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: 1316157
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: they were concerned about blood clot; shaking uncontrollably; pouring sweat; sheet white with no color to skin at all; blood pressure 68/30; not particularly coherent; This is a spontaneous report received from a contactable consumer (patient's husband). A female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated his wife had adverse event to the COVID vaccine last week. He stated that they both got the vaccine. At 3 AM on unspecified date, the reporter woke up because his wife (patient) was shaking uncontrollably, pouring sweat, sheet white no color to skin at all, not particularly coherent and had blood pressure 68/30. They had to call an ambulance and she was brought to the hospital. They were able to get her blood pressure up and stabilized her after 8 hours. They were concerned about blood clot and did other scans. Lab data included blood pressure 68/30 (units unspecified) and scans with unknown results; both on unspecified date. The clinical outcomes of shaking uncontrollably, pouring sweat, sheet white no color to skin at all, not particularly coherent and blood clot were unknown, while of blood pressure 68/30 was recovering. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1316158
Sex: F
Age:
State: IL

Vax Date: 04/23/2021
Onset Date: 04/25/2021
Rec V Date: 05/14/2021
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 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Apr2021 01:00 (Batch/Lot Number: EW0164) (at the age of 48 years old) at 1st dose, single for COVID-19 immunization. Medical history included low iron, Bell's palsy in Jan2020 and patient had no known allergies. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications within 2 weeks of vaccination. On 25Apr2021 08:00 (after receiving the vaccine 2 days later), the patient had Bells Palsy symptoms started along with a head ache. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1316159
Sex: M
Age:
State: FL

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 05/14/2021
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: Cellulitis; immune system being weakened; fevers which came and went; chills; sweats; nausea; loss of appetite; light headedness; lack of energy; This is a spontaneous report from a contactable consumer (the patient). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0151) via an unspecified route of administration in left arm on 06Apr2021 12:30 at age of 36-year-old at single dose for COVID-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6205) via an unspecified route of administration in left arm from 16Mar2021 12:30 at age of 36-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was very sick for 4 days: fevers which came and went, chills, sweats, nausea, loss of appetite, light headedness, lack of energy. As a result of his immune system being weakened, he wound up with Cellulitis which he was still fighting over 3 weeks after the shot. As the patient was normally a healthy male, it was strange that he would wind up with a bacterial infection. The patient also stated that after the second dose he experienced cellulitis in his left leg to thigh area. He went to emergency room for scan and to rule out clot. He thought he was immunocompromised and that was why he got the cellulitis in the leg. Caller wanted to get the compensation information to help with the bills. The events onset date was 06Apr2021 17:00. 2 rounds of antibiotics was received for the events. The 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 ultrasound with unknown result. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1316160
Sex: F
Age:
State: PA

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 05/14/2021
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: left hand was edematous and cold; left hand was edematous and cold; left hand pain; blood clot; swollen submandibular gland that got bigger/could feel her mouth getting bigger; ill with something not related to the vaccine; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 03Mar2021 15:00 (Lot Number: EN6201) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included stroke on 2007, COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included clopidogrel bisulfate (PLAVIX) taken for stroke from 2007 to an unspecified stop date; and acetylsalicylic acid (ASPIRIN (E.C.)) taken for stroke from 2007 to an unspecified stop date. The next day on 04Mar2021, the patient had a swollen submandibular gland that got bigger. She could feel her mouth getting bigger. The patient was admitted into the hospital on 07Mar2021 and released on 09Mar2021. She was readmitted to the hospital on 11Mar2021 until 18Mar2021. The patient went back into the hospital on 21Mar2021 and released 20Apr2021. The gland was removed on 13Apr2021. She developed a blood clot. She went to the emergency room and was sent home on Xarelto. The patient mentioned that she received the 1st dose of the vaccine on 03Mar2021 and came down ill with something not related to the vaccine. She was hospitalized for 4 weeks and ended up missing her 2nd dose appointment on 24/Mar/2021. She would like to get her 2nd dose but she is now 5 weeks overdue for it. She mentioned the hospital is recommending that she restart her vaccination. She is looking for guidance from Pfizer. The facility where the most recent COVID-19 vaccine was administered was in the hospital. 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 has not been tested for COVID-19. The patient underwent had CT and MRI of left arm/wrist which she does not have results to provide. Event relatedness to vaccine was unknown for events, swollen submandibular gland that got bigger, left hand was edematous and cold, left hand pain and blood clot. The outcome of the event blood clot swollen submandibular gland was recovered with sequel on unspecified date, the outcome of ill feeling was unknown and the outcome of the rest of the events was recovering.; Sender's Comments: The 67-year-old female patient had medical history of stroke. Based on information available, the reported thrombosis and other events were unlikely related to the vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: PLAVIX; ASPIRIN (E.C.)

Current Illness:

ID: 1316161
Sex: F
Age:
State:

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 05/14/2021
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: diagnosed her with inflammatory breast cancer; experienced chills and such that started in the middle of the night; a week after having that Pfizer vaccine she started noticing bruising on her right breast and there was swelling; a week after having that Pfizer vaccine she started noticing bruising on her right breast and there was swelling; This is a spontaneous report a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in the left arm on 04Mar2021 (Lot number: UNKNOWN) as single dose for COVID-19 immunisation. Medical history included ovarian cancer (12 years ago and she survived). Concomitant medication included ibuprofen. The patient reported after 1st dose she was diagnosed her with inflammatory breast cancer. The patient experienced chills and such that started in the middle of the night. She had no real aches and pains in that first couple of days. The patient reported that a week after having that Pfizer vaccine she started noticing bruising on her right breast and there was swelling. She noticed some unusual things happening with her breast and at first she thought that she didn't know if it was from the COVID vaccine or if maybe she had hit something. But within a week or two she had severe breast swelling and noticed other bruising. After that first COVID vaccine she thought that it was an unusual thing that happened so she called her doctor and they have now diagnosed her with inflammatory breast cancer which comes up quickly and can't always be diagnosed on a mammogram. It wasn't with a lump that they decided to see if she had this, it was because of the swelling and bruising. The doctor said well it could be coincidental with the COVID vaccine but it is awfully strange that this came up shortly after the first vaccine. The clinical outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds: IBUPROFEN

Current Illness:

ID: 1316162
Sex: F
Age:
State: VA

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 05/14/2021
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: bursts of energy; headache; Chills; Panic attack; Panic attack; Hyperventilation; seeing green; feeling faint / dizzy; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6206), via an unspecified route of administration in the right arm on 26Apr2021 at 08:45 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included ductal carcinoma in situ (DCIS), asthma from 5 years old, calcification of the breast, vitamin D deficiency, "keep immune system up", ongoing panic and anxiety disorder. Concomitant medications included ascorbic acid/calcium carbonate/calcium pantothenate/calcium phosphate/chromium/cyanocobalamin/folic acid/magnesium carbonate/ magnesium hydroxide/manganese gluconate/nicotinic acid/potassium bicarbonate/potassium carbonate/potassium phosphate dibasic/pyridoxine hydrochloride/quercetin/riboflavin sodium phosphate/sodium bicarbonate/sodium phosphate/thiamine hydrochloride/thioctic acid/zinc ascorbate (EMERGEN-C) to keep immune system up and colecalciferol (D3) for vitamin D deficiency. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 26Apr2021, right after the vaccination, the patient felt a little dizzy but proceeded to her car anyway, got about half a mile away and felt extreme panic. On 26Apr2021 at 09:35, the patient had a major panic attack (which the patient gets, "but it had to be something really big"). She began hyperventilating on 26Apr2021, felt like she was going to faint. She pulled over and started breathing in her hands until she felt almost normal; the anxiety didn't go away, but that was normal for her. Then the faintness came back, and she pulled over again; mentioned she was in heavy traffic and hurried up to pull over. Eventually she contacted her son and he came and took over the wheel. This happened three times on her 45-minute drive; at 15 minutes, then 10 minutes and then at 9 or 8 minutes. She stated she had nothing to eat or drink before the vaccine and they didn't advise her to get anything to eat or drink and that may have had something to do with it. She could see everything looking greenish and it was a sunny day outside. She had a bottle of water and started to drink, and it subsided for a little bit. She pulled over and sat for 15 minutes; there were trucks and cars going really fast; she was doing self-talk saying you can do this and get home; then she drove about 10 or 15 more minutes; she had stayed on the side so she could pull over; cars honked at her for going so slow and she pulled over again. It happened again after 20 minutes. She was feeling really funny. Her son took her for coffee and something to eat. Throughout the day she was having hyperventilation and anxiety feelings until about 19:30 it went away. She had a good night's rest. On 27Apr2021 in the evening, the patient experienced chills so she put on socks; and she had a headache (she never had headaches), so she went to bed. Then she woke up at midnight and felt really energetic, so she watched a little TV then went back to sleep. Now it was day three and she had a lot of bursts of energy. This morning, 28Apr2021, she had a burst of energy and felt renewed. The events did not require a visit to the physician office or emergency room. The clinical outcome of feeling faint and seeing green was resolved on 26Apr2021; of dizzy, headache, and chills was resolved on 27Apr2021; of panic attack and hyperventilation was not resolved; of bursts of energy was unknown. Information on batch number has been requested

Other Meds: EMERGEN C; D3

Current Illness: Anxiety disorder; Panic disorder

ID: 1316163
Sex: M
Age:
State: CA

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 05/14/2021
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: Seizure; Felt dizzy; Eye sight was blurry; Shake and jerk; Shake and jerk; Skin turned pale; Heart rate was high; Nauseous; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Apr2021 16:00 as unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fish oil; magnesium [magnesium citrate]; vitamin d [vitamin d nos]; probiotic [bifidobacterium lactis]; vitamin b complex (VITAMIN B). The consumer stated, approximately 20 minutes after receiving the vaccine (28Apr2021 16:15) the patient felt dizzy, eyesight was blurry, and he began to shake and jerk. It resembled a seizure. His skin turned pale, heart rate was high, and he felt nauseous. It took him approximately 5-10 minutes to feel "normal" again. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in emergency room/department or urgent care. There is no treatment for AE. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolving. Information about Batch/Lot no. has been requested.

Other Meds: FISH OIL; MAGNESIUM [MAGNESIUM CITRATE]; VITAMIN D [VITAMIN D NOS]; PROBIOTIC [BIFIDOBACTERIUM LACTIS]; VITAMIN B

Current Illness:

ID: 1316164
Sex: F
Age:
State: NY

Vax Date: 04/06/2021
Onset Date: 04/01/2021
Rec V Date: 05/14/2021
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: site of where she got injected got infected and she was diagnosed with Cellulitis/ arm pain; rash is mostly on her shin, on that part of her body, and goes up her leg. It is like little raised bumps; injection site itchy; scratching so much like she would scratch her skin off; scratching so much like she would scratch her skin off; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration (at the age of 49-years-old), administered in Arm Left on 06Apr2021 12:00 (Batch/Lot Number: Unknown) as 1st dose, single for COVID-19 immunization. Medical history included cellulitis from a bug bite in a different location. The patient's concomitant medications were not reported. The patient initially stated she had an allergic reaction, then clarified to reaction. She had this reaction three weeks to the date of the first shot. She had to go Urgent Care. The site of where she got injected got infected and she was diagnosed with Cellulitis. Her injection site is all red and infected, it is like a rash there. She further explained she is unsure if this is an allergic reaction, but she has a rash, it is itchy. Her injection site is tender, itchy, warm, and red. She was given antibiotics to take. She does not have her primary care doctors address to provide at time of call. She further clarified today is like the 3rd or 4th day of having a rash, later clarified the start as 24Apr2021. The rash is mostly on her shin, on that part of her body, and goes up her leg. It is like little raised bumps. In the middle of the night she found herself scratching so much like she would scratch her skin off. The rash on her arm feels different. There is site pain there, but it also itches. It feels hard like she just got the shot in the arm. She feels like she wants to scratch and there are bumps there. Time of onset of rash in arm was started mid-afternoon. The arm pain started as clarified 26Apr2021. She confirmed she still feels the arm pain. It is bothersome. She wants to itch it. She does not think it is has gotten worse. However, she just started the antibiotics. Time of onset of arm pain was middle of the night. She went to urgent care yesterday and was officially diagnosed with cellulitis yesterday, 27Apr2021. Treatment included an antibiotic and antihistamine, but she does not have the name to provide. She scheduled an appointment to see the doctor when she gets back home. Sure he will do testing/blood work. The outcome of the events was unknown. The event "site of where she got injected got infected and she was diagnosed with Cellulitis" was considered as serious (medically significant). No history of all previous immunizations with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. She was supposed to get the second shot yesterday, but she did not due to everything going on. She wants to know if she should see her doctor before getting the second vaccination. She stated she is not comfortable with getting the second dose. If she wanted to get the second dose wanted to know what the window of opportunity was to get the second dose. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1316165
Sex: F
Age:
State:

Vax Date: 04/23/2021
Onset Date: 04/24/2021
Rec V Date: 05/14/2021
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: 12 hours post vaccination blacked out. Post regaining consciousness both hands and arms became numb; Mild migrane; Forehead felt numb for 3 d/Post regaining consciousness both hands and arms became numb; slight tingling in fingers; This is a spontaneous report from a non-contactable other hcp (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 23Apr2021 19:00 as single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. The patient felt okay after vaccine. 12 hours post vaccination (24Apr2021 08:00) blacked out. Post regaining consciousness both hands and arms became numb. Felt slight tingling in fingers. Mild migrane. Forehead felt numb for 3 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no known allergies and other medical history. The outcome of the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The causal association cannot be excluded between the reported event of Loss of consciousness and BNT162B2. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. 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: 1316166
Sex: F
Age:
State:

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 05/14/2021
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: worried that she was having a heart attack; terrible pains in her upper back, down her chest and into her arms; terrible pains in her upper back, down her chest and into her arms; terrible pains in her upper back, down her chest and into her arms; very fatigued for several days afterwards, like 5 to 6 days; might of been having a reaction where her bone marrow flared up in response to activating the immune system after the vaccine; This is a spontaneous report received via agency from a contactable consumer, the patient. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunisation. Medical history included ovarian cancer from 2009 to an unknown date (12 years ago), and ongoing inflammatory breast cancer in Mar2021 (diagnosed after the first dose of BNT162B2). Concomitant medications included ibuprofen for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 around 04Mar2021 (Lot Number:) for COVID-19 immunisation and experienced chills, and was diagnosed with inflammatory breast cancer. The patient experienced worried that she was having a heart attack, terrible pains in her upper back, down her chest and into her arms, very fatigued for several days afterwards, like 5 to 6 days, might of been having a reaction where her bone marrow flared up in response to activating the immune system after the vaccine. Clinical course: The patient was diagnosed with inflammatory breast cancer in Mar2021 after the first dose of BNT162B2 (captured in Pfizer case #2021478054). The patient has had all the tests and the mammogram did show that she had a couple of calcifications but it mainly showed all of the fluid that has went into her breast and she could of had a mammogram beforehand and the calcifications may not of shown. They have been doing PET scans and there has not been any spread. The patient took ibuprofen after the second dose of BNT162B2 vaccination. The next day after her second dose she had terrible pains in her upper back, down her chest and into her arms. She also was very fatigued for several days afterwards, like 5 to 6 days. Her pain was pretty significant. It was even affecting her upper body and down her chest so she was worried that she was having a heart attack, but that subsided after a day or a couple of days. When it kind of went away, she was very fatigued. She told her doctor about all the pain that she had after the second dose. The doctor indicated that she might have been having a reaction where her bone marrow flared up in response to activating the immune system after the vaccine. The outcome of the events, experienced worried that she was having a heart attack, terrible pains in her upper back, down her chest and into her arms, very fatigued for several days afterwards, like 5 to 6 days, might of been having a reaction where her bone marrow flared up in response to activating the immune system after the vaccine, was unknown. Information on the lot/batch number has been requested.

Other Meds: IBUPROFEN

Current Illness: Inflammatory breast cancer (diagnosed after the first dose of BNT162B2)

ID: 1316167
Sex: F
Age:
State:

Vax Date: 04/07/2021
Onset Date: 04/20/2021
Rec V Date: 05/14/2021
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: My period started two weeks early. This was already strange because my periods are very regular. I was bleeding very heavily; My period started two weeks early. This was already strange because my periods are very regular.; lightheaded; My period started two weeks early. This was already strange because my periods are very regular. I was bleeding very heavilynoticed several blood clots; This is a spontaneous report from a contactable consume (patient). A 22-years-old non pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 07Apr2021 (at the age of 22 years old) (Batch/Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation. The patients medical history and concomitant medications were not reported. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Apr2021 the patient experienced period started two weeks early, bleeding very heavily (medically significant), noticed several blood clots as well and lightheaded. The clinical course was reported as follows ' My period started two weeks early. This was already strange because my periods are very regular. I was bleeding very heavily and I considered going to urgent care but I was light headed and decided against driving. I noticed several blood clots as well. No Treatment was given for the events. The clinical outcome of the events was recovered. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Single dose, Lot number EW0170 on 28Apr2021 No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1316168
Sex: F
Age:
State: MS

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 05/14/2021
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: anxiety; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine; mental problem; so sick; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. Medical history included bipolar from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Mar2021, the patient experienced sleepiness. On an unspecified date, the patient experienced anxiety, they felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine, mental problem, so sick. She had really serious problem, had to leave work and go to the hospital and get treated for anxiety in the emergency room. Causing her anxiety to go crazy. After taking the Vistaril yesterday it calmed the girlfriend down. Outcome of events anxiety, felt soreness in the arm, mental problem, so sick was unknown. Outcome of Sleepiness was recovered in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1316170
Sex: M
Age:
State: NC

Vax Date: 04/19/2021
Onset Date: 04/20/2021
Rec V Date: 05/14/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Pulmonary embolism in his left lung; Chills; Hard to breathe; shaking a lot; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0164) via an unspecified route of administration on 19Apr2021 at 12:00 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unspecified date and ongoing and urinary tract infection (UTI) from an unspecified date and unspecified if ongoing. Concomitant medications were reported as none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: first letter is either a G or O but he thought it was OE8732) via an unspecified route of administration on 29Mar2021 at 11:45 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Illness at vaccination was UTI. On 20Apr2021 the patient experienced pulmonary embolism in his left lung, chills, hard to breathe and shaking a lot. The patient was hospitalized for pulmonary embolism in his left lung (blood clot) from 20Apr2021 to 26Apr2021. The clinical course was reported as follows: The patient stated that he had the second Pfizer shot on 19Apr2021 and on the 20Apr2021 he had a really bad reaction to it. He had chills, it was hard to breath, he was shaking a lot and had a UTI and COPD and had to call an ambulance to come get him. When he went to the emergency room, they did a CT (computerized tomography) scan of his chest and found a pulmonary embolism in his left lung and he was put on a Heparin drip for 7 days and stayed in the hospital for 7 days. The event hard to breathe ended shortly after he got to the emergency room since he was on oxygen. The patient had a history of COPD, so sometimes he had trouble breathing, but right now he did not. The event shaking a lot ended a little after he got to the emergency room. The patient also stated that he had a history of UTI in the past and had a UTI during the vaccine but was not treated for the UTI until he was at the hospital. The clinical outcomes of the event pulmonary embolism in his left lung was unknown; chills, hard to breathe and shaking a lot were all recovered/resolved on 20Apr2021.

Other Meds:

Current Illness: COPD

ID: 1316171
Sex: F
Age:
State:

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 05/14/2021
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: Says she got her first dose on 03/5 and tested positive for covid on 03/27; Says she got her first dose on 03/5 and tested positive for covid on 03/27; This is a spontaneous report from a Pfizer-sponsored program, via a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 at first dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient wanted to know if her covid vaccine was effective. Said she got her first dose on 05Mar2021and tested positive for covid on 27Mar2021; she rescheduled her second shot and got it on 27Apr2021. Outcome of the event was unknown. Information on batch number has been request.

Other Meds:

Current Illness:

ID: 1316172
Sex: F
Age:
State: NY

Vax Date: 04/19/2021
Onset Date: 04/25/2021
Rec V Date: 05/14/2021
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: Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; This is a spontaneous report from a contactable consumer (patient). A 45 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 17:30 (Lot Number: EW0171) as SINGLE DOSE for covid-19 immunisation. Medical history included colitis ulcerative from an unknown date and unknown if ongoing. Concomitant medication included linaclotide (LINZESS) taken for an unspecified indication, start and stop date were not reported; mesalazine (CANASA) taken for an unspecified indication, start and stop date were not reported; mesalazine (APRISO) taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Prior to the vaccination, the patient was not diagnosed with COVID-19. covid The patient was tested for COVID post vaccination.On 25Apr2021 17:00, the patient experienced severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion."The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care". The patient underwent lab tests and procedures which included chest x-ray: unknown result on unknown date, Rapid test Nasal Swab: negative on 26Apr2021. Therapeutic measures were taken as a result of severe chest pain, shortness of breath, inability to breathe which included Prednisone, at home nebulizer. Outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: LINZESS; CANASA; APRISO

Current Illness:

ID: 1316173
Sex: F
Age:
State: TX

Vax Date: 03/02/2021
Onset Date: 04/24/2021
Rec V Date: 05/14/2021
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: fever blisters; ear ache; stress; 2nd dose of the Pfizer Covid vaccine on 02Mar2021 and on 24Apr2021 she went to the emergency room with Bell's Palsy; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A currently 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 02Mar2021 16:00 (also reported as 16:30) (Batch/Lot Number: Unknown) as 2nd dose, single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included bell's palsy from 07Jan2015; and an unspecified risk factor. The patient had no concomitant medications. The patient did not have any prior vaccinations within 4 weeks. The patient did not have family medical history that was relevant to adverse events and no relevant tests were done. The patient previously took shingles vaccine (Merck) that started with the letter 'Z' and had Bell's Palsy in Jan2015 which was exactly 6 weeks after she got a shingles vaccine; tetanus vaccines 10 years ago as a booster and experienced severe swelling on her arm, swelling in her body; Quadravalent flu vaccine and never had a reaction to the flu vaccines; and the first dose of BNT162B2 (reported as 'Pfizer COVID') for COVID-19 immunisation on 02Feb2021 in the left arm. On 24Apr2021, the patient experienced bell's palsy. On unspecified dates, the patient experienced fever blisters, ear ache and stress. The events were reported as follows: Her HCP should have the information on the shingles vaccine she got in 2015. When she had bell's palsy the 1st time in 2015, she had to go to the hospital for a day and a half to rule out everything and the best they found was that she had herpes simplex based on the blood work done at that time and it was what her HCP believed it was at that because it showed she had some kind of virus but neither time she had bell's palsy did she have seizure or other symptoms other than the ear ache she had this time. The patient got the second dose of the vaccine on 02Mar2021 and on 24Apr2021 she went to the emergency room with Bell's palsy. She can talk better when she holds her mouth. She was out of town when she noticed the symptoms of bell's palsy the night before on 24Apr2021 and when she got home she then went to the emergency room on 25Apr2021; she could tell something was happening again and it was noticeable and she had an ear ache the day before and her face was drooping. The HCPs swear there was no correlation between the vaccine and bell's palsy but she found this very coincidental. The patient stated that she would rather get bell's palsy again than get covid. For treatment, the only thing she has done was to call the HCP to schedule the follow-up visit as directed by the emergency room (ER) HCP; she went to the ER to rule out stroke and they did rule out stroke; states the only other thing she can think of is that she had quite a bit of stress because they put down her dog on Sunday and other than that she had an ear ache at her granddaughter's track meet on the day before on 24Apr2021 and the emergency room visit was on 25Apr2021. She has had recurrent fever blisters and her HCP has given her a prescription for Valcyclovir and she takes that at the onset of fever blisters and where she gets the fever blisters is constantly on the previous side where she had bell's palsy and was in the same spot on her left side of her lip. States the Valcyclovir she has was one gram tablets and she takes one when she has a fever blister and one 12 hours later; states she has two prescriptions for the Valcyclovir and they are in orange pharmacy bottles with no lot numbers, expiry dates and NDC numbers and the other prescription for Valcyclovir is also 1 gram and she takes it three times per day now after this outbreak. The patient required a visit to the ER or medical doctor office. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1316174
Sex: M
Age:
State: MI

Vax Date: 03/30/2021
Onset Date:
Rec V Date: 05/14/2021
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: Blood clot in leg - first dose; This is a spontaneous report received from a contactable consumer, the patient. A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: CR2613), via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 77-years-old) as a single dose for COVID-19 immunization. Medical history included broke femur of right leg on 09Nov2020 and hospitalized from 09Nov2020 until 15Nov2020 or 16Nov2020, surgery to repair broken right femur on 12Nov2020, rehabilitation following hospital discharge and got out of the rehab facility on 14Dec2020, been in either a walker or a wheelchair and still not fully recovered (ongoing); chronic obstructive pulmonary disease (COPD), asthma diagnosed at least 13-14 years ago, bronchitis, all ongoing from an unspecified date diagnosed at least 13-14 years ago. Concomitant medications were not reported. There were no other vaccinations within 4 weeks of the vaccine. On an unspecified date, the patient experienced a blood clot in the leg. The clinical course was follows: After he was discharged from rehab, the patient went to his own family doctor on 30Mar2021 because his ankle and leg were still swollen. The physician sent him to have a vascular done, on an unspecified date after 30Mar2021, with unknown results. The patient reported that the physician determined that he had blood clots in his leg. The patient was sent to the emergency room and started "that stuff" for about a week until he went to a regular vascular doctor and the physician determined what the patient should be doing. The patient reported that he was diagnosed with the blood clots after he got out of rehab. The patient received apixaban (ELIQUIS) from Apr2021 for blood clot in leg. The clinical outcome of blood clot in leg was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021478767 same patient, different dose/event

Other Meds:

Current Illness: Asthma (he was diagnosed with asthma at least 13 or 14 years ago.); Bronchitis (he was diagnosed with bronchitis at least 13 or 14 years ago.); COPD (he was diagnosed with chronic COPD at least 13 or 14 years ago.); Walker user; Wheelchair user

ID: 1316175
Sex: F
Age:
State: NJ

Vax Date: 04/10/2021
Onset Date: 04/20/2021
Rec V Date: 05/14/2021
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: positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient had a positive COVID-19 test on 20Apr2021 with outcome of unknown. The event was considered as non-serious. She was scheduled to get the second dose on 01May2021. The information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 1316176
Sex: F
Age:
State: PA

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 05/14/2021
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: By 12:50 hands were starting to swell; chest pain; heart palpitations; pulse felt like her heart was racing very hard; non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia; non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia; blood pressure was up; throat felt like it was starting to tighten; eyes itchy; eyes itching much worse; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Lot number and expiration date: unknown), via an unspecified route of administration in left upper arm on 22Apr2021 12:10 (at the age of 61-year-old) as unknown single for COVID-19 immunization. This report was not related to a study or programme. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse events following prior vaccinations was first time had flu shot made her very ill, next year doctor suggested she should just have half of a shot instead of full shot to see if she tolerated it and she was able to tolerate that. She had not any other problems with flu vaccines in general. Some of the other vaccines, she was just supposed to take Benadryl with them because of some of the filler ingredients people put in things. She had previously had the 1 dose shingles vaccine, but she had gotten probably shingles probably a couple of months after that so they encouraged her to get the 2 part shingles vaccine at a later date and told her to do the pre-medicate routine like Benadryl day before, day of and at least 2 days after shingles vaccine doses and if any major problems call for help. She did not have a noticeable problem from the 2 part shingles vaccine. Some of the times depends on what filler ingredients people use. She was allergic to nutmeg which was used as an emollient oil or it's called Myristicin something or other oil; if something has too high a dose of mannitol it can cause a problem. She has a very long list of allergies and high sensitivities; if it was a high enough sensitivity it goes in allergies list, even though it may not be a true allergy. Family has lots of allergies. Regarding prescribed indication additional details: She had 3 doctors who initially advised her to get the vaccine including her primary care physician, oncologist and haematologist; this was because she was a high risk person because of various health issues. Her haematologist 2-3 months ago when she had her last appointment with him he was saying to get the shot and prescribed the epi-pen at that time; no one was having it yet, but he expected she would have some sort of reaction to it not able to be covered by Benadryl alone. Medical history included ongoing platelet disorder Verbatim: Unidentified platelet disorder, Lots of allergies, cardiac murmur, ongoing asthma, osteoarthritis, glucose tolerance impaired, hypoglycaemia slow thyroid and back and neck pain. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) taken for hypersensitivity (50mg taken as needed), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for hypersensitivity (10mg daily), fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma (250/50 twice daily), levothyroxine sodium (SYNTHROID) taken for hypothyroidism (137mcg-1 tablet daily), methylphenidate hydrochloride (RITALIN) (20mg tablet twice daily), salsalate, colestyramine (QUESTRAN LIGHT) (2-500mg tablets 3 times daily), sucralfate (CARAFATE) (1mg tablet 4 times daily-dosage verified with caller as milligrams and captured as provided), loperamide hydrochloride (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) (2.5/0.25 takes 2 tablets of that 4 times daily), calcium carbonate (CALCIUM OYSTER SHELL [CALCIUM CARBONATE]) (Alternates dose of 500mg and 1000mg on days takes Vitamin D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) (250 mg), vitamin D (50,000 units every other day taken), vitamin B12 (1mg injection every 14 days), clonazepam (KLONOPIN) (2-1mg tablets at bedtime), montelukast sodium (SINGULAIR) taken for asthma (10mg tablets at bedtime) and cefixime (FLEXERIL [CEFIXIME]) taken for back pain, neck pain (10mg tablets 3 times daily as needed). On 22Apr2021, Onset time: She had a note saying her eyes itchy at 12:20, but they were itching before that because she waited long enough to report it; so onset time was less than 10 minutes when her eyes started itching. Then her pulse; she could feel chest pain; heart palpitations; pulse felt like her heart was racing very hard. They did check her pulse while she was in their initial observation and her pulse was only in the 70s, but oxygenation was at 96%.When at doctors office less than 1 hour before that reading, oxygenation was at 98%.Recorded at 12:30 eyes itching much worse, throat felt like it was starting to tighten, heart felt like it was starting to race. By 12:50 hands were starting to swell. She had already been pre-medicated with Benadryl before this before she went down to get the Pfizer Covid-19 Vaccine, she had Benadryl in her system. She had that same morning with her morning meds had taken Zyrtec and Benadryl in anticipation of getting the possibility of getting the Pfizer Covid-19 Vaccine because she has to pre-medicate for vaccines just in case she starts to react in anyway. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines was not administered on same date of the Pfizer Suspect. Emergency Room taken from the location where vaccine administered-they gave her Pfizer Covid-19 Vaccine shot had her sit for basic observation then sit for extended observation. In that time period telling them her symptoms were going on, increasing. They gave her another 50mg Benadryl even though she had already had 1 before and then called emergency room, took her down, left her in waiting area even though she had heart and chest palpitations. Physician Office seen prior to event on 20Apr2021, seen after event 27Apr2021. Primary Care Physician didn't hear anything in lungs either visit. Not admitted to hospital; seen in emergency room, theoretically she got treated; however her basic blood pressure and stuff even with what they were doing was higher than when she was triaged in the ER; blood pressure was up and something else,oxygenation level moderately reduced from when she came down to when she was just let go; however her symptoms were worse when she was leaving than when she got there. She knows what they gave her while she was there was IV of normal saline, solumedrol and IV Benadryl. Thinks they later gave her Tylenol tablets. Finally got them to do an EKG because kept saying her chest was getting worse but that was several hours after she was back there even though came there having chest pains. In her opinion this hospital was not taking reaction seriously. Not admitted to hospital even though symptoms were worse and blood pressure higher on discharge, well above her normal levels. Currently trying to get them to explain why they took so long to do anything for her. Finally did a chest x-ray on 22Apr2021:discharge papers say abnormal x-ray and they gave a couple of different possibilities as to what that might be so Primary Care Physician wrote a prescription to get a follow-up chest x-ray to make sure that everything is fine and back to normal and not ongoing or progressing or anything because they gave some strange things: what their impressions were: findings: there is non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia. It says the left lung appears clear; cardiomediastinal silhouette is within normal limits; impression restates non specific right findings there is non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia. This was from front and lateral views of the chest x-ray at 19:00pm 22Apr2021. 2 ECGs: She guesses this is what they call EKG not, relevant point is that in the notes there for the re

Other Meds: BENADRYL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ADVAIR; SYNTHROID; RITALIN; SALSALATE; QUESTRAN LIGHT; CARAFATE; LOMOTIL [LOPERAMIDE HYDROCHLORIDE]; CALCIUM OYSTER SHELL [CALCIUM CARBONATE]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]

Current Illness: Allergy (Verbatim: Allergies); Asthma (Verbatim: Asthma); Back pain; Glucose tolerance abnormal (Verbatim: Impaired glucose tolerance); Heart murmur (Verbatim: Heart murmur); Hypoglycemia (Verbatim: Hypoglycemic); Hypothyroidism; Neck pain; Osteoarthritis (Verbatim: Osteoarthritis); Platelet disorder (Verbatim: Unidentified platelet disorder)

ID: 1316177
Sex: M
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
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: her Husband who had COVID at that time; her Husband who had COVID at that time; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. Medical history included Type 2 Diabetic from 1995. The patient's concomitant medications were not reported. The reporter suspected that she was infected by her husband who had COVID at that time. While reporting adverse event for herself, she mentioned that her husband also was positive for the COVID virus after receiving the COVID vaccine. She mentioned that her husband was healthier than her that's why he got the 2nd dose 6 and a half weeks after the 1st one. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1316178
Sex: M
Age:
State: VA

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 05/14/2021
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: he noticed a large amount of blood when the needle was removed/quite a bit of blood came out of the injection site; the person giving him the vaccine, may have nicked an artery in his arm; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program COVAX US Support. A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation and experienced pain at the injection site, low grade temp, fatigue and sore arm. On an unspecified date, the patient reported that when he received his second Pfizer Covid 19 Vaccine he noticed a large amount of blood when the needle was removed. The patient also reported no side effects from the second vaccine. He's concerned he didn't receive the full dose. The patient got both doses of the Pfizer Covid vaccine and at his 2nd dose during administration quite a bit of blood came out of the injection site, he believes they may have hit a blood vessel, so he wants to know if that means he didn't get his full vaccination. The patient stated that the person giving him the vaccine, may have nicked an artery in his arm. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1316179
Sex: F
Age:
State:

Vax Date: 04/23/2021
Onset Date:
Rec V Date: 05/14/2021
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: little bumps all over her body, on her back, stomach, back of knees, breasts and tops of thighs; This is a spontaneous report received from a contactable female consumer (patient). A 57-years-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via unspecified route of administration on 23Apr2021 00:00, as a SINGLE DOSE for COVID-19 immunization. Patient has history with past dose of BNT162B2 on an unspecified date. Concomitant medication of the patient was not reported. Patient received second dose on 23Apr2021, then on Monday she developed little bumps all over her body, on her back, stomach, back of knees, breasts and tops of thighs. Her two sisters who live with her aged 56 (INT 227111) and 55 (INT 227113) also developed a similar rash after developing symptoms. Outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1316180
Sex: F
Age:
State: IN

Vax Date: 04/24/2021
Onset Date: 04/25/2021
Rec V Date: 05/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: its kind of scratchy and red in rays its kind of itches; its kind of scratchy and red in rays its kind of itches; its kind of scratchy and red in rays its kind of itches; lip swelled up on left side; really tired; Dry mouth; soreness at injection site; still had not had periods/ had not yet started her cycle; anaphylactic reaction; rash so it is on her left armpit kind of going towards her chest; swelling; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8736), via unspecified route of administration in left arm on 24Apr2021 at single dose for COVID-19 immunisation. The relevant medical history included react like that normally is it eat bananas or sweet potato, asthmatic. Concomitant medications included vitamins nos. The patient previously took Wellbutrin, Methocarbamol and both experienced drug allergy. The patient previously received first dose of BNT162B2 (Lot number: ER8735) on 02Apr2021 at the age of 35 years old for COVID-19 immunisation and had menstruation irregular. The patient got her 2nd Vaccine that past Saturday and she got it on her left side of her body and her lip swelled up on left side and then she got a rash but the rash was going away and swelling going down but she thought she needed to report that. The patient still had not had periods which was very unusual for her and she tested the pregnancy test and she was not pregnant. Anatomical site of swelling was stated as left side of her lip on her face it looked like she got stung by a bee and then the swelling had been going down on that, the rash was going away as well. When confirmed the event start date, 25Apr2021 was stated for the swelling and rash. For causality the patient stated that she thought so because she was allergic and she avoided she had not got a rash like that from eating them. She also got like swelled lips or hives and she did not get hives and in this period that was the only thing and she had couple of other friends that had biological symptoms too, so that was the reason she was pretty sure it was connected. The patient stated that the swelling and the rash was still there, the swollen lip was going down and she had not yet started her cycle. She also stated that swelling was improved, rash was better but she could still see it. After her vaccine she was really tired and she was sure a lot of people were so she just fall asleep for 12 hours. When she woke up it was a little better. So she did not take anything specifically for that. When described the signs and symptoms of the anaphylactic reaction, the patient stated that it looked kind of well she mean let her look at the rash so its on her left armpit kind of going towards her chest and its kind of scratchy and red in rays its kind of itches over then but its not writhing or sheathing. She was asleep for 12hrs she thought it came up some time either late Saturday night or early Sunday morning. She didn't had any problem in breathing, she didn't have tightness in her chest no racing heartrate nothing like that. No medical intervention required. No Emergency Department and no hospitalization. The patient got dry mouth but again she didn't like super weird, she didn't had any racing heart rate, she did not had any respiratory symptoms, obviously dermatologically did. She would say as reaction go well significantly minor she had soreness at injection site but she didn't had any raised she wasn't raised can't even tell now for that well that fine. No initiation of new medication or other treatment or procedure required. Her husband was positive back in the fall. She was tested but she quarantined from him and she never got it. She tested 4 times negative. The outcome of the event rash, lip swelling and swelling was recovering, while other events were unknown.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1316181
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
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: The consumer called on behalf of her daughter who received the first dose of the Pfizer-Biontech Covid19 vaccine, 2 weeks ago. The patient developed stiffness in her neck, and they thought maybe she had "pulled her back out" because she was experiencing pain on the right side of her back. The medical staff at the Clinic (also reported as urgent care (pending clarification), where she was seen, think that she's experiencing "shingles without the rash" and indicated that they'd had "a lot of people" present this way after vaccination. The patient will be having bloodwork done to confirm shingles and will know in the next 72 hours. The reporter asked if there had been reports of shingles following vaccination. The reporter indicated that she does not want her daughter to receive a second dose of vaccine. The outcome of events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1316182
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
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: Left side of face froze up/Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (batch/lot number and expiry date not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced left side of face froze up/Bell's palsy on an unspecified date. The patient underwent lab tests and procedures which included test in the emergency room: unknown result on 24Apr2021. Therapeutic measures were taken as a result of left side of face froze up/Bell's palsy (unspecified medication). The patient has not recovered from the event. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1316183
Sex: M
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
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: Shingles; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history includes hearing disability, diagnosed about 3 years ago, so she uses speakerphone so she can hear instead of wearing a hearing aid. Concomitant medications were not reported. The patient experienced shingles on an unspecified date. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1316184
Sex: F
Age:
State: CA

Vax Date: 04/23/2021
Onset Date: 04/24/2021
Rec V Date: 05/14/2021
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: she fainted; hit her head; This is a spontaneous report from a contactable consumer (patient's mother) reported that a 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0171), via an unspecified route of administration, administered in arm left on 23Apr2021 (at the age of 16-years-old) as 1st dose, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24Apr2021, she fainted and hit her head. Clinical course details was reported as the patient got her Pfizer COVID vaccine on Friday (23Apr2021), and she fainted on Saturday (24Apr2021), knocked her head on counter and was knocked out. The doctor was taking her to ER. The patient was not yet admitted to the hospital, since when the patient's mother called they were going there (hospital) now. The doctor had her blood drawn to find out what was going on. The patient underwent lab tests and procedures included weight: 58.97 (no unit), and height: 157 (no unit) both on an unspecified date. The patient was scheduled on 15May2021 for 2nd vaccine. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1316185
Sex: M
Age:
State: FL

Vax Date: 04/09/2021
Onset Date: 04/23/2021
Rec V Date: 05/14/2021
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: A male patient received the second dose of BNT162B2 (Lot Number: EW0151), via an unspecified route of administration, administered in left arm on 09Apr2021 15:00 as single dose for COVID-19 immunization. Medical history included allergy with NSAID, narcotics, cloves, wheat, soy, corn, scallops, peanuts, tree nuts, environmental allergens; lupus; C2 deficiency. Concomitant medications included prednisone. The patient previously took tetracycline, minocycline, doxycycline, azithromycin, clindamycin and experienced drug allergy. The patient previously received the first dose of BNT162B2 (Lot Number: 6208) administered in left arm on 19Mar2021 15:30 as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. Exactly two weeks after the second vaccine, the patient developed an extremely mild case of Herpes zoster virus on 23Apr2021 04:00. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included 1000mg valacyclovir 3x/day. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: PREDNISONE

Current Illness:

ID: 1316186
Sex: M
Age:
State:

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 05/14/2021
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: Facial twitching on the left side of his face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8735; NDC number: unknown, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 21Apr2021 09:00 as single dose for COVID-19 immunisation (Because he travels internationally for work once that opens up and for safety purposes). There was no patient medical history (no diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity). There was no family medical history relevant to AE, they all were pretty healthy. The patient did not take concomitant medications (no other products). There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There were no additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccinations (within 4 weeks). There was no AE following prior vaccinations. On 22Apr2021 he noticed facial twitching on the left side of his face, which is same side that he was administered the Pfizer Covid Vaccine injection given in his left arm. He does not have any droopiness, just the facial twitching on the left side of his face. He asked for further information regarding this event relative to the Pfizer Covid Vaccine. Facial twitching on the left side of his face: outcome persistent, about the same, just annoying. Onset time is unknown, just sometime on 22Apr2021. He mentioned that he read some clinical reports where people you know ended up getting the bell's palsy on the second one, so if he is already getting twitching he does not want to get the second dose of the Pfizer Covid Vaccine and end up with this for 6 months or bell's palsy. His second dose was going to be 13May2021, but he has permanently stopped product in response to this event. There was no emergency room or physician office visit. There was no relevant test. Seriousness for event was unspecified. The patient was not hospitalized. There was no investigation assessment. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1316187
Sex: U
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Shingles; This is a spontaneous report from a contactable other health professional reporting similar events under the same suspect product for 4 patients. This is second of 4 reports. An elderly patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was one of the 4 seniors that the doctor knewof that has had developed shingles on an unspecified date with Pfizer vaccine for COVID 19. The outcome was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481986 same reporter/drug, similar events, different patient

Other Meds:

Current Illness:

ID: 1316188
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
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: Tingling all over my body; Started having pain and then it started messing with my nerve and it got really bad; Started having pain and then it started messing with my nerve and it got really bad; Three days after I got the first vaccine, my period came even though I already had period in that month; common cold; This is a spontaneous report from a contactable consumer (patient). This is the report for the first dose. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER8736) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the first day the patient got the vaccine about two to three hours after getting the vaccine, she started having tingling all over her body and by Friday, she started having pain and then it started messing with her nerve and it got really bad. She went to the emergency room and they tried to give her some medication and she took some. So, she didn't like the way she felt, so she stopped thinking that. When she went to Emergency Room (ER), the doctor told her that these are the unknown side effects because these are not the ones that they heard of but she heard that they talk about that you could have a rare side effect. The patient commented that she was told that was the only thing that she heard, this was what happened to her. Also, three days after she got the first vaccine, her period came even though she already had period in that month and they said it could be a coincidence. So, they automatically set up her second shot four weeks later and she was using a natural stuff for the pain and the tingling and all that sort of things. Three weeks after, everything was the same, nothing has changed, it was like common cold. Therapeutic measures were taken as a result of tingling, 'pain and then it started messing with my nerve and it got really bad'. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021484668 same patient, same event;different vaccine doses

Other Meds:

Current Illness:

ID: 1316189
Sex: F
Age:
State: CA

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 05/14/2021
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: slept for 2-3 days; Body was Sore; First Dose: Diarrhea; worn out; Arm was sore; This is a spontaneous report received from a contactable consumer (patient's husband). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Jan2021 13:45 at 61 years old (Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included ongoing seizure, seizures began when she was 5 years old, minor seizures. Seizures were under control in 1984, possibility configuration it is the right cocktail; Nerve injury; swelling on the wound leg; Blood pressure abnormal. Family history was none, states her Dad died last year, he was old, died of old age and natural causes. As people get older their body falls apart, nothing that is cancerous. States her Mother died of her heart, something to do with the heart and that was before they got married in 1984, he never met her mom. Concomitant medications included ongoing gabapentin taken for Nerves, she has been taking that for the last 7 years, states she has a wound on her left leg and that was being treated by a wound doctor for the last 7 years, states he got tired of what the wound doctor was doing so he drove her to (withheld) to be treated. Caller states the wound doctor at (withheld) made a suggestion on how to bandage it up and medicate it and it went from 8Jan2021 length was 7.5mm by 10mm and with (withheld) suggestion yesterday it was 1mm by 0.7 mm, so half the size of a penny, states he anticipated within the next week or two weeks that it will be healed; ongoing valproate semisodium (DIVALPROEX) taken for seizure, states she has been taking for at least 20 years; ongoing furosemide taken for Water Pill, states she takes it to reduce swelling on the wound leg; states he gives it to her on the odd day of the month; ongoing metoprolol taken for Blood pressure abnormal, start and stop date were not reported; ongoing zinc taken for an unspecified indication, start and stop date were not reported; ongoing acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported; ongoing pramipexole taken for seizure, start and stop date were not reported, states she takes it at 6pm, because it makes her drowsy and so the best time is at night time when she goes to bed; ongoing Vitamin C taken for an unspecified indication. No other vaccines were administered on same Date of the Pfizer Suspect, every year they get the flu shot and everything is normal. Caller states his wife got her first shot on 09Jan2021. States the effects started immediately, her arm was sore and then the next day (10Jan2021) her body was sore and she had diarrhea for 2-3 days and she also slept for 2-3 days, she was worn out. On the 3rd or 5th day she said she feels good, lets go. Caller states, then they were okay. The outcome of the events was recovered on 12Jan2021.

Other Meds: GABAPENTIN; DIVALPROEX; FUROSEMIDE; METOPROLOL; ZINC; BABY ASPIRIN; PRAMIPEXOLE; VITAMIN C [ASCORBIC ACID]

Current Illness: Seizures (began when she was 5 years old, minor, were under control in 1984.)

ID: 1316190
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
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: the tingling came back and it was very intense; I got my period down again, three days after exactly like the first vaccine and my period has been worse; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2, via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER8736) as 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on an unspecified date (Batch/Lot Number: ER8736) for COVID-19 immunisation and experienced as stated, "the first day, I got the vaccine about two to three hours after getting the vaccine, I started having tingling all over my body and by Friday, I started having pain and then it started messing with my nerve and it got really bad. I went to the emergency room and they tried to give me some medication and I took some. So, I didn't like the way I felt, so I stopped thinking that. When I went to Emergency Room (ER), the doctor are telling me that these are the unknown side effects because these are not the ones that they heard of but I heard that they talk about that you could have a rare side effect and I am telling you that, that is the only thing that I heard, this is what happened to me. Also, three days after I got the first vaccine, my period came even though I already had period in that month and they said it could be a coincidence. So, they automatically set up my second shot four weeks later and I was using a natural stuff for the pain and the tingling and all that sort of things. Three weeks after, everything was the same, nothing has changed, it was like common cold and then I felt better because of that natural stuff that I was using, it helped me feel better. So, I went and got my second vaccine and this was on this last Saturday, I got my second vaccine, the tingling came back and it was very intense and then I got my period down again, three days after exactly like the first vaccine and my period has been worse. So, I am calling you, I even called CDC trying to get information and everything, then I got this number to call you guys and I called." The outcome of tingling was unknown and other event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021484439 same patient, similar event, different dose

Other Meds:

Current Illness:

ID: 1316191
Sex: U
Age:
State: CT

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 05/14/2021
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: Shingles; This is a spontaneous report from a contactable nurse reporting same event under the same suspect product for 4 patients. This is third of 4 reports. A elderly patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Apr2021 as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was one of the 4 seniors that the doctor knew of that has developed shingles on an unspecified date with Pfizer vaccine for COVID 19. The outcome was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481986 same reporter/drug/events, different patient

Other Meds:

Current Illness:

ID: 1316192
Sex: U
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
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: Shingles; This is a spontaneous report from a contactable nurse. This nurse reported same event for four patients. This is the fourth of four reports. An elderly patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number was not reported) at unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was one of the 4 seniors that the doctor knew that has had developed shingles on an unspecified date with Pfizer vaccine for COVID 19. Outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481986 same reporter/drug/events, different patient

Other Meds:

Current Illness:

ID: 1316193
Sex: U
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: tested positive for # COVID19; tested positive for #COVID19 / come down with Covid is that I'm 11 weeks out since my @pfizer vaccine; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number: UNKNOWN) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient tested positive for covid-19. The patient reported that "I, unfortunately, tested positive for COVID19 today. What sets me apart from millions of others who have come down with Covid is that I'm 11 weeks out since my Pfizer vaccine". The patient stated "please do not let your guard down even after the vaccine". My symptoms was or now are pretty mild. I will quarantine in my home until next Wednesday and I encourage you all to take this seriously and continue practicing Covid protocols. Be courteous to your colleagues and loved ones who are more susceptible. The pandemic has not come to an end. Be safe, take care do not let your guard down even after you have been vaccinated." The patient had tests which included sars-cov-2 test: positive on 28Apr2021. The clinical outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1316194
Sex: F
Age:
State: PA

Vax Date: 04/08/2021
Onset Date: 04/26/2021
Rec V Date: 05/14/2021
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: herpes zoster/Shingles; This is a spontaneous report from a contactable consumer (parent). A 29-year-old female patient received BNT162B2, via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) at the age of 28 years old as 2nd dose, single for COVID-19 immunization. Medical history included anxiety; psychogenic non-epileptic seizures (PNES); polycystic ovary syndrome (PCOS); was previously diagnosed as being bipolar, but that diagnosis was changed; had chicken pox at age 2 and did not get the varicella vaccine. Concomitant medications included clonazepam (KLONOPIN) taken for anxiety, and on birth control for PCOS. The patient previously took BNT162B2 1st dose on an unspecified date for COVID-19 immunization. The patient received her second dose of the Pfizer COVID vaccine on 08Apr2021 (Thursday). On 26Apr2021 (Monday, 18 days later), she reported hives and blisters on her leg. At time of report, her primary care physician diagnosed her as having herpes zoster. Parent has no idea if patient's shingles is related to the vaccine but reported it as a possible adverse event. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: KLONOPIN

Current Illness:

ID: 1316195
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
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: Shingles; Severe headaches; Vomiting; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's sister) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, as first dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine and then got shingles and experienced severe headaches and vomiting on an unspecified date. The second dose is scheduled for tomorrow (29Apr2021) and they are wondering if she should take it. The outcome of the events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Other Meds:

Current Illness:

ID: 1316196
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
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: Pneumonia; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 1st dose of vaccine and now she has pneumonia. She was told by her doctor to wait to receive her 2nd dose she was calling to cancel 2nd appointment in till she finishes her antibiotic. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1316197
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: His girlfriend developed a high temperature after first shot of vaccine; This is a spontaneous report from a Pfizer sponsored program . A non-contactable consumer (patient's boyfriend) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a high temperature after first shot of vaccine. The outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1316198
Sex: F
Age:
State:

Vax Date: 04/28/2021
Onset Date: 04/29/2021
Rec V Date: 05/14/2021
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: experiencing a "red, itchy" rash around her neck, face, and chest; experiencing a "red, itchy" rash around her neck, face; Some of them started having sticky water coming out of them. She confirmed like a drainage from the rashes; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 28Apr2021 (Lot Number: EW0173) at left arm as 0.3ml single dose for covid-19 immunisation. The patient medical history included allergic to shrimp and she had no allergies to medications. There were no relevant concomitant medications. The patient reported on 29Apr2021 14:00 she started experiencing a "red, itchy" rashes around her neck, face, and chest. Some of them started having sticky water coming out of them. She confirmed like a drainage from the rashes. She didn't know what it was but it was so itchy last night she took Benadryl (expiration Mar2022 and lot number SJF001, strength 25 mg) and it was helping for an hour or 2 and it helped her to sleep but when she up woke up this morning on 30Apr2021 all the itchiness came back and was the same as yesterday. She did not know if she can continue taking Benadryl or if it will affect the vaccine or what effect will happen. Due to these side effects, she would like to know if she can receive the second dose of the vaccine. She was concerned about what the signs of a severe allergic reaction could be. The outcome of the events was not resolved and reported as "on going and persisting about the same".

Other Meds:

Current Illness:

ID: 1316199
Sex: F
Age:
State:

Vax Date: 03/31/2021
Onset Date: 04/08/2021
Rec V Date: 05/14/2021
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: tested positive for COVID-19/got COVID; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: EW0150) as 1st dose, single (at the age of 39-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received Pfizer-BioNTech COVID-19 Vaccine first dose on 31Mar2021, she was scheduled for second dose on 30Apr2021, however she wanted to know if she is okay to receive her second dose on 30Apr2021because on 08Apr2021 she tested positive for COVID-19, she got COVID and then tested negative for COVID-19 on 18Apr2021. The patient underwent lab tests and procedures which included Covid-19 Test: positive on 08Apr2021, Covid-19 Test: negative on 18Apr2021. The outcome of event was recovered on 18Apr2021.

Other Meds:

Current Illness:

ID: 1316200
Sex: F
Age:
State: SC

Vax Date:
Onset Date:
Rec V Date: 05/14/2021
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: compression fracture; she had back injury; This is a spontaneous report from a Pfizer sponsored program support from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications were not reported. On an unknown date, after taking the first dose, the patient experienced back injury and compression fracture. Therapeutic measures were taken as a result of the events and included cyclobenzaprine hydrochloride (FLEXERIL), a muscle relaxer. The patient was originally scheduled for the 2nd dose on 15Apr2021 but was rescheduled on 29Apr2021 because of the injury, and the patient asked if it is okay to take the vaccine when taking Flexeril. The clinical outcome of the events back injury and compression fracture was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1316201
Sex: F
Age:
State: KS

Vax Date: 01/01/2019
Onset Date:
Rec V Date: 05/14/2021
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: I had covid and got the vaccine; I had covid and got the vaccine; This is a spontaneous report from a contactable other hcp. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as unknown, dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), oral from Jan2019 (expiration date: 30Jan2021) at 11 mg, daily for rheumatoid arthritis. Medical history included ongoing rheumatoid arthritis. Concomitant medications included denosumab (PROLIA); methotrexate sodium; estradiol (VIVELLE-DOT); pilocarpine hydrochloride; paracetamol, tramadol hydrochloride (ULTRAM); hydroxychloroquine phosphate (PLAQUENIL); ciclosporin (RESTASIS); pantoprazole; alendronate sodium (FOSAMAX); calcium carbonate, colecalciferol (CALTRATE 600 + D); chondroitin sulfate; meloxicam (MOBIC); glucosamine sulfate; acyclovir [aciclovir]; tizanidine hcl. The patient previously took Betadine swabstick, codeine phosphate 30 mg tab, sulfa drugs CEP ID 54550 and acetaminophen, experienced allergies. The patient stated she had covid and got the vaccine. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The events are unlikely related to the suspected drug of Xeljanz XR. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021487323

Other Meds: PROLIA; METHOTREXATE SODIUM; VIVELLE-DOT; PILOCARPINE HYDROCHLORIDE; ULTRAM [PARACETAMOL;TRAMADOL HYDROCHLORIDE]; PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]; RESTASIS; PANTOPRAZOLE; FOSAMAX; CALTRATE 600 + D; CHONDROITIN SULFATE; MOBIC; GLUCO

Current Illness: Rheumatoid arthritis

ID: 1316202
Sex: M
Age:
State: KY

Vax Date: 04/26/2021
Onset Date: 04/28/2021
Rec V Date: 05/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: received the first dose of the Covid vaccine on Monday 26Apr2021. On Wednesday 28Apr2021 he was tested positive for Covid-19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for her husband and herself. This is the second of two reports for her husband. A 65-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Apr2021 (Lot Number: ER8737; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. The patient medical history included ongoing exposed prior to getting the vaccine. Concomitant medications were not reported. The patient received the first dose of the Covid vaccine on Monday 26Apr2021. On Wednesday 28Apr2021 he was tested positive for Covid-19. He didn't know he had been exposed prior to getting the vaccine. He was exposed and didn't know it and then he got the symptoms. Patient's second shot was due 18 MAY 2021 and he will be cleared by the 08May2021.the outcome of the event was unknown.

Other Meds:

Current Illness: Exposure to SARS-CoV-2

ID: 1316203
Sex: M
Age:
State: FL

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 05/14/2021
Hospital: Y

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: Pericarditis; cardiac enzymes have continued to go up, not down; myocarditis; ST evaluation on the EKG; Increased troponins and enzymes, troponin levels were elevated; Severe Chest Pain; Chest tightness; Lightheadedness; didn't sleep at all and were uncomfortable all night and had pain; didn't sleep at all and were uncomfortable all night and had pain; feeling really crappy and they thought it was like the flu; feeling really crappy and they thought it was like the flu; Tiredness and Fatigue; Headache; This is a spontaneous report from a contactable consumer (patient's mother). A 22-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation Solution for injection, Lot number EW0170 and expiration date not reported) via an unspecified route of administration, administered in Arm Left on 26Apr2021 10:00 as single dose for covid-19 immunization. Medical history included ongoing incredibly rare metabolic disorder. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 on 05Apr2021, lot number: ER8735, administered in left shoulder for covid-19 immunization. The patient experienced tiredness and fatigue and headache on 26Apr2021,severe chest pain, chest tightness, lightheadedness, didn't sleep at all and were uncomfortable all night and had pain, feeling really crappy and they thought it was like the flu on 27Apr2021, pericarditis and Increased troponins and enzymes, troponin levels were elevated on 28Apr2021, cardiac enzymes have continued to go up, not down, ST evaluation on the EKG and myocarditis on an unspecified date. The reporter stated that she has identical twin sons that are 22 years old and they received their second dose on Monday morning, 26APR2021. Reporter states all 5 member of the family have gotten the Pfizer vaccine. Reporter states the twins were hospitalized on Wednesday with myocarditis/pericarditis, inflammation around the heart. Reporter states she knows there have been incidents reported. Reporter states she saw in Israel there were 62 out of unknown amount of people and some members of the military. Reporter states that two identical males with the DNA same, that had the vaccine at the same time, had the reaction at the same length of time, and it would go a long way to help understand the complication. Reporter added, they have the same lifestyle and live at the same house. The reporter stated that they received the vaccine at 10:00a.m. on 26APR2021 and then that evening they were felling pretty tired and fatigued and a little headachy, but nothing anyone worried about because they all had that same reaction. Call states Tuesday morning they were feeling really crappy and they thought it was like the flu and it would pass. Tuesday evening they said they didn't sleep at all and were uncomfortable all night and had pain. Wednesday the pain didn't go away., and the twins had ST evaluation on the EKG that they have. Reporter sated they decided to take one in and said the other twin had the same symptoms but he kept saying his wasn't as bad as his brothers because he didn't want to go to the hospital. Reporter states the doctor advised her to come back home and bring the other one in. Reporter states they had the same echo cardiogram, and their troponin levels were elevated. Caller states their cardiac enzymes have continued to go up, not down. Treatment: States they have them on Ibuprofen and Colchicine, which is the therapy for Pericarditis and they are using Toradol for breakthrough pain and severe chest pain. The seriousness of the event pericarditis was reported as (hospitalization, medically significant), cardiac enzymes have continued to go up, not down, myocarditis and ST evaluation on the EKG reported as medically significant and other events was reported as non-serious. The event pericarditis was resulted in emergency room visit. The outcome of the events pericarditis, cardiac enzymes have continued to go up, not down, severe chest pain, chest tightness, increased troponins and enzymes, troponin levels were elevated, tiredness and fatigue, was reported as not recovered feeling really crappy and they thought it was like the flu was reported as recovered on 27Apr2021, headache and lightheadedness recovered on 28Apr2021 myocarditis, ST evaluation on the EKG, didn't sleep at all and were uncomfortable all night and had pain was reported as unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Metabolic disorder

ID: 1316204
Sex: F
Age:
State: MD

Vax Date: 04/27/2021
Onset Date: 04/28/2021
Rec V Date: 05/14/2021
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: (thinking it's swollen neck lymph nodes); sore neck; Shingles; upper torso skin HURTS; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 27Apr2021 at 09:15 (at the age of 57-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included psoriasis, migraine and known allergies to some medications from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EW0150), on 06Apr2021 at 14:00 for COVID-19 immunisation and experienced sore arm. The day the patient received the second dose, she felt fine. Woke up on the 2nd day (28Apr2021 04:30) to sore neck (thinking it was swollen neck lymph nodes) and upper torso skin hurts (she feels like it's the shingles again). Two (2) ibuprofen (MOTRIN) has helped, but the MOTRIN is wearing off. Therapeutic measures were taken as a result of neck pain and skin pain; no treatment received for other events. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1316205
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 03/11/2021
Rec V Date: 05/14/2021
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: Shingles/ it came on pretty severe all around her back, fore and front of the upper chest; Shingles/ it came on pretty severe all around her back, fore and front of the upper chest; This is a spontaneous report received from a contactable consumer (patient's child). An 87-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on an unspecified date (Lot: EN5318) as 1 st dose, single then on 27Feb2021 (Lot: EL9260) as 2 nd dose, single; both via an unspecified route of administration in left arm (at the age of 87-years-old) for covid-19 immunisation. Medical history included blood cholesterol, hypertension, heartburn and very small outbreak of shingles (35-40 years ago). Concomitant medications included amlodipine for hypertension; losartan for hypertension; omeprazole for heartburn and simvastatin for cholesterol. The patient had no investigation assessment. The patient had reaction after the second shot was shingles on 11Mar2021. The patient had shingles virus obviously in her system, viruses remain dormant, like that in the system. So her virus shingles was in her system. The patient's child guessed 35-40 years ago when she had a very small outbreak of shingles and then this time after the second shot it came on pretty severe all around her back, fore and front of the upper chest. The patient's child wanted to make sure that this was reported because he/she did think there was relation to it and think that people have them reporting the same thing. The patient's child stated, "She still has some facing from it I mean the shingles, I have not asked it anymore but she still has the after nerve sensation, you know that you get after shingles, yes; she still has some of the nerve sensation. That's common after shingles." On treatment for event, the patient's doctor called in a liquid medication that she took for a week for shingles, didn't have that name and bottle, also prescribed the pill that she could take in the evening if she need before bed called gabapentin was for when she had the nerve pain obviously standing on virus after shingle taken as needed prior to bed. Well the liquid was for to address the shingle that they were after shingle and the gabapentin was for her to take when she had that nerve pain obviously standing from the shingles virus, taken as needed prior to that. The outcome of the events was recovering.

Other Meds: AMLODIPINE; LOSARTAN; OMEPRAZOLE; SIMVASTATIN

Current Illness:

ID: 1316206
Sex: M
Age:
State: IL

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 05/14/2021
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: light dizziness; cognitive reduction ("covid brain fog"); general confusion; sore arm; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left arm on 26Apr2021 at 14:15 (Lot Number: ER8735) as SINGLE DOSE for COVID-19 immunization in pharmacy or drug store. The patient's medical history was not reported. The patient previously took Cefzil and experienced allergies. Concomitant medication included loratadine (LORATADINE 10 mg) at a dose of 10 mg daily from an unspecified date for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left arm on 05Apr2021 at 12:00 (Lot Number: EW0150) as SINGLE DOSE for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021 at 20:15, the patient experienced sore arm. On 27Apr2021 at 09:00, the patient was having general confusion/cognitive reduction ("COVID brain fog"), and on the same day at 11:00, the patient felt light dizziness. No corrective measure was received by the patient for the reported events. The outcome was reported as recovered in morning of 28Apr2021 for the reported events. No follow-up attempts are needed. No further information is expected.

Other Meds: LORATADINE

Current Illness:

ID: 1316207
Sex: F
Age:
State: IN

Vax Date: 04/12/2021
Onset Date: 04/01/2021
Rec V Date: 05/14/2021
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: tested positive on 22Apr2021; a mild case with a stuffy nose; This is a spontaneous report from a contactable consumer (Patient) and received from a Pfizer sponsored program. A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported tested positive on 22apr2021 and a mild case with a stuffy nose on Apr2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event tested positive on 22apr2021 was not recovered while for another event it was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm