID-19 vaccine to the patient; also get the Hepatitis B vaccine afterward(administered on Same Date of the Pfizer Suspect); body aches, pains; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported for a 23-year-old female patient (Reporter's Niece). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported) at the age of 23-year-old as single dose at arm for covid-19 immunisation; hepatitis b vaccine via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported), at single dose for immunization. The patient's other medical history reported as none. The patient's dad was diabetic, but the reporter did not know for sure. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 at the age of 23-year-old(Maybe 3 weeks before second dose) for covid-19 immunisation. Prior vaccinations (within 4 weeks) also reported as no. The patient previously received second dose of bnt162b2 on May2021 (22May2021 or 23May2021) at the age of 23-year-old for covid-19 immunisation and experienced body aches, pains, tiredness. The patient had the second dose of the Pfizer COVID-19 vaccine 10 days before. The day before yesterday, the patient had an appointment for the hepatitis B vaccine. By mistake, the pharmacist had administered the Pfizer COVID-19 vaccine to the patient and at the time of the report, from Jun2021, the patient was experiencing minor adverse events that were similar to the adverse events she had experienced during her Pfizer COVID-19 vaccine second dose. She did also get the Hepatitis B vaccine afterward(administered on Same Date of the Pfizer Suspect). She felt nervous because she had both. Report reported as non-serious. Events did not resulted in emergency room and physician office. Treatment reported as none. Relevant tests was none. The outcome of the events body aches, pains, tiredness was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1409674
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: suffered a PE; This is a spontaneous report from a non-contactable consumer via a sales representative. A 23-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 23-years-old, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included hereditary gene disorder with lupus. The patient's concomitant medications were not reported. The patient experienced suffered a PE (pulmonary embolism) on an unspecified date with outcome of unknown. Her team of physicians treating her acutely, did not feel it was attributed to the vaccine and rather due to a hereditary gene disorder with lupus. Event took place after use of product. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1409675
Sex: F
Age:
State: CA

Vax Date: 05/27/2021
Onset Date: 05/28/2021
Rec V Date: 06/18/2021
Hospital: Y

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: woke up the next day feeling sick and it got worse; She said that she got sick after taking the first dose to the point that she was going to the hospital; body aches; Fever; Headache; had lymph node swelling; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself that the 53-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE) at the age of 53-year-old, dose 1 via an unspecified route of administration, administered in Arm Left on 27May2021 14:00 (Batch/Lot Number: EW0185) as 1st dose, single for covid-19 immunisation. Medical history included covid-19 from Dec2020 to an unknown date. Family Medical History was none. Concomitant medications included ongoing probiotic and Multivitamin and she explains she doesn't really take medication, only supplements like a probiotic and a multivitamin. The patient experienced she said that she got sick after taking the first dose to the point that she was going to the hospital (illness) (hospitalization) on 28May2021 with outcome of recovered , had lymph node swelling on an unspecified date with outcome of unknown, body aches on 28May2021 with outcome of recovered, fever on 28May2021 with outcome of recovered, headache on 28May2021 with outcome of recovered, woke up the next day feeling sick and it got worse on 28May2021 10:00 with outcome of recovered. The patient underwent lab tests and procedures which included body temperature: 103.6 on unknown date (Her fever was 103.6, this was the highest), body temperature: 101.8 on unknown date (It would go down to 101.8), body temperature: 102.5 on unknown date (she still had 102.5, would not drop), body temperature: 103.2 on unknown date (It was at 103.2 and it wouldn't drop, that is when she showered). Therapeutic measures were taken as a result of she said that she got sick after taking the first dose to the point that she was going to the hospital, body aches, fever, headache. Consumer wanted to know the coverage of protection after one dose of the Pfizer OCVID-19 vaccine. She also would like to verify if the first dose primes the immune system, helping it recognize the virus and if the second dose boosts the immune system. Consumer (53-yr old female) has taken the first dose of the Pfizer COVID-19 vaccine. She said that she got sick after taking the first dose to the point that she was going to the hospital. She also mentioned that she had lymph node swelling that lasted for about a week. She wanted to know if the adverse events with the second dose of the vaccine are grater than those of the first dose's. Consumer mentioned that she had COVID-19 infection back in Dec2020. She wanted to know if having COVID-19 would increase her immunity and would it act as the first dose of vaccination. "The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19." Caller wanted to know if she could only take one dose of the vaccine. Consumer also mentioned that she had lymph node swelling that occurred for about a week. Warm transfer of a caller reporting that she came down with COVID in Dec2020. On 27May2021 she got her first dose and after the dose she became so sick, worse than when she had COVID. It was too the point that her husband almost took her to the hospital. She explains she has read articles about the first dose, and how it is getting a person ready for the second. That the second dose is supposed to be a lot harder that the first dose. The caller wonders if she should take the second dose. Consumer reports that she wants the coverage from the vaccines and to be protected but at the cost of what she went through with the first dose, she is scared to take the second dose. The events started the following day, after the vaccine. She got the vaccine at 2pm then woke up the next day feeling sick and it got worse. The events lasted about a day and a half with the worst part being from about 10am on 28May2021 until about 7am on 29May2021. When talking about the sick feeling the caller explains she still had body aches till about 5pm on the 29May2021 but they were not as severe, which is what she had expected. Treatment: The following day on 28May2021 in the morning she took 400mg of Ibuprofen which was 2 of them, and they did not help. UPC: 8113107845, Lot: The first digit is a 0 or O followed by AE3334A, Expiry: Nov2021. Then she took 2 Excedrin mid-day and that didn't help. UPC: 8113136703, Lot: WJ1984 followed by a G or 6, Expiry: Aug2022. Then that evening she took 1000mg Tylenol which she later clarified as Equate pain reliever pain extra and that didn't help much. UPC: 8113111254, Lot: 0KV1625, Expiry: Aug2022. Her fever was 103.6, this was the highest. She also took cool showers to control the fever and this would help a little for about 30 minutes. It would go down to 101.8. At midnight, she took another 1000mg of the Equate pain reliever and 2 hours later she still had 102.5, would not drop. The body aches were terrible. She also had a headache and that was mild. It was the body aches that were unbearable, she could hardly walk they were so severe, and the fever. It was at 103.2 and it wouldn't drop, that is when she showered. She felt so sick, she couldn't move. The caller explains she has never been that sick, even with the flu. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.

Other Meds:

Current Illness:

ID: 1409677
Sex: F
Age:
State: NC

Vax Date: 01/25/2021
Onset Date: 01/29/2021
Rec V Date: 06/18/2021
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: Moderate to severe inflammation; This is a spontaneous report from a contactable other HCP (patient). A 56-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 25Jan2021 (Batch/Lot Number: EC3247) as 1st dose, single for covid-19 immunisation. Medical history included Auto immune disease, depression, Hypercholemia, Anemia. No Covid prior vaccination. Concomitant medication(s) included secukinumab (COSENTYX); celecoxib (CELEXA); ergocalciferol (VIT D); vitamin b complex (B COMPLEX (B50)); rosuvastatin calcium (CRESTOR). The patient was allergy to Sulfur. The patient experienced moderate to severe inflammation on 29Jan2021 17:00. Patient received: Prednisone tabs, Streoid injection, lab work, x rays. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of Inflammation. 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: COSENTYX; CELEXA [CELECOXIB]; VIT D; B COMPLEX (B50); CRESTOR

Current Illness:

ID: 1409678
Sex: F
Age:
State: MI

Vax Date: 05/24/2021
Onset Date: 05/27/2021
Rec V Date: 06/18/2021
Hospital: Y

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: Allergic reaction; This is a spontaneous report from a contactable consumer (patient). This 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24May2021 at single dose (lot: EW0191) for COVID-19 immunization. Medical history included blood pressure abnormal, she had blood pressure medicine (medical condition was not clarified further). Concomitant medications included carvedilol and hydrochlorothiazide for blood pressure. Patient stated she had an allergic reaction on 27May2021 and she thought she was still having reaction, she was at the hospital, ER for two days really. She was in the emergency room. Treatment included paracetamol (TYLENOL), 500 mg tablet. The outcome of event was not recovered.

Other Meds: CARVEDILOL; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1409680
Sex: M
Age:
State: CA

Vax Date: 05/18/2021
Onset Date: 05/01/2021
Rec V Date: 06/18/2021
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: Having stabbing pain in his heart; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE ), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EW0170) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Sleep apnea which he had surgery for sleep apnea a long time ago, arthritis in his hand.The patient's concomitant medications were not reported. The patient previously took lisinopril for blood pressure, and has been on it for 2 years or so and has never had that experience with it. He received flu vaccine vii. A week after, he started having stabbing pain in his heart. He said it was not real bad, but enough to know it was there. He added that it was periodically on and off, and in the last 2 days, he did not feel it anymore. Outcome of event was unknown.

Other Meds:

Current Illness:

ID: 1409681
Sex: M
Age:
State: NY

Vax Date: 06/02/2021
Onset Date: 06/03/2021
Rec V Date: 06/18/2021
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: run a fever of 107F; He also had aches all over; He just feels horrible; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jun2021 17:30 (at the age of 13 years old) (Lot Number: EW0217) as single dose for covid-19 immunisation. Medical history included had gotten Covid twice this year; He had allergies to food, dog dander, and fish; Asthma. He had them for years. He had an asthma medication, Qvar. He was an allergy kid and had an epi pen. Concomitant medications included epinephrine (EPIPEN 2-PAK); beclometasone dipropionate (QVAR) ongoing for asthma (They just changed his medication about a year ago. She (mother) didn't know where it was to give a dosage). No vaccines administered on same date with the Pfizer vaccine considered as suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No Family Medical History Relevant to AE(s). The patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine yesterday, 02Jun2021. Today (03Jun2021) he started to run a fever of 107F and was given Tylenol and went down to 100.3F. He also had aches all over. Caller was asking how high was the normal fever, what can she give to her son and how long would the AE last. He was running a fever and had aches all over. This was his first dose of the Covid vaccine. She asked if that was normal and how high his temperature should go. Aches all over was reported as worsened. The mother called and said he was running a fever. Her daughter just gave him Tylenol and he still had a fever of 100.3. It was a little bit higher. It was like 100.7 and came down to 100.3 (03Jun2021). He just feels horrible. It was Extra Strength Tylenol, lot: SMC200, expiration date: Jun2022. The aches started this morning. The events did not require a visit to Emergency Room and Physician Office. The outcome of the events was not recovered.

Other Meds: EPIPEN 2-PAK; QVAR

Current Illness:

ID: 1409682
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 06/18/2021
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: Anaphylactic reaction; This is a spontaneous report from a non-contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) at 71-year-old as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated she received a call from a community member who received her first dose of the Pfizer COVID-19 vaccine in Feb2021 and had an anaphylactic reaction to the vaccine, she reported this already to the CDC and to her HCP who has reported it as well. Caller was looking for information to give to the member about the possibility of being vaccinated with the Jansen COVID_19 vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1409685
Sex: M
Age:
State: VA

Vax Date: 05/13/2021
Onset Date: 05/01/2021
Rec V Date: 06/18/2021
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: lost so much weight; there it inflamed the places where you have bumps; dry skin; had fungus things push under the nail; fever, says 98.6 is about a half point to a point high; passed out; dead for a while; Itching; Stomach a little bit bad/Sick to his stomach; Really, really tired; Brain is scrambled a little bit/Brain things get a little not right/Brain things get a little not right/Fogged up a little bit more lately/ Feeling kind of crummy/ Feeling a little bit bad; Dry mouth; Judgement is off; Falling a bunch of times; Slept and slept and slept; This is a spontaneous report from a contactable consumer reported for himself. This 59-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Deltoid on 13May2021 (Lot Number: EW0167; Expiration Date: Aug2021) at single dose for COVID-19 immunisation. Medical history included ongoing cardiac failure, ongoing hypoxia (Hypoxia, brain injury), Kidney problems , ongoing myoclonus (he has several different things, says stuff comes from the brain injury, and from medicines they gave him), hepatitis C (he had treatment for Hepatitis C when it first came out, says it's cleared up and has never had bad liver function. States he was diagnosed 15 years ago), ongoing attention deficit hyperactivity disorder (ADHD, combined type), ongoing ventricular fibrillation, ongoing gastrooesophageal reflux disease (GERD, he has had GERD all his adult life), ongoing back pain (chronic back pain, he has had chronic back pain since he was about 15). Handicapped/ disabled, depression, heartburn and acid reflux, cardiomyopathy, pain, urine flow decreased. Concomitant medications included ongoing acetylsalicylic acid (ASPIRIN (E.C.)) taken for cardiac failure, he has been taking this medication for years; ongoing atorvastatin (LIPITOR [ATORVASTATIN]) as heart medicine, he has been taking this medication for years; ongoing clonazepam (CLONAZEPAM) taken for brain injury; ongoing escitalopram oxalate (LEXAPRO) taken for depression, he has been taking this for 25 years; ongoing esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for heartburn and acid reflux; ongoing furosemide (FUROSEMIDE) taken for heart failure and fluid, he has been taking this somewhere between 5-10 yrs; ongoing isosorbide mononitrate (ISOSORBIDE MONONITRATE), he doesn't know what he takes these for, something for added heart; ongoing levothyroxine sodium (SYNTHROID) taken for thyroid disorder; ongoing losartan (LOSARTAN) taken for cardiomyopathy; nystatin (NYSTATIN), he doesn't know why he takes this, says it's probably for his heart; ongoing primidone (PRIMIDONE); ongoing promethazine (PROMETHAZINE); ongoing spironolactone (SPIRONOLACTONE); ongoing trazodone (TRAZODONE) taken for sleep disorder, he uses it as a tranquilizer, uses it for pain, they say he's a drug seeker and won't give pain medicine.; ongoing morniflumate (FLOMAX [MORNIFLUMATE]) taken for urine flow decreased. The patient experienced passed out on May2021 with outcome of unknown , dead for a while on May2021 with outcome of unknown, itching on May2021 with outcome of recovered in 2021, stomach a little bit bad/sick to his stomach on May2021 with outcome of recovered on May2021, really tired on May2021 with outcome of unknown, brain is scrambled a little bit/brain things get a little not right/brain things get a little not right/fogged up a little bit more lately/ feeling kind of crummy/ feeling a little bit bad on May2021 with outcome of recovering , dry mouth on May2021 with outcome of recovered in 2021, judgement is off on May2021 with outcome of recovered in 2021, falling a bunch of times on May2021 with outcome of recovering , slept and slept on May2021 with outcome of unknown, lost so much weight on unspecified date with outcome of unknown, there it inflamed the places where you have bumps and dry skin on unspecified date with outcome of unknown, had fungus things push under the nail on unspecified date with outcome of unknown, fever on unspecified date with outcome of unknown. The clinical course was reported as follows: This past week he has been feeling kind of crummy, says he's disabled, and can lose track. He says his brain is scrambled a little bit since he got hit, says he passed out, was dead for a while, states that affects him quite a bit, and he says he loses track. He says when he tells about that, he didn't know he got the first shot and it had a little place that hopes it didn't mess up. He states he put on small wounds, corcetin. States when they did the shot, says usually they'll make you hold, ask you to hold the cotton ball in place, says they get a Band-Aid on tight and push down, says they put compression so it doesn't leak. He states this was loose when he got home, it was leaking like a little bubble, a little fluid. When he washed it, he washed it off. Right close to it, there were two other places. He states when they gave him some steroid cream, he put that on there it inflamed the places where you have bumps and dry skin and a cut and looks like a little cut. Says when he put cream, it got inflamed and angry. He stated he was watching Dr, and when she calls it a cyst or something is infected, she calls it angry. He says there was a bunch where they put the Band-Aid, and he put just a dab of corcetin, believe that's what he had when he put, took it off the first time, and it had two bigger places that were a scab. He says once he put 2 by 3 Band-Aids and left it on for a couple of days, says he did this several times since last year or two, says to try to clear some of this stuff up, don't scratch, says he did get an itch in that location when he got the shot. He didn't scratch, said he wanted to pull Band-Aid off and scratch but didn't do it. He says it cleared up but he's been feeling a little funny, just maybe a little sick to his stomach, dry mouth, stuff like that. He says he didn't think it's a problem, says he had that problem like after 3, 4, or 5 weeks and all of a sudden he has a little episode where he gets to feeling funny, says his judgement is off and the brain things get a little not right. He stated he then fell a lot, says he's been falling a bunch of times in the last week, he'll feel better and it won't bother him. He says it's a cycle he's gone through since he lost oxygen. He doesn't think it's anything, it's confusing, says it has so many symptoms, and when he read this it has so many symptoms. Confirmed patient was referring to COVID vaccine. He states he hasn't had eczema then most of it, sometimes he'll scratch, it will build up like a scab and he'll scrape it off, put some of the ointment on there. but a band aid on top, leave it down for a couple of days, after a shower, a couple of showers, it comes off. He says it clears it up, says if it doesn't, just wash, wash it hard, it scrubs the scab off. He states the worst thing he had was his toenails, he had to work on them, had fungus things push under the nail, under the side, and he cut it. He used cortisone 10 on it, says they always quit making something that works well, states you know how you get a yellow toenail. He says he's been putting Neosporin on it. Clarified corcetin is Cortizone 10, it is pretty strong stuff. He says he puts it on these places on his arm using Neosporin. Attempted to clarify that itching began after use of Cortizone 10, states nothing like that, says it did itch a few days after still a little bit, there were three little places under that Band-Aid where they put the shot. He ended up putting Neosporin right when he took that band aid off it was itching, says he washed it good, then put Neosporin on it, says it's cleared back up to its normal roughness. For event itching, he states at first it was almost a scab, but it was not quite a scab, it was wet like a little bubble. After the scab, when he got ready to take, it was itchy after the band aid was on there a couple of days, he took a shower, washed it, and put more ointment on it. Each time he took the Band-Aid off, he washed it, washed his arm, and put the Band-Aid back on. He did the same aga

Other Meds: ASPIRIN (E.C.); LIPITOR [ATORVASTATIN]; CLONAZEPAM; LEXAPRO; NEXIUM [ESOMEPRAZOLE SODIUM]; FUROSEMIDE; ISOSORBIDE MONONITRATE; SYNTHROID; LOSARTAN; NYSTATIN; PRIMIDONE; PROMETHAZINE; SPIRONOLACTONE; TRAZODONE; FLOMAX [MORNIFLUMATE]

Current Illness: ADHD, combined type (ADHD, combined type); Brain injury; Chronic back pain (Chronic back pain Caller states he has had chronic back pain since he was about 15.); GERD (he has had GERD all his adult life.); Heart failure; Hypoxia; Myoclonus; Ventricular fibrillation

ID: 1409686
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date: 03/01/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pericarditis; This is a spontaneous report received from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982) via unspecified route of administration in left arm on 02Feb2021 01:00 PM as 2nd dose, single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at hospital (facility type). The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior vaccination. The patient's concomitant medications received within two weeks of vaccination included simvastatin and telmisartan both from unspecified date. The patient previously took levofloxacin (LEVAQUIN) and it was reported as known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via unspecified route of administration in left arm on 12Jan2021 12:00 PM (at the age of 73-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On unspecified date in Mar2021 the patient experienced pericarditis treated with unspecified medication and resulted in doctor or other healthcare professional office/clinic visit. The had patient been tested for COVID-19 on unspecified date in May2021 with nasal swab test and a negative result was reported. The outcome of the event was not resolved.

Other Meds: SIMVASTATIN; TELMISARTAN

Current Illness:

ID: 1409687
Sex: F
Age:
State: FL

Vax Date: 05/13/2021
Onset Date: 05/26/2021
Rec V Date: 06/18/2021
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: Bleeding in the middle of the cycle; This is a spontaneous report from a contactable consumer(patient). This 40-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0167)on 13May2021 16:30 via an unknown route in left arm at 40-year-old for Covid-19 immunization. Medical history and past drug history were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications the patient received within 2 weeks of vaccination. Patient experienced adverse event of bleeding in the middle of the cycle on 26May2021. The event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Outcome of the event was unknown. Since the vaccination, the patient had not been tested for COVID-19. The reported was assessed as non-serious. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1409688
Sex: F
Age:
State: NJ

Vax Date: 04/08/2021
Onset Date: 05/09/2021
Rec V Date: 06/18/2021
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: Difficulty breathing; joint pain; headache; chills; nausea; diarrhea; body ache; hives; my throat started to close down it was very hard to breathe; I could barely talk; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0161) on 08Apr2021 at 13:00 (at the age of 41 years), as first single dose, in left arm, for COVID-19 immunization. Medical history included penicillin allergy, latex allergy and peach, papaya allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levocetirizine dihydrochloride (XYZAL) pro air inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09May2021 at 14:00 the patient experience difficulty breathing, joint pain, headache, chills, nausea, diarrhea, body ache, hives, her throat started to close down, it was very hard to breathe and she could barely talk. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included allergy medication, another inhaler and epinephrine (EPIPEN). The events were resolving. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds: XYZAL

Current Illness:

ID: 1409689
Sex: M
Age:
State: DC

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 06/18/2021
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: His weight is fluctuating; This is a spontaneous report from a Pfizer-sponsored program. A contactable 62 years old male consumer (patient) received 1st dose of Pfizer-BioNTech Covid-19 Vaccine BNT162B2 (Lot Number: EN6203), at the age of 62 years old, on 11Mar2021 in the Left arm for covid-19 immunization. Patient History was Blood clot in both legs. No Family Medical History Relevant. Concomitant Products clopidogrel bisulfate (PLAVIX) Ongoing for Blood thinner, he began taking Plavix 2 years ago after he had blood clots in both legs. Caller reported that he was supposed to get his second dose on 01Apr2021 but was hospitalized for a bypass that he had on 26Mar2021. Patient experienced Vascular graft on 26Mar2021. His weight is fluctuating. Outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: PLAVIX

Current Illness:

ID: 1409690
Sex: M
Age:
State: FL

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 06/18/2021
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: Severe eye pain; difficulty seeing; This is a spontaneous report received from a contactable consumer. This 18-years-old male consumer (patient) reported for himself that he received the first dose of BNT162B2 (lot number: EW0171) at single dose for COVID-19 immunisation on 08Apr2021. Relevant medical history included tumor in leg when young. Known allergies: not aware off but had food allergies in childhood. Relevant concomitant drug was unknown. The patient experienced severe eye pain, difficulty seeing after the first vaccination on 08Apr2021. The patient received antibiotic for the eye. Outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Follow-up attempts are needed. Further information is expected.

Other Meds:

Current Illness:

ID: 1409691
Sex: F
Age:
State:

Vax Date: 04/26/2021
Onset Date: 04/01/2021
Rec V Date: 06/18/2021
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: pain in the left arm; Loss of grip strength; pain in the left arm, her whole left side/ right side had pain; This is a spontaneous report from a contactable consumer(patient). This 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 05Apr2021 (lot number EW0150), 2nd dose on 26Apr2021 (lot number EW0164), both at 53-year-old via an unknown route for Covid-19 immunization. Patient stated she had no medical conditions, was a healthy individual. Concomitant drug was not provided. Patient experienced pain in the left arm, her whole left side, and pain was continuing. It was severe. She went to the emergency room on 23May2021. When she got the second vaccine she was still having pain and it had not gone away. She went to the hospital they gave her a muscle relaxer and an injection. She had taken Diclofenac Sodium and then changed to take Diclofenac Potassium. The right side had pain but the left was much worse. She had also lost her grip strength. She could not carry anything, could not open a bottle. She has a doctor appointment upcoming this month (as of 03Jun2021) related to these symptoms. Patient also stated that pain was getting worse. Her pain was extreme. She was worried and hopes she does not die. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1409692
Sex: M
Age:
State: PA

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 06/18/2021
Hospital: Y

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: Had to postpone the second dose because of a medical issue, anemia; Red blood cell aplasia; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2), first dose intramuscularly, administered in arm left at 23Mar2021 07:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at age of 64-year-old. Medical history included Addison's disease from 1980 and ongoing, slightly hypothyroid from 1980 and ongoing, ongoing Good syndrome, cholesterol increased from 2018 and ongoing, adrenal insufficiency and IGG deficiency (diagnosed with it five to six years prior to this report). No family medical history relevant to event. Concomitant medications included hydrocortisone taken for Addison's disease from 1980 and ongoing; fludrocortisone taken for Addison's disease from 1980 and ongoing; atorvastatin (LIPITOR) taken for lowering cholesterol from 2018 and ongoing; levothyroxine taken for slightly hypothyroid from 1980 and ongoing; immunoglobulin human normal (HIZENTRA) taken for Good syndrome. History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional vaccines administered on same date of the Pfizer Suspect was none. The patient got his first dose on 23Mar2021. He knew it is supposed to be within 42 days for the second dose, but his was scheduled about 60 days. He would like to get his second dose. His second dose was scheduled pretty far apart, about 60-70 days since his first dose. The patient had anemia and still had it. The patient had to postpone the second dose because of a medical issue, anemia. They decided to postpone. He was diagnosed with a red blood cell aplasia. He got blood transfusions. He was hospitalized three weeks after getting the first dose. The same day he was supposed to have the second vaccine they discovered the problem and he had to be hospitalized. He had blood transfusions. They are still trying to figure out why he had it. The treatment included blood transfusions, he got concentrated red blood cells. Four times, once in the hospital. Confirmed as he received four units. The third one he just had outpatient. He had one two weeks after, since the beginning of April. He just had one yesterday. He had them about every two weeks. He was about to start treatment for this anemia. The both events require a visit to emergency room and physician office. The patient had relevant tests and was diagnosed with red blood cell aplasia and then hospitalized, but unable to provide exact details. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds: HYDROCORTISONE; FLUDROCORTISONE; LIPITOR [ATORVASTATIN]; LEVOTHYROXINE; HIZENTRA

Current Illness: Addison's disease; Blood cholesterol increased; Good syndrome; Hypothyroidism

ID: 1409693
Sex: F
Age:
State: IL

Vax Date: 02/23/2021
Onset Date: 02/01/2021
Rec V Date: 06/18/2021
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: short of breath; Couldn't sleep; Couldn't eat; Severe headache; Fever; Body aches; High heart rate. The highest her heart rate has been is 183.; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201; expiration date: Jun2021), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 13:00 as 2ND DOSE, SINGLE for covid-19 immunisation. The patients medical history include asthma is allergy induced. States she has a sulfa allergy, so she doesnt even have an inhaler, so she just avoids all of her allergens. She has had asthma since she was 30. She has nerve pain that sporadically happens in her rear end where she can't even walk. She clarifies it's like sciatica, but it's not sciatica because she has been tested for that multiple times. She states the nerve pain began in 2010, where she was involved in a front end collision. Nerve pain States she avoids allergens, but can't avoid maple trees, or cottonwoods. Caller states she is pretty much allergic to everything but cats and dogs. Had surgery on her heart for WPW syndrome. she had shingles in Jan2020 not in Feb2020, says she isn't sure how long it stays in your system. Hypersensitivity, herpes zoster and wolff-parkinson-white syndrome. She states in 2006 she met with the same doctor, (Withheld) and had surgery on her heart for WPW syndrome. She states she was cured because she had a follow up at a year and it was gone. The patient states she is allergic to the flu shot so she was hesitant about getting the COVID vaccine. However, work was offering it for free so that is why she did it. She states she works for Jewel and is the closing manager. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265; expiration date: May2021) administered in left arm on 02Feb2021 (at the age of 45-year-old) administered in left arm for COVID-19 Immunization. The patient states after the first dose, her arm just hurt, says that she has recovered completely from her arm hurting. Concomitant medications included ongoing medroxyprogesterone acetate (DEPO-PROVERA, she has been taking this medication for 17 years and will be 18 years in Jul2021.); duloxetine hydrochloride (CYMBALTA, she has been taking this about a year and a half) from Jan2020 and ongoing for nerve blocker; ongoing zolpidem (the ptient states this is the generic version of Ambien, says she started taking this medication within the year) to fall asleep. Depo Provera: the patient doesn't know the dose, the caller states she just turns around and they inject her. She states she is horrible with remembering stuff, says she keeps pills in pill organizer, and her prescriptions in a pencil case. Zolpidem: Caller states she takes one a day to fall asleep. She can't fall asleep, but once she's asleep, she is fine. This has been going on for about 10 years, but she started taking the Zolpidem within a year. She would be up for 36 hours straight and couldn't fall asleep so it was time to take the Ambien. She clarifies she couldn't fall asleep without the Ambien. She was taking melatonin and Tylenol PM, and nothing worked. This had been going on for 10 years and when her doctor found out he said to her how are you not dead? She was taking 12mg of melatonin with a capsule of magnesium to process it, two Tylenol PMs and a muscle relaxer just to fall asleep. Caller says the magnesium is what processes the melatonin, just to make it go faster. Caller states she does not know the NDC/LOT/EXP for any of these products mentioned, says this was about 7 to 8 months ago. Caller states she started Ambien (Zolpidem) in Sep2020 or Oct2020. Caller states she had the flu for three weeks, was tested for COVID three times, but it was not COVID. She was not sleeping, even just laying in bed, so this is why the doctor prescribed it. The patient states the Cardizem is in a pharmacy bottle but provides the following product information off of the bottle: LOT: AB46505. For the second digit/letter, caller doesn't know if it's the number 8 or the letter B. She believes it is a B. Caller confirms the lot as AB46505. EXP: Mar2022. GTIN: 00363304719901. Caller states she needs to get her reading glasses for the GTIN number, this number is even tinier. She states the Cardizem packaging was intact, the pharmacy just stuck a label on it, says the bottle still has the silica gel capsule thingy in the bottle. She had her two doses of the Pfizer vaccine in February, the last dose being 23 Feb 2021. She got every side effect known to man the next day. Caller says they all went away within the first 24 hours. However, 48 hours later, she started having a high heart rate. She went to the emergency room on 23Mar2021 with a 124 resting heart rate. The highest her heart rate has been is 183. She is on heart medication and her heart rate is currently 113, and she is just laying in bed. Three days after her vaccine, clarified as 26 Feb 2021, her heart rate was 111. She was short of breath that day but couldn't figure out why. She felt her heart was racing and luckily she has an apple watch that does an EKG, so she has been monitoring this. She is allergic to the flu shot so she was hesitant about getting the COVID vaccine. However, work was offering it for free so that is why she did it. She works for Jewel and is the closing manager. She visited the emergency room on 23Mar2021. She was taking it easy, talking to her doctor and he said not to do runs, says she used to do 5ks, but she hasn't run since Oct 2020. She had been taking it easy. She has asthma and on 23 Mar 2021, she just couldn't get a breath in and her heart rate was high at the time. Even before she went to the emergency room, her heart rate was at 150, so she drove herself to the emergency room at 2am, and that's when she was referred to her electro cardiologist, and he has been treating the caller since. on the day of the shot, 8 hours later, she couldn't eat, she couldn't sleep, she had a severe headache- like her head was being crushed in. She had a 102 fever and had body aches. She had it all. These began on the day of the second shot. Caller states everything was gone by Thursday, 25Feb2021. She clarifies she received her shot-on Tuesday, 23 Feb 2021, the side effects happened all night long and the next day. She went to bed at 8am on Wednesday. She slept all day Wednesday. Confirmed with caller that she has recovered completely from these side effects. After the first dose, her arm just hurt, says that she has recovered completely from her arm hurting. High heart rate: She confirms this is still ongoing. her doctor got her on 360mg of Cardizem for it. With this medication, her heart rate is currently 111. The resting heart rate is supposed to be 50-90. Caller states her high heart rate is slightly improving. Her heart rate was running around 150 to 183 before her doctor placed on her on the medication. She states the high heart rate is not going away, and she may have to be on meds for rest of her life. Short of breath: Caller states the high heart rate alerted her to her shortness of breath, says she felt like she ran a couple of miles. The doctor told her it was like her heart was running a marathon without her. The shortness of breath has improved and is currently very, very slight. If she starts moving around too much, she starts getting wheezy. to get her vaccine record card that she has to get up or she freezes up. She was taking melatonin and Tylenol PM. This had been going on for 10 years and when her doctor found out he said to her how are you not dead? She was taking 12mg of melatonin with a capsule of magnesium to process it, two Tylenol PMs and a muscle relaxer just to fall asleep. says the magnesium is what processes the melatonin, just to make it go faster. says this was about 7 to 8 months ago. she had the flu for three weeks, was tested for COVID three times, but it was not COVID. She was not sleeping, even just lying-in bed, so this is why the doctor prescribed it. The patient underwent lab tests and

Other Meds: DEPO-PROVERA; CYMBALTA; ZOLPIDEM

Current Illness: Asthma (she has had asthma since she was 30."); Nerve pain

ID: 1409694
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: had a side effect (nearly passed out); This is a spontaneous report from a Pfizer sponsored program from a non-contactable male consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a side effect (nearly passed out) and would like to know if he should take the second covid vaccine. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1409695
Sex: M
Age:
State:

Vax Date: 05/20/2021
Onset Date: 05/23/2021
Rec V Date: 06/18/2021
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: heart attack; he ended up having a triple bypass to clear the blockage found.; extremely lethargic; chest pains; This is a spontaneous report received from a Non-contactable consumer(patient). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 20May2021 (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 patient previously received first dose of bnt162b2 for covid-19 immunisation and tested COVID positive a few weeks after receiving his first vaccine. Once all virus symptoms were gone, he was advised by the clinic to go ahead and get his second shot (approximately 1 week after virus symptoms cleared). The vaccine was given on 20May2021 and within several days, he was extremely lethargic and experiencing chest pains. During a visit to local urgent care he was told he had had a heart attack. Following an echocardiogram, he ended up having a triple bypass to clear the blockage found. He did have some family history of heart disease but was unaware of any issues with his own health and had not experienced any symptoms prior to this incident. Date of start of reaction/event was 23May2021. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported no hospitalization prolonged. The outcome of event extremely lethargic was unknown, of the other events was recovering. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1409696
Sex: M
Age:
State: FL

Vax Date: 04/29/2021
Onset Date:
Rec V Date: 06/18/2021
Hospital: Y

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: three severe gallbladder attacks; elevated liver enzymes and bloodwork; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 29Apr2021 (lot no: EW0151) (at age 18 years old) as single dose for covid-19 immunisation. Medical history included neoplasm tumor in leg when young and food allergies in childhood. No COVID prior to vaccination. The patient's concomitant medications included antibiotics. The patient previously received the first dose of BNT162B2 in left arm on 08Apr2021 (lot no: EW0171) (at age 18 years old) for COVID-19 immunization and experienced severe eye pain, difficulty seeing after the first vaccination. On an unspecified date, within a few weeks after the second vaccination, the patient experienced three severe gallbladder attacks, two emergency room (ER) visits. The second ER visit resulted in admission in hospital for 4 days and removal of the gallbladder and cleaning of the bile ducts; elevated liver enzymes and bloodwork. The events were reported as serious (hospitalization). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Antibiotic for the eye/surgery for gallbladder att. The patient underwent COVID test (nasal swab) with negative result on 24May2021. The patient was recovering from the events.

Other Meds:

Current Illness:

ID: 1409698
Sex: M
Age:
State: CA

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Atrial fibrillation; mild stroke; my skin was kind of different looking you know like aging a little bit you know like wrinkling; seeing flash burn every once in a while; have a obstruction in the main artery of left eye; went totally blind in my left eye; probably got macular degeneration; pain in the arm; This is a spontaneous report from a contactable consumer reported for himself. A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration in the left arm upper muscle on 02Apr2021 11:45 at age of 66-year-old (Lot Number: ER8737) as 2nd dose, single for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT number was EN6204) for Covid-19 immunisation in Mar2021, at age of 66-year-old and experienced pain in the arm. Medical history included Barrett's esophagus, Diverticulitis, Gastrooesophageal reflux disease, Generalised anxiety disorder, Cataracts, Kidney stones, Chlamydial infection, Left ventricular hypertrophy, Vertigo, hiatal hernia repair done, hypertension, had a colonoscopy quite often in another words to remove the polyps from his colon. Concomitant medication included omeprazole taken for GERD (gastrooesophageal reflux disease) and paracetamol (TYLENOL). The patient experienced atrial fibrillation on an unspecified date with outcome of unknown, mild stroke on an unspecified date with outcome of unknown, went totally blind in my left eye on 09Apr2021 with outcome of not recovered, probably got macular degeneration on 09Apr2021 with outcome of unknown, pain in the arm on 02Apr2021 with outcome of unknown , my skin was kind of different looking you know like aging a little bit you know like wrinkling on an unspecified date with outcome of unknown , seeing flash burn every once in a while on 09Apr2021 with outcome of unknown , have a obstruction in the main artery of left eye on 09Apr2021 with outcome of unknown. The patient underwent lab tests and procedures which included CAT scan and EKG both with unknown results on 24May2021. The events result in Physician Office Visit, no treatment was received. Clinical course: Consumer stated, "Well, I got my first Pfizer shot I just thought I should just call and discuss this with somebody bit of some sheet I got I got the Pfizer vaccine and I got that one on 15Mar2021 the first one and then I received the second one 02Apr2021 and when after I received the second one I had the pain in the arm like normal but it was a lot more severe than I got from the first one but it went away but you know normal 3 to 4 days it went away so I did not wasn't that concerned but I also know this to ask. After I got my skin was kind of different looking you know like aging a little bit you know like wrinkling but then all of a sudden it cleared up too that went away probably about the same time a week after I got the shot I started having vision problem(distorted voice and incomplete sentence). I visited an ophthalmologist an regular eye doctor it was an ophthalmologist (distorted voice and incomplete sentence) and he said no I don't see that you have a stroke I don't see that you have vision problems with your retina this time you probably got macular degeneration going on so anyways he said comeback if you have an issue then I said so you are telling me that even though my vision is going in my left eye I am not gonna go blind and I didn't have a stroke he said yes. Ok, so anyways exactly a month after that I went totally blind in my left eye my vision came back, my vision came back. I forgot to tell you my vision came back fully for a while but it was different in my left eye like I was seeing flash burn every once in a while when I was in the sunlight and stuff. Anyway a month later after I got the second shot when I went totally blind in my left eye and so I got upset about the doctor's here and I had to go to (Address) to pick my new eyeglasses anyway so I had to drive to (Address) with one eye which is 230 miles from me anyways, so when I got my glasses there at they were the right prescription thank god and I told them about the eye issue so they didn't throw a eye test really thorough and said yes I definitely see a problem in your left eye looks like a flash burn or something like that so then they had me setup an appointment with really good ophthalmologist in (Address) because I wanted a second opinion whether my insurance covered it or not. So I went to this retinal specialist and I was in his office for like 3 hours they were checking me out in there you know he said yes definitely you have an obstruction in the main artery of your left eye and that's why you lost your vision and this doctor said there's only two things it could be it it could be you had a stroke or that you had a bad reaction to the Pfizer vaccine and so anyway he wanted me to go either into the emergency room a good (Address) to further do testing, I said no I don't wanna do that because that's all out of my own pocket that would have been thousands of dollars you know, but I don't know I am all confused about this medical care. I am just trying to give you all a scenario from day 1 going forward you know anyway so I refused to go to good (Name) and he said well it should be okay anyway because it's been so much time since the original problem that you would be probably alright to just back to your hometown there and go to the hospital and have your testing then there I did and the next day I got back to (Address) from (Address) I went to the hospital there they did an EKG on my heart and they did a CAT scan on my head and they said they couldn't see anything from the EKG or the CAT scan that I had but that doesn't mean you didn't have(Incomplete sentence), so they said you could have a mild stroke and you know anyway we want you to go further testing well I had a primary care physician appointment two weeks later which is still coming up so I have to her so they want to order an MRI and some other tests on my heart because they think I have might have an AFib atrial fibrillation where the blockage I mean where the blood flow properly to my heart you know if I want to do those tests too but I am just letting you know this cause the one doctor said it could be that you have the eye problem because of the vaccine that's what I am calling you about." Consumer Stated, "Yes, you can follow up sure because I am more anyway cause on the 09June2021 I have an appointment with my primary care physician which is the one that have to do the order in heart chest and the MRI and the following week. I am going back to (Address) to that Ophthalmologist that said that it might because of Pfizer vaccine I am going back to him I got a follow up with him because he wants to me to take care of my eye issue so maybe I can get my eye sight back in other words or so." Date adverse event started: Consumer stated, "I had my first shot on Friday 02Apr2021. The exact day that I started having issues was exactly one week later on 09Apr2021. Other than the normal you now pain in the arms because that started and went away normal that started you know. Well that started basically right after I got the shot on 02Apr2021 with the pain and the arm thing that was right after I got the shot 02Apr2021 and it was the little bit more severe than the original shot. 09Apr2021 is when I stated having eye problem." Anatomical Sites of administered: Consumer Stated, "The first one I had them do it in my right arm in the muscle top in my right arm and the second one was done in the left arm upper muscle." Other Medical Conditions: Consumer Stated, "Nothing life threatening but I have chronic health conditions, quite a few of them. I got Barrett's esophagus, then Diverticulitis of the sigmoid colon then electro cardiogram(Further not clarified) they did was abnormal they said. I got GRD Gastroesophageal reflux disease. I got generalized anxiety disorder, GAD. I have Cataracts. They said I had a genital disorder I don't know what that means. I got history of Calculus in the kidneys, kidney stones but I haven't had a problem wi

Other Meds: OMEPRAZOLE; TYLENOL

Current Illness:

ID: 1409699
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: Stomach ulcer; Heart burn; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced stomach ulcer and heart burn on an unspecified date. It was reported that the patient got the finally shot couple of days ago and the patient's doctor is closed. The patient had a heartburn and inquired if Gaviscon is gonna interact with the vaccine that the patient took the first dose. The patient paraphrased and reported that "for stomach ulcer, for heart burn." The outcome of the events was unknown. Information about lot/batch has been requested.

Other Meds:

Current Illness:

ID: 1409700
Sex: M
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: broke out into hives; throat began to swell; breathing became difficult; anaphylaxis; patient age: 15; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217), dose 2 via an unspecified route of administration, administered in left arm on 03Jun2021 14:30 (at 15-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included low growth hormone production, and known allergies: many foods. Concomitant medications included somatropin (NORDITROPIN); anastrozole (ANASTRAZOLE DENK); olopatadine; levocetirizine dihydrochloride (XYZAL); diclofenac sodium, heparin sodium (ALLE). 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 previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173), via an unspecified route of administration, administered in left arm on 13May2021 17:30 (at 15-year-old) as 1st dose, single dose for COVID-19 immunization. On 03Jun2021 at 17:30, the patient experienced 3-4 hours after dose, broke out into hives. He took benadryl. Throat began to swell and breathing became difficult. He used epi-pen to stop anaphylaxis. The seriousness criteria of the events was reported as life threatening. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events hives, throat began to swell, breathing became difficult, anaphylaxis was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Other Meds: NORDITROPIN; ANASTRAZOLE DENK; OLOPATADINE; XYZAL; ALLE

Current Illness:

ID: 1409701
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: passed out after receiving first vaccine; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a male patient of an unspecified age received the 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 single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient passed out after receiving first vaccine on an unspecified date. The outcome of the event was unknown. The event was considered as serious (medically signficant). No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1409702
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: familiar to a seizure; collapsed; unconscious; fever; shaking; they told possible sign of infection; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported that a 14-year-old female patient (consumer's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The relevant medical history was not reported. Concomitant medications were not reported. On an unspecified date, after getting the second dose of the Covid Vaccine immediately started experiencing fever, shaking; her eyes were back as she seemed unconscious and collapsed; it was familiar to a seizure; was taken to the hospital, they told possible sign of infection and she was advised to go ahead and just to report what had happened. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1409704
Sex: F
Age:
State: NY

Vax Date: 05/24/2021
Onset Date: 05/01/2021
Rec V Date: 06/18/2021
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 no taste now, and she lost her sense of taste 2 days ago; She was not able to eat because of her twisted mouth; She said the COVID-19 Vaccine left her partially paralyzed in the left side of her face only/On the night of 24May2021, she couldn't close her left eye/mouth was getting "twisted; She had a terrible pain in the left-side of her head that started on the afternoon of 24May2021; On the night of 24May2021, her left eye began hurting a lot; On the night of 24May2021, her left eye had a lot of tears coming out of it.; She said she was not able to work; This is a spontaneous report from a contactable consumer. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on 24May2021 10:00 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that on 24May2021, covid-19 vaccine left her partially paralyzed in the left side of her face only, she had a terrible pain in the left-side of her head that started in the afternoon. On the night of 24May2021, her left eye began hurting a lot, her left eye had a lot of tears coming out of it and she couldn't close her left eye. On the morning of 25May2021, when she went to brush her teeth, she saw her mouth was getting "twisted". She was not able to eat because of her twisted mouth. She said she was not able to work. She had no taste now, and she lost her sense of taste 2 days ago. The events She said the COVID-19 Vaccine left her partially paralyzed in the left side of her face only was reported as serious, medically significant. The outcome of the events she said the COVID-19 vaccine left her partially paralyzed in the left side of her face only, on the night of 24May2021, her left eye began hurting a lot, on the night of 24May2021, her left eye had a lot of tears coming out of it, on the night of 24May2021, she couldn't close her left eye, on the morning of 25May2021, when she went to brush her teeth, she saw her mouth was getting "twisted", she had no taste now, and she lost her sense of taste 2 days ago and she said she was not able to work was not recovered while the outcome of the event she had a terrible pain in the left-side of her head that started on the afternoon of 24May2021 was resolved on unspecified date of 2021.

Other Meds:

Current Illness:

ID: 1409705
Sex: M
Age:
State: CA

Vax Date: 06/03/2021
Onset Date: 06/03/2021
Rec V Date: 06/18/2021
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: Nearly passed out; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in right arm at the age of 42-year-old on 03Jun2021 (Batch/Lot Number: ER8736) as single dose for COVID-19 immunisation. Medical history included None. There were no concomitant medications. The patient experienced nearly passed out on 03Jun2021. As reported as follows: Transferring agent stated, "I have the caller on the line. The reason for this transfer is because he nearly passed out after receiving the first Covid vaccine about 2 hours ago and he wants to know if he should take the second vaccination and if this vaccination card that he received from his first vaccination will be valid for him to get the second one." When paraphrased the concern, consumer stated, "Yes that was half of my question. I wanted to consult with my physician but it is a little late in the day today, so I couldn't get a hold of him after I received it. But I am pretty sure that the second dose probably will not necessarily have this circumstances now, am I correct?" The patient underwent lab tests and procedures which included laboratory test: unknown results in May2021 (3 weeks ago). Not received treatment for the event. The outcome of event was unknown.

Other Meds:

Current Illness:

ID: 1409706
Sex: F
Age:
State: GA

Vax Date: 06/03/2021
Onset Date: 06/03/2021
Rec V Date: 06/18/2021
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: Erythema, Pruritus

Symptoms: Fallen unconscious and collapsed; Fell down and she was not conscious/passed out; Had concussion like falling on the ground but it appears like a seizure, that was a immediate thing; Fallen unconscious and collapsed; Fell down and she was not conscious; Had concussion like falling on the ground but it appears like a seizure, that was a immediate thing; Low blood pressure; Fever; Shaking/She was shaking/still moving; She was not feeling well; She is still twitching; Eyes go back; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (mother) reported that a 14-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Jun2021 (Batch/Lot number was reported as EW 'O or 0' 186) at the age of 14-years-old as SINGLE DOSE for covid-19 immunisation. The patient medical history was none. There were no concomitant medications. No family medical history of seizure. The patient previously received the first dose of BNT162B2 on an unknown date at Arm Left for covid-19 immunisation. The reason for the transfer today (03Jun2021) was that her 14 year old daughter immediately after getting her second dose of the COVID vaccine started shaking, experiencing fever and fallen unconscious and collapsed and was taken to the hospital and she wanted to go ahead and report those adverse side effects for her. She (patient) was 14 year old and she got her second vaccination today and few minutes after she got it, she stood up and she said she was not feeling well and then the next thing reporter knew like her eyes go back, she do not seem conscious and she was shaking as if, looks like she was having a seizure and then she fell down and she was not conscious, so she fell down, she is still twitching. She has no history of like seizures but that is like twisting and now she was taken to the hospital. So, the hospital treated her as if she had a concussion. Reporter have reported to them that she looks like it was a seizure before she fell down, into her head. Reporter further stated "That day was her second shot and like I said she stood up, she got up from that, she said that she got funny and that I can see where she just kind of lost consciousness, eyes going back, shaking as if she was having seizures and then she fell down and she was unconscious and she is like still moving as if she is having a seizure and she was taken. Reporter stated, "it was a like a seizure but it is like over and she had concussion like falling on the ground but it appears like a seizure, that was a immediate thing." For treatment, reporter stated that "Any treatment, No. She was taken to the hospital and the hospital needs to write it down and I don't understand that, the hospital wrote down concussion but the hospital they took the vital signs and she had low blood pressure." For the date when patient went to the hospital, reporter stated "That was today, June 3rd and she is discharged. The reason she was taken was potential seizure and it was concussion and it was after she fell, she passed out and had low blood pressure. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1409707
Sex: U
Age:
State: OR

Vax Date: 05/02/2021
Onset Date: 05/02/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: tested positive for Covid, on 02Jun2021; Tested positive for Covid virus, after the second vaccine; light fever; Felt really sick; queasy with low energy; queasy with low energy; This is a spontaneous report from a contactable consumer, the patient. A 28-years-old Female/ transgender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0179, expiration date: unknown)), dose 2 via an unspecified route of administration, administered in arm right (right bicep) on 02May2021 12:00 as 2nd dose, single dose for covid-19 immunisation. Medical history included overweight from 1993 to 2010 (Verbatim: Overweight , asthma from an unknown date and unknown if ongoing Verbatim: Childhood history of asthma, she was diagnosed sometime in middle school, and had an inhaler for a couple years. Reclarified, did not use the inhaler in college or after that time). The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8733, expiration date: unknown) via an unspecified route of administration in arm right bicep on 01Apr2021 09:00 as single dose for covid-19 immunization and took Flu shots (INFLUENZA VACCINE, Lot Number not reported, expiration date: unknown) started, in the eighth grade, around 2007 and got sick for the first couple of years, got mildly sick, for a day or two, and this included feeling like she had a cold, chills, and was achy. Concomitant medication(s) included estradiol cipionate (DEPO-ESTRADIOL) taken for hormone therapy from Aug2019 and ongoing; progesterone (PROGESTERONE, 200mg) taken for hormone therapy from an unspecified start date and ongoing. On 02May2021, patient felt really sick, nauseas, but not vomiting, queasy with low energy, after the second vaccine, patient reports as 8 or 9 pm at night and went on until 04May2021 or 05May2021. On 03May2021, patient had light fever in the morning. On 02Jun2021, patient tested positive for Covid. Patient reported herself as female and later in report that she was transgender. Patient Age at Time of Vaccination was 28 Years. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the pfizer suspect. AE did not require a visit to Emergency Room or physician Office. No prior vaccinations (within 4 weeks) or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Primary infection site was not applicable and secondary site (e.g. empyema) was none. Culture was not performed.Patient stated that work was a predisposing factor. Patient thinks that someone at work was asymptomatic, and he was exposed to that person No antipyretic been used around the date of vaccination, only took one pill of Tylenol the day after the second vaccine. On 01Jun2021, She took the test of Covid 19 NAA/PCR on 01Jun2021 at 13:23, and the results were noted the next day positive. the outcome if the event was recovered on may2021 for the events patient felt really sick, nauseas, but not vomiting, queasy with low energy, for light fever it recovered on 05May2021 and for patient tested positive for Covid it was recovering.

Other Meds: DEPO-ESTRADIOL; PROGESTERONE

Current Illness:

ID: 1409708
Sex: F
Age:
State: NC

Vax Date: 04/08/2021
Onset Date: 05/25/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bell's palsy over one month later. Right side facial paralysis.; Bell's palsy over one month later. Right side facial paralysis.; This is a spontaneous report from a contactable consumer. A 55-years-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in right arm on 08Apr2021 at 11:00 (at the age 54-years-old) as 2nd single dose for COVID-19 immunization. Patient's medical history included hypothyroidism and patient had known allergies gluten, bee or wasp venom. Patient took 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6207) administered in right arm on 11Mar2021; administration time at 11:00 AM. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient's concomitant medications were not reported. The patient experienced bell's palsy over one month later and right side facial paralysis on 25May2021 at 12:00. The treatment medications include prednisone and Valtrex. The outcome of the event was not resolved. Follow-up attempts are needed. Further information is expected.

Other Meds:

Current Illness:

ID: 1409709
Sex: M
Age:
State: IL

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Chron's disease flare up; Discolored stools; Inflammation; diarrhea; This is a spontaneous report received from a contactable physician. A 63-year old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly on 07Apr2021 (at the age of 63-year old) at single dose for COVID-19 immunization and adalimumab (HUMIRA) solution for injection in pre-filled pen, subcutaneous on an unknown date at an unspecified dosage for Moderate to severe adult Crohn's disease and moderate to severe ulcerative colitis. relevant medical history and concomitant medications were not reported. On an unknown date the patient experienced dark stools, inflammation, diarrhea and Crohn's disease flare up. The action taken with adalimumab was unknown. The outcome of the events diarrhea and Crohn's disease aggravated was recovered while the outcome of the other events was unknown. The causality assessment with adalimumab was No reasonable possibility for events diarrhea and Crohn's disease aggravated and not reported for the other events. The causality assessment with BNT162B2 was not reported for all events. Information on the lot/batch number has been requested.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.

Other Meds:

Current Illness:

ID: 1409711
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 06/18/2021
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: Losing vision in her right eye; The eye, sight issues or anything to do with the optic nerve; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Unknown), via an unspecified route of administration in Mar2021 for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration for COVID-19 immunization. Caller stated she had the second dose of the Pfizer covid 19 vaccine the end of March. Caller was wondering if there were any side effects linked to the vaccine that were related to the eye, sight issues or anything to do with the optic nerve. Caller stated she was losing vision in her right eye. Caller stated they were having trouble diagnosing the cause. she just got out of the hospital. she had no history of any eye issues or optic nerve issues. she was calling about the Covid Vaccine. she was just wondering if Pfizer has seen any side effects linked to the vaccine relating to the optic nerve, eye or sight issues. Caller states that she does not know if she needs to report it. She does not know if it was from the vaccine. She just knows that before she had no eye issues. States she had the second shot at the end of March. She was recently at the hospital because she was losing sight in her right eye. Caller states they were having a hard time diagnosing what was going on. States her CAT scan, MRI, and spinal tap didn't show anything. Says she was told her optic nerve was having trouble sending messages to her brain. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1409712
Sex: M
Age:
State: CA

Vax Date: 05/17/2021
Onset Date: 06/01/2021
Rec V Date: 06/18/2021
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: I got Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 16-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), via an unknown route of administration, in left arm on 17May2021 at 15:45 (at the age of 16-years-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included I used to have Bell's Palsy and shellfish allergy. The patient's concomitant medications were not reported. 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. About 2 weeks later (may be on 02Jun2021 or 03Jun2021), the patient got bell's palsy. On 03Jun2021, the patient underwent nasal swab sars-cov-2 test and tested negative. Therapeutic measures were taken as a result of bell's palsy and patient received 21 Prednisone 20 mg and 10 Valacyclovir HCL 500 mg. The clinical outcome of event was recovering. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1409713
Sex: M
Age:
State: MA

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 06/18/2021
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: Bell's palsy; sore arm; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0151), via an unspecified route of administration on 14Apr2021 at 11:00 (at the age of 39-year-old), as 2nd dose, single dose in right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8727), via an unspecified route of administration on 24Mar2021 as single dose in left arm for COVID-19 immunization. On 14Apr2021, after the second shot of vaccine, the patient experienced a sore arm. Patient felt sore arm for 2-3 days and then recovered completely. On 31May2021 Monday, morning around 07:00 or 08:00, the patient visited Emergency room because he thought he was having a stroke. But it was not stroke, and the ER told him he had Bell's Palsy. Patient thought it was a side effect and was given with medication for the event but was not able to afford it. The patient was not under any medications before the vaccine, but he continued medications for Bell's Palsy. Patient has not received any vaccines since the Pfizer vaccine. The clinical outcome of the event Bell's palsy was resolving, and the clinical outcome of the event sore arm was resolved on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1409714
Sex: M
Age:
State: NY

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 06/18/2021
Hospital: Y

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: acute kidney injury; minimal change disease presenting with nephrotic syndrome; minimal change disease presenting with nephrotic syndrome; This is a Literature report. As mass vaccinations for coronavirus disease 2019 (COVID-19) are being administered worldwide, rare reports of adverse events are emerging. We report a case of minimal change disease presenting with nephrotic syndrome 1 week after a first injection of the COVID-19 vaccine (Pfizer-BioNTech). A 77-year-old male with a 15-year history of type 2 diabetes mellitus without retinopathy received a first dose of the Pfizer-BioNTech vaccine on March 17, 2021. Medical history included obesity, prior smoking, and coronary artery disease. Baseline serum creatinine ranged from1.0 to 1.3mg/dl, with no proteinuria over the previous year. Outpatient medications included atorvastatin, aspirin, dulaglutide, empagliflozin, glipizide, losartan, metformin, and metoprolol. There was no history of nonsteroidal anti-inflammatory drug use. Seven days after vaccination, he presented to his local physician complaining of abrupt onset of lower-extremity edema. Laboratory testing revealed 4+proteinuria by dipstick and serum albumin of 2.5 g/ dl. Nephrology consultation 12 days after vaccination(29-MAR-2021) found anasarca with 13.6-kg weight gain due to edema, elevated blood pressure (152/81 mm Hg), and 4+ proteinuria on urinalysis with inactive urine sediment, prompting hospital admission. Laboratory evaluation by 14 days after vaccination(31-MAR-2021) showed 24- hour urine protein of 23.2 g/d, serum creatinine of 2.33 mg/ dl, and serum albumin of 3.0 g/dl. Complete blood cell count was normal, and hemoglobin A1c was 7.5%. Serologies included elevated C3 and C4 and negative hepatitis B surface antigen and hepatitis C antibody. A kidney biopsy was performed 16 days after vaccination (02-APR-2021). Among 7 glomeruli sampled for light microscopy, 4 were globally sclerotic and 3 were histologically unremarkable. There was 25% tubular atrophy and interstitial fibrosis with moderate arteriosclerosis. Cortical tubules displayed diffuse acute epithelial injury. No immune deposits were identified by immunofluorescence (2 glomeruli) or electron microscopy (2 glomeruli). Electron microscopy revealed 100% podocyte foot process effacement, leading to a diagnosis of minimal change disease with acute tubular injury. The ultrastructural findings of minimal segmental mesangial sclerosis and glomerular basement membrane thickening (mean, 460 nm) suggested underlying mild diabetic changes. Empiric pulse methylprednisolone, 1 g daily for 3 days, was initiated on hospital admission, followed by oral prednisone, 60 mg daily, after biopsy. In the hospital, he required i.v. furosemide drip, 10 mg/h, transitioned to bumetanide, 0.25 mg/h, for 5 days for fluid overload. Creatinine peaked during the hospitalization at 3.17 mg/dl at 19 days after vaccination(05-APR-2021). The patient was discharged 3 days later(08-APR-2021) with 19.8 g/g proteinuria by spot ratio, serum albumin of 2.9 g/dl, and serum creatinine of 2.54 mg/dl. At the most recent follow-up, approximately 3 weeks after initiation of corticosteroids, creatinine remained elevated at 3.74 mg/dl, with 24-hour urine protein of 18.8 g/d (Figure 2). This is the second report of the onset of minimal change disease occurring within a week of an initial dose of the Pfizer-BioNTech vaccine. Although definitive causality is difficult to establish, greater awareness of this potential adverse effect of vaccination is needed to determine its frequency. With prompt renal biopsy and initiation of steroid therapy, complete remission of nephrotic syndrome and acute kidney injury can be achieved. It is uncertain if and when it is safe to administer a second dose of the Pfizer vaccine in these individuals.; Sender's Comments: Based on temporal association, the causal relationship between BNT162b2 and the events glomerulonephritis minimal lesion, acute kidney injury and nephrotic syndrome 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: ATORVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; DULAGLUTIDE; EMPAGLIFLOZIN; GLIPIZIDE; LOSARTAN; METFORMIN; METOPROLOL

Current Illness:

ID: 1409715
Sex: M
Age:
State:

Vax Date: 05/01/2021
Onset Date: 06/08/2021
Rec V Date: 06/18/2021
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: Bell's Palsy; This is a spontaneous report from a contactable consumer (caregiver). A male patient (in his 60s) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number, Expiration date and NDC number: Unknown) via an unspecified route of administration in May2021 (about 3 weeks-1 month ago) as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was completely healthy before the vaccine. On 08Jun2021 (post vaccination), patient's left side of the face was completely dropping and was later diagnosed as Bell's Palsy (this morning). The event led to hospitalization from 08Jun2021 to an unspecified date. The clinical outcome of the event was unknown. Investigation assessment: not provided. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1409716
Sex: F
Age:
State: TX

Vax Date: 05/19/2021
Onset Date: 05/19/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: lost sense of taste; felt really tired; Her whole face and neck was really red and felt like it was on fire; trouble breathing; face felt like it was on fire; headache; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 19May2021 09:00 (age at vaccination: 60 years) as 1st dose, single dose for covid-19 immunisation. The patient's medical history included ongoing multiple allergies. She has had allergies her whole life. Concomitant medication included rosuvastatin calcium (CRESTOR OD) taken for blood cholesterol increased which she has taken it for 15 or 20 years; fenofibrate (LIPOFEN) taken for blood cholesterol increased, which probably she has taken it for 15. On 19May2021, she experienced multiple symptoms 15 minutes after initial vaccination including, trouble breathing which started maybe an hour after she had the vaccine, face felt like it was on fire which lasted for 2 or 3 days, headache, felt really tired and her whole face and neck was really red and felt like it was on fire; on 21May2021, the patient lost sense of taste. Her sense of taste is back now. She thinks her tiredness has gone away. The adverse events did not require emergency room visit or a physician's office visit. The patient did not get other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient feels hesitant about getting her second dose of the vaccine tomorrow and would like some guidance, asking if she should get her second dose or not. The outcome of the event dyspnoea was reported as not recovered; burning sensation, erythema was unknown; headache was recovered on 24May2021, Ageusia was recovered on 23May2021 and tiredness was recovered on May2021. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: CRESTOR OD; LIPOFEN

Current Illness: Multiple allergies (She has had allergies her whole life)

ID: 1409717
Sex: F
Age:
State: RI

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: she had pain in her knee; it was hard for her to walk; blood clot found in right leg; This is a solicited report from a non-Pfizer sponsored program, PSP-ELIQUIS-CONDUENT-USA: PSP-ELIQUIS-CONDUENT-USA-CW3050920, from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-051474). This case was split from master case 2021623975 for Covid-19 vaccine with she had pain in her knee and it was hard for her to walk. An 88-year-old elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at an unknown, single dose for covid-19 immunisation. The patient medical history was not reported. The patient had no allergies. Concomitant medication included apixaban (ELIQUIS) (batch no. 1798944, expiration date: SEP 2023) via oral route at 5 milligram, twice a day taken for venous thromboembolism from an unspecified date in Jan 2021. On an unspecified date she had pain in her knee, it was hard for her to walk and on an unspecified date in Jan2021 the patient experienced blood clot found in right leg. The patient underwent lab tests and procedures which included blood pressure measurement: normal. This 88-year-old female patient was involved in a patient support program described. The patient received APIXABAN. The report describes a case of HOSPITALISATION. The occurrence of additional non-serious events is detailed below. In January 2021, the patient started APIXABAN (batch no. 1798944) (Oral), (5 milligram, twice a day). On an unknown date, the patient underwent hospitalisation (seriousness criterion hospitalization), OEDEMA PERIPHERAL (Swelling in her feet/fluid in her feet) and arthralgia (Bad knee pain). The patient was hospitalized for 2 days due to Hospitalisation. The action taken with apixaban(oral) was unknown. At the time of the report, hospitalisation and oedema peripheral outcome was unknown and arthralgia did not resolve. The patient reported that she was in hospital for two days. The consumer stated her feet swells up. After receiving the coronavirus vaccine she had pain in her knee and it was hard for her to walk. Patient was inquiring if she can take green leafy vegetables with Eliquis. Patient started on Eliquis for a blood clot found in her right leg in Jan-2021. Patient reported that she believes the blood clot was there longer because her feet would become swollen. Patient re-ported that her feet were swollen today however, it will go away tomorrow. The swelling will go away for three or four days, sometimes up to a week. Patient reported that there was nothing all winter, the swelling was down. There was increased swelling with the warmer weather. Doctor told her the blood clot should go away. She went back to the doctor because she still had swelling. The doctor told her she has fluid in her feet. Her doctor told her to follow up with her primary physician because she never had a blood clot before and she should have her medications checked. Patient reported that after receiving the vaccine she can run but she still feels pain in her knee. The strength of apixaban was 5 mg For APIXABAN(Oral), the reporter did not provide any causality assessments. The primary reporter was the consumer Most recent follow up information received from the consumer incorporated above includes: 26-May-2021: Event Hospitalisation was added, Event verbatim was amended from Swelling in her feet to Swelling in her feet/fluid in her feet, Covid-19 vaccine was changed from suspect to concomitant drug, product attributes, event attributes, patient demographic details and narrative updated. BMS Medical evaluation comment: This patient had hospitalized for unknown reason after apixaban therapy. Based on the limited information regarding hospitalization details, laboratory reports, treatment details, it cannot be ascertained that the suspect drug contributed to the reported event. Outcome of the events was unknown.

Other Meds: ELIQUIS

Current Illness:

ID: 1409718
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: Turned into MRSA infection; Severe allergic reaction; Little bit of a rash that started going all over body; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot# and expiration date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, on unknown date, she had a severe allergic reaction to the vaccine. She has been out of work. It has been a 2-month struggle. Also stated that, it started out like a little bit of a rash that started going all over her body. From that point, it turned into Methicillin-resistant Staphylococcus aureus (MRSA) infection. She has needed so many medications. Her pharmacist let her know that she can get reimbursement for medical bills and lost wages, she wanted to know how to go about getting it. Caller stated there was a study that she was connected to now regarding how the vaccine affecting some people's skin. The outcome of the events was unknown. Information on Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1409719
Sex: F
Age:
State: SC

Vax Date: 06/03/2021
Onset Date:
Rec V Date: 06/18/2021
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: Bells palsy; I have severe low blood sugar where I pass out 3 or 4 times a month; I have severe low blood sugar where I pass out 3 or 4 times a month; After shot blood sugar went to 350! Fasting 220; I have severe low blood sugar where I pass out 3 or 4 times a month; This is a spontaneous report from a contactable consumer (reported for herself). A 50-years-old female patient received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW6206/Batch number was not reported), via an unspecified route of administration administered in the left arm on 03Jun2021 (at the age of 50-years-old) as unknown, single dose for COVID-19 immunization. Medical history included systemic lupus erythematosus from an unknown date and unknown if ongoing, ischaemia from an unknown date and unknown if ongoing and diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received cafeine and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced Bells palsy, she has severe low blood sugar where she pass out 3 or 4 times a month. After shot blood sugar went to 350, Fasting 220. She was always tested her blood daily for 10 plus years. She was still diabetic 3 months later and her blood sugar was extremely high. The reporter stated the events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood glucose abnormal: 350 on an unspecified date, blood glucose decreased: 220 on an unspecified date. Therapeutic measures were taken for the events with diabetic medication. The events Bells palsy, she has severe low blood sugar where she pass out 3 or 4 times a month assessed as serious (medically significant). The clinical outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1409721
Sex: F
Age:
State:

Vax Date: 03/26/2021
Onset Date: 04/18/2021
Rec V Date: 06/18/2021
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: I was tested positive for COVID on April 18; I was tested positive for COVID on April 18; I also had pneumonia after; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced i was tested positive for covid on april 18 on 18Apr2021, i also had pneumonia after, if she choose to get the second dose of the vaccine does she need to restart the vaccination series all over again on unspecified date in 2021. Patient stated that when could she receive the Pfizer COVID-19 vaccine after catching the COVID infection. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 18Apr2021. The seriousness of the i was tested positive for covid on april 18 on 18Apr2021, i also had pneumonia after was medically significant. The outcome of the events was unknown. Information on Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1409722
Sex: F
Age:
State: VA

Vax Date: 05/19/2021
Onset Date:
Rec V Date: 06/18/2021
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: triggered lyme disease; she experienced one year ago such as her teeth hurt, developed a diminished sense of smell and taste and dry cough.; she experienced one year ago such as her teeth hurt, developed a diminished sense of smell and taste and dry cough.; she experienced one year ago such as her teeth hurt, developed a diminished sense of smell and taste and dry cough.; she experienced one year ago such as her teeth hurt, developed a diminished sense of smell and taste and dry cough.; This is a spontaneous report from a contactable consumer or other non hcp. A 72-year-old female patient received bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on 19May2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, states he had the first shot and second one due this week however he had some family guests. Caller added that his wife received first dose of pfizer covid vaccine 19May2021 and the shot triggered Lyme disease. She believes she had covid one year ago however it was never confirmed via testing. States her shot also triggered the same 'covid ' she experienced one year ago such as her teeth hurt, developed a diminished sense of smell and taste and dry cough. It took 2 weeks for her sense of smell and taste to come back after the covid vaccine shot. Also her teeth hurt a few days after the first shot for 2 days then it resolved. The outcome of the events lyme disease was unknown and tooth ache, cough, ansomia, aguesia was recovered. Information about the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1409723
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: I fell down and I started to bleed and I had some swelling; I fell down and I started to bleed and I had some swelling; Two medications are overlapping; I fell down and I started to bleed and I had some swelling; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose single for covid-19 immunisation. Medical history included Haemophilia type A ongoing. The patient's concomitant medications included antihemophilic factor, human recombinant (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT), (Batch/Lot number was not reported) to an unspecified date, for factor viii deficiency. It was reported that, Consumer stated, that took the second dose for the Pfizer Biotech dose, and second dose was at the last Sunday. However in the next few days had to take my own Pfizer antihemophilic factor recombinant because had a Haemophilia type A and just wanted to know if there is any complex with taking both the dose in short period of time because recently had to take the Antihemophilic Factor 8 because fell down and started to bleed and had some swelling and have not seen that much complex and she wanted to know two medications are overlapping or there is anything to worry. The out come of the events was unknown Information about lot/batch number has been requested.

Other Meds: ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm