VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1483579
Sex: F
Age:
State: CA

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: I tested positive for Covid; I tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot number: 6203 not confirmed It's either EN or FN) as single dose and dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot number: FR not confirmed 2613 or 7613) as single dose (at the age of 53 year) for covid-19 immunization. The patient had no medical history and no concomitant medications. Patient was not probed for any medical conditions or concomitant medications. Patient was not received any other vaccine prior four weeks of vaccination. Patient reported I just want Pfizer to know that I was fully vaccinated with the Pfizer vaccine and I tested positive for Covid on unspecified date. I tested positive in Mexico, but I caught Covid from my mother before I left who was in the United stated, so United States. Patient was not performed any lab test. Patient stated I am taken some steroid (further clarification unknown) from my doctor's office and I am taken over the counter medication that help with the congestion and I am taken an inhaler (Further clarification unknown). Patient visited to physician's office for the events COVID-19. Therapeutic measures were taken as a result of the events. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1483580
Sex: F
Age:
State: TX

Vax Date: 04/15/2021
Onset Date: 07/02/2021
Rec V Date: 07/18/2021
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: This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration in right arm on 15Apr2021 (Lot number: ER8731, patient was 69-year-old at the time of vaccination) as single dose for COVID-19 immunisation/ because of the better protection for her. The patient's medical history included metastatic breast cancer. It was reported that patient also take ibrance (start date: Dec2020, dose: 100 mg daily for 3 weeks and one week off, Film-coated tablet) for metastatic breast cancer. There were no concomitant medications. Reported that she thinks that she caught COVID from someone. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EP6955, patient was 69-year-old at the time of vaccination), via an unspecified route of administration in right arm on 20Mar2021 as single dose for COVID-19 immunisation. On 02Jul2021, the patient experienced she has COVID/came back positive on 03Jul2021. On 02Jul2021, the patient underwent lab tests and procedures which included COVID nasal swab resulted as positive 03Jul2021 in the evening. Caller stated that her head is foggy on an unspecified date. The outcome of events was unknown. No follow-up attempts are possible. No further information expected.

Other Meds:

Current Illness:

ID: 1483581
Sex: M
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: Got sick and a little lethargic and out of it for a day or so; Got sick and a little lethargic and out of it for a day or so; He was not feeling well; This is a spontaneous report from a contactable consumer (patient's son) from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got sick and a little lethargic on an unspecified date and was out of it for a day or so. The patient was not feeling well. The outcome of the events was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1483582
Sex: F
Age:
State: NJ

Vax Date: 06/24/2021
Onset Date: 06/24/2021
Rec V Date: 07/18/2021
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: Labored breathing; chest pressure; fatigue; chest felt very tight; she is not planning to get her second vaccine; because has vertigo besides this; she can't swallow; Wheezing; got very sick; pains all over; headache; neck pain; arm pain; bone pain; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: GWO196), via an unspecified route of administration in Arm Left on 24Jun2021 at 04:00 (83-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included bl high cholesterol; reported that her body makes cholesterol, it is not what she eats. It is 350 sometimes, 300 is high. Asthma, swollen, blood pressure, allergy with some soaps, adhesives they have to put one with cloth that does not have the same qualities as adhesive or otherwise she gets a rash, history of stents for heart attack, couple of arteries clogged but not showing any signs of causing problems, cancer. The patient had allergy with some medicines like clindamycin, Percocet, Percodan, penicillins. Concomitant medications included amlodipine (AMLODIPINE, dose: 5 mg, 1x/day) taken for blood pressure; atorvastatin (ATORVASTATIN, dose: 40 mg (she has been taking for years)) taken for blood cholesterol; furosemide (LASIX [FUROSEMIDE, dose: 20 mg (for three years. Not every day)]) taken for when her legs get swollen; salbutamol sulfate (VENTOLIN ACCUHALER) taken for asthma. It was reported that amlodipine was taken 3 or 5 years she has been on, but does not remember off hand, atorvastatin was taken maybe 8 years, it runs in her family everybody has it. She has been taking all her medications 50 years but not her cholesterol medication, for Lasix she is running like a chicken with her head cut off because everything that has happened to her. She takes 20, her daughter takes 40 mg not every day, for Ventolin when foggy outside she gets wheezy and when she is outside walking, she does one spray once and that is it. Years ago, she had bad asthma but not in the last 5 years except with weather. The patient previously took flu vaccine vii every year and experienced her arm hurt a little bit, coughing, chest hurt, did not have breathing thing, she got the flu, fainted. Reported that she was getting the flu vaccine every year, she takes it, and was okay the first time but her arm hurt a little bit and it never hurt. Two years ago, she took it and 2 weeks later felt sick like coughing and her chest hurt and she did not have breathing thing. Coughing and chest hurting led to her going to the emergency because she also fainted, so she called # and they took her to the hospital. She did tests and it was not her heart. They tested her for the flu and she said oh I already got my flu shot and they said well good thing you did. Caller confirms she got the flu after getting the flu shot. Reported that after experiencing labored breathing, chest pain, she called a cardiologist and went to the doctors and was admitted to the hospital for cardiac testing, and complains of labored breathing and fatigue. She wants this documented and has a history of stents in the past but hospital workup was negative. She had a heart attack 3 years ago and has stents in her heart. What happened when she called, she had cancer 5 years ago, when she called the oncologist and told him he said call cardiologist and she told her that she had the vaccine. She was taken by ambulance to the hospital and they did a bunch of tests and electrocardiogram and xrays and put her on monitor. After a few hours, they sent her to the cardiac floor where they gave her an injection, more blood tests, more of everything. The next day, nuclear testing of the heard and all of that stuff and sent her home and said it was not her heart and it was fine. She still had a couple of arteries clogged but not showing any signs of causing problems so they do not have to put a stent in. Caller confirms this was prior to receiving the vaccine because she has arteries clogged but only one with a stent and she still does not need a stent. No history of previous immunization with the Pfizer vaccine considered as suspect. No prior Vaccinations within 4 weeks. Reported that after vaccination they left her there for the 15 minutes and she had no reaction and came home and said my God, I should have done this a long time ago, because her arm was perfect and did not hurt and she had no symptoms till 2 o'clock in the morning. Reported that she is not planning to get her second vaccine. The second one she hears has worse and more side effects. She does not know what is going to happen if she only has one. She is supposed to have one 15Jul2021 in a couple days and right now she cannot take it if she is feeling this way because it is impossible and how should she do it if she is sick. Reported that Dr was afraid she was having a heart attack because she felt think someone was squeezing her chest and her breathing wasn't normal, so the hospital did all kinds of cardiac evaluation and they admitted her to the cardiac floor and continued to have all kinds of cardiac testing done, turns out her heart was okay, even though she has a stent in her heart and has 2 arteries that are clogged but they do not need to be fixed because there are not clogged to the point where it would cause her any problems, All the test showed that she did not have a heart attack. She has a lot of fatigue, if she walks from the bedroom to the kitchen, she really tires and feels like her breathing is labored, it's awful, and pains in the neck, even though before used to have a little pain in the neck, because has vertigo besides this but now has to be putting Ice packs constantly on the neck, waits and hour and then again and takes Motrin for the pain. Also the muscles, the doctor says the muscle in the chest, not in her heart and when she touches it hurts. Also having episodes where she can't swallow like she used to and had Asthma but kinda went away and now has started the past 2 days having Asthma, always has a pump with her because when it is foggy out she gets a little wheezing since yesterday, when she wakes up in the morning she hears the wheezing so will take a puff from the inhaler, so she would like this to be registered because she is 84 year old lady and has some issues that she never had other than when she had a heart attack, to which she had to change her medication. On 26Jun2021, the patient experienced labored breathing, chest pressure, fatigue, chest felt very tight, on an unspecified date, the patient experienced she is not planning to get her second vaccine, because has vertigo besides this, on 07Jul2021, the patient experienced wheezing, on 24Jun2021, the patient experienced got very sick, pains all over, headache, neck pain, arm pain, bone pain. It was reported that some term highlighted by the reporter as Labored breathing, chest pressure, fatigue. It was reported that it was not chest pain but it was pressure like somebody was squeezing her heart or had a rock on it and it weighed 100 pounds. It has gotten worse now that she is having wheezing in the morning. She had to use an inhaler for asthma yesterday. It has not gotten worse but it is the same. AE(s) require a visit to emergency Room and physician Office and hospitalized for one day. The patient was hospitalized for labored breathing, chest pressure and fatigue and chest felt very tight from 30Jun2021 to 01Jul2021. The patient underwent lab tests and procedures which included blood test resulted as unknown results, height resulted as 149.86 cm which she think shrunk and got fat, she used to be 4'11", electrocardiogram resulted as unknown results, nuclear testing of the heard resulted as it was fine, weight resulted as 100 lbs on 26Jun2021 which rock on it and it weighed 100 pounds, x-ray resulted as unknown results. Reported that all tests were negative but they put her in for her heart and no other reason to keep her because she did not need any kind of procedure done. Once they found it, she went home.

Other Meds: AMLODIPINE; ATORVASTATIN; LASIX [FUROSEMIDE]; VENTOLIN ACCUHALER

Current Illness:

ID: 1483583
Sex: F
Age:
State:

Vax Date: 02/26/2021
Onset Date: 05/29/2021
Rec V Date: 07/18/2021
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: the pressure in her eye and the inflammation, they are going down; the pressure in her eye and the inflammation, they are going down; have the eye stroke and it caused a partial loss of vision in her right eye; have the eye stroke and it caused a partial loss of vision in her right eye; have the eye stroke and it caused a partial loss of vision in her right eye; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 60-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unknown route of administration on 26Feb2021 (Lot Number: EN6200) at single dose for COVID-19 immunisation. Co-suspect drug included estradiol (ESTRING) Vaginal delivery system from unknown date via unknown route of administration at 1 ring every 12 weeks as directed (lot number: VK993A, Expiry Date: 30Sep2021) for drying out down. Medical history and concomitant medications were reported none. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unknown route of administration on 05Feb2021 (Lot Number: EL9265) at single dose for COVID-19 immunisation. Patient stated that she used Estring and that she had an eye stroke. She had been using this estradiol product for quite a while. She did also have the two Pfizer COVID vaccines. She did have the eye stroke on 29May2021 and it caused a partial loss of vision in her right eye. The eye stroke and partial loss of vision occurred after the COVID vaccines and after use of the estradiol product. She gave permission to leave a voice message if needed because she did not answer the phone. There were so many people trying to rip you off. She was still experiencing the effects of this and she was under doctors care for it. She saw the doctor yesterday and as far as the pressure in her eye and the inflammation, they were going down. They did some more x-rays and her eye had gotten a little better but she did not go back for another follow up until 16Aug2021. Her doctor told her that sometimes it could take a while for it to come back, if her vision would come back at all. She was hoping and praying that it would though. Patient had been using estradiol about 2 to 3 years. When asked about the indication, Jokingly she said old age, She clarified and said that she was actually drying out down there and that was when her doctor first inserted one in a couple years prior to the report. About the COVID vaccines, Probed for NDC, lot number and expiry date and patient did not see the NDC or expiry date on the COVID vaccination record card. Therapy start date populated as the date for the callers first COVID vaccine and the therapy stop date populated as the date for the callers second COVID vaccine. She was scared after the eye stroke. She had heard of some people having strokes after the COVID vaccines but she did not know what kind of stroke or whatever that they have had. Probed for further details on the callers statement regarding other having strokes and she said that this was something that she had just seen on the news where they had reported that some people were having strokes and stuff from certain vaccines but she was unsure if it was the Pfizer one. She was kind of asking if a question on if Pfizer had anything like this that had been reported. Patient was a 60 years old female who experienced a right eye stroke on 29May2021. She received the Pfizer Covid-19 vaccine in Feb2021. She had been taking estradiol for years and was taking it at the time she was vaccinated. Patient asking have eye stokes been reported after receiving the Pfizer COvid-19 Vaccine. She had heard of people on the news experiencing a stoke but they did not specify what kind of a stroke. The action taken in response to the events for estradiol was unknown. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1483584
Sex: M
Age:
State: MI

Vax Date: 07/06/2021
Onset Date: 07/06/2021
Rec V Date: 07/18/2021
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: a patient received a dose of the Pfizer Covid-19 vaccine after it was diluted and left in the syringe in the fridge for 4 days; a patient received a dose of the Pfizer Covid-19 vaccine after it was diluted and left in the syringe in the fridge for 4 days; Received Vaccine that was punctured more than the time of 6 hours.; This is a spontaneous report from a contactable other hcp via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0179, Expiration Date: 31Aug2021), via an unspecified route of administration on 06Jul2021 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received vaccine that was punctured more than the time of 6 hours on 06Jul2021 and received a dose of the Pfizer Covid-19 vaccine after it was diluted and left in the syringe in the fridge for 4 days. The reporter wanted to know if the patient needed to receive another Pfizer Covid 19 Vaccine immediately or if the Pfizer Covid 19 dose already administered was okay. The outcome of the events was unknown.; Sender's Comments: Based on the information provided, the association between the event production preparation error and the vaccination cannot be completely ruled out.

Other Meds:

Current Illness:

ID: 1483585
Sex: M
Age:
State: AL

Vax Date: 04/22/2021
Onset Date: 04/27/2021
Rec V Date: 07/18/2021
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: Pyrexia, White blood cell count decreased

Symptoms: 5 days after Covid vaccine dose 1 I experienced pain on the left side of my torso, On the evening of day 6 I noticed a quarter sized rash under my left arm, On day 7 was diagnosed with Shingles; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 22Apr2021 12:00, (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation. Medical history included Multinodular goiter under control and Penicillin allergy. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) which the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19; did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had not been tested for COVID-19 post vaccination. On 27Apr2021 07:00 (also reported as 5 days after Covid vaccine dose 1), the patient experienced pain on the left side of torso. On the evening of day 6 the patient noticed a quarter sized rash under left arm. On day 7 the patient was diagnosed with Shingles and started medication. The patient visited physician office and was treated with Antiviral medicines due to the event. The patient recovered from the event in Apr2021. Information about Lot/batch number has been requested.

Other Meds: LEVOTHYROXIN

Current Illness:

ID: 1483586
Sex: F
Age:
State:

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 07/18/2021
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: Her daughter tested positive both on the rapid and RT-PCR Test for COVID-19. Her daughter is asymptomatic; Her daughter tested positive both on the rapid and RT-PCR Test for COVID-19. Her daughter is asymptomatic; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer sponsored program. This consumer reported for 20-Year-old female patient that received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date was not reported), via an unspecified route of administration on 01Jul2021 dose 1 single as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reportedly, the reporter's son tested positive for COVID-19, so they all went out to get checked and her daughter tested positive both on the rapid and RT-PCR Test for COVID-19 on an unspecified date Jul2021. Her daughter was asymptomatic. Patient was scheduled to take her 2nd shot of the Pfizer vaccine on 22Jul2021. Reporter wanted to know if her daughter could still get the 2nd dose of the Pfizer COVID Vaccine on 22Jul2021. The outcome of each event was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1483587
Sex: F
Age:
State: NY

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 07/18/2021
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: maybe she is just stressed.; she has constant headaches at night; nausea; chest pain; dizziness; mild abdominal pain; This is a spontaneous report from a Pfizer sponsored program. A contactable 50-year-old female consumer (patient) via medical information team. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 01Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter was a consumer who received the 1st dose of the Pfizer-Biontech COVID19 vaccine on 01Jul2021 and six days after was still experiencing side effects which include headache that happens mostly at night, nausea, chest pain, and sometimes dizziness, as well as mild abdominal pain. She said that her main concern was the headache in which she takes Tylenol extra strength at 500 mg but it only works temporarily. She was not sure if the vaccine was causing the headache or maybe she is just stressed. The reporter was asked if it was normal for day 6 of being vaccinated to be having side effects. Medical questions were addressed by this program forwarded/referred to medical information. The outcome of the events was reported as not resolved. Information about lot/batch number is requested.

Other Meds:

Current Illness:

ID: 1483588
Sex: F
Age:
State: NY

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: the other 2 patients that were diagnosed with shingles after receiving the Covid-19 vaccine.; This is a spontaneous report from a contactable consumer (patient). This case is for patient 2 of other 2 patients. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced the other 2 patients that were diagnosed with shingles after receiving the covid-19 vaccine. on an unspecified date. The outcome of the events was Unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021856878 Same reporter/drug/AE, different patient

Other Meds:

Current Illness:

ID: 1483589
Sex: U
Age:
State:

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 07/18/2021
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: malaise; felt weak-ringing in ears.; Chills began then fever; fever; Headache shortly after exhaustion; next day headache+ Exhausted; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205, Expiration date: unknown), via intramuscular route of administration, in left arm, on 08Mar2021 at 08:00 (at the age of 53-year-old), as a single dose for COVID-19 immunization. The patient medical history includes ongoing anxiety and depression and concomitant medications included ongoing sertraline hydrochloride (ZOLOFT) orally for Anxiety/Depression. On 08Mar2021, after the vaccination at 20:30 PM, 12 Hours post vaccine, the patient experienced Chills began then fever, Headache shortly after exhaustion, then 24 Hours in felt weak ringing in ears. Patient felt like was going to pass out-Sat down on bed and collapsed + Passed out- Woke up shortly after. Felt malaise ace day stayed at bed, 18 Hours next day headache+ Exhausted- Felt more like self is 72 Hours. + malaise all day. Treatment received includes Advil. Outcome of the events was reported as recovered on an unspecified date in 2021. The seriousness criteria was reported as non-serious. No follow-up attempts possible. No further information expected.

Other Meds: ZOLOFT

Current Illness: Anxiety; Depression

ID: 1483590
Sex: F
Age:
State:

Vax Date: 04/18/2021
Onset Date: 04/01/2021
Rec V Date: 07/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Coughing; This is a spontaneous report from a contactable consumer. Report 2 of 3. A female patient (Reporters neighbours mother) of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: was not reported) via unspecified route of administration on 18Apr2021 as single dose for COVID-19 immunization.Medical history and concomitant medications were not reported. Patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: was not reported) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization.Reporter stated she was calling regarding the Pfizer Covid 19 vaccine. She had been doing some research and her neighbour and her mother had the Pfizer covid virus vaccine. She gave them a ride to pick up their car, which is about 15 minutes from her house. She had done some research and unfortunately, she was supposed to stay away from them. They were in her car. Her neighbour and her neighbours mother were both fully vaccinated with Pfizer and the caller is having massive and horrible headaches. Reporter confirmed she herself never had the covid vaccine. They (neighbour and neighbours mother) said they had received their vaccines at the end of Apr2021. They had both doses of the Pfizer vaccine. Reporter gave them a ride in her car 23Jun2021, it was the day before her birthday. She had been perfectly fine and healthy during the whole pandemic and had a mask on and everything. It was known that they were fully vaccinated at the end of Apr2021. Reporter stated that the ladies gave her numbers but does not have the number of the vaccine shot from their card. They said it was the Pfizer second dose was on 18Apr2021, she did not write down the numbers. Breathing or coughing in small, confined areas coming from those that had injections. The mother was coughing on an unspecified date in Apr2021. The outcome of the event was unknown. Information about batch/lot number has been requested

Other Meds:

Current Illness:

ID: 1483591
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: She stopped breathing; She like passed out but her eyes were still open; her vision started to go; Her vision start to get blurry; She started getting very hot; her vision started to go; Her vision start to get blurry; This is a spontaneous report from a contactable consumer. This consumer reported for a 21-years-old female patient. A 21-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EY0196 and Expiry date was not reported) dose 1 via an unspecified route of administration in Left arm on an unspecified date (21-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history was none. The patient was healthy. Concomitant Medication used for Just birth control (drug name not clarified). On unspecified, same day of vaccination the patient started getting very hot, has stopped breathing, like passed out but her eyes were still open, her vision started to go, her vision start to get blurry. The reporter stated that On unspecified date after 10, 5 minutes when it happened a pharmacy tech did gave her the EpiPen (treatment) because that's how we found out of it she was not with it, she was passed out, she stopped completely. she took the vaccine and they were sitting there you know to wait to make sure she didn't have reactions she started getting very hot. She poured water on herself because she was so hot then her vision started to go and her vision start to get blurry and the patient called the reporter to come stand by her when reporter walked over there she like passed out but her eyes were still open and she was calling my name looking at me but she was looking at me but she wasn't there, she was like looking straight through me. She stopped breathing, it was a horrible experience." The reporter stated that the patient had had a severe reaction after first dose. The reporter stated that She supposed to receive 2nd dose, its the 23rd but she is not getting it. The Reporter stated, "Yes, I would like to speak with somebody in regards to what she went through and what might affect if anything else is going to happened to her." Reporter stated, "So, when I call, I will speak to a medical professional and they'll have this information to discuss it with me and help me you know, because I mean, I wanna know, what I need to pay attention to if she is gonna have more other side effects from this or what." No laboratory tests. The outcome of the events was unknown. Follow-Up: Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1483592
Sex: M
Age:
State: NY

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 07/18/2021
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: can't lift his arm; feeling a lot of numbness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in arm right on 07Jul2021 (Lot Number: FA6780) as a single dose at the age of 59-year-old for covid-19 immunisation. Medical history included hypertension (diagnosed a million years ago). The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route on 03Jun2021 (Lot Number: EV0179 or EVI079) as a single dose at the age of 59-year-old for covid-19 immunisation. The patient's concomitant medications were not reported. The patient feeling a numbness started a few hours after the shot and unable to lift his arm started on 07Jul2021 night. The outcome of the events was not recovered. No follow-up attempts are possible; No further information is expected.

Other Meds:

Current Illness:

ID: 1483593
Sex: F
Age:
State: TX

Vax Date: 02/06/2021
Onset Date: 03/02/2021
Rec V Date: 07/18/2021
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: Constant pain in both hip area radiating down bilateral thighs worse at nights.; bilateral thighs worse at nights.; Pain in lower back; Constant cough; General body weakness with sleepless nights.; sleepless nights; This is a spontaneous report from a contactable female nurse (patient) via medical information team. An elderly female patient (non pregnant) unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in arm left on 06Feb2021 14:00 (Lot Number: EL9269) as a single dose at the age of 71 year old for covid-19 immunisation from hospital. Medical history included high blood pressure. Concomitant medications included levothyroxine, hydrochlorothiazide and diltiazem all taken for an unspecified indication, start and stop date were not reported. The patient previously took betamethasone benzoate, diltiazem. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in arm left on 16Jan2021 14:00 (Lot Number: EL3249) as a single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. On 02Mar2021 03:00, patient experienced Constant pain in both hip area radiating down bilateral thighs worse at nights. Pain in lower back. Constant cough. General body weakness with sleepless nights which result doctor or other healthcare professional office/clinic visit. Patient was treated with pain medication, x-ray of hip, bone density, refera in repose to the event. The patient underwent lab tests and procedures which included X-ray of hips, bone density measurement (report not provided). The outcome of the events was not recovered.

Other Meds: LEVOTHYROXINE; HYDROCHLOROTHIAZIDE; DILTIAZEM

Current Illness:

ID: 1483594
Sex: F
Age:
State:

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 07/18/2021
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: tested positive after getting the first dose (Jul2021), but patient did not have any symptoms; This is a spontaneous report from a Pfizer sponsored Program. The contactable consumer (patient's mother) reported for her daughter (the patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, on 01Jul2021, as single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received the first dose of COVID-19 vaccine on the first of this month (01Jul2021) and then tested positive after getting the first dose (Jul2021), but patient did not have any symptoms and just wanted to report that now what reporter should if patient should get the second dose. Reporter wanted to know if patient should go on 22Jul2021 for her second dose. Outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1483595
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: difficulty in breathing; chest pain; numbness; severe headache; nausea; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient experienced difficulty in breathing, chest pain, numbness, nausea and severe headache on an unspecified date. Event took place after use of product. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1483596
Sex: F
Age:
State:

Vax Date: 07/07/2021
Onset Date: 07/01/2021
Rec V Date: 07/18/2021
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: Running with fever 102.1; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Jul2021 (Lot Number: Unknown) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on unspecified date as a single dose for covid-19 immunisation. The patient received vaccine shot yesterday (on Jul2021, second one) and she left with she is running with fever 102.1. Patient took one tylenol for the event and patient's husband told she shouldn't take that, so she didn't take the second (Tylenol). The reported want to know can patient take the tylenol with the vaccine if she has the fever. The outcome of event was unknown. No follow-up attempts are possible; No further information is expected.

Other Meds:

Current Illness:

ID: 1483597
Sex: M
Age:
State: CA

Vax Date: 02/27/2021
Onset Date: 03/01/2021
Rec V Date: 07/18/2021
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: neck/shoulder pain; Extreme pain in left arm for over 3 months now; neck/shoulder pain; This is a spontaneous report from a contactable consumer (patient) received via Pfizer sponsored program and medical information team. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number En6203 and expiry date not reported), via an unspecified route of administration, administered in Arm Right on 27Feb2021 (at the age of 69-year-old) as dose 1, single for COVID-19 immunisation. Medical history included coronary artery disease and COVID. Concomitant medications included metoprolol tartrate; metoprolol tartrate (LOPRESSOR); acetylsalicylic acid (ASPIRIN) and niacin taken in two weeks prior vaccination. It was unknown if patient received any other vaccine in four weeks. The patient was not tested COVID post vaccination On 01Mar2021, patient experienced neck/shoulder pain, extreme pain in left arm for over 3 months now. The patient went to Physician Office due to the events. No treatment was given for the events. The outcome for the events was not recovered.

Other Meds: METOPROLOL TARTRATE; LOPRESSOR; ASPIRIN; NIACIN

Current Illness:

ID: 1483598
Sex: F
Age:
State:

Vax Date: 05/03/2021
Onset Date: 06/06/2021
Rec V Date: 07/18/2021
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: Hashimotos; Caller reports she received the vaccine in her butt and whenever she took the bandaid off it was full of blood; Caller reports she received the vaccine in her butt and whenever she took the bandaid off it was full of blood; blood pressure being up; shaking; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: Not provided), via an unspecified route of administration on 03May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included hypothyroidism. The concomitant medications were not reported. On an unspecified date, she received the vaccine in her butt and whenever she took the band aid off it was full of blood. On 06Jun2021, she had her blood pressure being up for no reason and she was shaking for 1.5 hours. On an unspecified date, she was diagnosed with Hashimoto's. On 06Jun2021, the patient went emergency room (ER) for blood pressure being up for no reason and shaking. The reporter reported that, took the band aid off it was full of blood. On 06Jun2021 Patient reported she had to call 911 due to her blood pressure being up for no reason and she was shaking for 1.5 hours. She was taken to the ER. She has now been diagnosed with Hashimoto's. Patient seeking information if others have reported this symptom. The lab data included blood pressure was increased on 06Jun2021. Outcome of the events was unknown.; Sender's Comments: The event of Hashimoto's thyroiditis is assessed as possibly related to the suspect drug BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.. 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: 1483599
Sex: F
Age:
State: DC

Vax Date: 07/06/2021
Onset Date: 07/08/2021
Rec V Date: 07/18/2021
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: Swollen lymph nodes but it's swollen to the extent that she can't put her arm down without a great deal discomfort; Swollen lymph nodes but it's swollen to the extent that she can't put her arm down without a great deal discomfort; This is a spontaneous report received from a contactable consumer. A 35-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0191 and expiration date: not reported), via intramuscular, on Right arm, on 06Jul2021 (at the age of 35-year-old), as DOSE 1, SINGLE for covid-19 immunization. The patient had no medical history and concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. On 08Jul2021, the patient experienced swollen lymph nodes, but it's swollen to the extent that patient can't put her arm down without a great deal discomfort. The patient wants to report it and ask if patient need to seek additional medical advice from Healthcare provider or vaccine distribution site. Further reported that, patient still having the problems and it was worsened and currently in a worsened state. The second dose of the vaccine was scheduled on 27Jul2021. The patient did not receive any treatment for the event. The outcome of the events was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1483600
Sex: F
Age:
State: NJ

Vax Date: 06/06/2021
Onset Date: 06/06/2021
Rec V Date: 07/18/2021
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: a tingling feeling on her top lip that was also puffy; a tingling feeling on her top lip that was also puffy; headache; eye itching; 2 hives on her arm; sore arm; cheeks were a lot of color; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on 06Jun2021 (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Jun2021, the patient experienced a tingling feeling on her top lip that was also puffy, headache, eye itching, 2 hives on her arm, sore arm and cheeks were a lot of color. It was reported that the patient had the first dose of the Pfizer COVID-19 vaccine last Tuesday (06Jun2021) and 48 minutes after, she had a tingling feeling on her top lip that was also puffy. She also had headache (in which she took Tylenol afterwards), eye itching, 2 hives on her arm (in which she thought were mosquito bites but she said they were not because the shape looked like hives instead of the circular mosquito bites), sore arm, and her cheeks were a lot of color. She was primarily concerned about her upper lip. It has been 2 days and she was still feeling the tingling sensation until today. She wanted to know how long it would last. She also wanted to know if she should be worried about taking the second dose of the vaccine . In response it was mentioned that as noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. She was suggested to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection as healthcare provider knows her health situation and has access to information that can better help inform this decision. She also wanted to know if she should take something for her adverse event like a Benadryl. In response it was suggested that Pfizer was unable to make treatment recommendations and referred her to HCP. Therapeutic measures were taken as a result of headache. The clinical outcome of the events was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1483601
Sex: U
Age:
State: FL

Vax Date: 12/23/2020
Onset Date:
Rec V Date: 07/18/2021
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: Caller stated that her family member got hospitalized for 2 months at some point after getting the first dose of the Pfizer BioNTech Covid-19 vaccine and missed the 2nd dose until now; This is a spontaneous report from a contactable consumer or other non hcp. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 23Dec2020 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that her family member got hospitalized for 2 months at some point after getting the first dose of the Pfizer BioNTech Covid-19 vaccine and missed the 2nd dose until now. It was stated that she was frustrated that Pfizer cannot provide recommendation whether to restart the vaccination series for a patient who still hasn't received the 2nd dose after 42 days. Reporter wanted to know if there will be a need to start over the Pfizer BioNTech Covid-19 vaccination series for one of her family members who got the first dose on 23Dec2020. The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1483602
Sex: M
Age:
State: CA

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 07/18/2021
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: dizzy; Just extremely tired; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 08Jul2021 11:00 (Lot Number: Unknown) as dose number unknown, single at the age of 34-year-old for covid-19 immunisation. Medical history included MS multiple sclerosis, migraines, seizures and known allergies to Ibuprofen, naproxen. Concomitant medications included gabapentin, glatiramer acetate (GLATOPA) and oxybutynin all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced just extremely tired and dizzy on 08Jul2021 11:00. The outcome of the events was recovering with no treatment. Information on the lot/batch number has been requested.

Other Meds: GABAPENTIN; GLATOPA; OXYBUTYNIN

Current Illness:

ID: 1483603
Sex: F
Age:
State: MI

Vax Date: 03/18/2021
Onset Date: 03/21/2021
Rec V Date: 07/18/2021
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: Visual disturbance; Inability to concentrate; Brain fog; Covid test result: Positive; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 53-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 18Mar2021 16:30 (at the age of 53-years-old) as dose 1, single for covid-19 immunisation. Medical history included hashimoto's thyroiditis, food allergy, dairy intolerance (Known allergies: dairy), gluten sensitivity from an unknown date and unknown if ongoing Known allergies: gluten. Concomitant medications included thyroid (ARMOUR THYROID), estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took levothyroxine and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The patient experienced covid test result: positive on 21Mar2021 and about 4-5 days afterward I suffered from brain fog, inability to concentrate, visual disturbance, On 22Mar2021 13:15. This lasted for several days. The events Covid test result: Positive assessed as serious (medically significant) while other event was non-serious. No treatment was received for the events. The outcome of the events Covid test result: Positive was reported as unknown and while for other was resolved with Sequel. Information on lot/batch number has been requested.

Other Meds: ARMOUR THYROID; ESTRADIOL

Current Illness:

ID: 1483604
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: Developing a cold sore due to sun exposure/broke out with fever blister; Swelling in her armpit that was pretty big; This is a spontaneous report received from Pfizer Sponsored Program. A contactable 50-year-old female consumer (patient) reported for herself. A 50-year-old female patient received first dose of 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 as dose 1, single for Covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. On an unspecified date The patient experienced developing a cold sore due to sun exposure/broke out with fever blister and swelling in her armpit that was pretty big. The patient asked developing a cold sore due to sun exposure. She is scheduled to receive her second dose of the Pfizer-Biontech Covid19 vaccine today. Will the vaccine interact with the cold sore and make it worse. The reporter stated that about 2 days after her first dose, she developed swelling in her armpit that was "pretty big, but went away". The reporter asked she was out in the sun and broke out with fever blister and is asking if she should still get the covax or wait. Reviewed fact sheet for information regarding cold sores with no results. Discussed lymphadenopathy as found in the attached Cons doc, which states, "Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days." Referred to HCP for additional guidance. As Per FAQ: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1483605
Sex: F
Age:
State: IL

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 07/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: a moderate fever (99.9), a mild fever that came and went; fatigue, fatigue but not as bad; a headache, a headache that was mild but had not gone away; swelling at the injection site; muscle pain; This is a spontaneous report from a contactable consumer (patient) received. A 34-year-old female patient received bnt162b2, via an unspecified route of administration, administered in left arm on 08Jul2021 01:15 PM (Batch/Lot Number: Unknown Unable to locate or read the details) as dose 1, single at the age of 34-year-old for covid-19 immunisation. Medical history included panic disorder, autism spectrum disorder, ADHD (attention deficit hyperactivity disorder), and PTSD (post-traumatic stress disorder), all from an unknown date. Concomitant medications included multivitamin; aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX); ascorbic acid (VITAMIN C), all taken for an unspecified indication. The event onset date was 08Jul2021 03:30 PM. The patient had a moderate fever (99.9), fatigue, and a headache the first day. She was on the second day (as reported) and had a mild fever that came and went, fatigue but not as bad, and a headache that was mild but had not gone away. She also had swelling at the injection site and muscle pain. 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. Since the vaccination, the patient had not been tested for COVID-19. Lab test included a moderate fever (99.9) on 08Jul2021. The outcome of events was recovering. Information on the Lot/Batch number has been requested.

Other Meds: B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACI; VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1483606
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: Received her first dose of the Pfizer BioNTech covid vaccine then became positive for covid; Received her first dose of the Pfizer BioNTech covid vaccine then became positive for covid; This is a spontaneous report from a contactable Nurse. A 59-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient received her first dose of the Pfizer BioNTech covid vaccine then became positive for covid and was given monoclonal antibody -Bamlanivimab on an unspecified date. She was directed by her physician and the manufacturer of bamlanivimab (monoclonal antibody) to wait 90 days to get 2nd dose of the covid vaccine. The patient underwent lab tests and procedures which included Covid which was positive (received her first dose of the Pfizer BioNTech covid vaccine then became positive for covid) on an unspecified date. The outcome of the events was unknown. Information about batch/Lot number has been requested. ; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events drug ineffective and COVID-19 cannot be totally excluded

Other Meds:

Current Illness:

ID: 1483607
Sex: M
Age:
State: WA

Vax Date: 07/07/2021
Onset Date: 07/08/2021
Rec V Date: 07/18/2021
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: Caller received first dose yesterday and noticed "baseball" bruise on right calf after shower.; arm was stiff/average weight in his arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 29-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 07Jul2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history included Hepatitis C shot on an unknown date and had stiffness in arm. The patient's concomitant medications were not reported. On 08Jul2021, post vaccination the patient reported that when he woke up this morning and had average weight in his arm. He clarified as stiffness. About an hour after he woke up, he went in the shower and there was a baseball size bruise on his calf, on his right calf. Not at the injection site. The outcome of the events was reported as unknown at the time of report. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1483608
Sex: F
Age:
State: CA

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 07/18/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: beginning of kidney failure due to high creatinine levels most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots, severely swollen leg; beginning of kidney failure due to high creatinine levels most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots, severely swollen leg; beginning of kidney failure due to high creatinine levels most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots, severely swollen leg; lower back pain; fever up to 103.7 degrees; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration in mid May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation. It was reported that the patient was generally healthy. The patient received her second dose of Pfizer COVID vaccine on mid-May. The patient was hospitalized with 5 blood clots and lower back pain. The patient was initially given Aleve and a muscle relaxant thinking it was a back strain. The patient woke up three hours later with a severely swollen leg and immediately went to ER and the ultrasound confirmed blood clots with 4 clots reaching the lungs. The patient had fever up to 103.7 degrees. The patient was told at the hospital that she was in the beginning of kidney failure due to high creatinine levels. Doctors told her that it was most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots. The events took place after the use of vaccine. The patient underwent lab tests and procedures which included body temperature: 103.7 degrees (Fever), ultrasound scan: blood clots on ultrasound confirmed blood clots with 4 clots reaching the lungs, blood creatinine: high. The outcome for the events was unknown. Information about Lot/batch number has been requested.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1483609
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: Cannot walk right; Her balance was horrible; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in 2021 as dose 1 single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, patient stated she was having second side effects from the Pfizer covid vaccine that she got. She said that she had a reaction to the first COVID shot. Her balance was horrible and could not walk right in 2021. She stated that the first time she called in about at the end of Feb or beginning of Mar. Patient confirmed that she was experiencing the same symptoms that she was experiencing when she called in Feb or Mar and she just wanted to walk normally again. The outcome of events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1483610
Sex: F
Age:
State: FL

Vax Date: 01/31/2021
Onset Date: 06/09/2021
Rec V Date: 07/18/2021
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 induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Both of them then contracted COVID19; Both of them then contracted COVID19; mild cold; This is a spontaneous report from a contactable consumer (patient, self-reported). A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9262 and expiry date was not reported), via an unspecified route of administration, on 31Jan2021 (age at vaccination: 70 years), as a single dose for COVID-19 immunization and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3246 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 10Jan2021 at 12:50 pm (age at vaccination: 70 years), as a single dose for COVID-19 immunization. Vaccine was not administered at military facility. The patient's medical history included COVID-19. Concomitant medications were not reported. The patient did not receive any vaccine prior Vaccinations (within 4 weeks). The patient reported that she and her husband both of them then contracted COVID19 on 09Jun2021. The patient would like to know more information pertaining to booster vaccines. She wanted to know since the booster shot was not "out," was it recommended to get the 2 shots or "whatever information" we might have on this because she was a little worried. She stated that she remained very concerned although her husband did feel they have antibodies due to the vaccine as well as previous history of having COVID19. She did not seem to agree with his thinking currently and worried about the booster dose "issue and the efficacy of 6 months." She felt as though since they were break through cases, they should get another set of shots while "they were still giving them." The patient spoke on the latest press release from Pfizer and feels as though in essence they were unprotected at this point and she did not want to be unprotected. She and her husband went to (withheld) and on the way back, both tested positive. They were both over the age of 70 and are concerned. She was reading about efficacy after six months and that was where they were, at about the six-month mark. She wondered, since there was no booster shot currently, while the vaccines were still being giving out should they both get revaccinated. The patient did not receive any treatments. The adverse events did not require a visit to emergency room and physician office. The short and long tests were before the trip, on 02Jun2021, and both were negative. On 09Jun2021 they did the nasal swab and had immediate results, this was while in (withheld). After testing positive, the department of health came and did another test, they did the longer one they had to wait 24 hours for, and it was still positive. They then had 14 days of quarantine. Caller did not know the type of testing used; the name was unknown. It was explained that all the information was the same for her and her husband, they had the same product details, same positive results, and the same symptoms after testing positive. Once testing positive they had 3 days of a mild cold, it was very mild. They thought it was just a cold, they couldn't believe they had COVID. There was a product complaint. It was explained that all the information was the same for her and her husband, they had the same product details, same positive results, and the same symptoms after testing positive. Once testing positive they had 3 days of a mild cold on an unspecified date in 2021, it was very mild. They thought it was just a cold, they couldn't believe they had COVID. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1483611
Sex: M
Age:
State: FL

Vax Date: 01/31/2021
Onset Date: 06/09/2021
Rec V Date: 07/18/2021
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: Both of them then contracted COVID19; Both of them then contracted COVID19; This is a spontaneous report received from a contactable consumer. This consumer reported for a 78-year-old male patient (husband) that: A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 2 via an unspecified route of administration on 31Jan2021 (Batch/Lot Number: EL9262) (at the age of 78-year-old) and dose 1 via an unspecified route of administration in Arm Right on 10Jan2021 12:50 (Batch/Lot Number: EL3246) (at the age of 78-year-old) as single dose for COVID-19 immunisation. Patient's medical history (including any illness at time of vaccination) was none. The patient concomitant medications were not reported. Additional vaccines administered on same date of the Pfizer suspect was none. Patient did not received any other vaccine within 4 weeks of COVID vaccine. No adverse event prior to vaccination. The patient experienced as, both of them then contracted COVID-19 on 09Jun2021, and mild cold on an unspecified date. Reported as, they received the COVID-19 Vaccine, both doses, 1st: 10Jan2021 and the 2nd dose: 31Jan2021. Both of them then contracted COVID19 09Jun2021. One question being how could she and or her husband become part of a clinical study or trial that may help with the data for a needed booster dose. Her husband went to (withheld) and on the way back, both tested positive. They were both over the age of 70 and are concerned. The short and long tests were before the trip, on 02Jun2021, and both were negative. On 09Jun2021 they did the nasal swab and had immediate results, this was while in (withheld). After testing positive, the department of health came and did another test, they did the longer one they had to wait 24 hours for and it was still positive. They then had 14 days of quarantine. No treatments reported. It was explained that all the information is the same for her and her husband, they had the same product details, same positive results, and the same symptoms after testing positive. Once testing positive they had 3 days of a mild cold, it was very mild. They thought it was just a cold, they couldn't believe they had COVID. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Jun2021, sars-cov-2 test: positive on 09Jun2021(nasal swab). Outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1483612
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: a little out of it the day after the second shot; but she got really exhausted; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional via Medical Staff. This consumer reported similar events for daughter and lot of people. This is the 2nd of 2 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced a little out of it the day after the second shot and got really exhausted. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021726880 similar report from same reporter

Other Meds:

Current Illness:

ID: 1483613
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: Erythema, Pruritus

Symptoms: Bleeding under the skin since the covid vaccine; This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported for a female patient (reporter's mother) via telephonic follow-up activity. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown, Expiry date: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bleeding under the skin since the covid vaccine. The event outcome was unknown. Information about lot/batch number cannot be obtained. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1483614
Sex: F
Age:
State: CO

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/18/2021
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: I contracted Covid-19 two months after getting my second dose with symptoms; I contracted Covid-19 two months after getting my second dose with symptoms; This is a spontaneous report from a contactable consumer (patient). A 29-yeas-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0171), dose 2 via an unspecified route of administration, administered in left arm on an unspecified date, as single dose and dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 (Lot Number: ER8730), as single dose for COVID-19 immunisation. The patient had no other medical history and no known allergies. The patient had no any other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient contracted COVID-19 (01Jul2021 at 10:00) two months after got her second dose with loss of taste and smell, body aches, nausea, vomiting and chills and fever while on vacation. The patient underwent lab tests and procedures which included rapid test (nasal swab): positive on 01Jul2021. Event occurred in a location different from that of the reporter. The patient did not receive treatment in response to the events. Outcome of the events was resolving. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1483615
Sex: F
Age:
State: NY

Vax Date: 06/14/2021
Onset Date: 06/17/2021
Rec V Date: 07/18/2021
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: Severely sick; Flu like symptoms; Chest discomfort-a heavy feeling in my heart; Chest discomfort-a heavy feeling in my heart; palpitations; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Jun2021 10:30 (at the age of 45-year-old) (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any concomitant medications (within 2 weeks of vaccination). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 19May2021 (at the age of 45-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine with 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. After receiving the second dose on 17Jun2021, the patient got severely sick (felt like the flu 4 days after receiving the vaccine). The patient started to experience chest discomfort--a heavy feeling in heart and palpitations. The flu like symptoms lasted a full week. The patient still felt chest discomfort presently. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent echocardiogram (EKG), results were unknown on an unspecified date. The patient received unspecified treatment for the events. The outcome of flu-like symptoms was recovered after 7 days (24Jun2021). The outcome of other events was not recovered. The events were assessed as non-serious by the reporter. On 26Jun2021, the patient had PCR COVID test (nasal swab) with negative results. On 04Jul2021, the patient had Rapid Antigen COVID test (nasal swab) with negative results. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1483616
Sex: F
Age:
State:

Vax Date: 07/09/2021
Onset Date: 07/01/2021
Rec V Date: 07/18/2021
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: Does not feel well; Headache; This is a spontaneous report from a contactable consumer. This consumer (patient's parent) reported for a 16-year-old female patient (reporter's daughter) that: A 16-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0198), via an unspecified route of administration on 09Jul2021 (at the age of 16-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated I have a question I got a new information about Pfizer that their vaccine is not as effective now because of the new variant. My daughter is 16, so the Pfizer vaccine is the only one she qualified for right now, yesterday she got her first vaccine. Reporter stated she does not feel well today on 10Jul2021, but she said she doesn't eat any Tylenol or anything, she also had a headache on unknown date in Jul2021 that's the only thing. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as unknown.

Other Meds:

Current Illness:

ID: 1483617
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Symptomatic Positive COVID test after vaccination; Symptomatic Positive COVID test after vaccination; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported for herself. A patient with unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.On an unspecified date, after the vaccination, the patient experienced symptomatic positive COVID test after vaccination with congestion and loss of smell. Event took place after use of product. Lab data include SARS-CoV-2 test which showed positive on an unspecified date. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1483618
Sex: F
Age:
State: FL

Vax Date: 04/12/2021
Onset Date: 04/01/2021
Rec V Date: 07/18/2021
Hospital: Y

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 was having some foot pain; amputated to my lower right leg/chopped my leg; blood clot; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: ER8730, expiry date: unknown), via an unspecified route of administration, administered in right arm on 12Apr2021 (at the age of 56 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included cervical cancer stage IV from Jun2019 and thyroid disorder unknown if ongoing. The patient had no prior vaccination. Historical vaccine includes first dose of BNT162B2 (lot: EN6208/expiration: unknown) via an unspecified route of administration administered in left arm on an unspecified date for covid-19 immunisation. The concomitant medications included levothyroxine and pembrolizumab (KEYTRUDA) on an unspecified date. April about three weeks after the second shot; i didn't know I thought it was just a foot ache and it didn't get bad until i went into the hospital and they couldn't save my leg and they amputated my right leg. I had blood clot and caused chopped my leg. Consumer stated, I started in April, but i can't remember the exact date, I start having foot pain until 10May2021 and I realize that it was something serious and went to the hospital. I am trying to report that I had Pfizer second vaccine and after that I had a blood clot, and I lost my leg. I am trying to report it to let you guys know because I know you keep record on that, but I had a blood clot that amputated my right leg. The patient was caused/prolonged hospitalization in ICU for the events from May2021 to an unspecified date. The patient had several unspecified lab tests on an unspecified date for which results were unknown. On 10May2021, the patient was treated with blood thinner and a bunch of things for events. Outcome of the events was unknown. Follow-Up (13Jul2021): Follow-up attempts are completed. No further information is expected.

Other Meds: LEVOTHYROXINE; KEYTRUDA

Current Illness:

ID: 1483619
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 07/18/2021
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: Swelling near the ribs; Resulting in pain; Experienced neurological symptoms; This is a spontaneous report from two contactable consumers via a Pfizer colleague. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. Medical history included comorbidity of celiac disease. The patient's concomitant medications were not reported. Patient had experienced neurological symptoms and swelling near the ribs, resulting in pain since the administration of the vaccine in Feb2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1483620
Sex: F
Age:
State: CA

Vax Date: 07/06/2021
Onset Date: 07/08/2021
Rec V Date: 07/18/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Hives all over my body; Chills; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Jul2021 (at the age of 38-year-old) (Lot Number: EWO196) as dose 2, single for COVID-19 immunization. Medical history was none. The patient's concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 15Jun2021 11:30 (at the age of 38-year-old) (Lot Number: EWO217) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced hives all over her body and started getting chills with the hives on 08Jul2021 23:00. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1483621
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 04/28/2021
Rec V Date: 07/18/2021
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: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Tested Covid positive after being full vaccinated; Tested Covid positive after being full vaccinated; Had Fever; I do now have my taste, smell back; I do now have my taste, smell back; Have slight bit of congestion; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), dose 2 intramuscular, administered in Deltoid Right (On right shoulder) on 28Apr2021 10:00 AM morning (at the age of 33-years-old) as dose 2, single and dose 1 received on an unspecified date for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported and no other products. The patient had no other Prior Vaccination. The patient got Covid positive result this morning on 10Jul2021 after being fully vaccinated. He did two different type of tests, he got a rapid test and PCR test. He does know there was possibility that he can still get Covid. He was not calling to complaint or being rude or whatever he just didn't know he guess who to reach out regarding that just because he does know that this was all new, he didn't know if you guys are collecting data on this type of test or anything, but he also wanted to let you know that he personally feel that your vaccine did helped a lot regarding the symptoms. He was like in and out the fever and all of that within a day and he do now have his taste and smell back. He would clarify if he needs to report that or what. He was not taking any right now, at first onset of symptoms he did take Allegra 24 to help with the decongestion and it did help and once he developed a slight fever (on 28Apr2021) he did take Tylenol and that also helped the symptoms and then he was symptom free other than slight bit of congestion (in 2021), just normal. He also had taste and smell loss (on 28Apr2021) and stated his taste and smell came back today (on 10Jul2021) and he don't have any other symptoms. He just wants to figure out that do you know the difference between the ongoing things, he just wanted to make sure that he would be followed up with you guys. The outcome of vaccination failure and Covid 19 was unknown. The outcome of the events smell loss, taste loss was recovered on 10Jul2021 and fever in 2021. The outcome of congestion nasal was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1483622
Sex: U
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: Positive COVID 19 test/body aches, runny nose, loss of smell; Positive COVID 19 test/body aches, runny nose, loss of smell; This is a spontaneous report from a contactable consumer. This consumer reported for a patient that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced Positive Covid 19 test, Body aches, Runny nose, Loss of smell on an unspecified date. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on an unspecified date. Query was raised to confirm the Adverse Event. And response was received that reporter is the one who experienced the AE. The outcome of events was unknown.

Other Meds:

Current Illness:

ID: 1483623
Sex: M
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: A blood clot precise upper thigh down to the calf in one leg/ Several blood clots in his lungs/ Major blood clot that was 11 inches in length that was scattered between both of his lungs; Shortness of breath/some shortness of breath; Severe lung pain; Severe pain in the leg; This is a spontaneous report from a contactable consumer. This consumer (parent) reported for a 40-year-old male patient (reporter's son) that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, UPC Number, NDC Number: Unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. Medical history included palsy and reporter considered it not an illness, but related to brain. The patient's concomitant medications were not reported. Reporter stated that the patient had the COVID vaccine as per reporter it was about 8 weeks ago, and then about 5 weeks ago, he never felt well after he got the vaccine the second one and he went in emergency room with shortness of breath and severe pain in the leg. He was admitted to the ICU with a blood clot precise probably from the upper thigh down to the calf in one leg, several blood clots in his lungs and one major blood clot that was 11 inches in length that was scattered between both of his lungs. The doctors were absolutely shocked that he was alive and they said that they never had seen anybody coming with that size of blood clot. He was in ICU for 4 or 5 days and they put him on blood thinners which reporter thought was like why they were not sending him to a heart hospital they were smaller hospital which reporter thought that they made a major mistake and his pulmonologist would said the same thing that they should have taken it out. But at that point, he was on complete rest he was on blood thinners and if that thing enlarges, he would be dead and they said that he went back to the emergency room on Wednesday with severe pain and they said that a part of it started to dissipate and dislodge in his lungs which was going to cause him severe lung pain and some shortness of breath so we had him monitor his oxygen level and his blood pressure if they went down then they said to come back and that's how we are at. And reporter didn't believe that they reported it and was really angry that they haven't reported it because he also had the palsy and he was not sedentary, but he just started using a wheel chair and we were trying to see that rectify. He was 40 years old but he had never been sick ever and he had never had problems with any kind of blood clot, his heart was healthy, his blood pressure was normal, and 'they were like all those' because people in wheel chairs would have blood clots sometimes and reporter believed that there was no way. The outcome of events were unknown. The patient experienced a blood clot precise upper thigh down to the calf in one leg/ several blood clots in his lungs/ major blood clot that was 11 inches in length that was scattered between both of his lungs (thrombosis) (hospitalization, medically significant, life threatening) on an unspecified date with outcome of unknown , shortness of breath (dyspnoea) (hospitalization) on an unspecified date with outcome of unknown , severe lung pain (pulmonary pain) (hospitalization) on an unspecified date with outcome of unknown , severe pain in the leg (pain in extremity) (hospitalization) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: unknown on, oxygen consumption: unknown on. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of a blood clot precise upper thigh down to the calf in one leg/ several blood clots in his lungs/ major blood clot that was 11 inches in length that was scattered between both of his lungs (thrombosis). Information about lot/batch number has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1483624
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/18/2021
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: Stroke; This is a spontaneous report received from a contactable consumer. This consumer reported for a female patient (reporters friend's mom) that an unspecified age elder female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via unspecified route on an unspecified date as single dose for COVID-19 immunization. On an unspecified date patient died she had a stroke, and they were trying to say that because she was older, she just passed her organ test, and she was perfectly fine and 2 days later after her second shot she had a stroke (Not clarified hence split not made) and it was like they keep on and understood that there were multiple reasons that someone could have a stroke specially if patient was older. The outcome of evet was fatal Information on the lot/batch number has been requested. Additional information is requested.; Reported Cause(s) of Death: stroke

Other Meds:

Current Illness:

ID: 1483625
Sex: F
Age:
State: MA

Vax Date: 04/27/2021
Onset Date: 05/18/2021
Rec V Date: 07/18/2021
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: Ovarian cyst; heavier period at 22 day cycle/10 day shed/ 27day cycle with liquid like menstruation with clumps 9 day duration; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on Left arm, on 27Apr2021 09:00 (at the age of 43-year-old), as DOSE 2, SINGLE for covid-19 immunization. Medical history included type 1 diabetes mellitus and Ferritin deplete anemia. The patient's concomitant medications were not reported. The patient previously received fluorescein and experienced allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on Left arm, on 06Apr2021 (at the age of 43-year-old), as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has been tested for COVID-19. The patient experienced heavier period at 22 day cycle on 18May2021, ovarian cyst in Jun2021, 10 day shed on 09Jun2021, 27day cycle with liquid like menstruation with clumps 9 day duration on Jul2021. It was reported that events result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Pct (nasal swab) in 2021 (unknown result). The events were assessed as non-serious. The patient didn't receive any treatment for the events. The outcome of the events was not recovered at the time of report. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1483626
Sex: F
Age:
State: TX

Vax Date: 04/04/2021
Onset Date: 07/07/2021
Rec V Date: 07/18/2021
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: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received BNT162B2 (Lot Number: emu199) via an unspecified route of administration, administered in Left arm, on 13Mar2021 at 13:00 as dose 1, single (age at vaccination: 47 years) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ew0150), via an unspecified route of administration, administered in Left arm on 04Apr2021 at 14:00 as dose 2, single (age at vaccination: 47 years) for COVID-19 immunization. Medical history included known allergies to sulfa drugs from an unknown date and unknown if ongoing. Concomitant medication included valaciclovir hydrochloride (VALTREX); bupropion hydrochloride (WELLBUTRIN); berberine; magnesium; menaquinone-7 (K2) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that, on 07Jul2021, she contracted COVID and COVID-19 confirmed by positive COVID-19 test on 10Jul2021. Reportedly, the patient was not diagnosed with COVID-19, prior to vaccination and since the vaccination, had been tested for COVID-19 via Nasal Swab on 19Jun2021 and 01Jul2021, both with negative results. There was no corrective treatment. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: VALTREX; WELLBUTRIN; BERBERINE; MAGNESIUM; K2; OMEGA 3 & 6

Current Illness:

ID: 1483627
Sex: U
Age:
State:

Vax Date: 07/12/2021
Onset Date: 07/01/2021
Rec V Date: 07/18/2021
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: Diarrhea; This is a spontaneous report from a contactable consumer. This consumer (patient) of unspecified age and gender reported that the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: the number was 19289, it was EW0196 (as reported), Expiry Date: Unknown), via an unspecified route of administration on 12Jul2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Jul2021, after the patient took the shot, the patient had diarrhea. The outcome of event was unknown. Information about lot and batch number was requested.

Other Meds:

Current Illness:

ID: 1483628
Sex: F
Age:
State: WA

Vax Date: 07/07/2021
Onset Date: 07/09/2021
Rec V Date: 07/18/2021
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: Getting like dizziness spells; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 22-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0181, Expiry date was unknown) via unspecified route of administration in Arm Left (at the age of 22-years-old) on 07Jul2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, levonorgestrel (CHATEAL) taken for an unspecified indication, start and stop date were not reported. On 09Jul2021, the patient experienced getting like dizziness spells. Patient got the vaccine, the Pfizer vaccine dose number 2 on Wednesday, this Wednesday and she didn't feel bad the day after but the following Friday, Friday after, patient started getting like dizziness spells and she had read that something she should call someone about. Patient don't have a primary provider at this time, so she did not know where else to call. Therapeutic measures were taken with Advil painkiller today but that was it, it was Advil Liqui-Gels. The outcome of the event was unknown. Follow-Up (13Jul2021): Follow-up attempts are completed. No further information is expected.

Other Meds: CHATEAL

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm